Atopic Dermatitis, Eczema
Conditions
Keywords
KY1005, Monoclonal Antibody, Atopic Dermatitis, Atopic Eczema, OX40L
Brief summary
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis. The estimated duration is 28 days for screening and then up to approximately day 477 (last dose no later than day 337+140 days safety follow-up) for all patients unless enrolled into the Long-Term Extension (LTE) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.
Interventions
DRUGAmlitelimab
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
DRUGPlacebo
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Sponsors
Sanofi
Kymab Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults (18 to \< 75 years of age) with AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at Baseline. * Eczema Area and Severity Index (EASI) of 12 or higher at the Screening Visit and 16 or higher at Baseline. * Investigator's Global Assessment (IGA) Scale of 3 or 4 at Baseline. * AD involvement of 10% or more of body surface area (BSA) at Baseline. * Baseline worst/maximum pruritus Numeric Rating Scale (NRS) of ≥4. * Documented history, within 6 months prior to Baseline, of either inadequate response or inadvisability of topical treatments. * Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives \[e.g., urea\]) at least twice daily for a minimum of 7 consecutive days before Baseline. * Able to complete patient questionnaires. * Able and willing to comply with requested study visits/telephone visits and procedures. * Able and willing to provide written informed consent. * For patients who decide to join the biopsy sub-study be able and willing to provide skin biopsies.
Exclusion criteria
* Treatment within specific time windows before the baseline visit for the management of atopic dermatitis such as topical or systemic corticosteroids, biologic or investigational therapies and/or phototherapy. * Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration. * Weight \<40 kg or \>150 kg at Baseline. * Treatment with a live (attenuated) immunization within 12 weeks prior to Baseline. * Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding. * Any malignancies or history of malignancies prior to Baseline (except for non-melanoma skin cancer that has been excised and cured for more than 3 years prior to Baseline; in situ cervical carcinoma that has been excised and cured). * Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit. * Severe concomitant illness that would in the Investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease. * In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, hematology or urinalysis tests at the Screening Visit. * Concurrent participation in any other clinical study, including non-interventional studies. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) | Baseline to week 16 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) | Baseline to week 16 and week 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) | Baseline to week 16 and week 24 | The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear,1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD. |
| Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) | Baseline to week 16 and week 24 | The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'. |
| Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Baseline to weeks week 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52 | The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'. |
| Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20 and 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Baseline to weeks 2,4, 8,12,16, 20 and 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20 and 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Baseline at weeks 2, 4, 8, 12, 16, 20 and 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20 and 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20 and 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20, & 24 | The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD |
| Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Baseline to weeks 24, 28, 31, 36, 40, 44, 48 & 52 | The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD |
| Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Baseline to weeks 2, 4, 8,12,16,20 & 24 | The IGA is a five-point scale that provides a global clinical assessment of AD (Atopic Dermatitis) severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD |
| Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Baseline to weeks 4, 8, 12, 16, 20 & 24 | SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease) |
| Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Baseline to week 24, 28, 32, 36, 40, 44, 48 & 52 | SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease) |
| Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Baseline to weeks 4, 8, 12, 16, 20, & 24 | SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease) |
| Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52 | SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease) |
| Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20, & 24 | — |
| Absolute Change in Affected BSA From Baseline (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52 | — |
| Percentage Change in Affected BSA From Baseline (Part 1) | Baseline to weeks 2, 4, 8, 12, 16, 20, & 24 | — |
| Percentage Change in Affected BSA From Baseline (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52 | — |
| Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Baseline to weeks 4, 8, 12, 16, 20, & 24 | POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity |
| Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Baseline to weeks 24, 32, 36, 40, 44, 48 & 52 | POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity |
| Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Baseline to weeks 4, 8, 12, 16, 20, & 24 | POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity |
| Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Baseline to weeks 24, 32, 36, 40. 44, 48, & 52 | POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity |
| Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Baseline to weeks 2, 8, 16, 20, & 24 | DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL. |
| Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52 | DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL. |
| Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Baseline to weeks 2, 8, 16, 20, & 24 | DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL. |
| Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52 | DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL. |
| Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Baseline to weeks 16, & 24 | ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control |
| Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Baseline to weeks 24, 36 & 52 | ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control |
| Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Baseline to weeks 16, & 24 | ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control |
| Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Baseline to weeks 24, 36 & 52 | ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control |
| Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Baseline to weeks 8 16, 20, & 24 | The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state. |
| Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52 | The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state. |
| Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Baseline to weeks 8, 16, 20, & 24 | The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state. |
| Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52 | The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state. |
| Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24 | The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'. |
| Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52 | The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'. |
| Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 & 24 | The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'. |
| Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52 | The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'. |
| Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24 | The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'. |
| Incidence Rate of Loss of EASI 50 (Part 2) | Week 24 to week 52 | The incidence rate of loss of EASI 50 is calculated for participants who achieved EASI 50 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 50 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 50) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion. |
| Incidence Rate of Loss of EASI 75 (Part 2) | Week 24 to week 52 | The incidence rate of loss of EASI 75 is calculated for participants who achieved EASI 75 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 75 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 75) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion. |
| Incidence Rate of Loss of IGA 0/1 (Part 2) | Week 24 to week 68 | The incidence rate of loss of IGA 0/1 is calculated for participants who achieved IGA 0/1 at re-randomization (week 24). The incidence rate is computed as the number of participants losing IGA 0/1 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of IGA 0/1) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion. |
| Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) | Baseline to week 24 | Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. |
| Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Baseline and at weeks 24, 25, 28, 32, 36, 40, 44, 48, & 52 | — |
| Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1) | Baseline through week 24 | — |
| Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Week 24 through week 68 | — |
| Percentage of Participants With Treatment-emergent ADA (Part 1) | Baseline through week 24 | — |
| Percentage of Participants With Treatment-emergent ADA (Part 2) | Baseline through week 68 | — |
| Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Baseline and at weeks 1, 2, 4, 8, 12, 16, 17, 20, & 24 | — |
Countries
Australia, Bulgaria, Canada, Czechia, Germany, Hungary, Japan, Poland, Spain, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
This study started in December 2021 and ended in February 2024. An individual participant was part of this study for about 1 year and 5 months. The study took place at 100 sites in 12 countries. Up to 350 participants (approximately 70 participants per treatment group) were planned to be enrolled.
Pre-assignment details
The study was performed in 2 parts: Part 1 for all population (baseline to Week 24) for efficacy and safety and Part 2 for Part 1 Responders (Week 24 to Week 52 for efficacy and Week 24 to Week 68 for safety). Responders are defined as participants who achieved ≥EASI 75 and/or IGA 0/1 at Week 24.
Participants by arm
| Arm | Count |
|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks. | 77 |
| 250 mg (No LD) KY1005 (Part 1) Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks. | 78 |
| 125 mg KY1005 (Part 1) Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks. | 77 |
| 62.5 mg KY1005 (Part 1) Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks. | 79 |
| Placebo (Part 1) Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks. | 79 |
| Total | 390 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PART 1 | Adverse Event | 3 | 5 | 1 | 6 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PART 1 | Lack of Efficacy | 0 | 1 | 1 | 2 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PART 1 | Physician Decision | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PART 1 | Protocol Violation | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PART 1 | Randomized and not treated | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PART 1 | unclassified | 1 | 1 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PART 1 | Withdrawal by Subject | 2 | 9 | 6 | 2 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PART 2 | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 3 | 0 | 1 | 0 | 2 | 0 |
| PART 2 | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 |
| PART 2 | Re-randomized and not treated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 |
| PART 2 | Unclassified | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| PART 2 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | 250 mg (500 mg LD) KY1005 (Part 1) | Total | Placebo (Part 1) | 62.5 mg KY1005 (Part 1) | 125 mg KY1005 (Part 1) | 250 mg (No LD) KY1005 (Part 1) |
|---|---|---|---|---|---|---|
| Age, Continuous | 36.3 years STANDARD_DEVIATION 13.32 | 37.8 years STANDARD_DEVIATION 14.36 | 36.4 years STANDARD_DEVIATION 13.07 | 37.6 years STANDARD_DEVIATION 14.78 | 37.9 years STANDARD_DEVIATION 15.17 | 40.8 years STANDARD_DEVIATION 15.24 |
| EASI Score at Baseline | 30.3 units on a scale STANDARD_DEVIATION 11.66 | 28.9 units on a scale STANDARD_DEVIATION 10.65 | 26.4 units on a scale STANDARD_DEVIATION 7.85 | 28.7 units on a scale STANDARD_DEVIATION 10.09 | 30.3 units on a scale STANDARD_DEVIATION 12.43 | 28.7 units on a scale STANDARD_DEVIATION 10.53 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 60 Participants | 12 Participants | 14 Participants | 10 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 20 Participants | 6 Participants | 4 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 61 Participants | 307 Participants | 60 Participants | 60 Participants | 63 Participants | 63 Participants |
| Sex: Female, Male Female | 30 Participants | 171 Participants | 30 Participants | 37 Participants | 39 Participants | 35 Participants |
| Sex: Female, Male Male | 47 Participants | 219 Participants | 49 Participants | 42 Participants | 38 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 78 | 0 / 77 | 0 / 78 | 0 / 78 | 0 / 13 | 0 / 34 | 0 / 11 | 0 / 28 | 0 / 12 | 0 / 32 | 0 / 7 | 0 / 34 | 0 / 15 |
| other Total, other adverse events | 42 / 77 | 39 / 78 | 39 / 77 | 41 / 78 | 41 / 78 | 11 / 13 | 21 / 34 | 7 / 11 | 19 / 28 | 8 / 12 | 27 / 32 | 4 / 7 | 21 / 34 | 10 / 15 |
| serious Total, serious adverse events | 2 / 77 | 0 / 78 | 1 / 77 | 5 / 78 | 1 / 78 | 1 / 13 | 1 / 34 | 0 / 11 | 2 / 28 | 1 / 12 | 0 / 32 | 0 / 7 | 0 / 34 | 0 / 15 |
Outcome results
Primary
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Time frame: Baseline to week 16
Population: Full Analysis Set for Part 1. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Efficacy analyses were based on treatment allocated at randomization. The Primary efficacy endpoint is the percentage of change in EASI from Baseline to Day 113 (Week 16). The primary analysis was conducted on FAS1 after all the randomized patients had reached the Day 169 (Week 24) visit/ early termination. Missing data were imputed by multiple imputation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) | -61.5 percentage of change | Standard Error 4.68 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) | -56.8 percentage of change | Standard Error 4.59 |
| 125 mg KY1005 (Part 1) | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) | -51.6 percentage of change | Standard Error 4.59 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) | -59.6 percentage of change | Standard Error 4.53 |
| Placebo (Part 1) | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) | -29.4 percentage of change | Standard Error 4.76 |
p-value: <0.000195% CI: [-43.9, -20.3]ANCOVA
p-value: <0.000195% CI: [-39.1, -15.6]ANCOVA
p-value: 0.000295% CI: [-34, -10.4]ANCOVA
p-value: <0.000195% CI: [-41.9, -18.5]ANCOVA
Secondary
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 2 | -8.49 score on a scale | Standard Deviation 10.777 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 24 | -21.92 score on a scale | Standard Deviation 14.475 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 20 | -21.93 score on a scale | Standard Deviation 14.283 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 8 | -15.67 score on a scale | Standard Deviation 11.872 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 4 | -11.21 score on a scale | Standard Deviation 10.612 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 12 | -18.49 score on a scale | Standard Deviation 12.411 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 16 | -19.71 score on a scale | Standard Deviation 12.731 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 16 | -16.31 score on a scale | Standard Deviation 12.329 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 12 | -13.84 score on a scale | Standard Deviation 11.121 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 4 | -8.38 score on a scale | Standard Deviation 9.944 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 2 | -5.27 score on a scale | Standard Deviation 8.485 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 20 | -16.46 score on a scale | Standard Deviation 12.834 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 8 | -11.93 score on a scale | Standard Deviation 11.018 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 24 | -15.72 score on a scale | Standard Deviation 12.977 |
| 125 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 12 | -16.56 score on a scale | Standard Deviation 14.062 |
| 125 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 2 | -6.17 score on a scale | Standard Deviation 10.071 |
| 125 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 4 | -10.33 score on a scale | Standard Deviation 10.861 |
| 125 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 8 | -13.77 score on a scale | Standard Deviation 12.964 |
| 125 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 16 | -15.70 score on a scale | Standard Deviation 14.226 |
| 125 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 20 | -16.98 score on a scale | Standard Deviation 15.321 |
| 125 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 24 | -16.91 score on a scale | Standard Deviation 15.085 |
| 62.5 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 8 | -14.37 score on a scale | Standard Deviation 10.054 |
| 62.5 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 16 | -17.82 score on a scale | Standard Deviation 11.73 |
| 62.5 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 4 | -10.27 score on a scale | Standard Deviation 10.55 |
| 62.5 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 24 | -17.09 score on a scale | Standard Deviation 13.088 |
| 62.5 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 20 | -16.76 score on a scale | Standard Deviation 12.59 |
| 62.5 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 2 | -7.51 score on a scale | Standard Deviation 8.836 |
| 62.5 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 12 | -16.46 score on a scale | Standard Deviation 11.699 |
| Placebo (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 8 | -7.64 score on a scale | Standard Deviation 10.45 |
| Placebo (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 24 | -7.52 score on a scale | Standard Deviation 12.537 |
| Placebo (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 20 | -7.91 score on a scale | Standard Deviation 11.163 |
| Placebo (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 16 | -7.47 score on a scale | Standard Deviation 11.338 |
| Placebo (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 4 | -7.20 score on a scale | Standard Deviation 8.51 |
| Placebo (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 2 | -3.98 score on a scale | Standard Deviation 7.855 |
| Placebo (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 12 | -8.76 score on a scale | Standard Deviation 9.608 |
Secondary
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -22.03 Score on a scale | Standard Deviation 14.889 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -29.65 Score on a scale | Standard Deviation 11.278 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -28.54 Score on a scale | Standard Deviation 15.203 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -28.15 Score on a scale | Standard Deviation 15.138 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -29.08 Score on a scale | Standard Deviation 14.544 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -22.15 Score on a scale | Standard Deviation 14.876 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -28.43 Score on a scale | Standard Deviation 15.061 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -30.51 Score on a scale | Standard Deviation 12.422 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -26.28 Score on a scale | Standard Deviation 13.353 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -21.82 Score on a scale | Standard Deviation 17.764 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -19.59 Score on a scale | Standard Deviation 15.321 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -26.34 Score on a scale | Standard Deviation 14.353 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -24.79 Score on a scale | Standard Deviation 15.775 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -22.78 Score on a scale | Standard Deviation 17.505 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -22.30 Score on a scale | Standard Deviation 17.908 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -22.23 Score on a scale | Standard Deviation 17.487 |
| 125 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -27.60 Score on a scale | Standard Deviation 11.17 |
| 125 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -22.27 Score on a scale | Standard Deviation 16.368 |
| 125 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -22.99 Score on a scale | Standard Deviation 15.741 |
| 125 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -22.68 Score on a scale | Standard Deviation 15.418 |
| 125 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -23.07 Score on a scale | Standard Deviation 15.679 |
| 125 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -22.24 Score on a scale | Standard Deviation 16.312 |
| 125 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -22.56 Score on a scale | Standard Deviation 14.949 |
| 125 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -25.86 Score on a scale | Standard Deviation 13.128 |
| 62.5 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -17.29 Score on a scale | Standard Deviation 12.458 |
| 62.5 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -14.81 Score on a scale | Standard Deviation 13.178 |
| 62.5 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -15.38 Score on a scale | Standard Deviation 12.62 |
| 62.5 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -14.57 Score on a scale | Standard Deviation 13.55 |
| 62.5 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -18.90 Score on a scale | Standard Deviation 11.932 |
| 62.5 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -13.95 Score on a scale | Standard Deviation 13.596 |
| 62.5 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -13.89 Score on a scale | Standard Deviation 13.427 |
| 62.5 mg KY1005 (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -14.49 Score on a scale | Standard Deviation 12.877 |
| Placebo (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -28.08 Score on a scale | Standard Deviation 16.097 |
| Placebo (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -27.10 Score on a scale | Standard Deviation 12.67 |
| Placebo (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -27.49 Score on a scale | Standard Deviation 14.324 |
| Placebo (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -26.37 Score on a scale | Standard Deviation 13.067 |
| Placebo (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -27.36 Score on a scale | Standard Deviation 13.383 |
| Placebo (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -27.51 Score on a scale | Standard Deviation 13.55 |
| Placebo (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -27.96 Score on a scale | Standard Deviation 14.444 |
| Placebo (Part 1) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -27.72 Score on a scale | Standard Deviation 14.882 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -19.76 Score on a scale | Standard Deviation 16.561 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -22.45 Score on a scale | Standard Deviation 14.998 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -20.45 Score on a scale | Standard Deviation 16.659 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -22.87 Score on a scale | Standard Deviation 15.667 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -22.99 Score on a scale | Standard Deviation 14.978 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -22.94 Score on a scale | Standard Deviation 14.915 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -18.34 Score on a scale | Standard Deviation 16.959 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -17.30 Score on a scale | Standard Deviation 16.752 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -24.65 Score on a scale | Standard Deviation 10.801 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -23.88 Score on a scale | Standard Deviation 12.517 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -25.47 Score on a scale | Standard Deviation 12.209 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -22.34 Score on a scale | Standard Deviation 11.07 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -25.51 Score on a scale | Standard Deviation 11.796 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -24.94 Score on a scale | Standard Deviation 11.245 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -23.26 Score on a scale | Standard Deviation 11.789 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -23.79 Score on a scale | Standard Deviation 10.424 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -21.75 Score on a scale | Standard Deviation 13.106 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -20.32 Score on a scale | Standard Deviation 14.189 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -20.70 Score on a scale | Standard Deviation 14.343 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -20.09 Score on a scale | Standard Deviation 15.098 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -20.81 Score on a scale | Standard Deviation 14.813 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -20.80 Score on a scale | Standard Deviation 14.601 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -22.41 Score on a scale | Standard Deviation 12.841 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -19.74 Score on a scale | Standard Deviation 15.277 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -20.30 Score on a scale | Standard Deviation 11.526 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -21.69 Score on a scale | Standard Deviation 11.918 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -19.99 Score on a scale | Standard Deviation 11.292 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -20.20 Score on a scale | Standard Deviation 10.436 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -20.43 Score on a scale | Standard Deviation 11.007 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -19.60 Score on a scale | Standard Deviation 10.632 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -20.05 Score on a scale | Standard Deviation 10.596 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -21.47 Score on a scale | Standard Deviation 10.42 |
Secondary
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 2 | -4.50 Percentage of body surface area | Standard Deviation 10.61 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 24 | -31.35 Percentage of body surface area | Standard Deviation 22.434 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 20 | -30.25 Percentage of body surface area | Standard Deviation 21.85 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 8 | -19.37 Percentage of body surface area | Standard Deviation 18.857 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 4 | -12.83 Percentage of body surface area | Standard Deviation 15.922 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 12 | -24.13 Percentage of body surface area | Standard Deviation 18.097 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 16 | -26.91 Percentage of body surface area | Standard Deviation 20.286 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 16 | -22.71 Percentage of body surface area | Standard Deviation 21.966 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 12 | -19.54 Percentage of body surface area | Standard Deviation 19.578 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 4 | -10.16 Percentage of body surface area | Standard Deviation 12.917 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 2 | -5.61 Percentage of body surface area | Standard Deviation 10.165 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 20 | -23.33 Percentage of body surface area | Standard Deviation 22.6 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 8 | -15.77 Percentage of body surface area | Standard Deviation 17.004 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 24 | -21.82 Percentage of body surface area | Standard Deviation 21.882 |
| 125 mg KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 12 | -21.94 Percentage of body surface area | Standard Deviation 22.715 |
| 125 mg KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 2 | -9.08 Percentage of body surface area | Standard Deviation 15.999 |
| 125 mg KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 4 | -13.34 Percentage of body surface area | Standard Deviation 17.347 |
| 125 mg KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 8 | -17.55 Percentage of body surface area | Standard Deviation 21.064 |
| 125 mg KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 16 | -21.74 Percentage of body surface area | Standard Deviation 24.799 |
| 125 mg KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 20 | -24.35 Percentage of body surface area | Standard Deviation 26.238 |
| 125 mg KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 24 | -22.66 Percentage of body surface area | Standard Deviation 27.317 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 8 | -19.11 Percentage of body surface area | Standard Deviation 18.253 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 16 | -26.04 Percentage of body surface area | Standard Deviation 20.403 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 4 | -12.51 Percentage of body surface area | Standard Deviation 16.318 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 24 | -25.77 Percentage of body surface area | Standard Deviation 22.085 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 20 | -24.63 Percentage of body surface area | Standard Deviation 21.263 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 2 | -7.41 Percentage of body surface area | Standard Deviation 12.588 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 12 | -24.14 Percentage of body surface area | Standard Deviation 19.903 |
| Placebo (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 8 | -10.00 Percentage of body surface area | Standard Deviation 17.375 |
| Placebo (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 24 | -10.45 Percentage of body surface area | Standard Deviation 20.837 |
| Placebo (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 20 | -11.04 Percentage of body surface area | Standard Deviation 19.653 |
| Placebo (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 16 | -8.87 Percentage of body surface area | Standard Deviation 16.956 |
| Placebo (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 4 | -9.67 Percentage of body surface area | Standard Deviation 16.941 |
| Placebo (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 2 | -4.84 Percentage of body surface area | Standard Deviation 9.113 |
| Placebo (Part 1) | Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1) | Week 12 | -11.46 Percentage of body surface area | Standard Deviation 17.035 |
Secondary
Absolute Change in Affected BSA From Baseline (Part 2)
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 24 | -46.92 Percentage of body surface area | Standard Deviation 22.009 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 44 | -47.23 Percentage of body surface area | Standard Deviation 26.54 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 40 | -46.62 Percentage of body surface area | Standard Deviation 26.314 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 48 | -35.69 Percentage of body surface area | Standard Deviation 26.183 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 52 | -35.54 Percentage of body surface area | Standard Deviation 26.384 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 28 | -48.69 Percentage of body surface area | Standard Deviation 23.329 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 36 | -46.00 Percentage of body surface area | Standard Deviation 26.242 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 32 | -47.15 Percentage of body surface area | Standard Deviation 25.271 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 36 | -33.61 Percentage of body surface area | Standard Deviation 24.187 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 44 | -33.22 Percentage of body surface area | Standard Deviation 24.143 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 32 | -36.62 Percentage of body surface area | Standard Deviation 23.049 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 40 | -32.94 Percentage of body surface area | Standard Deviation 24.589 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 28 | -38.68 Percentage of body surface area | Standard Deviation 20.582 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 48 | -32.72 Percentage of body surface area | Standard Deviation 25.358 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 52 | -29.48 Percentage of body surface area | Standard Deviation 22.232 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 24 | -37.94 Percentage of body surface area | Standard Deviation 18.723 |
| 125 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 40 | -29.18 Percentage of body surface area | Standard Deviation 24.774 |
| 125 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 44 | -29.73 Percentage of body surface area | Standard Deviation 25.503 |
| 125 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 28 | -35.92 Percentage of body surface area | Standard Deviation 20.804 |
| 125 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 24 | -37.17 Percentage of body surface area | Standard Deviation 17.994 |
| 125 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 32 | -29.64 Percentage of body surface area | Standard Deviation 25.59 |
| 125 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 52 | -29.55 Percentage of body surface area | Standard Deviation 25.359 |
| 125 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 36 | -28.30 Percentage of body surface area | Standard Deviation 26.437 |
| 125 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 48 | -28.30 Percentage of body surface area | Standard Deviation 26.378 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 40 | -22.57 Percentage of body surface area | Standard Deviation 23.841 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 36 | -22.21 Percentage of body surface area | Standard Deviation 23.857 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 48 | -21.50 Percentage of body surface area | Standard Deviation 24.053 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 52 | -21.46 Percentage of body surface area | Standard Deviation 23.562 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 24 | -28.14 Percentage of body surface area | Standard Deviation 21.79 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 28 | -25.54 Percentage of body surface area | Standard Deviation 22.718 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 44 | -22.21 Percentage of body surface area | Standard Deviation 23.706 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 32 | -23.21 Percentage of body surface area | Standard Deviation 23.71 |
| Placebo (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 32 | -42.08 Percentage of body surface area | Standard Deviation 22.685 |
| Placebo (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 36 | -41.67 Percentage of body surface area | Standard Deviation 23.051 |
| Placebo (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 28 | -40.00 Percentage of body surface area | Standard Deviation 23.394 |
| Placebo (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 52 | -45.09 Percentage of body surface area | Standard Deviation 25.77 |
| Placebo (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 44 | -42.17 Percentage of body surface area | Standard Deviation 25.283 |
| Placebo (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 24 | -41.17 Percentage of body surface area | Standard Deviation 22.982 |
| Placebo (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 48 | -42.92 Percentage of body surface area | Standard Deviation 25.336 |
| Placebo (Part 1) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 40 | -41.45 Percentage of body surface area | Standard Deviation 23.729 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 32 | -35.94 Percentage of body surface area | Standard Deviation 26.193 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 24 | -33.81 Percentage of body surface area | Standard Deviation 26.454 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 48 | -30.53 Percentage of body surface area | Standard Deviation 23.544 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 40 | -33.41 Percentage of body surface area | Standard Deviation 22.649 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 28 | -35.61 Percentage of body surface area | Standard Deviation 25.72 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 44 | -31.91 Percentage of body surface area | Standard Deviation 22.069 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 36 | -35.75 Percentage of body surface area | Standard Deviation 25.664 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 52 | -29.66 Percentage of body surface area | Standard Deviation 23.818 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 36 | -37.86 Percentage of body surface area | Standard Deviation 24.674 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 48 | -36.43 Percentage of body surface area | Standard Deviation 21.141 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 32 | -38.00 Percentage of body surface area | Standard Deviation 23.847 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 40 | -39.57 Percentage of body surface area | Standard Deviation 24.758 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 52 | -34.71 Percentage of body surface area | Standard Deviation 18.688 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 28 | -37.14 Percentage of body surface area | Standard Deviation 23.801 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 44 | -34.43 Percentage of body surface area | Standard Deviation 25.172 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 24 | -40.60 Percentage of body surface area | Standard Deviation 26.006 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 28 | -33.62 Percentage of body surface area | Standard Deviation 19.692 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 44 | -32.23 Percentage of body surface area | Standard Deviation 23.25 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 48 | -31.13 Percentage of body surface area | Standard Deviation 26.208 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 52 | -33.33 Percentage of body surface area | Standard Deviation 22.702 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 24 | -34.30 Percentage of body surface area | Standard Deviation 19.787 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 40 | -32.00 Percentage of body surface area | Standard Deviation 23.697 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 32 | -32.13 Percentage of body surface area | Standard Deviation 21.515 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Affected BSA From Baseline (Part 2) | Week 36 | -30.91 Percentage of body surface area | Standard Deviation 24.288 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Affected BSA From Baseline (Part 2) | Week 36 | -31.27 Percentage of body surface area | Standard Deviation 24.391 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Affected BSA From Baseline (Part 2) | Week 32 | -30.07 Percentage of body surface area | Standard Deviation 22.861 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Affected BSA From Baseline (Part 2) | Week 28 | -36.00 Percentage of body surface area | Standard Deviation 24.553 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Affected BSA From Baseline (Part 2) | Week 24 | -32.06 Percentage of body surface area | Standard Deviation 22.831 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Affected BSA From Baseline (Part 2) | Week 52 | -27.21 Percentage of body surface area | Standard Deviation 20.955 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Affected BSA From Baseline (Part 2) | Week 48 | -26.93 Percentage of body surface area | Standard Deviation 20.775 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Affected BSA From Baseline (Part 2) | Week 44 | -27.43 Percentage of body surface area | Standard Deviation 20.478 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Affected BSA From Baseline (Part 2) | Week 40 | -31.27 Percentage of body surface area | Standard Deviation 24.566 |
Secondary
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Time frame: Baseline to weeks 16, & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 16 | -6.70 Score on a scale | Standard Deviation 5.813 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 24 | -7.35 Score on a scale | Standard Deviation 6.695 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 16 | -5.41 Score on a scale | Standard Deviation 6.054 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 24 | -5.80 Score on a scale | Standard Deviation 6.187 |
| 125 mg KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 16 | -6.22 Score on a scale | Standard Deviation 6.272 |
| 125 mg KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 24 | -6.70 Score on a scale | Standard Deviation 6.566 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 24 | -6.66 Score on a scale | Standard Deviation 5.868 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 16 | -6.61 Score on a scale | Standard Deviation 5.804 |
| Placebo (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 16 | -2.50 Score on a scale | Standard Deviation 4.589 |
| Placebo (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 24 | -1.90 Score on a scale | Standard Deviation 5.046 |
Secondary
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Time frame: Baseline to weeks 24, 36 & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -11.23 Score on a scale | Standard Deviation 6.071 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -11.31 Score on a scale | Standard Deviation 4.768 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -11.46 Score on a scale | Standard Deviation 5.681 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -8.30 Score on a scale | Standard Deviation 5.706 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -8.13 Score on a scale | Standard Deviation 6.463 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -8.64 Score on a scale | Standard Deviation 5.927 |
| 125 mg KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -8.20 Score on a scale | Standard Deviation 6.143 |
| 125 mg KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -9.83 Score on a scale | Standard Deviation 6.506 |
| 125 mg KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -8.82 Score on a scale | Standard Deviation 6.809 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -7.44 Score on a scale | Standard Deviation 6.594 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -7.44 Score on a scale | Standard Deviation 5.673 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -7.78 Score on a scale | Standard Deviation 6.123 |
| Placebo (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -10.33 Score on a scale | Standard Deviation 5.483 |
| Placebo (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -9.83 Score on a scale | Standard Deviation 5.132 |
| Placebo (Part 1) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -10.45 Score on a scale | Standard Deviation 5.989 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -9.26 Score on a scale | Standard Deviation 6.875 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -8.42 Score on a scale | Standard Deviation 6.386 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -6.48 Score on a scale | Standard Deviation 6.539 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -9.71 Score on a scale | Standard Deviation 4.751 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -12.60 Score on a scale | Standard Deviation 6.986 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -10.71 Score on a scale | Standard Deviation 6.55 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -8.03 Score on a scale | Standard Deviation 6.385 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -8.34 Score on a scale | Standard Deviation 6.893 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -8.29 Score on a scale | Standard Deviation 5.996 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -6.38 Score on a scale | Standard Deviation 6.063 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -7.14 Score on a scale | Standard Deviation 6.125 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -6.25 Score on a scale | Standard Deviation 6.083 |
Secondary
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -12.38 Score on a scale | Standard Deviation 8.272 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -9.08 Score on a scale | Standard Deviation 6.652 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -12.62 Score on a scale | Standard Deviation 8.191 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -11.38 Score on a scale | Standard Deviation 8.109 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -9.92 Score on a scale | Standard Deviation 6.8 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -12.23 Score on a scale | Standard Deviation 7.715 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -12.54 Score on a scale | Standard Deviation 6.703 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -11.85 Score on a scale | Standard Deviation 8.122 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -6.83 Score on a scale | Standard Deviation 7.852 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -9.00 Score on a scale | Standard Deviation 6.29 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -7.29 Score on a scale | Standard Deviation 8.022 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -7.19 Score on a scale | Standard Deviation 7.943 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -8.00 Score on a scale | Standard Deviation 7.612 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -7.07 Score on a scale | Standard Deviation 8.073 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -9.52 Score on a scale | Standard Deviation 6.929 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -7.72 Score on a scale | Standard Deviation 7.985 |
| 125 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -8.18 Score on a scale | Standard Deviation 6.258 |
| 125 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -8.40 Score on a scale | Standard Deviation 7.516 |
| 125 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -9.83 Score on a scale | Standard Deviation 6.658 |
| 125 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -8.55 Score on a scale | Standard Deviation 8.238 |
| 125 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -9.08 Score on a scale | Standard Deviation 6.487 |
| 125 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -7.90 Score on a scale | Standard Deviation 6.903 |
| 125 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -8.09 Score on a scale | Standard Deviation 7.077 |
| 125 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -7.18 Score on a scale | Standard Deviation 5.456 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -5.68 Score on a scale | Standard Deviation 7.029 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -6.21 Score on a scale | Standard Deviation 7.218 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -7.21 Score on a scale | Standard Deviation 6.488 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -5.93 Score on a scale | Standard Deviation 7.383 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -6.21 Score on a scale | Standard Deviation 7.279 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -5.75 Score on a scale | Standard Deviation 7.183 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -7.57 Score on a scale | Standard Deviation 7.295 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -6.18 Score on a scale | Standard Deviation 7.222 |
| Placebo (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -12.25 Score on a scale | Standard Deviation 7.7 |
| Placebo (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -11.33 Score on a scale | Standard Deviation 7.832 |
| Placebo (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -12.58 Score on a scale | Standard Deviation 7.716 |
| Placebo (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -11.42 Score on a scale | Standard Deviation 7.115 |
| Placebo (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -11.92 Score on a scale | Standard Deviation 8.229 |
| Placebo (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -11.27 Score on a scale | Standard Deviation 7.976 |
| Placebo (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -12.08 Score on a scale | Standard Deviation 8.426 |
| Placebo (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -12.55 Score on a scale | Standard Deviation 9.136 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -8.84 Score on a scale | Standard Deviation 9.893 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -6.88 Score on a scale | Standard Deviation 9.587 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -8.06 Score on a scale | Standard Deviation 9.844 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -8.26 Score on a scale | Standard Deviation 9.338 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -6.41 Score on a scale | Standard Deviation 9.428 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -6.83 Score on a scale | Standard Deviation 9.322 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -8.50 Score on a scale | Standard Deviation 9.629 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -8.45 Score on a scale | Standard Deviation 9.705 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -14.00 Score on a scale | Standard Deviation 8.446 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -10.29 Score on a scale | Standard Deviation 7.889 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -13.14 Score on a scale | Standard Deviation 8.05 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -14.57 Score on a scale | Standard Deviation 7.569 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -11.57 Score on a scale | Standard Deviation 6.705 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -12.29 Score on a scale | Standard Deviation 9.232 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -15.40 Score on a scale | Standard Deviation 8.562 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -11.29 Score on a scale | Standard Deviation 6.237 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -8.26 Score on a scale | Standard Deviation 8.058 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -9.67 Score on a scale | Standard Deviation 7.712 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -9.68 Score on a scale | Standard Deviation 8.029 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -9.13 Score on a scale | Standard Deviation 7.906 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -8.53 Score on a scale | Standard Deviation 7.927 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -8.23 Score on a scale | Standard Deviation 8.281 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -7.93 Score on a scale | Standard Deviation 7.891 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -8.10 Score on a scale | Standard Deviation 7.752 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -5.93 Score on a scale | Standard Deviation 6.889 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -5.36 Score on a scale | Standard Deviation 8.308 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -5.93 Score on a scale | Standard Deviation 7.839 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -5.47 Score on a scale | Standard Deviation 7.963 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -5.77 Score on a scale | Standard Deviation 8.633 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -6.44 Score on a scale | Standard Deviation 7.42 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -6.64 Score on a scale | Standard Deviation 6.902 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -6.79 Score on a scale | Standard Deviation 7.04 |
Secondary
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1)
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Time frame: Baseline to weeks 2, 8, 16, 20, & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 24 | -8.33 Score on a scale | Standard Deviation 7.036 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 8 | -6.13 Score on a scale | Standard Deviation 6.164 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 2 | -3.63 Score on a scale | Standard Deviation 4.992 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 16 | -7.79 Score on a scale | Standard Deviation 6.832 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 20 | -7.89 Score on a scale | Standard Deviation 6.848 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 24 | -6.54 Score on a scale | Standard Deviation 6.384 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 20 | -6.42 Score on a scale | Standard Deviation 6.833 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 16 | -6.25 Score on a scale | Standard Deviation 6.246 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 2 | -2.82 Score on a scale | Standard Deviation 4.85 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 8 | -5.59 Score on a scale | Standard Deviation 5.553 |
| 125 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 20 | -6.97 Score on a scale | Standard Deviation 8.512 |
| 125 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 8 | -5.08 Score on a scale | Standard Deviation 7.252 |
| 125 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 16 | -6.47 Score on a scale | Standard Deviation 7.835 |
| 125 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 24 | -6.74 Score on a scale | Standard Deviation 8.681 |
| 125 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 2 | -3.32 Score on a scale | Standard Deviation 5.745 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 2 | -3.40 Score on a scale | Standard Deviation 5.131 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 8 | -7.13 Score on a scale | Standard Deviation 5.954 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 24 | -7.69 Score on a scale | Standard Deviation 7.23 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 20 | -7.31 Score on a scale | Standard Deviation 7.132 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 16 | -7.76 Score on a scale | Standard Deviation 6.265 |
| Placebo (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 20 | -2.39 Score on a scale | Standard Deviation 6.391 |
| Placebo (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 24 | -2.30 Score on a scale | Standard Deviation 6.406 |
| Placebo (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 8 | -2.43 Score on a scale | Standard Deviation 5.466 |
| Placebo (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 2 | -2.09 Score on a scale | Standard Deviation 4.71 |
| Placebo (Part 1) | Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1) | Week 16 | -2.35 Score on a scale | Standard Deviation 6.069 |
Secondary
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Time frame: Baseline to weeks 8 16, 20, & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 8 | -2.20 Score on a scale | Standard Deviation 4.639 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 16 | -2.67 Score on a scale | Standard Deviation 5.761 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 20 | -2.52 Score on a scale | Standard Deviation 7.254 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 24 | -2.96 Score on a scale | Standard Deviation 7.55 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 8 | -2.07 Score on a scale | Standard Deviation 6.194 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 24 | -2.30 Score on a scale | Standard Deviation 6.88 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 16 | -2.53 Score on a scale | Standard Deviation 6.51 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 20 | -2.35 Score on a scale | Standard Deviation 7.326 |
| 125 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 24 | -2.83 Score on a scale | Standard Deviation 6.818 |
| 125 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 16 | -3.04 Score on a scale | Standard Deviation 6.292 |
| 125 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 20 | -3.38 Score on a scale | Standard Deviation 6.787 |
| 125 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 8 | -2.35 Score on a scale | Standard Deviation 5.641 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 8 | -3.29 Score on a scale | Standard Deviation 5.132 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 16 | -3.74 Score on a scale | Standard Deviation 6.401 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 24 | -4.00 Score on a scale | Standard Deviation 6.802 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 20 | -4.24 Score on a scale | Standard Deviation 5.873 |
| Placebo (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 24 | -0.97 Score on a scale | Standard Deviation 4.196 |
| Placebo (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 20 | -0.66 Score on a scale | Standard Deviation 4.176 |
| Placebo (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 16 | -0.57 Score on a scale | Standard Deviation 5.088 |
| Placebo (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 8 | -0.97 Score on a scale | Standard Deviation 3.94 |
Secondary
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -2.46 score on a scale | Standard Deviation 9.162 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -2.69 score on a scale | Standard Deviation 8.873 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -1.85 score on a scale | Standard Deviation 9.754 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -3.38 score on a scale | Standard Deviation 8.893 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -3.08 score on a scale | Standard Deviation 8.883 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -3.54 score on a scale | Standard Deviation 7.965 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -4.54 score on a scale | Standard Deviation 8.482 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | -2.92 score on a scale | Standard Deviation 8.864 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | -1.40 score on a scale | Standard Deviation 6.966 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -1.22 score on a scale | Standard Deviation 8.015 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -2.52 score on a scale | Standard Deviation 6.205 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -0.80 score on a scale | Standard Deviation 7.092 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -0.68 score on a scale | Standard Deviation 7.078 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -0.29 score on a scale | Standard Deviation 6.963 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -1.73 score on a scale | Standard Deviation 7.434 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -1.24 score on a scale | Standard Deviation 6.996 |
| 125 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -3.45 score on a scale | Standard Deviation 10.511 |
| 125 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -6.50 score on a scale | Standard Deviation 11.43 |
| 125 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -4.09 score on a scale | Standard Deviation 9.027 |
| 125 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -3.80 score on a scale | Standard Deviation 10.497 |
| 125 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -5.58 score on a scale | Standard Deviation 10.184 |
| 125 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | -3.09 score on a scale | Standard Deviation 10.222 |
| 125 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -4.40 score on a scale | Standard Deviation 10.024 |
| 125 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -2.55 score on a scale | Standard Deviation 8.359 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | -2.70 score on a scale | Standard Deviation 6.151 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -2.81 score on a scale | Standard Deviation 6.822 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -3.00 score on a scale | Standard Deviation 5.877 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -2.70 score on a scale | Standard Deviation 6.916 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -2.85 score on a scale | Standard Deviation 5.559 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -3.07 score on a scale | Standard Deviation 5.313 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -2.52 score on a scale | Standard Deviation 5.833 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -2.74 score on a scale | Standard Deviation 7.593 |
| Placebo (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -4.42 score on a scale | Standard Deviation 6.999 |
| Placebo (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -4.42 score on a scale | Standard Deviation 7.242 |
| Placebo (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -3.67 score on a scale | Standard Deviation 6.998 |
| Placebo (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | -3.55 score on a scale | Standard Deviation 7.594 |
| Placebo (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -4.25 score on a scale | Standard Deviation 7.225 |
| Placebo (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -4.33 score on a scale | Standard Deviation 7.679 |
| Placebo (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -3.33 score on a scale | Standard Deviation 7.797 |
| Placebo (Part 1) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -4.18 score on a scale | Standard Deviation 7.167 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -4.56 score on a scale | Standard Deviation 8.879 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -4.59 score on a scale | Standard Deviation 8.454 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -4.97 score on a scale | Standard Deviation 8.428 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -5.50 score on a scale | Standard Deviation 8.828 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | -5.16 score on a scale | Standard Deviation 8.674 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -5.23 score on a scale | Standard Deviation 8.724 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -5.66 score on a scale | Standard Deviation 8.28 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -4.42 score on a scale | Standard Deviation 7.89 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -7.29 score on a scale | Standard Deviation 5.794 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -7.29 score on a scale | Standard Deviation 5.251 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -5.43 score on a scale | Standard Deviation 5.192 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -6.86 score on a scale | Standard Deviation 5.46 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | -7.43 score on a scale | Standard Deviation 5.563 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -7.43 score on a scale | Standard Deviation 5.412 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -8.20 score on a scale | Standard Deviation 6.34 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -7.14 score on a scale | Standard Deviation 4.88 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | -3.29 score on a scale | Standard Deviation 5.593 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -5.26 score on a scale | Standard Deviation 7.034 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -3.13 score on a scale | Standard Deviation 8.082 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -3.75 score on a scale | Standard Deviation 7.878 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -3.71 score on a scale | Standard Deviation 7.408 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -4.17 score on a scale | Standard Deviation 7.269 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -3.97 score on a scale | Standard Deviation 6.483 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -4.03 score on a scale | Standard Deviation 6.71 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | 0.29 score on a scale | Standard Deviation 4.25 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | 0.38 score on a scale | Standard Deviation 4.753 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -1.00 score on a scale | Standard Deviation 4.852 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -0.38 score on a scale | Standard Deviation 4.66 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -0.20 score on a scale | Standard Deviation 4.491 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -0.21 score on a scale | Standard Deviation 4.318 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | 0.50 score on a scale | Standard Deviation 5.125 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -0.64 score on a scale | Standard Deviation 5.719 |
Secondary
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Time frame: Baseline to weeks 4, 8, 12, 16, 20, & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 4 | -4.40 Score on a scale | Standard Deviation 6.403 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 8 | -7.03 Score on a scale | Standard Deviation 6.869 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 12 | -7.87 Score on a scale | Standard Deviation 7.286 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 16 | -8.28 Score on a scale | Standard Deviation 7.286 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 20 | -9.39 Score on a scale | Standard Deviation 7.577 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 24 | -9.96 Score on a scale | Standard Deviation 7.888 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 20 | -7.13 Score on a scale | Standard Deviation 8.662 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 12 | -6.50 Score on a scale | Standard Deviation 7.229 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 4 | -4.01 Score on a scale | Standard Deviation 6.287 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 24 | -7.21 Score on a scale | Standard Deviation 8.213 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 16 | -7.23 Score on a scale | Standard Deviation 7.744 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 8 | -5.13 Score on a scale | Standard Deviation 7.093 |
| 125 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 16 | -7.19 Score on a scale | Standard Deviation 7.72 |
| 125 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 20 | -8.10 Score on a scale | Standard Deviation 8.15 |
| 125 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 24 | -7.86 Score on a scale | Standard Deviation 8.572 |
| 125 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 8 | -5.70 Score on a scale | Standard Deviation 6.943 |
| 125 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 12 | -7.29 Score on a scale | Standard Deviation 7.216 |
| 125 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 4 | -5.42 Score on a scale | Standard Deviation 6.498 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 16 | -7.32 Score on a scale | Standard Deviation 7.017 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 8 | -6.75 Score on a scale | Standard Deviation 6.646 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 24 | -7.64 Score on a scale | Standard Deviation 7.011 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 12 | -7.36 Score on a scale | Standard Deviation 7.46 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 20 | -7.39 Score on a scale | Standard Deviation 7.721 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 4 | -4.08 Score on a scale | Standard Deviation 5.448 |
| Placebo (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 4 | -2.32 Score on a scale | Standard Deviation 5.91 |
| Placebo (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 12 | -2.26 Score on a scale | Standard Deviation 6.088 |
| Placebo (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 8 | -2.13 Score on a scale | Standard Deviation 6.4 |
| Placebo (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 20 | -2.33 Score on a scale | Standard Deviation 6.821 |
| Placebo (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 24 | -2.19 Score on a scale | Standard Deviation 7.31 |
| Placebo (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 16 | -2.37 Score on a scale | Standard Deviation 6.867 |
Secondary
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Time frame: Baseline to weeks 24, 32, 36, 40, 44, 48 & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -13.31 Score on a scale | Standard Deviation 8.46 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -13.92 Score on a scale | Standard Deviation 8.411 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -14.69 Score on a scale | Standard Deviation 8.499 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -15.31 Score on a scale | Standard Deviation 6.061 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -13.23 Score on a scale | Standard Deviation 8.738 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -11.85 Score on a scale | Standard Deviation 10.148 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -11.69 Score on a scale | Standard Deviation 9.861 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -11.97 Score on a scale | Standard Deviation 6.41 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -9.10 Score on a scale | Standard Deviation 8.715 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -9.91 Score on a scale | Standard Deviation 8.129 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -9.81 Score on a scale | Standard Deviation 8.92 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -10.23 Score on a scale | Standard Deviation 8.32 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -10.39 Score on a scale | Standard Deviation 8.519 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -9.13 Score on a scale | Standard Deviation 8.32 |
| 125 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -11.50 Score on a scale | Standard Deviation 6.916 |
| 125 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -11.58 Score on a scale | Standard Deviation 8.586 |
| 125 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -11.36 Score on a scale | Standard Deviation 6.889 |
| 125 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -11.90 Score on a scale | Standard Deviation 7.264 |
| 125 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -11.00 Score on a scale | Standard Deviation 6.633 |
| 125 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -10.45 Score on a scale | Standard Deviation 6.699 |
| 125 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -11.91 Score on a scale | Standard Deviation 8.24 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -7.50 Score on a scale | Standard Deviation 9.268 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -9.25 Score on a scale | Standard Deviation 8.347 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -6.79 Score on a scale | Standard Deviation 8.875 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -7.00 Score on a scale | Standard Deviation 8.932 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -6.50 Score on a scale | Standard Deviation 8.804 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -7.82 Score on a scale | Standard Deviation 9.302 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -6.82 Score on a scale | Standard Deviation 9.318 |
| Placebo (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -11.75 Score on a scale | Standard Deviation 9.836 |
| Placebo (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -11.73 Score on a scale | Standard Deviation 8.162 |
| Placebo (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -11.75 Score on a scale | Standard Deviation 7.086 |
| Placebo (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -12.83 Score on a scale | Standard Deviation 7.082 |
| Placebo (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -11.92 Score on a scale | Standard Deviation 8.262 |
| Placebo (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -13.00 Score on a scale | Standard Deviation 7.019 |
| Placebo (Part 1) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -10.64 Score on a scale | Standard Deviation 10.053 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -11.32 Score on a scale | Standard Deviation 8.113 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -8.55 Score on a scale | Standard Deviation 8.24 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -11.75 Score on a scale | Standard Deviation 8.37 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -10.19 Score on a scale | Standard Deviation 8.361 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -10.42 Score on a scale | Standard Deviation 7.58 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -10.33 Score on a scale | Standard Deviation 8.125 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -11.88 Score on a scale | Standard Deviation 8.698 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -7.86 Score on a scale | Standard Deviation 7.515 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -11.29 Score on a scale | Standard Deviation 10.323 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -9.57 Score on a scale | Standard Deviation 9.126 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -14.00 Score on a scale | Standard Deviation 6.205 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -12.57 Score on a scale | Standard Deviation 9.502 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -10.00 Score on a scale | Standard Deviation 9.452 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -11.29 Score on a scale | Standard Deviation 8.995 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -9.42 Score on a scale | Standard Deviation 7.784 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -8.71 Score on a scale | Standard Deviation 8.158 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -8.66 Score on a scale | Standard Deviation 7.79 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -9.90 Score on a scale | Standard Deviation 8.66 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -8.81 Score on a scale | Standard Deviation 8.3 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -9.45 Score on a scale | Standard Deviation 7.155 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -8.58 Score on a scale | Standard Deviation 9.164 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -7.50 Score on a scale | Standard Deviation 7.714 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -8.50 Score on a scale | Standard Deviation 9.146 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -8.75 Score on a scale | Standard Deviation 7.197 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -7.93 Score on a scale | Standard Deviation 7.908 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -7.50 Score on a scale | Standard Deviation 8.438 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -7.62 Score on a scale | Standard Deviation 8.856 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -7.93 Score on a scale | Standard Deviation 7.966 |
Secondary
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Time frame: Baseline to weeks 4, 8, 12, 16, 20 & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 4 | -15.30 Score on a scale | Standard Deviation 16.517 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 8 | -22.39 Score on a scale | Standard Deviation 19.368 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 12 | -27.80 Score on a scale | Standard Deviation 19.621 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 16 | -30.12 Score on a scale | Standard Deviation 20.086 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 20 | -34.89 Score on a scale | Standard Deviation 22.369 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 24 | -36.19 Score on a scale | Standard Deviation 24.605 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 20 | -28.04 Score on a scale | Standard Deviation 22.472 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 24 | -27.28 Score on a scale | Standard Deviation 22.937 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 4 | -12.27 Score on a scale | Standard Deviation 13.455 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 12 | -22.31 Score on a scale | Standard Deviation 17.936 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 16 | -25.07 Score on a scale | Standard Deviation 20.233 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 8 | -19.61 Score on a scale | Standard Deviation 17.527 |
| 125 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 16 | -26.28 Score on a scale | Standard Deviation 21.258 |
| 125 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 20 | -29.80 Score on a scale | Standard Deviation 23.594 |
| 125 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 4 | -15.89 Score on a scale | Standard Deviation 14.865 |
| 125 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 12 | -27.72 Score on a scale | Standard Deviation 20.084 |
| 125 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 8 | -21.49 Score on a scale | Standard Deviation 19.2 |
| 125 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 24 | -29.96 Score on a scale | Standard Deviation 25.735 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 16 | -28.15 Score on a scale | Standard Deviation 19.831 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 8 | -21.42 Score on a scale | Standard Deviation 16.956 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 12 | -26.45 Score on a scale | Standard Deviation 19.649 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 24 | -28.48 Score on a scale | Standard Deviation 21.793 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 20 | -26.71 Score on a scale | Standard Deviation 21.056 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 4 | -14.43 Score on a scale | Standard Deviation 13.691 |
| Placebo (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 20 | -13.91 Score on a scale | Standard Deviation 19.325 |
| Placebo (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 12 | -13.97 Score on a scale | Standard Deviation 16.898 |
| Placebo (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 8 | -12.50 Score on a scale | Standard Deviation 16.584 |
| Placebo (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 24 | -15.08 Score on a scale | Standard Deviation 22.739 |
| Placebo (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 16 | -13.85 Score on a scale | Standard Deviation 18.123 |
| Placebo (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 4 | -11.13 Score on a scale | Standard Deviation 14.243 |
Secondary
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Time frame: Baseline to week 24, 28, 32, 36, 40, 44, 48 & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -52.22 Score on a scale | Standard Deviation 14.314 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -54.19 Score on a scale | Standard Deviation 18.525 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -49.68 Score on a scale | Standard Deviation 25.709 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -51.19 Score on a scale | Standard Deviation 23.086 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -49.88 Score on a scale | Standard Deviation 26.342 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -47.38 Score on a scale | Standard Deviation 26.194 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -39.75 Score on a scale | Standard Deviation 25.447 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -40.26 Score on a scale | Standard Deviation 26.751 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -38.18 Score on a scale | Standard Deviation 29.948 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -44.30 Score on a scale | Standard Deviation 23.737 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -38.96 Score on a scale | Standard Deviation 29.09 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -44.25 Score on a scale | Standard Deviation 21.373 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -34.69 Score on a scale | Standard Deviation 28.925 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -38.72 Score on a scale | Standard Deviation 27.164 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -38.61 Score on a scale | Standard Deviation 28.602 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -41.55 Score on a scale | Standard Deviation 25.962 |
| 125 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -37.95 Score on a scale | Standard Deviation 28.362 |
| 125 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -36.05 Score on a scale | Standard Deviation 27.55 |
| 125 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -37.58 Score on a scale | Standard Deviation 27 |
| 125 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -35.04 Score on a scale | Standard Deviation 27.12 |
| 125 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -42.44 Score on a scale | Standard Deviation 21.879 |
| 125 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -35.13 Score on a scale | Standard Deviation 27.409 |
| 125 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -43.38 Score on a scale | Standard Deviation 24.261 |
| 125 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -33.91 Score on a scale | Standard Deviation 26.686 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -29.26 Score on a scale | Standard Deviation 27.488 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -29.98 Score on a scale | Standard Deviation 26.387 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -27.91 Score on a scale | Standard Deviation 24.154 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -36.77 Score on a scale | Standard Deviation 21.919 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -30.05 Score on a scale | Standard Deviation 26.602 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -29.71 Score on a scale | Standard Deviation 28.021 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -33.40 Score on a scale | Standard Deviation 23.845 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -28.31 Score on a scale | Standard Deviation 23.318 |
| Placebo (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -52.42 Score on a scale | Standard Deviation 19.56 |
| Placebo (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -47.15 Score on a scale | Standard Deviation 16.401 |
| Placebo (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -50.76 Score on a scale | Standard Deviation 16.285 |
| Placebo (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -50.26 Score on a scale | Standard Deviation 26.772 |
| Placebo (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -52.12 Score on a scale | Standard Deviation 19.167 |
| Placebo (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -51.14 Score on a scale | Standard Deviation 20.299 |
| Placebo (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -52.40 Score on a scale | Standard Deviation 22.25 |
| Placebo (Part 1) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -49.87 Score on a scale | Standard Deviation 13.012 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -44.04 Score on a scale | Standard Deviation 22.541 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -41.65 Score on a scale | Standard Deviation 24.173 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -40.96 Score on a scale | Standard Deviation 24.47 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -43.95 Score on a scale | Standard Deviation 24.475 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -38.38 Score on a scale | Standard Deviation 24.94 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -37.07 Score on a scale | Standard Deviation 25.763 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -45.28 Score on a scale | Standard Deviation 23.438 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -42.93 Score on a scale | Standard Deviation 24.694 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -40.76 Score on a scale | Standard Deviation 17.685 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -41.17 Score on a scale | Standard Deviation 19.19 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -45.31 Score on a scale | Standard Deviation 22.71 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -36.39 Score on a scale | Standard Deviation 21.651 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -45.20 Score on a scale | Standard Deviation 18.017 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -43.80 Score on a scale | Standard Deviation 27.38 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -42.26 Score on a scale | Standard Deviation 25.861 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -40.09 Score on a scale | Standard Deviation 16.767 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -37.15 Score on a scale | Standard Deviation 27.483 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -36.72 Score on a scale | Standard Deviation 25.421 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -37.64 Score on a scale | Standard Deviation 28.543 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -38.45 Score on a scale | Standard Deviation 22.077 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -36.83 Score on a scale | Standard Deviation 27.061 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -37.75 Score on a scale | Standard Deviation 27.127 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -38.41 Score on a scale | Standard Deviation 26.915 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -37.46 Score on a scale | Standard Deviation 23.843 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -37.81 Score on a scale | Standard Deviation 25.964 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -36.74 Score on a scale | Standard Deviation 25.865 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -42.98 Score on a scale | Standard Deviation 24.77 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -37.47 Score on a scale | Standard Deviation 27.887 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -40.54 Score on a scale | Standard Deviation 23.584 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -38.10 Score on a scale | Standard Deviation 28.181 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -39.94 Score on a scale | Standard Deviation 29.182 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -39.35 Score on a scale | Standard Deviation 25.34 |
Secondary
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Time frame: Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 7 | -1.25 score on a scale | Standard Deviation 1.966 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 2 | -0.65 score on a scale | Standard Deviation 1.316 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 3 | -0.90 score on a scale | Standard Deviation 1.619 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 4 | -.096 score on a scale | Standard Deviation 1.672 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 5 | -0.99 score on a scale | Standard Deviation 1.811 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 6 | -1.09 score on a scale | Standard Deviation 1.679 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 1 | -0.54 score on a scale | Standard Deviation 1.096 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 8 | -1.42 score on a scale | Standard Deviation 2.062 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 9 | -1.44 score on a scale | Standard Deviation 2.104 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 10 | -1.62 score on a scale | Standard Deviation 2.162 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 11 | -1.68 score on a scale | Standard Deviation 2.176 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 12 | -1.70 score on a scale | Standard Deviation 2.204 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 13 | -1.83 score on a scale | Standard Deviation 2.295 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 14 | -1.82 score on a scale | Standard Deviation 2.355 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 19 | -2.19 score on a scale | Standard Deviation 2.484 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 15 | -1.87 score on a scale | Standard Deviation 2.386 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 16 | -2.06 score on a scale | Standard Deviation 2.539 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 17 | -2.13 score on a scale | Standard Deviation 2.465 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 18 | -2.18 score on a scale | Standard Deviation 2.534 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 20 | -2.28 score on a scale | Standard Deviation 2.522 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 21 | -2.28 score on a scale | Standard Deviation 2.516 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 22 | -2.38 score on a scale | Standard Deviation 2.622 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 23 | -2.56 score on a scale | Standard Deviation 2.671 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 24 | -2.58 score on a scale | Standard Deviation 2.662 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 15 | -2.08 score on a scale | Standard Deviation 2.511 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 19 | -2.22 score on a scale | Standard Deviation 2.563 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 7 | -1.54 score on a scale | Standard Deviation 1.85 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 11 | -1.67 score on a scale | Standard Deviation 1.936 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 6 | -1.35 score on a scale | Standard Deviation 1.818 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 23 | -2.27 score on a scale | Standard Deviation 2.538 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 14 | -2.02 score on a scale | Standard Deviation 2.468 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 13 | -1.87 score on a scale | Standard Deviation 2.247 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 12 | -1.65 score on a scale | Standard Deviation 2.074 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 3 | -0.92 score on a scale | Standard Deviation 1.392 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 2 | -0.79 score on a scale | Standard Deviation 1.367 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 1 | -0.56 score on a scale | Standard Deviation 0.978 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 8 | -1.50 score on a scale | Standard Deviation 1.786 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 5 | -1.38 score on a scale | Standard Deviation 1.653 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 20 | -2.19 score on a scale | Standard Deviation 2.53 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 24 | -2.30 score on a scale | Standard Deviation 2.672 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 18 | -2.21 score on a scale | Standard Deviation 2.543 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 9 | -1.52 score on a scale | Standard Deviation 1.805 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 21 | -2.23 score on a scale | Standard Deviation 2.576 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 17 | -2.18 score on a scale | Standard Deviation 2.457 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 16 | -2.09 score on a scale | Standard Deviation 2.497 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 22 | -2.29 score on a scale | Standard Deviation 2.699 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 10 | -1.67 score on a scale | Standard Deviation 1.852 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 4 | -1.25 score on a scale | Standard Deviation 1.657 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 17 | -2.14 score on a scale | Standard Deviation 2.368 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 21 | -2.27 score on a scale | Standard Deviation 2.352 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 6 | -1.38 score on a scale | Standard Deviation 1.666 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 7 | -1.57 score on a scale | Standard Deviation 1.71 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 8 | -1.60 score on a scale | Standard Deviation 1.816 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 9 | -1.89 score on a scale | Standard Deviation 1.885 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 10 | -1.82 score on a scale | Standard Deviation 2.082 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 22 | -2.25 score on a scale | Standard Deviation 2.438 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 11 | -2.06 score on a scale | Standard Deviation 2.091 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 12 | -1.96 score on a scale | Standard Deviation 2.107 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 13 | -2.05 score on a scale | Standard Deviation 2.164 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 14 | -2.13 score on a scale | Standard Deviation 2.308 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 23 | -2.20 score on a scale | Standard Deviation 2.529 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 15 | -2.10 score on a scale | Standard Deviation 2.29 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 16 | -2.22 score on a scale | Standard Deviation 2.275 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 18 | -2.16 score on a scale | Standard Deviation 2.307 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 19 | -2.14 score on a scale | Standard Deviation 2.291 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 20 | -2.13 score on a scale | Standard Deviation 2.36 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 1 | -0.49 score on a scale | Standard Deviation 0.965 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 2 | -0.73 score on a scale | Standard Deviation 1.075 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 3 | -1.05 score on a scale | Standard Deviation 1.302 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 24 | -2.21 score on a scale | Standard Deviation 2.616 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 4 | -1.36 score on a scale | Standard Deviation 1.443 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 5 | -1.42 score on a scale | Standard Deviation 1.591 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 5 | -1.49 score on a scale | Standard Deviation 1.799 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 23 | -2.59 score on a scale | Standard Deviation 2.453 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 4 | -1.09 score on a scale | Standard Deviation 1.668 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 1 | -0.45 score on a scale | Standard Deviation 0.908 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 9 | -2.13 score on a scale | Standard Deviation 2.031 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 20 | -2.31 score on a scale | Standard Deviation 2.401 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 3 | -0.88 score on a scale | Standard Deviation 1.478 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 17 | -2.35 score on a scale | Standard Deviation 2.346 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 2 | -0.81 score on a scale | Standard Deviation 1.224 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 15 | -2.32 score on a scale | Standard Deviation 2.288 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 12 | -2.28 score on a scale | Standard Deviation 2.262 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 14 | -2.35 score on a scale | Standard Deviation 2.316 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 24 | -2.46 score on a scale | Standard Deviation 2.427 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 22 | -2.44 score on a scale | Standard Deviation 2.383 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 6 | -1.58 score on a scale | Standard Deviation 2.057 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 13 | -2.28 score on a scale | Standard Deviation 2.291 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 18 | -2.37 score on a scale | Standard Deviation 2.383 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 21 | -2.43 score on a scale | Standard Deviation 2.404 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 19 | -2.38 score on a scale | Standard Deviation 2.463 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 7 | -1.78 score on a scale | Standard Deviation 2.002 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 16 | -2.31 score on a scale | Standard Deviation 2.301 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 11 | -2.31 score on a scale | Standard Deviation 2.248 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 10 | -2.17 score on a scale | Standard Deviation 2.137 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 8 | -1.93 score on a scale | Standard Deviation 2.053 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 14 | -0.58 score on a scale | Standard Deviation 2.055 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 15 | -0.57 score on a scale | Standard Deviation 2.018 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 9 | -1.00 score on a scale | Standard Deviation 2.142 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 3 | -0.65 score on a scale | Standard Deviation 1.567 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 16 | -0.54 score on a scale | Standard Deviation 2.077 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 23 | -0.61 score on a scale | Standard Deviation 2.215 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 5 | -0.83 score on a scale | Standard Deviation 2.03 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 17 | -0.61 score on a scale | Standard Deviation 2.143 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 19 | -0.75 score on a scale | Standard Deviation 2.278 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 8 | -0.80 score on a scale | Standard Deviation 1.979 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 21 | -0.76 score on a scale | Standard Deviation 2.332 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 1 | -0.28 score on a scale | Standard Deviation 1.071 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 7 | -0.78 score on a scale | Standard Deviation 1.922 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 4 | -0.77 score on a scale | Standard Deviation 1.744 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 2 | -0.42 score on a scale | Standard Deviation 1.046 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 12 | -0.79 score on a scale | Standard Deviation 2.162 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 22 | -0.73 score on a scale | Standard Deviation 2.314 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 20 | -0.67 score on a scale | Standard Deviation 2.201 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 13 | -0.72 score on a scale | Standard Deviation 2.087 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 24 | -0.55 score on a scale | Standard Deviation 2.224 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 11 | -0.93 score on a scale | Standard Deviation 2.111 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 18 | -0.55 score on a scale | Standard Deviation 2.168 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 10 | -0.97 score on a scale | Standard Deviation 2.244 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 6 | -0.94 score on a scale | Standard Deviation 1.899 |
Secondary
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Time frame: Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified timepoints are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -3.47 Score on a scale | Standard Deviation 2.712 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -3.34 Score on a scale | Standard Deviation 3.206 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -3.30 Score on a scale | Standard Deviation 3.246 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -3.73 Score on a scale | Standard Deviation 2.612 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -3.41 Score on a scale | Standard Deviation 2.58 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -3.63 Score on a scale | Standard Deviation 3.034 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -3.29 Score on a scale | Standard Deviation 3.245 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -2.82 Score on a scale | Standard Deviation 3.247 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -2.70 Score on a scale | Standard Deviation 3.119 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -3.44 Score on a scale | Standard Deviation 2.726 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -3.82 Score on a scale | Standard Deviation 2.442 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -3.34 Score on a scale | Standard Deviation 3.276 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -3.32 Score on a scale | Standard Deviation 2.564 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -3.63 Score on a scale | Standard Deviation 2.38 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -2.78 Score on a scale | Standard Deviation 3.223 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -3.21 Score on a scale | Standard Deviation 3.218 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -3.84 Score on a scale | Standard Deviation 2.444 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -3.29 Score on a scale | Standard Deviation 3.359 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -3.31 Score on a scale | Standard Deviation 3.182 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -3.17 Score on a scale | Standard Deviation 3.283 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -3.83 Score on a scale | Standard Deviation 2.353 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -2.80 Score on a scale | Standard Deviation 3.23 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -3.60 Score on a scale | Standard Deviation 2.722 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -2.67 Score on a scale | Standard Deviation 3.188 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -3.49 Score on a scale | Standard Deviation 2.644 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -3.43 Score on a scale | Standard Deviation 2.607 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -3.86 Score on a scale | Standard Deviation 2.432 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -3.48 Score on a scale | Standard Deviation 2.752 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -3.25 Score on a scale | Standard Deviation 3.188 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -2.51 Score on a scale | Standard Deviation 2.874 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -2.31 Score on a scale | Standard Deviation 3.183 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -2.26 Score on a scale | Standard Deviation 3.208 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -2.73 Score on a scale | Standard Deviation 2.973 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -2.28 Score on a scale | Standard Deviation 3.307 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -2.46 Score on a scale | Standard Deviation 3.219 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -2.71 Score on a scale | Standard Deviation 2.891 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -2.33 Score on a scale | Standard Deviation 3.159 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -2.27 Score on a scale | Standard Deviation 3.139 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -2.56 Score on a scale | Standard Deviation 2.892 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -2.43 Score on a scale | Standard Deviation 3.202 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -2.27 Score on a scale | Standard Deviation 3.158 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -2.23 Score on a scale | Standard Deviation 3.218 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -2.31 Score on a scale | Standard Deviation 3.196 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -2.78 Score on a scale | Standard Deviation 3.03 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -2.53 Score on a scale | Standard Deviation 3.244 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -2.41 Score on a scale | Standard Deviation 3.267 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -2.74 Score on a scale | Standard Deviation 3.213 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -2.17 Score on a scale | Standard Deviation 3.152 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -2.47 Score on a scale | Standard Deviation 3.262 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -2.56 Score on a scale | Standard Deviation 3.098 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -2.26 Score on a scale | Standard Deviation 3.213 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -2.49 Score on a scale | Standard Deviation 3.22 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -2.42 Score on a scale | Standard Deviation 3.317 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -2.58 Score on a scale | Standard Deviation 2.819 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -2.26 Score on a scale | Standard Deviation 3.114 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -2.35 Score on a scale | Standard Deviation 3.212 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -2.51 Score on a scale | Standard Deviation 3.219 |
| 250 mg (no LD) KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -2.83 Score on a scale | Standard Deviation 2.909 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -2.39 Score on a scale | Standard Deviation 2.399 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -3.59 Score on a scale | Standard Deviation 2.575 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -2.11 Score on a scale | Standard Deviation 2.064 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -3.13 Score on a scale | Standard Deviation 2.818 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -2.53 Score on a scale | Standard Deviation 2.917 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -3.32 Score on a scale | Standard Deviation 2.732 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -1.82 Score on a scale | Standard Deviation 1.991 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -3.65 Score on a scale | Standard Deviation 2.619 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -2.37 Score on a scale | Standard Deviation 2.349 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -2.53 Score on a scale | Standard Deviation 2.523 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -2.06 Score on a scale | Standard Deviation 2.464 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -4.00 Score on a scale | Standard Deviation 2.711 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -3.06 Score on a scale | Standard Deviation 2.755 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -2.66 Score on a scale | Standard Deviation 2.61 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -4.08 Score on a scale | Standard Deviation 2.726 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -3.76 Score on a scale | Standard Deviation 2.394 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -2.44 Score on a scale | Standard Deviation 2.699 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -1.97 Score on a scale | Standard Deviation 2.11 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -2.50 Score on a scale | Standard Deviation 2.523 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -1.95 Score on a scale | Standard Deviation 2.32 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -3.81 Score on a scale | Standard Deviation 2.425 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -2.61 Score on a scale | Standard Deviation 2.55 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -3.75 Score on a scale | Standard Deviation 2.654 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -3.73 Score on a scale | Standard Deviation 2.431 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -3.09 Score on a scale | Standard Deviation 2.6 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -2.36 Score on a scale | Standard Deviation 2.366 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -2.81 Score on a scale | Standard Deviation 2.693 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -2.53 Score on a scale | Standard Deviation 2.603 |
| 125 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -2.52 Score on a scale | Standard Deviation 2.462 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -1.74 Score on a scale | Standard Deviation 2.821 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -1.80 Score on a scale | Standard Deviation 2.86 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -1.79 Score on a scale | Standard Deviation 2.69 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -1.84 Score on a scale | Standard Deviation 2.779 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -1.74 Score on a scale | Standard Deviation 2.697 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -1.74 Score on a scale | Standard Deviation 2.803 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -2.29 Score on a scale | Standard Deviation 2.782 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -1.85 Score on a scale | Standard Deviation 2.733 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -2.07 Score on a scale | Standard Deviation 2.564 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -1.87 Score on a scale | Standard Deviation 2.745 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -1.71 Score on a scale | Standard Deviation 2.98 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -1.51 Score on a scale | Standard Deviation 2.736 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -1.85 Score on a scale | Standard Deviation 2.867 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -1.30 Score on a scale | Standard Deviation 2.792 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -2.25 Score on a scale | Standard Deviation 2.861 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -2.42 Score on a scale | Standard Deviation 2.895 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -1.91 Score on a scale | Standard Deviation 2.835 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -2.33 Score on a scale | Standard Deviation 3.096 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -1.97 Score on a scale | Standard Deviation 2.774 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -2.28 Score on a scale | Standard Deviation 2.994 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -1.84 Score on a scale | Standard Deviation 2.679 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -1.42 Score on a scale | Standard Deviation 2.685 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -1.85 Score on a scale | Standard Deviation 2.758 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -1.64 Score on a scale | Standard Deviation 2.67 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -1.84 Score on a scale | Standard Deviation 2.761 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -1.81 Score on a scale | Standard Deviation 2.792 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -2.02 Score on a scale | Standard Deviation 2.909 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -1.84 Score on a scale | Standard Deviation 2.796 |
| 62.5 mg KY1005 (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -1.90 Score on a scale | Standard Deviation 2.913 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -4.83 Score on a scale | Standard Deviation 2.484 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -4.56 Score on a scale | Standard Deviation 2.344 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -4.74 Score on a scale | Standard Deviation 2.909 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -4.32 Score on a scale | Standard Deviation 2.316 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -4.09 Score on a scale | Standard Deviation 2.567 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -4.57 Score on a scale | Standard Deviation 2.505 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -4.27 Score on a scale | Standard Deviation 2.261 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -4.64 Score on a scale | Standard Deviation 2.864 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -4.60 Score on a scale | Standard Deviation 2.497 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -4.68 Score on a scale | Standard Deviation 2.637 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -4.18 Score on a scale | Standard Deviation 2.428 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -4.44 Score on a scale | Standard Deviation 2.526 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -4.51 Score on a scale | Standard Deviation 2.429 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -4.64 Score on a scale | Standard Deviation 3.094 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -4.67 Score on a scale | Standard Deviation 2.468 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -4.41 Score on a scale | Standard Deviation 2.864 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -4.24 Score on a scale | Standard Deviation 2.451 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -4.16 Score on a scale | Standard Deviation 2.387 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -4.56 Score on a scale | Standard Deviation 2.923 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -4.64 Score on a scale | Standard Deviation 2.892 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -4.02 Score on a scale | Standard Deviation 2.525 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -4.46 Score on a scale | Standard Deviation 2.83 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -4.68 Score on a scale | Standard Deviation 2.893 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -4.24 Score on a scale | Standard Deviation 2.419 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -3.83 Score on a scale | Standard Deviation 2.428 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -4.12 Score on a scale | Standard Deviation 2.413 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -4.34 Score on a scale | Standard Deviation 2.169 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -4.43 Score on a scale | Standard Deviation 2.297 |
| Placebo (Part 1) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -4.67 Score on a scale | Standard Deviation 2.494 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -2.81 Score on a scale | Standard Deviation 2.405 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -2.67 Score on a scale | Standard Deviation 2.798 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -2.02 Score on a scale | Standard Deviation 2.625 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -2.92 Score on a scale | Standard Deviation 2.539 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -2.83 Score on a scale | Standard Deviation 2.579 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -2.30 Score on a scale | Standard Deviation 2.731 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -2.62 Score on a scale | Standard Deviation 2.636 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -2.92 Score on a scale | Standard Deviation 2.574 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -3.01 Score on a scale | Standard Deviation 2.504 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -2.84 Score on a scale | Standard Deviation 2.467 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -2.56 Score on a scale | Standard Deviation 2.4 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -2.86 Score on a scale | Standard Deviation 2.617 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -3.01 Score on a scale | Standard Deviation 2.529 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -2.04 Score on a scale | Standard Deviation 2.636 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -3.16 Score on a scale | Standard Deviation 2.672 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -2.33 Score on a scale | Standard Deviation 2.614 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -2.82 Score on a scale | Standard Deviation 2.612 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -1.87 Score on a scale | Standard Deviation 2.596 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -2.81 Score on a scale | Standard Deviation 2.662 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -2.84 Score on a scale | Standard Deviation 2.508 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -3.07 Score on a scale | Standard Deviation 2.548 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -2.68 Score on a scale | Standard Deviation 2.49 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -2.81 Score on a scale | Standard Deviation 2.693 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -2.99 Score on a scale | Standard Deviation 2.591 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -1.89 Score on a scale | Standard Deviation 2.692 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -3.11 Score on a scale | Standard Deviation 2.508 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -1.84 Score on a scale | Standard Deviation 2.929 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -2.92 Score on a scale | Standard Deviation 2.876 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -2.90 Score on a scale | Standard Deviation 2.527 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -3.51 Score on a scale | Standard Deviation 2.084 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -3.58 Score on a scale | Standard Deviation 1.992 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -3.78 Score on a scale | Standard Deviation 2.146 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -3.66 Score on a scale | Standard Deviation 2.139 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -4.38 Score on a scale | Standard Deviation 1.827 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -4.50 Score on a scale | Standard Deviation 2.035 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -3.73 Score on a scale | Standard Deviation 2.125 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -4.02 Score on a scale | Standard Deviation 2.28 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -4.40 Score on a scale | Standard Deviation 2.17 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -4.14 Score on a scale | Standard Deviation 1.843 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -4.63 Score on a scale | Standard Deviation 1.822 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -4.92 Score on a scale | Standard Deviation 1.863 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -4.56 Score on a scale | Standard Deviation 1.903 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -3.97 Score on a scale | Standard Deviation 1.948 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -4.55 Score on a scale | Standard Deviation 2.055 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -4.51 Score on a scale | Standard Deviation 1.79 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -4.14 Score on a scale | Standard Deviation 1.845 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -3.96 Score on a scale | Standard Deviation 2.251 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -3.65 Score on a scale | Standard Deviation 1.938 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -3.78 Score on a scale | Standard Deviation 2.092 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -3.66 Score on a scale | Standard Deviation 2.014 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -3.86 Score on a scale | Standard Deviation 2.135 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -4.49 Score on a scale | Standard Deviation 1.992 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -4.52 Score on a scale | Standard Deviation 2.046 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -2.98 Score on a scale | Standard Deviation 1.946 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -4.66 Score on a scale | Standard Deviation 2.07 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -3.73 Score on a scale | Standard Deviation 2.142 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -3.70 Score on a scale | Standard Deviation 2.063 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -3.78 Score on a scale | Standard Deviation 2.183 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -2.40 Score on a scale | Standard Deviation 2.777 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -2.37 Score on a scale | Standard Deviation 2.548 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -2.35 Score on a scale | Standard Deviation 2.788 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -2.38 Score on a scale | Standard Deviation 2.645 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -2.46 Score on a scale | Standard Deviation 2.847 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -2.31 Score on a scale | Standard Deviation 2.731 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -2.27 Score on a scale | Standard Deviation 2.605 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -2.38 Score on a scale | Standard Deviation 2.659 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -2.39 Score on a scale | Standard Deviation 2.626 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -2.57 Score on a scale | Standard Deviation 2.748 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -2.70 Score on a scale | Standard Deviation 2.634 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -2.28 Score on a scale | Standard Deviation 2.713 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -2.41 Score on a scale | Standard Deviation 2.697 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -2.65 Score on a scale | Standard Deviation 2.674 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -2.58 Score on a scale | Standard Deviation 2.665 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -2.64 Score on a scale | Standard Deviation 2.577 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -2.82 Score on a scale | Standard Deviation 2.571 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -2.66 Score on a scale | Standard Deviation 2.705 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -2.68 Score on a scale | Standard Deviation 2.674 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -2.78 Score on a scale | Standard Deviation 2.691 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -2.22 Score on a scale | Standard Deviation 2.736 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -2.23 Score on a scale | Standard Deviation 2.678 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -2.24 Score on a scale | Standard Deviation 2.655 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -2.21 Score on a scale | Standard Deviation 2.656 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -2.59 Score on a scale | Standard Deviation 2.653 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -2.64 Score on a scale | Standard Deviation 2.695 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -2.33 Score on a scale | Standard Deviation 2.564 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -2.33 Score on a scale | Standard Deviation 2.811 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -2.75 Score on a scale | Standard Deviation 2.753 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -2.08 Score on a scale | Standard Deviation 3.177 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -2.31 Score on a scale | Standard Deviation 3.823 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -1.64 Score on a scale | Standard Deviation 3.449 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -2.16 Score on a scale | Standard Deviation 3.87 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -1.95 Score on a scale | Standard Deviation 3.083 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -2.06 Score on a scale | Standard Deviation 3.875 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -1.58 Score on a scale | Standard Deviation 3.328 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -1.45 Score on a scale | Standard Deviation 3.332 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -2.05 Score on a scale | Standard Deviation 3.716 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -2.01 Score on a scale | Standard Deviation 3.73 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -1.78 Score on a scale | Standard Deviation 3.762 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -1.56 Score on a scale | Standard Deviation 3.318 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -1.99 Score on a scale | Standard Deviation 4.071 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -1.54 Score on a scale | Standard Deviation 3.221 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -1.80 Score on a scale | Standard Deviation 3.445 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -1.67 Score on a scale | Standard Deviation 3.413 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -1.46 Score on a scale | Standard Deviation 3.132 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -2.04 Score on a scale | Standard Deviation 3.351 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -2.12 Score on a scale | Standard Deviation 3.883 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -1.93 Score on a scale | Standard Deviation 3.202 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -1.87 Score on a scale | Standard Deviation 3.752 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -1.86 Score on a scale | Standard Deviation 3.39 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -1.81 Score on a scale | Standard Deviation 3.386 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -2.12 Score on a scale | Standard Deviation 3.904 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -1.64 Score on a scale | Standard Deviation 3.856 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -1.89 Score on a scale | Standard Deviation 3.459 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -1.86 Score on a scale | Standard Deviation 3.578 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -2.01 Score on a scale | Standard Deviation 3.719 |
| Placebo (Part 2) Continued From Part 1 Placebo | Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -1.78 Score on a scale | Standard Deviation 3.35 |
Secondary
Change in IGA (Investigator Global Assessment) From Baseline (Part 2)
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Time frame: Baseline to weeks 24, 28, 31, 36, 40, 44, 48 & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 32 | -2.00 Score on a scale | Standard Deviation 1 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 28 | -2.46 Score on a scale | Standard Deviation 0.967 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 24 | -2.31 Score on a scale | Standard Deviation 0.855 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 36 | -2.08 Score on a scale | Standard Deviation 1.188 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 40 | -2.08 Score on a scale | Standard Deviation 1.115 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 44 | -2.00 Score on a scale | Standard Deviation 1.155 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 48 | -1.69 Score on a scale | Standard Deviation 1.182 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 52 | -1.77 Score on a scale | Standard Deviation 1.301 |
| 250 mg (no LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 36 | -1.70 Score on a scale | Standard Deviation 1.38 |
| 250 mg (no LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 28 | -2.00 Score on a scale | Standard Deviation 1.155 |
| 250 mg (no LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 48 | -1.69 Score on a scale | Standard Deviation 1.469 |
| 250 mg (no LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 32 | -1.82 Score on a scale | Standard Deviation 1.314 |
| 250 mg (no LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 44 | -1.69 Score on a scale | Standard Deviation 1.447 |
| 250 mg (no LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 24 | -1.91 Score on a scale | Standard Deviation 1.026 |
| 250 mg (no LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 52 | -1.55 Score on a scale | Standard Deviation 1.434 |
| 250 mg (no LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 40 | -1.71 Score on a scale | Standard Deviation 1.395 |
| 125 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 52 | -1.64 Score on a scale | Standard Deviation 1.286 |
| 125 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 36 | -1.40 Score on a scale | Standard Deviation 1.174 |
| 125 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 44 | -1.73 Score on a scale | Standard Deviation 1.348 |
| 125 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 28 | -2.17 Score on a scale | Standard Deviation 1.193 |
| 125 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 48 | -1.60 Score on a scale | Standard Deviation 1.35 |
| 125 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 32 | -1.73 Score on a scale | Standard Deviation 1.348 |
| 125 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 24 | -2.00 Score on a scale | Standard Deviation 0.953 |
| 125 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 40 | -1.64 Score on a scale | Standard Deviation 1.286 |
| 62.5 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 28 | -1.46 Score on a scale | Standard Deviation 1.138 |
| 62.5 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 48 | -1.36 Score on a scale | Standard Deviation 1.367 |
| 62.5 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 52 | -1.36 Score on a scale | Standard Deviation 1.42 |
| 62.5 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 32 | -1.32 Score on a scale | Standard Deviation 1.188 |
| 62.5 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 36 | -1.29 Score on a scale | Standard Deviation 1.182 |
| 62.5 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 40 | -1.29 Score on a scale | Standard Deviation 1.301 |
| 62.5 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 24 | -1.82 Score on a scale | Standard Deviation 1.156 |
| 62.5 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 44 | -1.32 Score on a scale | Standard Deviation 1.335 |
| Placebo (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 40 | -2.36 Score on a scale | Standard Deviation 1.12 |
| Placebo (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 36 | -2.17 Score on a scale | Standard Deviation 1.115 |
| Placebo (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 52 | -2.18 Score on a scale | Standard Deviation 1.401 |
| Placebo (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 44 | -2.08 Score on a scale | Standard Deviation 1.084 |
| Placebo (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 28 | -2.25 Score on a scale | Standard Deviation 0.965 |
| Placebo (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 48 | -2.08 Score on a scale | Standard Deviation 1.24 |
| Placebo (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 32 | -2.33 Score on a scale | Standard Deviation 0.985 |
| Placebo (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 24 | -2.42 Score on a scale | Standard Deviation 0.793 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 28 | -1.74 Score on a scale | Standard Deviation 1.064 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 52 | -1.48 Score on a scale | Standard Deviation 1.214 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 32 | -1.75 Score on a scale | Standard Deviation 1.078 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 48 | -1.50 Score on a scale | Standard Deviation 1.137 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 40 | -1.75 Score on a scale | Standard Deviation 1.164 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 36 | -1.81 Score on a scale | Standard Deviation 1.23 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 44 | -1.63 Score on a scale | Standard Deviation 1.07 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 24 | -1.82 Score on a scale | Standard Deviation 1.131 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 52 | -2.00 Score on a scale | Standard Deviation 1.155 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 24 | -2.00 Score on a scale | Standard Deviation 1 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 32 | -1.71 Score on a scale | Standard Deviation 0.951 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 44 | -1.71 Score on a scale | Standard Deviation 1.113 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 40 | -1.86 Score on a scale | Standard Deviation 1.215 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 36 | -2.00 Score on a scale | Standard Deviation 1 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 28 | -1.71 Score on a scale | Standard Deviation 0.951 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 48 | -2.00 Score on a scale | Standard Deviation 1.414 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 24 | -1.73 Score on a scale | Standard Deviation 0.911 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 28 | -1.47 Score on a scale | Standard Deviation 0.961 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 32 | -1.41 Score on a scale | Standard Deviation 1.16 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 36 | -1.53 Score on a scale | Standard Deviation 1.344 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 40 | -1.58 Score on a scale | Standard Deviation 1.311 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 44 | -1.58 Score on a scale | Standard Deviation 1.259 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 52 | -1.65 Score on a scale | Standard Deviation 1.305 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 48 | -1.63 Score on a scale | Standard Deviation 1.351 |
| Placebo (Part 2) Continued From Part 1 Placebo | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 52 | -1.79 Score on a scale | Standard Deviation 1.672 |
| Placebo (Part 2) Continued From Part 1 Placebo | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 48 | -1.71 Score on a scale | Standard Deviation 1.59 |
| Placebo (Part 2) Continued From Part 1 Placebo | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 44 | -1.64 Score on a scale | Standard Deviation 1.393 |
| Placebo (Part 2) Continued From Part 1 Placebo | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 40 | -1.53 Score on a scale | Standard Deviation 1.302 |
| Placebo (Part 2) Continued From Part 1 Placebo | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 36 | -1.67 Score on a scale | Standard Deviation 1.234 |
| Placebo (Part 2) Continued From Part 1 Placebo | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 32 | -1.67 Score on a scale | Standard Deviation 1.234 |
| Placebo (Part 2) Continued From Part 1 Placebo | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 28 | -1.71 Score on a scale | Standard Deviation 1.383 |
| Placebo (Part 2) Continued From Part 1 Placebo | Change in IGA (Investigator Global Assessment) From Baseline (Part 2) | Week 24 | -1.63 Score on a scale | Standard Deviation 1.204 |
Secondary
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 2 | -0.33 Score on a scale | Standard Deviation 0.625 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 24 | -1.48 Score on a scale | Standard Deviation 1.205 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 20 | -1.43 Score on a scale | Standard Deviation 1.118 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 8 | -0.79 Score on a scale | Standard Deviation 0.976 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 4 | -0.57 Score on a scale | Standard Deviation 0.869 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 12 | -1.10 Score on a scale | Standard Deviation 1.024 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 16 | -1.23 Score on a scale | Standard Deviation 0.981 |
| 250 mg (no LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 16 | -0.99 Score on a scale | Standard Deviation 0.899 |
| 250 mg (no LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 12 | -0.87 Score on a scale | Standard Deviation 0.867 |
| 250 mg (no LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 4 | -0.38 Score on a scale | Standard Deviation 0.59 |
| 250 mg (no LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 2 | -0.21 Score on a scale | Standard Deviation 0.408 |
| 250 mg (no LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 20 | -1.17 Score on a scale | Standard Deviation 1.137 |
| 250 mg (no LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 8 | -0.74 Score on a scale | Standard Deviation 0.829 |
| 250 mg (no LD) KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 24 | -1.16 Score on a scale | Standard Deviation 1.241 |
| 125 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 12 | -1.04 Score on a scale | Standard Deviation 1.013 |
| 125 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 2 | -0.29 Score on a scale | Standard Deviation 0.54 |
| 125 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 4 | -0.45 Score on a scale | Standard Deviation 0.62 |
| 125 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 8 | -0.80 Score on a scale | Standard Deviation 0.9 |
| 125 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 16 | -0.96 Score on a scale | Standard Deviation 1.033 |
| 125 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 20 | -1.11 Score on a scale | Standard Deviation 1.12 |
| 125 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 24 | -1.32 Score on a scale | Standard Deviation 1.265 |
| 62.5 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 8 | -0.76 Score on a scale | Standard Deviation 0.709 |
| 62.5 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 16 | -1.09 Score on a scale | Standard Deviation 0.969 |
| 62.5 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 4 | -0.51 Score on a scale | Standard Deviation 0.661 |
| 62.5 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 24 | -1.16 Score on a scale | Standard Deviation 1.03 |
| 62.5 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 20 | -1.10 Score on a scale | Standard Deviation 0.981 |
| 62.5 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 2 | -0.23 Score on a scale | Standard Deviation 0.481 |
| 62.5 mg KY1005 (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 12 | -1.00 Score on a scale | Standard Deviation 0.973 |
| Placebo (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 8 | -0.32 Score on a scale | Standard Deviation 0.728 |
| Placebo (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 24 | -0.49 Score on a scale | Standard Deviation 0.959 |
| Placebo (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 20 | -0.45 Score on a scale | Standard Deviation 0.822 |
| Placebo (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 16 | -0.43 Score on a scale | Standard Deviation 0.757 |
| Placebo (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 4 | -0.31 Score on a scale | Standard Deviation 0.592 |
| Placebo (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 2 | -0.18 Score on a scale | Standard Deviation 0.503 |
| Placebo (Part 1) | Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1) | Week 12 | -0.36 Score on a scale | Standard Deviation 0.66 |
Secondary
Incidence Rate of Loss of EASI 50 (Part 2)
The incidence rate of loss of EASI 50 is calculated for participants who achieved EASI 50 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 50 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 50) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Time frame: Week 24 to week 52
Population: Participants who reached EASI 50 at week 24 and re-randomized participants at week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Incidence Rate of Loss of EASI 50 (Part 2) | 0 Events per patient-year |
| 250 mg (no LD) KY1005 (Part 1) | Incidence Rate of Loss of EASI 50 (Part 2) | 0.272 Events per patient-year |
| 125 mg KY1005 (Part 1) | Incidence Rate of Loss of EASI 50 (Part 2) | 0.188 Events per patient-year |
| 62.5 mg KY1005 (Part 1) | Incidence Rate of Loss of EASI 50 (Part 2) | 0.089 Events per patient-year |
| Placebo (Part 1) | Incidence Rate of Loss of EASI 50 (Part 2) | 0.165 Events per patient-year |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Incidence Rate of Loss of EASI 50 (Part 2) | 0.071 Events per patient-year |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Incidence Rate of Loss of EASI 50 (Part 2) | 0 Events per patient-year |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Incidence Rate of Loss of EASI 50 (Part 2) | 0.193 Events per patient-year |
| Placebo (Part 2) Continued From Part 1 Placebo | Incidence Rate of Loss of EASI 50 (Part 2) | 0.145 Events per patient-year |
Secondary
Incidence Rate of Loss of EASI 75 (Part 2)
The incidence rate of loss of EASI 75 is calculated for participants who achieved EASI 75 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 75 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 75) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Time frame: Week 24 to week 52
Population: Participants who reached EASI 75 at week 24 and re-randomized participants at week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Incidence Rate of Loss of EASI 75 (Part 2) | 0 Events per patient-year |
| 250 mg (no LD) KY1005 (Part 1) | Incidence Rate of Loss of EASI 75 (Part 2) | 0.587 Events per patient-year |
| 125 mg KY1005 (Part 1) | Incidence Rate of Loss of EASI 75 (Part 2) | 0.375 Events per patient-year |
| 62.5 mg KY1005 (Part 1) | Incidence Rate of Loss of EASI 75 (Part 2) | 0.486 Events per patient-year |
| Placebo (Part 1) | Incidence Rate of Loss of EASI 75 (Part 2) | 0.395 Events per patient-year |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Incidence Rate of Loss of EASI 75 (Part 2) | 0.446 Events per patient-year |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Incidence Rate of Loss of EASI 75 (Part 2) | 0.351 Events per patient-year |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Incidence Rate of Loss of EASI 75 (Part 2) | 0.573 Events per patient-year |
| Placebo (Part 2) Continued From Part 1 Placebo | Incidence Rate of Loss of EASI 75 (Part 2) | 0.646 Events per patient-year |
Secondary
Incidence Rate of Loss of IGA 0/1 (Part 2)
The incidence rate of loss of IGA 0/1 is calculated for participants who achieved IGA 0/1 at re-randomization (week 24). The incidence rate is computed as the number of participants losing IGA 0/1 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of IGA 0/1) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Time frame: Week 24 to week 68
Population: Participants who had IGA response 0 or 1 at week 24 and re-randomized at week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Incidence Rate of Loss of IGA 0/1 (Part 2) | 1.267 Events per patient-year |
| 250 mg (no LD) KY1005 (Part 1) | Incidence Rate of Loss of IGA 0/1 (Part 2) | 1.039 Events per patient-year |
| 125 mg KY1005 (Part 1) | Incidence Rate of Loss of IGA 0/1 (Part 2) | 0.981 Events per patient-year |
| 62.5 mg KY1005 (Part 1) | Incidence Rate of Loss of IGA 0/1 (Part 2) | 1.930 Events per patient-year |
| Placebo (Part 1) | Incidence Rate of Loss of IGA 0/1 (Part 2) | 1.154 Events per patient-year |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Incidence Rate of Loss of IGA 0/1 (Part 2) | 1.045 Events per patient-year |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Incidence Rate of Loss of IGA 0/1 (Part 2) | 1.096 Events per patient-year |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Incidence Rate of Loss of IGA 0/1 (Part 2) | 1.790 Events per patient-year |
| Placebo (Part 2) Continued From Part 1 Placebo | Incidence Rate of Loss of IGA 0/1 (Part 2) | 0.244 Events per patient-year |
Secondary
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Time frame: Baseline to weeks 2,4, 8,12,16, 20 and 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 2 | -27.94 Percentage of change | Standard Deviation 30.032 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 24 | -68.01 Percentage of change | Standard Deviation 36.052 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 20 | -67.85 Percentage of change | Standard Deviation 33.135 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 8 | -50.25 Percentage of change | Standard Deviation 30.666 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 4 | -36.85 Percentage of change | Standard Deviation 28.901 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 12 | -59.61 Percentage of change | Standard Deviation 30.717 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 16 | -62.35 Percentage of change | Standard Deviation 32.322 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 16 | -59.98 Percentage of change | Standard Deviation 37.444 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 12 | -50.15 Percentage of change | Standard Deviation 36.086 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 4 | -29.13 Percentage of change | Standard Deviation 42.013 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 2 | -17.75 Percentage of change | Standard Deviation 38.988 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 20 | -57.80 Percentage of change | Standard Deviation 38.921 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 8 | -41.21 Percentage of change | Standard Deviation 41.129 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 24 | -55.84 Percentage of change | Standard Deviation 40.299 |
| 125 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 12 | -55.23 Percentage of change | Standard Deviation 40.218 |
| 125 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 2 | -19.09 Percentage of change | Standard Deviation 39.499 |
| 125 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 4 | -35.10 Percentage of change | Standard Deviation 34.457 |
| 125 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 8 | -45.96 Percentage of change | Standard Deviation 38.15 |
| 125 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 16 | -52.50 Percentage of change | Standard Deviation 40.82 |
| 125 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 20 | -56.29 Percentage of change | Standard Deviation 43.103 |
| 125 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 24 | -56.72 Percentage of change | Standard Deviation 44.271 |
| 62.5 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 8 | -51.70 Percentage of change | Standard Deviation 31.046 |
| 62.5 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 16 | -61.51 Percentage of change | Standard Deviation 31.663 |
| 62.5 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 4 | -35.49 Percentage of change | Standard Deviation 38.786 |
| 62.5 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 24 | -57.37 Percentage of change | Standard Deviation 40.225 |
| 62.5 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 20 | -57.87 Percentage of change | Standard Deviation 38.977 |
| 62.5 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 2 | -26.03 Percentage of change | Standard Deviation 34.462 |
| 62.5 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 12 | -57.36 Percentage of change | Standard Deviation 34.275 |
| Placebo (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 8 | -28.70 Percentage of change | Standard Deviation 38.603 |
| Placebo (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 24 | -28.55 Percentage of change | Standard Deviation 44.004 |
| Placebo (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 20 | -30.32 Percentage of change | Standard Deviation 40.486 |
| Placebo (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 16 | -28.25 Percentage of change | Standard Deviation 41.173 |
| Placebo (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 4 | -27.56 Percentage of change | Standard Deviation 31.037 |
| Placebo (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 2 | -15.26 Percentage of change | Standard Deviation 34.143 |
| Placebo (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1) | Week 12 | -33.72 Percentage of change | Standard Deviation 35.358 |
Secondary
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -86.08 Percentage of change | Standard Deviation 24.896 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -71.66 Percentage of change | Standard Deviation 40.416 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -71.22 Percentage of change | Standard Deviation 40.152 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -84.46 Percentage of change | Standard Deviation 28.757 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -84.74 Percentage of change | Standard Deviation 28.948 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -91.71 Percentage of change | Standard Deviation 8.539 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -93.56 Percentage of change | Standard Deviation 8.382 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -86.56 Percentage of change | Standard Deviation 28.656 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -66.73 Percentage of change | Standard Deviation 44.328 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -69.33 Percentage of change | Standard Deviation 43.838 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -65.65 Percentage of change | Standard Deviation 44.932 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -65.18 Percentage of change | Standard Deviation 44.327 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -76.51 Percentage of change | Standard Deviation 38.401 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -61.78 Percentage of change | Standard Deviation 44.406 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -81.85 Percentage of change | Standard Deviation 31.624 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -81.47 Percentage of change | Standard Deviation 32.251 |
| 125 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -69.06 Percentage of change | Standard Deviation 38.468 |
| 125 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -66.61 Percentage of change | Standard Deviation 39.645 |
| 125 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -84.20 Percentage of change | Standard Deviation 16.741 |
| 125 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -69.41 Percentage of change | Standard Deviation 38.731 |
| 125 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -68.31 Percentage of change | Standard Deviation 38.024 |
| 125 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -79.34 Percentage of change | Standard Deviation 28.091 |
| 125 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -66.64 Percentage of change | Standard Deviation 39.631 |
| 125 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -68.09 Percentage of change | Standard Deviation 37.719 |
| 62.5 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -66.53 Percentage of change | Standard Deviation 43.437 |
| 62.5 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -56.30 Percentage of change | Standard Deviation 46.7 |
| 62.5 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -58.78 Percentage of change | Standard Deviation 44.767 |
| 62.5 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -53.59 Percentage of change | Standard Deviation 48.78 |
| 62.5 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -53.58 Percentage of change | Standard Deviation 48.725 |
| 62.5 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -57.39 Percentage of change | Standard Deviation 47.379 |
| 62.5 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -56.24 Percentage of change | Standard Deviation 46.469 |
| 62.5 mg KY1005 (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -72.72 Percentage of change | Standard Deviation 41.299 |
| Placebo (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -90.26 Percentage of change | Standard Deviation 12.961 |
| Placebo (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -87.78 Percentage of change | Standard Deviation 13.648 |
| Placebo (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -90.18 Percentage of change | Standard Deviation 12.912 |
| Placebo (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -90.68 Percentage of change | Standard Deviation 13.737 |
| Placebo (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -91.22 Percentage of change | Standard Deviation 13.203 |
| Placebo (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -89.09 Percentage of change | Standard Deviation 15.625 |
| Placebo (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -91.07 Percentage of change | Standard Deviation 13.744 |
| Placebo (Part 1) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -90.91 Percentage of change | Standard Deviation 10.585 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -74.18 Percentage of change | Standard Deviation 42.104 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -62.46 Percentage of change | Standard Deviation 63.983 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -57.47 Percentage of change | Standard Deviation 65.142 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -74.56 Percentage of change | Standard Deviation 39.811 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -75.64 Percentage of change | Standard Deviation 41.038 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -75.77 Percentage of change | Standard Deviation 40.984 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -64.68 Percentage of change | Standard Deviation 64.041 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -54.42 Percentage of change | Standard Deviation 65.177 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -88.02 Percentage of change | Standard Deviation 22.234 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -86.51 Percentage of change | Standard Deviation 22.331 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -85.81 Percentage of change | Standard Deviation 10.212 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -93.09 Percentage of change | Standard Deviation 6 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -95.55 Percentage of change | Standard Deviation 5.011 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -93.76 Percentage of change | Standard Deviation 4.96 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -83.57 Percentage of change | Standard Deviation 21.909 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -89.88 Percentage of change | Standard Deviation 6.304 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -69.76 Percentage of change | Standard Deviation 38.241 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -74.54 Percentage of change | Standard Deviation 31.665 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -67.27 Percentage of change | Standard Deviation 40.162 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -76.74 Percentage of change | Standard Deviation 30.922 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -66.63 Percentage of change | Standard Deviation 40.889 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -70.11 Percentage of change | Standard Deviation 37.802 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -69.98 Percentage of change | Standard Deviation 37.145 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -68.09 Percentage of change | Standard Deviation 34.85 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 24 | -78.51 Percentage of change | Standard Deviation 28.977 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 44 | -72.99 Percentage of change | Standard Deviation 33.353 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 48 | -70.92 Percentage of change | Standard Deviation 33.888 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 36 | -74.93 Percentage of change | Standard Deviation 32.664 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 52 | -72.04 Percentage of change | Standard Deviation 34.827 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 28 | -76.87 Percentage of change | Standard Deviation 31.377 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 32 | -71.98 Percentage of change | Standard Deviation 33.063 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2) | Week 40 | -74.05 Percentage of change | Standard Deviation 32.343 |
Secondary
Percentage Change in Affected BSA From Baseline (Part 1)
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 16 | -54.58 Percentage change | Standard Deviation 32.206 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 12 | -49.88 Percentage change | Standard Deviation 29.737 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 24 | -63.02 Percentage change | Standard Deviation 36.184 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 4 | -26.45 Percentage change | Standard Deviation 28.733 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 2 | -10.11 Percentage change | Standard Deviation 24.013 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 20 | -59.75 Percentage change | Standard Deviation 33.804 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 8 | -39.12 Percentage change | Standard Deviation 31.915 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 8 | -36.01 Percentage change | Standard Deviation 35.268 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 4 | -23.44 Percentage change | Standard Deviation 28.941 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 12 | -43.68 Percentage change | Standard Deviation 38.14 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 2 | -12.23 Percentage change | Standard Deviation 26.053 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 24 | -49.42 Percentage change | Standard Deviation 43.012 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 16 | -49.44 Percentage change | Standard Deviation 40.861 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 20 | -51.07 Percentage change | Standard Deviation 42.023 |
| 125 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 8 | -37.60 Percentage change | Standard Deviation 36.988 |
| 125 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 2 | -19.43 Percentage change | Standard Deviation 30.139 |
| 125 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 4 | -29.46 Percentage change | Standard Deviation 32.934 |
| 125 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 12 | -47.04 Percentage change | Standard Deviation 40.519 |
| 125 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 16 | -46.35 Percentage change | Standard Deviation 43.511 |
| 125 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 20 | -50.36 Percentage change | Standard Deviation 45.871 |
| 125 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 24 | -48.11 Percentage change | Standard Deviation 48.748 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 20 | -53.55 Percentage change | Standard Deviation 42.762 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 4 | -28.84 Percentage change | Standard Deviation 38.412 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 2 | -15.06 Percentage change | Standard Deviation 37.312 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 8 | -42.84 Percentage change | Standard Deviation 33.931 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 12 | -52.16 Percentage change | Standard Deviation 35.736 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 16 | -56.36 Percentage change | Standard Deviation 35.593 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 24 | -52.94 Percentage change | Standard Deviation 44.872 |
| Placebo (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 8 | -21.24 Percentage change | Standard Deviation 40.914 |
| Placebo (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 24 | -23.76 Percentage change | Standard Deviation 44.394 |
| Placebo (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 16 | -22.37 Percentage change | Standard Deviation 40.483 |
| Placebo (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 2 | -11.45 Percentage change | Standard Deviation 22.767 |
| Placebo (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 20 | -25.46 Percentage change | Standard Deviation 42.034 |
| Placebo (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 12 | -26.56 Percentage change | Standard Deviation 36.705 |
| Placebo (Part 1) | Percentage Change in Affected BSA From Baseline (Part 1) | Week 4 | -20.92 Percentage change | Standard Deviation 38.26 |
Secondary
Percentage Change in Affected BSA From Baseline (Part 2)
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 52 | -68.90 Percentage change | Standard Deviation 40.301 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 32 | -83.58 Percentage change | Standard Deviation 23.94 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 36 | -81.56 Percentage change | Standard Deviation 27.924 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 48 | -69.37 Percentage change | Standard Deviation 40.195 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 24 | -88.09 Percentage change | Standard Deviation 12.983 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 28 | -90.51 Percentage change | Standard Deviation 10.816 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 40 | -82.62 Percentage change | Standard Deviation 28.019 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 44 | -83.52 Percentage change | Standard Deviation 28.118 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 28 | -79.51 Percentage change | Standard Deviation 29.501 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 44 | -66.91 Percentage change | Standard Deviation 41.122 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 24 | -78.75 Percentage change | Standard Deviation 27.966 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 36 | -68.81 Percentage change | Standard Deviation 40.261 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 52 | -61.59 Percentage change | Standard Deviation 42.339 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 32 | -75.09 Percentage change | Standard Deviation 36.907 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 40 | -66.33 Percentage change | Standard Deviation 41.876 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 48 | -64.74 Percentage change | Standard Deviation 42.092 |
| 125 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 44 | -65.39 Percentage change | Standard Deviation 49.945 |
| 125 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 48 | -62.01 Percentage change | Standard Deviation 51.359 |
| 125 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 28 | -76.55 Percentage change | Standard Deviation 35.68 |
| 125 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 52 | -64.90 Percentage change | Standard Deviation 49.605 |
| 125 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 32 | -65.07 Percentage change | Standard Deviation 49.743 |
| 125 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 40 | -64.54 Percentage change | Standard Deviation 49.422 |
| 125 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 24 | -80.67 Percentage change | Standard Deviation 27.843 |
| 125 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 36 | -61.93 Percentage change | Standard Deviation 51.222 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 28 | -62.09 Percentage change | Standard Deviation 42.748 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 40 | -54.92 Percentage change | Standard Deviation 47.035 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 24 | -67.85 Percentage change | Standard Deviation 39.902 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 36 | -53.48 Percentage change | Standard Deviation 45.933 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 44 | -53.82 Percentage change | Standard Deviation 46.414 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 48 | -52.52 Percentage change | Standard Deviation 47.479 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 32 | -55.89 Percentage change | Standard Deviation 45.768 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 52 | -52.82 Percentage change | Standard Deviation 47.733 |
| Placebo (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 36 | -85.33 Percentage change | Standard Deviation 18.348 |
| Placebo (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 52 | -89.06 Percentage change | Standard Deviation 14.176 |
| Placebo (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 28 | -81.75 Percentage change | Standard Deviation 24.996 |
| Placebo (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 32 | -86.34 Percentage change | Standard Deviation 18.724 |
| Placebo (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 40 | -86.81 Percentage change | Standard Deviation 17.237 |
| Placebo (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 24 | -85.29 Percentage change | Standard Deviation 19.008 |
| Placebo (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 44 | -84.47 Percentage change | Standard Deviation 24.104 |
| Placebo (Part 1) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 48 | -85.70 Percentage change | Standard Deviation 19.04 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 48 | -64.73 Percentage change | Standard Deviation 42.7 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 28 | -73.28 Percentage change | Standard Deviation 40.454 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 24 | -71.05 Percentage change | Standard Deviation 39.9 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 44 | -69.38 Percentage change | Standard Deviation 41.133 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 36 | -74.73 Percentage change | Standard Deviation 40.57 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 40 | -72.10 Percentage change | Standard Deviation 41.016 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 32 | -74.61 Percentage change | Standard Deviation 40.429 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 52 | -62.25 Percentage change | Standard Deviation 42.451 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 32 | -90.31 Percentage change | Standard Deviation 10.263 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 40 | -94.09 Percentage change | Standard Deviation 5.083 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 48 | -87.79 Percentage change | Standard Deviation 16.209 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 28 | -88.57 Percentage change | Standard Deviation 5.8 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 44 | -81.11 Percentage change | Standard Deviation 19.107 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 52 | -85.46 Percentage change | Standard Deviation 16.921 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 24 | -80.52 Percentage change | Standard Deviation 14.717 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 36 | -89.70 Percentage change | Standard Deviation 10.552 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 52 | -68.75 Percentage change | Standard Deviation 39.935 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 32 | -66.90 Percentage change | Standard Deviation 35.357 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 28 | -72.98 Percentage change | Standard Deviation 30.947 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 40 | -66.00 Percentage change | Standard Deviation 43.207 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 36 | -63.85 Percentage change | Standard Deviation 46.152 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 44 | -66.54 Percentage change | Standard Deviation 41.241 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 48 | -62.58 Percentage change | Standard Deviation 48.827 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Affected BSA From Baseline (Part 2) | Week 24 | -74.02 Percentage change | Standard Deviation 31.419 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Affected BSA From Baseline (Part 2) | Week 40 | -72.08 Percentage change | Standard Deviation 39.691 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Affected BSA From Baseline (Part 2) | Week 24 | -72.91 Percentage change | Standard Deviation 34.317 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Affected BSA From Baseline (Part 2) | Week 28 | -75.14 Percentage change | Standard Deviation 37.955 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Affected BSA From Baseline (Part 2) | Week 32 | -69.74 Percentage change | Standard Deviation 38.644 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Affected BSA From Baseline (Part 2) | Week 36 | -72.34 Percentage change | Standard Deviation 39.621 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Affected BSA From Baseline (Part 2) | Week 52 | -68.78 Percentage change | Standard Deviation 41.236 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Affected BSA From Baseline (Part 2) | Week 44 | -70.30 Percentage change | Standard Deviation 40.56 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Affected BSA From Baseline (Part 2) | Week 48 | -68.01 Percentage change | Standard Deviation 40.428 |
Secondary
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Time frame: Baseline to weeks 16, & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 16 | -40.56 Percentage of change | Standard Deviation 37.34 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 24 | -45.18 Percentage of change | Standard Deviation 42.438 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 16 | -33.42 Percentage of change | Standard Deviation 34.745 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 24 | -36.20 Percentage of change | Standard Deviation 41.363 |
| 125 mg KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 16 | -36.42 Percentage of change | Standard Deviation 37.103 |
| 125 mg KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 24 | -40.45 Percentage of change | Standard Deviation 40.708 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 24 | -39.35 Percentage of change | Standard Deviation 31.799 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 16 | -38.72 Percentage of change | Standard Deviation 30.762 |
| Placebo (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 16 | -17.04 Percentage of change | Standard Deviation 32.553 |
| Placebo (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1) | Week 24 | -12.31 Percentage of change | Standard Deviation 37.504 |
Secondary
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Time frame: Baseline to weeks 24, 36 & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -69.01 Percentage of change | Standard Deviation 29.493 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -66.75 Percentage of change | Standard Deviation 32.632 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -69.93 Percentage of change | Standard Deviation 26.25 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -50.38 Percentage of change | Standard Deviation 42.649 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -57.08 Percentage of change | Standard Deviation 37.656 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -54.77 Percentage of change | Standard Deviation 34.128 |
| 125 mg KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -50.01 Percentage of change | Standard Deviation 37.199 |
| 125 mg KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -52.75 Percentage of change | Standard Deviation 41.167 |
| 125 mg KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -56.01 Percentage of change | Standard Deviation 36.112 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -47.15 Percentage of change | Standard Deviation 39.681 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -49.97 Percentage of change | Standard Deviation 34.078 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -50.87 Percentage of change | Standard Deviation 33.197 |
| Placebo (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -65.46 Percentage of change | Standard Deviation 26.823 |
| Placebo (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -67.84 Percentage of change | Standard Deviation 32.469 |
| Placebo (Part 1) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -69.73 Percentage of change | Standard Deviation 28.925 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -53.10 Percentage of change | Standard Deviation 40.207 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -58.44 Percentage of change | Standard Deviation 43.34 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -41.39 Percentage of change | Standard Deviation 43.875 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -64.19 Percentage of change | Standard Deviation 28.274 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -63.92 Percentage of change | Standard Deviation 29.784 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -62.63 Percentage of change | Standard Deviation 23.13 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -48.59 Percentage of change | Standard Deviation 38.274 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -50.66 Percentage of change | Standard Deviation 33.458 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -50.29 Percentage of change | Standard Deviation 41.341 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 24 | -44.95 Percentage of change | Standard Deviation 45.331 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 52 | -53.35 Percentage of change | Standard Deviation 47.196 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2) | Week 36 | -49.42 Percentage of change | Standard Deviation 45.902 |
Secondary
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Time frame: Baseline to weeks 2, 8, 16, 20, & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 20 | -47.48 Percentage of change | Standard Deviation 40.616 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 24 | -51.84 Percentage of change | Standard Deviation 41.442 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 8 | -36.87 Percentage of change | Standard Deviation 36.954 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 2 | -22.68 Percentage of change | Standard Deviation 31.305 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 16 | -46.69 Percentage of change | Standard Deviation 40.563 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 20 | -42.90 Percentage of change | Standard Deviation 46.336 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 16 | -41.27 Percentage of change | Standard Deviation 43.616 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 2 | -11.95 Percentage of change | Standard Deviation 47.921 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 24 | -42.36 Percentage of change | Standard Deviation 45.55 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 8 | -36.14 Percentage of change | Standard Deviation 41.176 |
| 125 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 16 | -34.02 Percentage of change | Standard Deviation 62.565 |
| 125 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 2 | -16.80 Percentage of change | Standard Deviation 41.68 |
| 125 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 8 | -27.54 Percentage of change | Standard Deviation 59.199 |
| 125 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 20 | -35.79 Percentage of change | Standard Deviation 67.398 |
| 125 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 24 | -33.28 Percentage of change | Standard Deviation 72.816 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 24 | -45.63 Percentage of change | Standard Deviation 33.86 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 2 | -22.73 Percentage of change | Standard Deviation 32.711 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 20 | -44.33 Percentage of change | Standard Deviation 36.816 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 16 | -48.96 Percentage of change | Standard Deviation 29.801 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 8 | -45.85 Percentage of change | Standard Deviation 32.198 |
| Placebo (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 16 | -11.35 Percentage of change | Standard Deviation 51.739 |
| Placebo (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 20 | -12.08 Percentage of change | Standard Deviation 49.973 |
| Placebo (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 2 | -10.30 Percentage of change | Standard Deviation 37.999 |
| Placebo (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 24 | -11.91 Percentage of change | Standard Deviation 55.694 |
| Placebo (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1) | Week 8 | -13.12 Percentage of change | Standard Deviation 42.775 |
Secondary
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized Participants at week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -53.62 Percentage of change | Standard Deviation 36.496 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -59.02 Percentage of change | Standard Deviation 36.676 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -63.03 Percentage of change | Standard Deviation 41.237 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -75.53 Percentage of change | Standard Deviation 26.705 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -72.50 Percentage of change | Standard Deviation 37.184 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -68.19 Percentage of change | Standard Deviation 38.039 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -65.76 Percentage of change | Standard Deviation 35.792 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -69.26 Percentage of change | Standard Deviation 34.172 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -61.64 Percentage of change | Standard Deviation 35.809 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -45.68 Percentage of change | Standard Deviation 59.933 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -48.69 Percentage of change | Standard Deviation 56.833 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -43.64 Percentage of change | Standard Deviation 56.804 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -48.12 Percentage of change | Standard Deviation 56.61 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -45.33 Percentage of change | Standard Deviation 60.47 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -62.65 Percentage of change | Standard Deviation 43.216 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -44.78 Percentage of change | Standard Deviation 59.798 |
| 125 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -63.97 Percentage of change | Standard Deviation 43.622 |
| 125 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -61.68 Percentage of change | Standard Deviation 42.315 |
| 125 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -58.29 Percentage of change | Standard Deviation 42.112 |
| 125 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -71.77 Percentage of change | Standard Deviation 29.97 |
| 125 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -60.50 Percentage of change | Standard Deviation 41.018 |
| 125 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -61.04 Percentage of change | Standard Deviation 42.716 |
| 125 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -63.04 Percentage of change | Standard Deviation 42.005 |
| 125 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -64.74 Percentage of change | Standard Deviation 31.091 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -35.98 Percentage of change | Standard Deviation 57.915 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -36.52 Percentage of change | Standard Deviation 58.909 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -33.21 Percentage of change | Standard Deviation 59.514 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -44.26 Percentage of change | Standard Deviation 57.217 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -44.81 Percentage of change | Standard Deviation 56.575 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -33.25 Percentage of change | Standard Deviation 58.48 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -31.65 Percentage of change | Standard Deviation 55.087 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -35.86 Percentage of change | Standard Deviation 58.071 |
| Placebo (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -72.47 Percentage of change | Standard Deviation 27.818 |
| Placebo (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -76.32 Percentage of change | Standard Deviation 31.166 |
| Placebo (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -72.35 Percentage of change | Standard Deviation 33.768 |
| Placebo (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -73.10 Percentage of change | Standard Deviation 28.704 |
| Placebo (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -70.02 Percentage of change | Standard Deviation 28.76 |
| Placebo (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -79.13 Percentage of change | Standard Deviation 24.98 |
| Placebo (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -77.14 Percentage of change | Standard Deviation 26.277 |
| Placebo (Part 1) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -72.31 Percentage of change | Standard Deviation 27.268 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -47.08 Percentage of change | Standard Deviation 82.439 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -48.86 Percentage of change | Standard Deviation 83.936 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -52.16 Percentage of change | Standard Deviation 84.141 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -40.20 Percentage of change | Standard Deviation 84.24 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -35.27 Percentage of change | Standard Deviation 85.953 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -46.41 Percentage of change | Standard Deviation 84.277 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -50.15 Percentage of change | Standard Deviation 83.141 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -39.27 Percentage of change | Standard Deviation 83.804 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -72.98 Percentage of change | Standard Deviation 17.074 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -70.77 Percentage of change | Standard Deviation 27.653 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -65.28 Percentage of change | Standard Deviation 26.807 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -70.04 Percentage of change | Standard Deviation 26.437 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -71.56 Percentage of change | Standard Deviation 28.287 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -83.18 Percentage of change | Standard Deviation 16.284 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -78.26 Percentage of change | Standard Deviation 23.932 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -60.44 Percentage of change | Standard Deviation 28.925 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -49.15 Percentage of change | Standard Deviation 43.228 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -50.82 Percentage of change | Standard Deviation 41.018 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -49.24 Percentage of change | Standard Deviation 43.003 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -55.36 Percentage of change | Standard Deviation 33.443 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -55.62 Percentage of change | Standard Deviation 34.382 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -52.99 Percentage of change | Standard Deviation 36.735 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -49.75 Percentage of change | Standard Deviation 42.024 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -49.48 Percentage of change | Standard Deviation 43.137 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 40 | -38.69 Percentage of change | Standard Deviation 80.196 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 36 | -45.04 Percentage of change | Standard Deviation 65.63 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 32 | -41.18 Percentage of change | Standard Deviation 68.097 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 28 | -41.13 Percentage of change | Standard Deviation 80.192 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 24 | -48.30 Percentage of change | Standard Deviation 57.726 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 52 | -57.12 Percentage of change | Standard Deviation 44.899 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 48 | -57.92 Percentage of change | Standard Deviation 45.339 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2) | Week 44 | -48.21 Percentage of change | Standard Deviation 48.871 |
Secondary
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Time frame: Baseline to week 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage change from baseline in EASI at Day 169 (Week 24). Missing data were imputed by multiple imputation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) | -64.4 percentage of change | Standard Error 5.17 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) | -52.2 percentage of change | Standard Error 5.14 |
| 125 mg KY1005 (Part 1) | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) | -53.7 percentage of change | Standard Error 5.08 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) | -54.4 percentage of change | Standard Error 5.09 |
| Placebo (Part 1) | Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1) | -27.6 percentage of change | Standard Error 5.29 |
p-value: <0.000195% CI: [-49.8, -23.8]ANCOVA
p-value: 0.000295% CI: [-37.7, -11.6]ANCOVA
p-value: <0.000195% CI: [-39.2, -13.1]ANCOVA
p-value: <0.000195% CI: [-39.7, -13.9]ANCOVA
Secondary
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Time frame: Baseline to weeks 8, 16, 20, & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 8 | -18.40 Percentage of change | Standard Deviation 46.151 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 16 | -18.12 Percentage of change | Standard Deviation 56.175 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 20 | -20.15 Percentage of change | Standard Deviation 65.506 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 24 | -13.22 Percentage of change | Standard Deviation 97.953 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 8 | -11.76 Percentage of change | Standard Deviation 48.829 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 24 | -8.67 Percentage of change | Standard Deviation 60.563 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 16 | -11.72 Percentage of change | Standard Deviation 54.678 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 20 | -7.39 Percentage of change | Standard Deviation 62.693 |
| 125 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 24 | -17.75 Percentage of change | Standard Deviation 52.049 |
| 125 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 16 | -15.84 Percentage of change | Standard Deviation 54.001 |
| 125 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 20 | -17.62 Percentage of change | Standard Deviation 59.518 |
| 125 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 8 | -10.22 Percentage of change | Standard Deviation 56.395 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 8 | -13.15 Percentage of change | Standard Deviation 69.427 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 16 | -17.47 Percentage of change | Standard Deviation 94.346 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 24 | -12.07 Percentage of change | Standard Deviation 120.061 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 20 | -25.97 Percentage of change | Standard Deviation 83.249 |
| Placebo (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 24 | -8.17 Percentage of change | Standard Deviation 77.872 |
| Placebo (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 20 | -5.02 Percentage of change | Standard Deviation 78.18 |
| Placebo (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 16 | 2.82 Percentage of change | Standard Deviation 101.93 |
| Placebo (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1) | Week 8 | -0.66 Percentage of change | Standard Deviation 77.969 |
Secondary
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -2.42 Percentage of change | Standard Deviation 54.527 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -8.10 Percentage of change | Standard Deviation 67.182 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -19.06 Percentage of change | Standard Deviation 60.844 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | 11.76 Percentage of change | Standard Deviation 84.979 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -18.57 Percentage of change | Standard Deviation 53.87 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | -13.29 Percentage of change | Standard Deviation 60.249 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -28.01 Percentage of change | Standard Deviation 54.369 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -14.15 Percentage of change | Standard Deviation 60.66 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -14.02 Percentage of change | Standard Deviation 82.893 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -4.47 Percentage of change | Standard Deviation 95.509 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | -18.23 Percentage of change | Standard Deviation 79.025 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -22.56 Percentage of change | Standard Deviation 67.645 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -17.89 Percentage of change | Standard Deviation 76.693 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -5.30 Percentage of change | Standard Deviation 88.418 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -7.59 Percentage of change | Standard Deviation 92.868 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -9.44 Percentage of change | Standard Deviation 81.662 |
| 125 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -29.10 Percentage of change | Standard Deviation 52.035 |
| 125 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -28.27 Percentage of change | Standard Deviation 51.499 |
| 125 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -30.97 Percentage of change | Standard Deviation 51.945 |
| 125 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -6.28 Percentage of change | Standard Deviation 62.772 |
| 125 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -13.70 Percentage of change | Standard Deviation 44.085 |
| 125 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -34.27 Percentage of change | Standard Deviation 48.841 |
| 125 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -23.23 Percentage of change | Standard Deviation 56.824 |
| 125 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | 7.25 Percentage of change | Standard Deviation 82.513 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -17.92 Percentage of change | Standard Deviation 53.098 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -21.89 Percentage of change | Standard Deviation 53.01 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -19.98 Percentage of change | Standard Deviation 56.405 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -31.88 Percentage of change | Standard Deviation 49.1 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -20.31 Percentage of change | Standard Deviation 63.189 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -13.63 Percentage of change | Standard Deviation 65.697 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | -21.32 Percentage of change | Standard Deviation 50.659 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -22.30 Percentage of change | Standard Deviation 51.02 |
| Placebo (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -8.75 Percentage of change | Standard Deviation 85.214 |
| Placebo (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -11.36 Percentage of change | Standard Deviation 87.084 |
| Placebo (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | 4.22 Percentage of change | Standard Deviation 96.782 |
| Placebo (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | 4.24 Percentage of change | Standard Deviation 91.941 |
| Placebo (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -15.90 Percentage of change | Standard Deviation 85.382 |
| Placebo (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -20.28 Percentage of change | Standard Deviation 49.825 |
| Placebo (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | 4.97 Percentage of change | Standard Deviation 88.017 |
| Placebo (Part 1) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | 0.43 Percentage of change | Standard Deviation 85.522 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | -40.11 Percentage of change | Standard Deviation 67.991 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -43.96 Percentage of change | Standard Deviation 68.306 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -30.93 Percentage of change | Standard Deviation 71.891 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -39.36 Percentage of change | Standard Deviation 69.672 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -32.24 Percentage of change | Standard Deviation 65.07 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -14.22 Percentage of change | Standard Deviation 78.739 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -37.19 Percentage of change | Standard Deviation 71.372 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -30.52 Percentage of change | Standard Deviation 66.305 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -51.27 Percentage of change | Standard Deviation 29.96 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -46.94 Percentage of change | Standard Deviation 22.063 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | -56.66 Percentage of change | Standard Deviation 33.879 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -42.56 Percentage of change | Standard Deviation 27.759 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -60.77 Percentage of change | Standard Deviation 35.19 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -41.44 Percentage of change | Standard Deviation 37.143 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -49.58 Percentage of change | Standard Deviation 31.509 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -59.23 Percentage of change | Standard Deviation 37.434 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -32.73 Percentage of change | Standard Deviation 57.357 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | -35.92 Percentage of change | Standard Deviation 46.888 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -32.59 Percentage of change | Standard Deviation 49.531 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -22.38 Percentage of change | Standard Deviation 58.898 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -32.62 Percentage of change | Standard Deviation 49.764 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -23.84 Percentage of change | Standard Deviation 50.933 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -36.32 Percentage of change | Standard Deviation 47.746 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -33.17 Percentage of change | Standard Deviation 41.412 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 44 | -22.21 Percentage of change | Standard Deviation 80.062 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 48 | -34.95 Percentage of change | Standard Deviation 67.833 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 32 | -38.06 Percentage of change | Standard Deviation 69.176 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 52 | -18.16 Percentage of change | Standard Deviation 69.31 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 24 | -32.55 Percentage of change | Standard Deviation 66.184 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 36 | -9.11 Percentage of change | Standard Deviation 110.289 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 40 | -1.02 Percentage of change | Standard Deviation 98.096 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2) | Week 28 | -38.39 Percentage of change | Standard Deviation 77.03 |
Secondary
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Time frame: Baseline to weeks 4, 8, 12, 16, 20, & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 16 | -37.08 Percentage of change | Standard Deviation 52.391 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 12 | -36.22 Percentage of change | Standard Deviation 43.169 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 24 | -44.69 Percentage of change | Standard Deviation 61.808 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 20 | -44.03 Percentage of change | Standard Deviation 38.85 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 8 | -33.06 Percentage of change | Standard Deviation 41.272 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 4 | -20.81 Percentage of change | Standard Deviation 34.179 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 16 | -34.71 Percentage of change | Standard Deviation 34.574 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 8 | -26.52 Percentage of change | Standard Deviation 33.397 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 12 | -32.42 Percentage of change | Standard Deviation 32.145 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 4 | -21.02 Percentage of change | Standard Deviation 31.36 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 20 | -34.23 Percentage of change | Standard Deviation 38.938 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 24 | -33.91 Percentage of change | Standard Deviation 48.273 |
| 125 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 12 | -33.33 Percentage of change | Standard Deviation 33.732 |
| 125 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 8 | -26.62 Percentage of change | Standard Deviation 34.946 |
| 125 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 16 | -32.78 Percentage of change | Standard Deviation 36.449 |
| 125 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 20 | -37.38 Percentage of change | Standard Deviation 38.448 |
| 125 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 4 | -22.77 Percentage of change | Standard Deviation 30.783 |
| 125 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 24 | -36.65 Percentage of change | Standard Deviation 40.947 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 16 | -35.49 Percentage of change | Standard Deviation 32.862 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 8 | -34.60 Percentage of change | Standard Deviation 31.584 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 20 | -35.37 Percentage of change | Standard Deviation 36.589 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 4 | -17.94 Percentage of change | Standard Deviation 30.152 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 12 | -34.61 Percentage of change | Standard Deviation 34.275 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 24 | -36.81 Percentage of change | Standard Deviation 34.444 |
| Placebo (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 16 | -8.12 Percentage of change | Standard Deviation 45.515 |
| Placebo (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 4 | -8.99 Percentage of change | Standard Deviation 39.554 |
| Placebo (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 24 | -6.98 Percentage of change | Standard Deviation 49.837 |
| Placebo (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 12 | -8.04 Percentage of change | Standard Deviation 41.445 |
| Placebo (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 8 | -6.28 Percentage of change | Standard Deviation 42.851 |
| Placebo (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1) | Week 20 | -8.32 Percentage of change | Standard Deviation 44.942 |
Secondary
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Time frame: Baseline to weeks 24, 32, 36, 40. 44, 48, & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified timepoints are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -54.68 Percentage of change | Standard Deviation 45.987 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -62.85 Percentage of change | Standard Deviation 38.659 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -60.09 Percentage of change | Standard Deviation 40.508 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -72.61 Percentage of change | Standard Deviation 19.898 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -64.90 Percentage of change | Standard Deviation 38.029 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -54.56 Percentage of change | Standard Deviation 46.38 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -60.83 Percentage of change | Standard Deviation 40.648 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -51.53 Percentage of change | Standard Deviation 44.857 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -50.03 Percentage of change | Standard Deviation 44.543 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -48.48 Percentage of change | Standard Deviation 47.524 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -61.00 Percentage of change | Standard Deviation 30.657 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -44.35 Percentage of change | Standard Deviation 45.524 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -44.51 Percentage of change | Standard Deviation 43.725 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -48.61 Percentage of change | Standard Deviation 43.883 |
| 125 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -54.05 Percentage of change | Standard Deviation 38.147 |
| 125 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -52.24 Percentage of change | Standard Deviation 36.218 |
| 125 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -57.09 Percentage of change | Standard Deviation 34.068 |
| 125 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -55.93 Percentage of change | Standard Deviation 35.043 |
| 125 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -56.00 Percentage of change | Standard Deviation 35.875 |
| 125 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -54.47 Percentage of change | Standard Deviation 34.319 |
| 125 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -54.47 Percentage of change | Standard Deviation 35.815 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -35.37 Percentage of change | Standard Deviation 42.309 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -33.73 Percentage of change | Standard Deviation 38.724 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -30.25 Percentage of change | Standard Deviation 43.11 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -29.38 Percentage of change | Standard Deviation 46.373 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -30.61 Percentage of change | Standard Deviation 39.689 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -46.08 Percentage of change | Standard Deviation 37.356 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -37.89 Percentage of change | Standard Deviation 40.032 |
| Placebo (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -59.17 Percentage of change | Standard Deviation 35.572 |
| Placebo (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -58.18 Percentage of change | Standard Deviation 46.077 |
| Placebo (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -52.64 Percentage of change | Standard Deviation 47.556 |
| Placebo (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -60.03 Percentage of change | Standard Deviation 30.545 |
| Placebo (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -64.21 Percentage of change | Standard Deviation 28.981 |
| Placebo (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -66.78 Percentage of change | Standard Deviation 27.084 |
| Placebo (Part 1) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -58.98 Percentage of change | Standard Deviation 33.289 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -43.45 Percentage of change | Standard Deviation 42.459 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -58.12 Percentage of change | Standard Deviation 38.754 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -57.38 Percentage of change | Standard Deviation 37.436 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -51.61 Percentage of change | Standard Deviation 35.438 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -50.10 Percentage of change | Standard Deviation 37.814 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -55.82 Percentage of change | Standard Deviation 36.229 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -51.56 Percentage of change | Standard Deviation 39.299 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -44.04 Percentage of change | Standard Deviation 58.904 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -48.82 Percentage of change | Standard Deviation 63.478 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -36.09 Percentage of change | Standard Deviation 53.637 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -49.79 Percentage of change | Standard Deviation 55.862 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -64.00 Percentage of change | Standard Deviation 20.049 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -57.54 Percentage of change | Standard Deviation 59.987 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -47.30 Percentage of change | Standard Deviation 57.463 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -43.35 Percentage of change | Standard Deviation 40 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -50.45 Percentage of change | Standard Deviation 41.809 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -43.01 Percentage of change | Standard Deviation 45.577 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -43.75 Percentage of change | Standard Deviation 40.933 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -46.42 Percentage of change | Standard Deviation 38.011 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -43.16 Percentage of change | Standard Deviation 39.688 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -45.63 Percentage of change | Standard Deviation 34.579 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 40 | -42.88 Percentage of change | Standard Deviation 45.567 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 24 | -47.92 Percentage of change | Standard Deviation 40.572 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 48 | -43.48 Percentage of change | Standard Deviation 48.292 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 32 | -43.95 Percentage of change | Standard Deviation 50.962 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 44 | -46.19 Percentage of change | Standard Deviation 46.429 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 36 | -44.58 Percentage of change | Standard Deviation 45.387 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2) | Week 52 | -47.62 Percentage of change | Standard Deviation 50.785 |
Secondary
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Time frame: Baseline to weeks 4, 8, 12, 16, 20, & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 4 | -22.02 Percentage of change | Standard Deviation 22.05 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 8 | -31.84 Percentage of change | Standard Deviation 24.549 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 12 | -40.32 Percentage of change | Standard Deviation 25.145 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 16 | -43.25 Percentage of change | Standard Deviation 26.555 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 20 | -49.92 Percentage of change | Standard Deviation 28.279 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 24 | -57.87 Percentage of change | Standard Deviation 32.609 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 20 | -42.07 Percentage of change | Standard Deviation 32.179 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 24 | -41.04 Percentage of change | Standard Deviation 34.212 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 4 | -18.52 Percentage of change | Standard Deviation 20.315 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 12 | -33.64 Percentage of change | Standard Deviation 26.502 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 16 | -37.18 Percentage of change | Standard Deviation 28.395 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 8 | -30.00 Percentage of change | Standard Deviation 28.05 |
| 125 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 16 | -37.33 Percentage of change | Standard Deviation 29.071 |
| 125 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 20 | -42.30 Percentage of change | Standard Deviation 32.422 |
| 125 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 4 | -22.76 Percentage of change | Standard Deviation 20.903 |
| 125 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 12 | -39.38 Percentage of change | Standard Deviation 27.228 |
| 125 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 8 | -30.47 Percentage of change | Standard Deviation 26.26 |
| 125 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 24 | -42.58 Percentage of change | Standard Deviation 35.812 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 16 | -41.44 Percentage of change | Standard Deviation 26.134 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 8 | -32.07 Percentage of change | Standard Deviation 23.6 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 12 | -39.22 Percentage of change | Standard Deviation 26.807 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 24 | -41.49 Percentage of change | Standard Deviation 29.263 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 20 | -39.05 Percentage of change | Standard Deviation 28.347 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 4 | -21.42 Percentage of change | Standard Deviation 21.101 |
| Placebo (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 20 | -20.88 Percentage of change | Standard Deviation 28.527 |
| Placebo (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 12 | -20.70 Percentage of change | Standard Deviation 24.587 |
| Placebo (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 8 | -18.27 Percentage of change | Standard Deviation 23.875 |
| Placebo (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 24 | -22.21 Percentage of change | Standard Deviation 33.233 |
| Placebo (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 16 | -20.87 Percentage of change | Standard Deviation 26.791 |
| Placebo (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1) | Week 4 | -16.67 Percentage of change | Standard Deviation 21.045 |
Secondary
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Time frame: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -72.44 Percentage of change | Standard Deviation 25.786 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -78.39 Percentage of change | Standard Deviation 16.236 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -76.47 Percentage of change | Standard Deviation 11.581 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -60.41 Percentage of change | Standard Deviation 36.686 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -59.99 Percentage of change | Standard Deviation 35.979 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -67.26 Percentage of change | Standard Deviation 31.749 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -71.43 Percentage of change | Standard Deviation 31.643 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -71.50 Percentage of change | Standard Deviation 31.364 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -53.71 Percentage of change | Standard Deviation 39.548 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -59.37 Percentage of change | Standard Deviation 33.889 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -55.13 Percentage of change | Standard Deviation 35.598 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -54.79 Percentage of change | Standard Deviation 38.533 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -54.96 Percentage of change | Standard Deviation 38.272 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -63.35 Percentage of change | Standard Deviation 28.625 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -49.90 Percentage of change | Standard Deviation 40.104 |
| 250 mg (no LD) KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -63.86 Percentage of change | Standard Deviation 27.005 |
| 125 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -53.42 Percentage of change | Standard Deviation 34.955 |
| 125 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -62.58 Percentage of change | Standard Deviation 32.229 |
| 125 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -54.10 Percentage of change | Standard Deviation 37.251 |
| 125 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -51.85 Percentage of change | Standard Deviation 37.053 |
| 125 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -51.66 Percentage of change | Standard Deviation 37.347 |
| 125 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -60.09 Percentage of change | Standard Deviation 26.373 |
| 125 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -49.88 Percentage of change | Standard Deviation 36.111 |
| 125 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -49.68 Percentage of change | Standard Deviation 35.129 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -43.78 Percentage of change | Standard Deviation 36.278 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -45.48 Percentage of change | Standard Deviation 41.426 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -44.49 Percentage of change | Standard Deviation 35.89 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -52.12 Percentage of change | Standard Deviation 35.95 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -46.81 Percentage of change | Standard Deviation 39.055 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -57.73 Percentage of change | Standard Deviation 34.302 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -44.93 Percentage of change | Standard Deviation 40.527 |
| 62.5 mg KY1005 (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -46.95 Percentage of change | Standard Deviation 39.736 |
| Placebo (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -68.39 Percentage of change | Standard Deviation 21.143 |
| Placebo (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -75.08 Percentage of change | Standard Deviation 21.563 |
| Placebo (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -69.62 Percentage of change | Standard Deviation 29.104 |
| Placebo (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -73.34 Percentage of change | Standard Deviation 22.409 |
| Placebo (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -72.55 Percentage of change | Standard Deviation 15.422 |
| Placebo (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -74.37 Percentage of change | Standard Deviation 23.066 |
| Placebo (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -74.34 Percentage of change | Standard Deviation 22.474 |
| Placebo (Part 1) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -74.03 Percentage of change | Standard Deviation 21.589 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -61.69 Percentage of change | Standard Deviation 32.214 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -63.79 Percentage of change | Standard Deviation 31.71 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -58.96 Percentage of change | Standard Deviation 31.26 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -61.12 Percentage of change | Standard Deviation 34.217 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -57.94 Percentage of change | Standard Deviation 33.953 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -54.55 Percentage of change | Standard Deviation 34.719 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -52.47 Percentage of change | Standard Deviation 35.396 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -62.38 Percentage of change | Standard Deviation 31.104 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -64.22 Percentage of change | Standard Deviation 18.649 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -65.97 Percentage of change | Standard Deviation 34.709 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -64.07 Percentage of change | Standard Deviation 16.853 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -67.92 Percentage of change | Standard Deviation 35.766 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -64.24 Percentage of change | Standard Deviation 20.73 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -58.19 Percentage of change | Standard Deviation 33.365 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -70.27 Percentage of change | Standard Deviation 22.037 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -66.12 Percentage of change | Standard Deviation 19.532 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -52.89 Percentage of change | Standard Deviation 34.032 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -52.47 Percentage of change | Standard Deviation 31.788 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -54.29 Percentage of change | Standard Deviation 35.851 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -56.19 Percentage of change | Standard Deviation 34.46 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -54.56 Percentage of change | Standard Deviation 34.785 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -53.98 Percentage of change | Standard Deviation 29.707 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -53.95 Percentage of change | Standard Deviation 35.053 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -55.75 Percentage of change | Standard Deviation 26.945 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 44 | -55.26 Percentage of change | Standard Deviation 39.204 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 36 | -58.72 Percentage of change | Standard Deviation 36.827 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 32 | -56.11 Percentage of change | Standard Deviation 38.003 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 40 | -54.24 Percentage of change | Standard Deviation 36.614 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 48 | -56.30 Percentage of change | Standard Deviation 39.696 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 52 | -58.86 Percentage of change | Standard Deviation 40.701 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 28 | -62.81 Percentage of change | Standard Deviation 36.3 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2) | Week 24 | -60.13 Percentage of change | Standard Deviation 33.848 |
Secondary
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 12 | 3.9 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 4 | 2.6 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 16 | 3.9 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 24 | 7.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 8 | 2.6 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 2 | 0 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 20 | 6.5 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 12 | 2.6 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 20 | 6.4 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 16 | 1.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 8 | 5.1 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 4 | 0 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 2 | 1.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 24 | 6.4 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 2 | 0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 4 | 0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 8 | 1.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 12 | 2.6 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 16 | 2.6 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 20 | 3.9 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 24 | 9.1 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 20 | 2.5 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 4 | 0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 2 | 0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 24 | 1.3 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 8 | 0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 12 | 2.5 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 16 | 1.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 24 | 3.8 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 16 | 1.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 8 | 0 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 2 | 0 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 20 | 1.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 4 | 0 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1) | Week 12 | 0 Percentage of participants |
Secondary
Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1)
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear,1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD.
Time frame: Baseline to week 16 and week 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage of patients with a response of IGA 0 or 1 and a reduction from baseline of ≥ 2 points at Days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) | Week 16 | 22.1 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) | Week 24 | 45.5 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) | Week 16 | 14.1 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) | Week 24 | 33.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) | Week 16 | 19.5 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) | Week 24 | 40.3 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) | Week 24 | 29.1 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) | Week 16 | 25.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) | Week 16 | 5.1 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1) | Week 24 | 11.4 Percentage of participants |
Comparison: Week 16p-value: 0.002295% CI: [0.06, 0.27]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.056295% CI: [0, 0.18]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.005495% CI: [0.04, 0.24]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.000395% CI: [0.1, 0.31]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: <0.000195% CI: [0.21, 0.47]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.000895% CI: [0.1, 0.34]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: <0.000195% CI: [0.16, 0.41]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.004695% CI: [0.06, 0.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)
The IGA is a five-point scale that provides a global clinical assessment of AD (Atopic Dermatitis) severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Time frame: Baseline to weeks 2, 4, 8,12,16,20 & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 16 | 22.1 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 8 | 9.1 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 20 | 33.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 2 | 1.3 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 12 | 16.9 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 4 | 5.2 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 24 | 45.5 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 16 | 14.1 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 24 | 33.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 20 | 25.6 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 12 | 12.8 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 8 | 9.0 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 4 | 1.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 2 | 0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 4 | 1.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 8 | 13.0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 12 | 19.5 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 16 | 19.5 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 20 | 27.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 24 | 40.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 2 | 0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 24 | 29.1 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 8 | 5.1 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 4 | 2.5 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 2 | 0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 12 | 19.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 16 | 25.3 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 20 | 21.5 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 2 | 1.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 20 | 8.9 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 12 | 3.8 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 4 | 2.5 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 24 | 11.4 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 8 | 5.1 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1) | Week 16 | 5.1 Percentage of participants |
Secondary
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participant with missing data were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 2 | 19.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 24 | 66.2 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 20 | 63.6 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 8 | 45.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 4 | 29.9 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 12 | 62.3 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 16 | 63.6 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 16 | 52.6 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 12 | 44.9 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 4 | 21.8 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 2 | 15.4 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 20 | 51.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 8 | 38.5 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 24 | 43.6 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 12 | 61.0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 2 | 16.9 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 4 | 39.0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 8 | 53.2 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 16 | 57.1 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 20 | 58.4 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 24 | 55.8 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 8 | 54.4 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 16 | 65.8 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 4 | 39.2 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 24 | 53.2 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 20 | 58.2 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 2 | 22.8 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 12 | 62.0 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 8 | 27.8 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 24 | 24.1 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 20 | 25.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 16 | 27.8 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 4 | 24.1 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 2 | 13.9 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1) | Week 12 | 26.6 Percentage of participants |
Secondary
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Time frame: Baseline to week 16 and week 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage of patients with at least 75% reduction from baseline in EASI (EASI 5) at days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) | Week 16 | 40.3 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) | Week 24 | 54.5 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) | Week 16 | 38.5 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) | Week 24 | 38.5 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) | Week 16 | 42.9 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) | Week 24 | 49.4 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) | Week 24 | 40.5 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) | Week 16 | 40.5 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) | Week 16 | 11.4 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1) | Week 24 | 17.7 Percentage of participants |
Comparison: Week 16p-value: <0.000195% CI: [0.16, 0.42]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.000195% CI: [0.14, 0.4]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.000195% CI: [0.18, 0.44]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.000195% CI: [0.16, 0.42]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: <0.000195% CI: [0.23, 0.5]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.00495% CI: [0.07, 0.34]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [0.17, 0.45]Cochran-Mantel-Haenszel
p-value: 0.001695% CI: [0.09, 0.36]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Time frame: Baseline at weeks 2, 4, 8, 12, 16, 20 and 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 2 | 9.1 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 24 | 54.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 20 | 49.4 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 8 | 23.4 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 4 | 9.1 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 12 | 33.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 16 | 40.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 16 | 38.5 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 12 | 25.6 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 4 | 9.0 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 2 | 2.6 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 20 | 42.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 8 | 16.7 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 24 | 38.5 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 12 | 44.2 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 2 | 2.6 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 4 | 11.7 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 8 | 27.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 16 | 42.9 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 20 | 48.1 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 24 | 49.4 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 8 | 25.3 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 16 | 40.5 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 4 | 11.4 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 24 | 40.5 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 20 | 40.5 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 2 | 2.5 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 12 | 43.0 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 8 | 8.9 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 24 | 17.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 20 | 13.9 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 16 | 11.4 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 4 | 6.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 2 | 5.1 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1) | Week 12 | 11.4 Percentage of participants |
Secondary
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 16 | 15.6 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 12 | 10.4 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 8 | 7.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 20 | 27.3 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 2 | 2.6 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 4 | 6.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 24 | 37.7 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 12 | 9.0 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 2 | 1.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 4 | 1.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 8 | 7.7 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 16 | 14.1 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 20 | 23.1 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 24 | 26.9 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 20 | 24.7 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 12 | 14.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 2 | 0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 4 | 1.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 8 | 9.1 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 24 | 32.5 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 16 | 16.9 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 24 | 24.1 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 20 | 19.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 16 | 19.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 12 | 12.7 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 4 | 2.5 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 2 | 1.3 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 8 | 8.9 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 16 | 3.8 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 2 | 0 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 12 | 5.1 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 8 | 1.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 20 | 7.6 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 4 | 0 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1) | Week 24 | 11.4 Percentage of participants |
Secondary
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1)
Time frame: Baseline through week 24
Population: Safety Analysis Part 1:Participants who took at least a dose of study treatment, including placebo up to Week 24. Analysis based on the SAF1 was based on the treatment received, regardless of assigned treatment according to the randomization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1) | Any Treatment Emergent Adverse Event | 66.2 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1) | Any Serious Treatment Emergent Adverse Event | 2.6 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1) | Any Treatment Emergent Adverse Event | 66.7 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1) | Any Serious Treatment Emergent Adverse Event | 0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1) | Any Treatment Emergent Adverse Event | 67.5 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1) | Any Serious Treatment Emergent Adverse Event | 1.3 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1) | Any Serious Treatment Emergent Adverse Event | 6.4 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1) | Any Treatment Emergent Adverse Event | 67.9 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1) | Any Treatment Emergent Adverse Event | 60.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1) | Any Serious Treatment Emergent Adverse Event | 1.3 Percentage of participants |
Secondary
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2)
Time frame: Week 24 through week 68
Population: Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least a dose of study treatment on/or after Week 24. Any analysis based on the SAF2 was based on the treatment at Week 24, regardless of treatment according to the randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Treatment Emergent Adverse Event | 84.6 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Serious Treatment Emergent Adverse Event | 7.7 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Treatment Emergent Adverse Event | 67.6 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Serious Treatment Emergent Adverse Event | 2.9 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Treatment Emergent Adverse Event | 63.6 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Serious Treatment Emergent Adverse Event | 0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Treatment Emergent Adverse Event | 78.6 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Serious Treatment Emergent Adverse Event | 7.1 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Treatment Emergent Adverse Event | 66.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Serious Treatment Emergent Adverse Event | 8.3 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Serious Treatment Emergent Adverse Event | 0 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Treatment Emergent Adverse Event | 87.5 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Serious Treatment Emergent Adverse Event | 0 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Treatment Emergent Adverse Event | 57.1 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Treatment Emergent Adverse Event | 67.6 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Serious Treatment Emergent Adverse Event | 0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Treatment Emergent Adverse Event | 66.7 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2) | Any Serious Treatment Emergent Adverse Event | 0 Percentage of participants |
Secondary
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Time frame: Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 7 | 16.9 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 2 | 3.9 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 3 | 9.1 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 4 | 10.4 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 5 | 15.6 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 6 | 10.4 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 1 | 2.6 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 8 | 22.1 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 9 | 20.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 10 | 27.3 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 11 | 26.0 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 12 | 26.0 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 13 | 28.6 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 14 | 35.1 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 15 | 29.9 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 16 | 32.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 17 | 32.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 18 | 36.4 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 19 | 35.1 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 20 | 33.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 21 | 37.7 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 22 | 37.7 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 23 | 41.6 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 24 | 40.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 1 | 1.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 21 | 32.1 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 22 | 30.8 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 11 | 23.1 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 18 | 33.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 7 | 23.1 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 3 | 6.4 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 20 | 30.8 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 12 | 20.5 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 9 | 19.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 19 | 32.1 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 23 | 35.9 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 6 | 19.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 13 | 26.9 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 17 | 30.8 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 5 | 15.4 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 2 | 6.4 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 4 | 14.1 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 14 | 29.5 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 16 | 33.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 10 | 23.1 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 24 | 30.8 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 8 | 17.9 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 15 | 28.2 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 20 | 31.2 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 8 | 22.1 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 16 | 29.9 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 23 | 37.7 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 17 | 27.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 19 | 33.8 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 4 | 15.6 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 18 | 29.9 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 9 | 27.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 5 | 16.9 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 24 | 36.4 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 10 | 28.6 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 21 | 33.8 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 3 | 10.4 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 11 | 31.2 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 22 | 33.8 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 12 | 28.6 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 7 | 20.8 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 2 | 1.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 13 | 29.9 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 15 | 28.6 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 14 | 28.6 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 6 | 18.2 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 1 | 1.3 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 5 | 19.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 6 | 21.5 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 7 | 25.3 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 21 | 36.7 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 8 | 26.6 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 9 | 31.6 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 10 | 38.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 11 | 36.7 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 12 | 38.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 22 | 39.2 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 13 | 38.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 14 | 40.5 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 24 | 39.2 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 15 | 40.5 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 16 | 41.8 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 17 | 38.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 23 | 43.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 18 | 43.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 19 | 43.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 1 | 1.3 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 2 | 6.3 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 20 | 36.7 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 3 | 7.6 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 4 | 13.9 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 16 | 10.1 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 15 | 10.1 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 14 | 13.9 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 4 | 7.6 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 1 | 1.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 22 | 13.9 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 13 | 13.9 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 12 | 16.5 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 8 | 15.2 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 2 | 2.5 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 7 | 11.4 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 11 | 13.9 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 10 | 15.2 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 6 | 12.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 3 | 6.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 20 | 10.1 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 9 | 13.9 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 21 | 15.2 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 23 | 12.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 18 | 12.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 17 | 13.9 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 5 | 11.4 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 19 | 15.2 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1) | Week 24 | 11.4 Percentage of participants |
Secondary
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Time frame: Baseline to week 16 and week 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Proportion of patients with improvement (reduction) of weekly average of pruritus NRS ≥ 4 a baseline pruritus NRS of ≥ 4 from baseline to Days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) | Week 16 | 24.7 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) | Week 24 | 31.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) | Week 16 | 19.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) | Week 24 | 24.4 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) | Week 16 | 20.8 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) | Week 24 | 28.6 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) | Week 24 | 27.8 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) | Week 16 | 22.8 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) | Week 16 | 5.1 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1) | Week 24 | 7.6 Percentage of participants |
Comparison: Week 16p-value: 0.000695% CI: [0.09, 0.3]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.005795% CI: [0.04, 0.24]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.003895% CI: [0.05, 0.26]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.001195% CI: [0.07, 0.28]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.000295% CI: [0.11, 0.35]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.003895% CI: [0.06, 0.28]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.000695% CI: [0.09, 0.32]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.000895% CI: [9, 32]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Time frame: Baseline to weeks week 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported. Participants with missing data were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 40 | 53.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 37 | 53.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 39 | 53.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 38 | 53.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 24 | 53.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 51 | 30.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 26 | 53.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 50 | 38.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 27 | 61.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 49 | 38.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 28 | 61.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 48 | 38.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 29 | 69.2 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 47 | 46.2 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 30 | 61.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 46 | 53.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 31 | 61.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 52 | 46.2 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 45 | 61.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 32 | 61.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 25 | 53.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 44 | 61.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 33 | 61.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 43 | 53.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 34 | 61.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 42 | 53.8 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 35 | 61.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 41 | 61.5 Percentage of participants |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 36 | 61.5 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 39 | 41.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 24 | 41.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 49 | 41.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 42 | 38.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 28 | 35.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 48 | 35.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 29 | 38.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 47 | 38.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 35 | 41.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 30 | 44.1 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 52 | 29.4 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 46 | 44.1 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 31 | 41.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 45 | 41.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 41 | 35.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 32 | 47.1 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 44 | 38.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 40 | 38.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 36 | 38.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 33 | 47.1 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 25 | 41.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 43 | 35.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 37 | 41.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 38 | 35.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 34 | 41.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 51 | 32.4 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 26 | 38.2 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 50 | 35.3 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 27 | 35.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 50 | 50.0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 46 | 50.0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 38 | 50.0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 31 | 58.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 45 | 41.7 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 41 | 41.7 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 51 | 41.7 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 32 | 50.0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 40 | 33.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 44 | 41.7 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 34 | 75.0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 25 | 66.7 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 33 | 58.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 26 | 66.7 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 43 | 50.0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 49 | 50.0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 42 | 50.0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 37 | 50.0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 28 | 66.7 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 48 | 41.7 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 24 | 75.0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 29 | 50.0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 52 | 41.7 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 47 | 33.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 39 | 50.0 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 27 | 58.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 35 | 66.7 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 36 | 58.3 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 30 | 58.3 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 51 | 28.6 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 46 | 28.6 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 27 | 28.6 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 50 | 32.1 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 35 | 21.4 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 25 | 39.3 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 26 | 32.1 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 49 | 35.7 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 31 | 25.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 41 | 28.6 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 45 | 21.4 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 30 | 25.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 38 | 25.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 24 | 35.7 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 36 | 21.4 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 40 | 25.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 39 | 25.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 32 | 25.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 37 | 28.6 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 44 | 21.4 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 47 | 28.6 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 42 | 28.6 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 28 | 35.7 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 34 | 21.4 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 52 | 25.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 48 | 28.6 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 33 | 28.6 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 29 | 25.0 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 43 | 28.6 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 38 | 58.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 24 | 58.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 25 | 66.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 26 | 58.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 27 | 58.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 28 | 58.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 29 | 58.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 30 | 66.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 31 | 66.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 32 | 75.0 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 33 | 58.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 34 | 75.0 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 35 | 66.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 36 | 66.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 37 | 66.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 39 | 58.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 40 | 58.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 41 | 66.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 42 | 66.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 43 | 58.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 44 | 75.0 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 45 | 75.0 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 46 | 50.0 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 47 | 58.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 48 | 66.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 49 | 66.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 50 | 66.7 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 51 | 58.3 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 52 | 66.7 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 40 | 36.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 51 | 27.3 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 49 | 30.3 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 52 | 27.3 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 37 | 42.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 29 | 45.5 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 24 | 45.5 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 47 | 30.3 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 27 | 39.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 46 | 27.3 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 28 | 42.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 48 | 27.3 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 34 | 30.3 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 42 | 36.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 38 | 42.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 33 | 42.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 25 | 39.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 43 | 36.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 39 | 39.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 36 | 42.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 32 | 42.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 50 | 24.2 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 44 | 39.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 26 | 33.3 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 35 | 39.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 31 | 36.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 45 | 36.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 41 | 39.4 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 30 | 36.4 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 26 | 71.4 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 46 | 42.9 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 49 | 57.1 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 31 | 42.9 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 43 | 42.9 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 41 | 57.1 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 29 | 57.1 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 25 | 57.1 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 50 | 57.1 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 51 | 42.9 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 47 | 42.9 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 37 | 71.4 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 32 | 71.4 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 27 | 71.4 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 30 | 42.9 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 28 | 57.1 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 45 | 42.9 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 48 | 57.1 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 24 | 71.4 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 34 | 42.9 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 44 | 42.9 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 40 | 28.6 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 35 | 71.4 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 42 | 42.9 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 36 | 71.4 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 38 | 71.4 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 52 | 57.1 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 39 | 71.4 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 33 | 71.4 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 49 | 40.0 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 40 | 31.4 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 35 | 34.3 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 41 | 34.3 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 34 | 37.1 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 51 | 34.3 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 42 | 31.4 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 33 | 40.0 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 43 | 34.3 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 32 | 40.0 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 44 | 37.1 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 31 | 40.0 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 24 | 45.7 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 45 | 40.0 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 30 | 42.9 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 46 | 37.1 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 29 | 40.0 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 47 | 45.7 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 28 | 37.1 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 48 | 37.1 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 27 | 37.1 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 36 | 40.0 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 26 | 42.9 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 50 | 37.1 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 25 | 37.1 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 38 | 31.4 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 37 | 37.1 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 52 | 40.0 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 39 | 31.4 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 34 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 49 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 26 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 41 | 31.3 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 45 | 31.3 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 31 | 18.8 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 44 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 24 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 32 | 18.8 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 39 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 50 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 25 | 31.3 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 35 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 43 | 31.3 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 51 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 33 | 18.8 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 42 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 40 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 38 | 18.8 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 52 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 37 | 18.8 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 48 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 27 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 36 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 28 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 47 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 29 | 25.0 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 46 | 31.3 Percentage of participants |
| Placebo (Part 2) Continued From Part 1 Placebo | Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2) | Week 30 | 18.8 Percentage of participants |
Secondary
Percentage of Participants With Treatment-emergent ADA (Part 1)
Time frame: Baseline through week 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Treatment-emergent ADA (Part 1) | 2.6 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Treatment-emergent ADA (Part 1) | 6.4 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Treatment-emergent ADA (Part 1) | 13.2 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Treatment-emergent ADA (Part 1) | 32.1 Percentage of participants |
Secondary
Percentage of Participants With Treatment-emergent ADA (Part 2)
Time frame: Baseline through week 68
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percentage of Participants With Treatment-emergent ADA (Part 2) | 7.7 Percentage of participants |
| 250 mg (no LD) KY1005 (Part 1) | Percentage of Participants With Treatment-emergent ADA (Part 2) | 9.1 Percentage of participants |
| 125 mg KY1005 (Part 1) | Percentage of Participants With Treatment-emergent ADA (Part 2) | 9.1 Percentage of participants |
| 62.5 mg KY1005 (Part 1) | Percentage of Participants With Treatment-emergent ADA (Part 2) | 19.2 Percentage of participants |
| Placebo (Part 1) | Percentage of Participants With Treatment-emergent ADA (Part 2) | 0 Percentage of participants |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percentage of Participants With Treatment-emergent ADA (Part 2) | 35.5 Percentage of participants |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percentage of Participants With Treatment-emergent ADA (Part 2) | 28.6 Percentage of participants |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percentage of Participants With Treatment-emergent ADA (Part 2) | 42.4 Percentage of participants |
Secondary
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Time frame: Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 & 24
Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 7 | -15.89 Percentage of change | Standard Deviation 28.992 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 2 | -7.50 Percentage of change | Standard Deviation 20.644 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 3 | -11.08 Percentage of change | Standard Deviation 24.712 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 4 | -12.16 Percentage of change | Standard Deviation 25.287 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 5 | -12.58 Percentage of change | Standard Deviation 27.613 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 6 | -13.73 Percentage of change | Standard Deviation 25.374 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 1 | -6.26 Percentage of change | Standard Deviation 16.312 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 8 | -18.41 Percentage of change | Standard Deviation 31.375 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 9 | -18.83 Percentage of change | Standard Deviation 32.003 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 10 | -21.19 Percentage of change | Standard Deviation 32.11 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 11 | -21.93 Percentage of change | Standard Deviation 31.966 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 12 | -22.59 Percentage of change | Standard Deviation 32.927 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 13 | -23.88 Percentage of change | Standard Deviation 33.561 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 14 | -23.87 Percentage of change | Standard Deviation 34.926 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 15 | -24.40 Percentage of change | Standard Deviation 34.899 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 16 | -26.85 Percentage of change | Standard Deviation 36.332 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 17 | -27.81 Percentage of change | Standard Deviation 35.262 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 18 | -28.78 Percentage of change | Standard Deviation 36.738 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 19 | -28.98 Percentage of change | Standard Deviation 36.372 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 20 | -30.61 Percentage of change | Standard Deviation 37.215 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 21 | -30.40 Percentage of change | Standard Deviation 36.928 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 22 | -31.81 Percentage of change | Standard Deviation 38.1 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 23 | -34.26 Percentage of change | Standard Deviation 38.693 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 24 | -34.70 Percentage of change | Standard Deviation 38.656 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 1 | -7.25 Percentage of change | Standard Deviation 13.575 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 21 | -29.63 Percentage of change | Standard Deviation 34.869 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 22 | -30.35 Percentage of change | Standard Deviation 36.881 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 11 | -22.37 Percentage of change | Standard Deviation 26.321 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 18 | -29.49 Percentage of change | Standard Deviation 34.514 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 7 | -20.18 Percentage of change | Standard Deviation 25.476 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 3 | -12.11 Percentage of change | Standard Deviation 18.977 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 20 | -29.30 Percentage of change | Standard Deviation 34.365 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 12 | -22.05 Percentage of change | Standard Deviation 28.445 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 9 | -20.36 Percentage of change | Standard Deviation 25.407 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 19 | -29.78 Percentage of change | Standard Deviation 35.087 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 23 | -30.30 Percentage of change | Standard Deviation 35.236 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 6 | -17.59 Percentage of change | Standard Deviation 25.814 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 13 | -24.71 Percentage of change | Standard Deviation 30.761 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 17 | -29.27 Percentage of change | Standard Deviation 33.331 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 5 | -18.64 Percentage of change | Standard Deviation 23.725 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 2 | -10.37 Percentage of change | Standard Deviation 19.307 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 4 | -16.73 Percentage of change | Standard Deviation 22.997 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 14 | -26.45 Percentage of change | Standard Deviation 32.87 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 16 | -27.92 Percentage of change | Standard Deviation 33.619 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 10 | -22.53 Percentage of change | Standard Deviation 25.815 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 24 | -30.44 Percentage of change | Standard Deviation 36.696 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 8 | -19.99 Percentage of change | Standard Deviation 24.992 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 15 | -27.46 Percentage of change | Standard Deviation 33.838 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 20 | -29.48 Percentage of change | Standard Deviation 32.361 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 8 | -21.14 Percentage of change | Standard Deviation 24.981 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 16 | -30.75 Percentage of change | Standard Deviation 30.46 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 23 | -30.52 Percentage of change | Standard Deviation 35.354 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 17 | -29.68 Percentage of change | Standard Deviation 31.753 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 19 | -29.83 Percentage of change | Standard Deviation 31.632 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 4 | -18.37 Percentage of change | Standard Deviation 19.932 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 18 | -29.89 Percentage of change | Standard Deviation 31.2 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 9 | -25.45 Percentage of change | Standard Deviation 24.895 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 5 | -19.20 Percentage of change | Standard Deviation 21.9 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 24 | -30.64 Percentage of change | Standard Deviation 36.647 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 10 | -24.46 Percentage of change | Standard Deviation 28.28 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 21 | -31.61 Percentage of change | Standard Deviation 32.551 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 3 | -14.11 Percentage of change | Standard Deviation 17.784 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 11 | -27.67 Percentage of change | Standard Deviation 28.079 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 22 | -31.15 Percentage of change | Standard Deviation 33.763 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 12 | -26.52 Percentage of change | Standard Deviation 28.426 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 7 | -21.18 Percentage of change | Standard Deviation 23.816 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 2 | -9.86 Percentage of change | Standard Deviation 14.734 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 13 | -28.18 Percentage of change | Standard Deviation 29.401 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 15 | -28.87 Percentage of change | Standard Deviation 31.207 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 14 | -29.19 Percentage of change | Standard Deviation 30.904 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 6 | -18.68 Percentage of change | Standard Deviation 22.79 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 1 | -6.18 Percentage of change | Standard Deviation 13.809 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 5 | -20.17 Percentage of change | Standard Deviation 25.112 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 6 | -21.29 Percentage of change | Standard Deviation 28.179 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 7 | -24.03 Percentage of change | Standard Deviation 27.65 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 21 | -33.20 Percentage of change | Standard Deviation 33.098 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 8 | -26.10 Percentage of change | Standard Deviation 27.81 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 9 | -29.18 Percentage of change | Standard Deviation 27.455 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 10 | -29.43 Percentage of change | Standard Deviation 28.109 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 11 | -31.26 Percentage of change | Standard Deviation 29.641 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 12 | -31.23 Percentage of change | Standard Deviation 30.323 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 22 | -33.28 Percentage of change | Standard Deviation 32.108 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 13 | -31.36 Percentage of change | Standard Deviation 31.724 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 14 | -32.57 Percentage of change | Standard Deviation 31.719 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 24 | -33.26 Percentage of change | Standard Deviation 32.433 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 15 | -32.01 Percentage of change | Standard Deviation 30.98 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 16 | -31.97 Percentage of change | Standard Deviation 31.194 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 17 | -32.60 Percentage of change | Standard Deviation 31.851 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 23 | -35.25 Percentage of change | Standard Deviation 33.102 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 18 | -32.50 Percentage of change | Standard Deviation 32.096 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 19 | -32.77 Percentage of change | Standard Deviation 33.698 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 1 | -6.05 Percentage of change | Standard Deviation 13.049 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 2 | -11.20 Percentage of change | Standard Deviation 18.124 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 20 | -31.85 Percentage of change | Standard Deviation 32.767 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 3 | -12.08 Percentage of change | Standard Deviation 22.244 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 4 | -14.95 Percentage of change | Standard Deviation 24.356 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 16 | -6.62 Percentage of change | Standard Deviation 30.591 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 15 | -6.87 Percentage of change | Standard Deviation 29.583 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 14 | -7.60 Percentage of change | Standard Deviation 31.351 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 4 | -9.83 Percentage of change | Standard Deviation 24.266 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 1 | -3.70 Percentage of change | Standard Deviation 16.432 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 22 | -9.36 Percentage of change | Standard Deviation 34.161 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 13 | -10.05 Percentage of change | Standard Deviation 32.122 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 12 | -10.62 Percentage of change | Standard Deviation 32.707 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 8 | -10.51 Percentage of change | Standard Deviation 29.803 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 2 | -5.63 Percentage of change | Standard Deviation 15.34 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 7 | -10.18 Percentage of change | Standard Deviation 28.308 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 11 | -12.73 Percentage of change | Standard Deviation 31.638 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 10 | -12.99 Percentage of change | Standard Deviation 33.194 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 6 | -12.43 Percentage of change | Standard Deviation 27.184 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 3 | -7.89 Percentage of change | Standard Deviation 22.004 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 20 | -8.56 Percentage of change | Standard Deviation 32.725 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 9 | -13.34 Percentage of change | Standard Deviation 32.225 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 21 | -9.71 Percentage of change | Standard Deviation 34.201 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 23 | -7.23 Percentage of change | Standard Deviation 32.486 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 18 | -6.37 Percentage of change | Standard Deviation 31.752 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 17 | -7.46 Percentage of change | Standard Deviation 31.529 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 5 | -10.14 Percentage of change | Standard Deviation 29.071 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 19 | -9.50 Percentage of change | Standard Deviation 33.411 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1) | Week 24 | -6.66 Percentage of change | Standard Deviation 32.55 |
Secondary
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Time frame: Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52
Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -42.94 Percentage of change | Standard Deviation 43.748 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -45.95 Percentage of change | Standard Deviation 35.161 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -43.54 Percentage of change | Standard Deviation 42.937 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -43.12 Percentage of change | Standard Deviation 42.814 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -49.61 Percentage of change | Standard Deviation 33.036 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -34.31 Percentage of change | Standard Deviation 43.008 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -51.62 Percentage of change | Standard Deviation 32.197 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -36.14 Percentage of change | Standard Deviation 44.279 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -52.09 Percentage of change | Standard Deviation 32.613 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -36.35 Percentage of change | Standard Deviation 44.233 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -52.36 Percentage of change | Standard Deviation 32.642 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -36.53 Percentage of change | Standard Deviation 44.443 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -50.48 Percentage of change | Standard Deviation 35.634 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -40.77 Percentage of change | Standard Deviation 44.58 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -44.79 Percentage of change | Standard Deviation 34.219 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -42.11 Percentage of change | Standard Deviation 45.119 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -46.03 Percentage of change | Standard Deviation 34.355 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -35.06 Percentage of change | Standard Deviation 42.961 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -47.27 Percentage of change | Standard Deviation 40.996 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -46.40 Percentage of change | Standard Deviation 35.233 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -52.15 Percentage of change | Standard Deviation 31.579 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -43.47 Percentage of change | Standard Deviation 44 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -48.66 Percentage of change | Standard Deviation 36.625 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -42.86 Percentage of change | Standard Deviation 43.495 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -47.09 Percentage of change | Standard Deviation 35.098 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -41.68 Percentage of change | Standard Deviation 42.874 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -46.67 Percentage of change | Standard Deviation 36.047 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -42.33 Percentage of change | Standard Deviation 43.065 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -46.63 Percentage of change | Standard Deviation 36.326 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -31.75 Percentage of change | Standard Deviation 48.313 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -38.71 Percentage of change | Standard Deviation 44.259 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -31.23 Percentage of change | Standard Deviation 48.493 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -30.76 Percentage of change | Standard Deviation 50.332 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -34.80 Percentage of change | Standard Deviation 45.063 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -33.50 Percentage of change | Standard Deviation 48.912 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -34.13 Percentage of change | Standard Deviation 44.735 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -31.88 Percentage of change | Standard Deviation 48.778 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -33.99 Percentage of change | Standard Deviation 48.416 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -37.91 Percentage of change | Standard Deviation 46.288 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -30.54 Percentage of change | Standard Deviation 49.791 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -33.68 Percentage of change | Standard Deviation 49.356 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -37.18 Percentage of change | Standard Deviation 49.311 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -33.33 Percentage of change | Standard Deviation 50.319 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -30.85 Percentage of change | Standard Deviation 48.9 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -34.68 Percentage of change | Standard Deviation 47.719 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -31.71 Percentage of change | Standard Deviation 49.607 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -30.52 Percentage of change | Standard Deviation 48.657 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -33.43 Percentage of change | Standard Deviation 48.72 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -33.52 Percentage of change | Standard Deviation 48.881 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -36.78 Percentage of change | Standard Deviation 45.402 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -30.51 Percentage of change | Standard Deviation 48.2 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -34.42 Percentage of change | Standard Deviation 48.542 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -31.62 Percentage of change | Standard Deviation 47.534 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -30.56 Percentage of change | Standard Deviation 48.227 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -34.07 Percentage of change | Standard Deviation 51.575 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -36.84 Percentage of change | Standard Deviation 44.342 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -31.62 Percentage of change | Standard Deviation 50.758 |
| 250 mg (no LD) KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -35.34 Percentage of change | Standard Deviation 44.056 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -32.01 Percentage of change | Standard Deviation 36.29 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -34.27 Percentage of change | Standard Deviation 33.932 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -26.80 Percentage of change | Standard Deviation 31.244 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -49.01 Percentage of change | Standard Deviation 28.581 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -25.91 Percentage of change | Standard Deviation 26.492 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -22.99 Percentage of change | Standard Deviation 23.218 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -30.83 Percentage of change | Standard Deviation 31.211 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -40.69 Percentage of change | Standard Deviation 34.523 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -27.37 Percentage of change | Standard Deviation 25.233 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -31.76 Percentage of change | Standard Deviation 30.96 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -43.33 Percentage of change | Standard Deviation 34.277 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -53.26 Percentage of change | Standard Deviation 33.81 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -39.31 Percentage of change | Standard Deviation 33.036 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -48.88 Percentage of change | Standard Deviation 32.071 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -33.86 Percentage of change | Standard Deviation 33.053 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -34.64 Percentage of change | Standard Deviation 34.631 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -34.23 Percentage of change | Standard Deviation 35.319 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -32.60 Percentage of change | Standard Deviation 31.909 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -47.19 Percentage of change | Standard Deviation 31.551 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -30.33 Percentage of change | Standard Deviation 30.351 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -52.36 Percentage of change | Standard Deviation 33.258 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -50.29 Percentage of change | Standard Deviation 29.286 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -33.29 Percentage of change | Standard Deviation 38.191 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -25.60 Percentage of change | Standard Deviation 30.211 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -32.75 Percentage of change | Standard Deviation 31.185 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -47.36 Percentage of change | Standard Deviation 30.909 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -40.21 Percentage of change | Standard Deviation 32.239 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -36.23 Percentage of change | Standard Deviation 33.872 |
| 125 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -49.35 Percentage of change | Standard Deviation 28.435 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -24.47 Percentage of change | Standard Deviation 39.779 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -25.58 Percentage of change | Standard Deviation 38.019 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -29.42 Percentage of change | Standard Deviation 40.379 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -26.10 Percentage of change | Standard Deviation 40.637 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -18.51 Percentage of change | Standard Deviation 37.67 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -31.69 Percentage of change | Standard Deviation 40.647 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -30.68 Percentage of change | Standard Deviation 42.883 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -28.21 Percentage of change | Standard Deviation 41.352 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -21.78 Percentage of change | Standard Deviation 41.439 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -27.38 Percentage of change | Standard Deviation 39.966 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -25.91 Percentage of change | Standard Deviation 38.68 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -28.00 Percentage of change | Standard Deviation 35.916 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -24.20 Percentage of change | Standard Deviation 40.063 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -29.76 Percentage of change | Standard Deviation 40.611 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -22.43 Percentage of change | Standard Deviation 37.322 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -24.24 Percentage of change | Standard Deviation 38.972 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -25.49 Percentage of change | Standard Deviation 40.126 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -19.61 Percentage of change | Standard Deviation 37.935 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -25.63 Percentage of change | Standard Deviation 39.489 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -24.67 Percentage of change | Standard Deviation 37.725 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -25.44 Percentage of change | Standard Deviation 39.798 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -26.33 Percentage of change | Standard Deviation 40.513 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -30.58 Percentage of change | Standard Deviation 38.398 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -17.18 Percentage of change | Standard Deviation 39.855 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -25.37 Percentage of change | Standard Deviation 39.165 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -25.04 Percentage of change | Standard Deviation 38.23 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -24.61 Percentage of change | Standard Deviation 39.502 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -24.35 Percentage of change | Standard Deviation 38.746 |
| 62.5 mg KY1005 (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -23.93 Percentage of change | Standard Deviation 40.455 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -60.83 Percentage of change | Standard Deviation 31.559 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -56.60 Percentage of change | Standard Deviation 24.568 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -54.31 Percentage of change | Standard Deviation 29.223 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -50.31 Percentage of change | Standard Deviation 29.134 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -53.62 Percentage of change | Standard Deviation 30.255 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -53.08 Percentage of change | Standard Deviation 30.684 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -54.93 Percentage of change | Standard Deviation 28.705 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -58.70 Percentage of change | Standard Deviation 30.6 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -55.77 Percentage of change | Standard Deviation 30.42 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -57.32 Percentage of change | Standard Deviation 29.14 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -57.76 Percentage of change | Standard Deviation 29.406 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -59.41 Percentage of change | Standard Deviation 29.414 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -61.70 Percentage of change | Standard Deviation 32.381 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -62.54 Percentage of change | Standard Deviation 31.831 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -60.49 Percentage of change | Standard Deviation 31.51 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -56.79 Percentage of change | Standard Deviation 31.763 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -56.78 Percentage of change | Standard Deviation 31.397 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -61.18 Percentage of change | Standard Deviation 30.487 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -62.53 Percentage of change | Standard Deviation 32.149 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -62.27 Percentage of change | Standard Deviation 36.647 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -64.61 Percentage of change | Standard Deviation 31.787 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -61.59 Percentage of change | Standard Deviation 33.745 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -58.81 Percentage of change | Standard Deviation 35.801 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -59.01 Percentage of change | Standard Deviation 35.211 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -61.01 Percentage of change | Standard Deviation 35.65 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -61.21 Percentage of change | Standard Deviation 35.897 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -59.59 Percentage of change | Standard Deviation 36.33 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -60.72 Percentage of change | Standard Deviation 38.664 |
| Placebo (Part 1) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -61.83 Percentage of change | Standard Deviation 35.861 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -43.62 Percentage of change | Standard Deviation 38.048 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -27.10 Percentage of change | Standard Deviation 39.79 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -29.37 Percentage of change | Standard Deviation 38.374 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -25.94 Percentage of change | Standard Deviation 43.683 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -46.52 Percentage of change | Standard Deviation 37.336 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -44.31 Percentage of change | Standard Deviation 37.579 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -42.27 Percentage of change | Standard Deviation 36.685 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -33.49 Percentage of change | Standard Deviation 39.386 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -42.65 Percentage of change | Standard Deviation 36.665 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -34.77 Percentage of change | Standard Deviation 38.757 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -44.86 Percentage of change | Standard Deviation 36.493 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -29.89 Percentage of change | Standard Deviation 38.681 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -42.96 Percentage of change | Standard Deviation 37.718 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -42.91 Percentage of change | Standard Deviation 42.866 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -47.17 Percentage of change | Standard Deviation 39.147 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -42.45 Percentage of change | Standard Deviation 38.1 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -41.26 Percentage of change | Standard Deviation 34.643 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -41.66 Percentage of change | Standard Deviation 38.115 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -46.10 Percentage of change | Standard Deviation 38.082 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -43.37 Percentage of change | Standard Deviation 37.251 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -42.64 Percentage of change | Standard Deviation 38.113 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -27.45 Percentage of change | Standard Deviation 38.441 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -42.36 Percentage of change | Standard Deviation 40.085 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -38.14 Percentage of change | Standard Deviation 35.393 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -44.99 Percentage of change | Standard Deviation 37.08 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -42.26 Percentage of change | Standard Deviation 39.161 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -39.63 Percentage of change | Standard Deviation 39.211 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -39.66 Percentage of change | Standard Deviation 42.054 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -40.30 Percentage of change | Standard Deviation 37.098 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -57.52 Percentage of change | Standard Deviation 22.28 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -49.76 Percentage of change | Standard Deviation 30.19 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -48.17 Percentage of change | Standard Deviation 27.76 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -52.67 Percentage of change | Standard Deviation 29.311 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -48.09 Percentage of change | Standard Deviation 26.148 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -47.95 Percentage of change | Standard Deviation 26.092 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -56.79 Percentage of change | Standard Deviation 23.453 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -63.84 Percentage of change | Standard Deviation 23.417 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -50.18 Percentage of change | Standard Deviation 30.773 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -48.66 Percentage of change | Standard Deviation 29.191 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -48.45 Percentage of change | Standard Deviation 30.519 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -58.05 Percentage of change | Standard Deviation 27.565 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -56.51 Percentage of change | Standard Deviation 27.668 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -57.00 Percentage of change | Standard Deviation 20.81 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -48.05 Percentage of change | Standard Deviation 24.892 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -56.28 Percentage of change | Standard Deviation 24.247 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -47.19 Percentage of change | Standard Deviation 28.645 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -51.75 Percentage of change | Standard Deviation 30.214 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -59.49 Percentage of change | Standard Deviation 22.14 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -50.34 Percentage of change | Standard Deviation 22.937 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -46.04 Percentage of change | Standard Deviation 28.399 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -38.57 Percentage of change | Standard Deviation 22.074 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -58.12 Percentage of change | Standard Deviation 24.772 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -49.33 Percentage of change | Standard Deviation 29.448 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -52.78 Percentage of change | Standard Deviation 22.12 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -58.43 Percentage of change | Standard Deviation 27.41 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -50.89 Percentage of change | Standard Deviation 29.752 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -59.36 Percentage of change | Standard Deviation 25.162 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -52.89 Percentage of change | Standard Deviation 22.337 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -34.32 Percentage of change | Standard Deviation 41.018 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -34.20 Percentage of change | Standard Deviation 39.168 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -36.74 Percentage of change | Standard Deviation 37.592 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -34.51 Percentage of change | Standard Deviation 40.123 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -35.63 Percentage of change | Standard Deviation 37.586 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -33.72 Percentage of change | Standard Deviation 40.79 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -32.01 Percentage of change | Standard Deviation 39.405 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -37.50 Percentage of change | Standard Deviation 39.368 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -31.34 Percentage of change | Standard Deviation 41.919 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -37.63 Percentage of change | Standard Deviation 38.453 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -31.28 Percentage of change | Standard Deviation 40.103 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -39.45 Percentage of change | Standard Deviation 38.697 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -38.95 Percentage of change | Standard Deviation 34.963 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -31.41 Percentage of change | Standard Deviation 39.716 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -36.03 Percentage of change | Standard Deviation 38.742 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -31.98 Percentage of change | Standard Deviation 39.64 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -36.46 Percentage of change | Standard Deviation 38.211 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -33.71 Percentage of change | Standard Deviation 38.282 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -38.37 Percentage of change | Standard Deviation 38.703 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -33.16 Percentage of change | Standard Deviation 40.239 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -35.32 Percentage of change | Standard Deviation 38.963 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -33.66 Percentage of change | Standard Deviation 38.52 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -37.71 Percentage of change | Standard Deviation 37.451 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -32.86 Percentage of change | Standard Deviation 40.33 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -37.04 Percentage of change | Standard Deviation 36.046 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -33.72 Percentage of change | Standard Deviation 37.516 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -33.22 Percentage of change | Standard Deviation 38.367 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -32.36 Percentage of change | Standard Deviation 40.612 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -32.70 Percentage of change | Standard Deviation 38.945 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 34 | -27.22 Percentage of change | Standard Deviation 51.629 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 49 | -29.80 Percentage of change | Standard Deviation 55.717 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 26 | -28.48 Percentage of change | Standard Deviation 46.252 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 41 | -24.13 Percentage of change | Standard Deviation 55.219 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 45 | -27.07 Percentage of change | Standard Deviation 54.016 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 31 | -21.51 Percentage of change | Standard Deviation 44.331 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 44 | -29.07 Percentage of change | Standard Deviation 53.672 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 24 | -29.09 Percentage of change | Standard Deviation 44.653 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 32 | -22.64 Percentage of change | Standard Deviation 46.122 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 39 | -25.98 Percentage of change | Standard Deviation 48.229 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 50 | -31.15 Percentage of change | Standard Deviation 55.571 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 25 | -30.81 Percentage of change | Standard Deviation 46.001 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 35 | -27.11 Percentage of change | Standard Deviation 48.897 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 43 | -33.70 Percentage of change | Standard Deviation 54.865 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 51 | -30.75 Percentage of change | Standard Deviation 55.841 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 33 | -21.49 Percentage of change | Standard Deviation 48.348 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 42 | -29.48 Percentage of change | Standard Deviation 53.423 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 40 | -24.22 Percentage of change | Standard Deviation 49.044 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 38 | -24.07 Percentage of change | Standard Deviation 49.645 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 52 | -30.50 Percentage of change | Standard Deviation 56.024 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 37 | -22.63 Percentage of change | Standard Deviation 48.038 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 48 | -29.29 Percentage of change | Standard Deviation 53.432 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 27 | -29.92 Percentage of change | Standard Deviation 48.506 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 36 | -22.57 Percentage of change | Standard Deviation 47.897 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 28 | -27.74 Percentage of change | Standard Deviation 49.936 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 47 | -25.86 Percentage of change | Standard Deviation 54.094 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 29 | -26.40 Percentage of change | Standard Deviation 48.994 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 46 | -28.89 Percentage of change | Standard Deviation 58.573 |
| Placebo (Part 2) Continued From Part 1 Placebo | Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2) | Week 30 | -26.58 Percentage of change | Standard Deviation 49.832 |
Secondary
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)
Time frame: Baseline and at weeks 1, 2, 4, 8, 12, 16, 17, 20, & 24
Population: This analysis was conducted for Part 1 and includes participants who took at least one dose of KY1005. Only those participants with data available at specified timepoints are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Baseline | 0.00 (ug/ml) | Standard Deviation 0.014 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 1 | 58.29 (ug/ml) | Standard Deviation 24.674 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 2 | 47.56 (ug/ml) | Standard Deviation 17.274 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 4 | 38.49 (ug/ml) | Standard Deviation 22.532 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 8 | 37.67 (ug/ml) | Standard Deviation 15.157 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 12 | 39.26 (ug/ml) | Standard Deviation 33.847 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 16 | 40.12 (ug/ml) | Standard Deviation 28.61 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 17 | 62.34 (ug/ml) | Standard Deviation 28.081 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 20 | 37.92 (ug/ml) | Standard Deviation 14.171 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 24 | 41.98 (ug/ml) | Standard Deviation 23.087 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 2 | 25.09 (ug/ml) | Standard Deviation 9.041 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 20 | 48.26 (ug/ml) | Standard Deviation 30.691 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 4 | 19.00 (ug/ml) | Standard Deviation 7.869 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 8 | 32.14 (ug/ml) | Standard Deviation 16.502 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 12 | 34.67 (ug/ml) | Standard Deviation 15.191 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 16 | 38.09 (ug/ml) | Standard Deviation 13.536 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 24 | 43.81 (ug/ml) | Standard Deviation 17.403 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 17 | 64.64 (ug/ml) | Standard Deviation 24.169 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Baseline | 0.00 (ug/ml) | Standard Deviation 0.014 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 1 | 30.49 (ug/ml) | Standard Deviation 18.52 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 17 | 29.26 (ug/ml) | Standard Deviation 11.659 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 16 | 18.39 (ug/ml) | Standard Deviation 7.245 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 24 | 20.25 (ug/ml) | Standard Deviation 10.575 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Baseline | 0.01 (ug/ml) | Standard Deviation 0.074 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 4 | 9.67 (ug/ml) | Standard Deviation 3.728 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 12 | 18.12 (ug/ml) | Standard Deviation 8.439 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 20 | 19.31 (ug/ml) | Standard Deviation 7.203 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 1 | 14.18 (ug/ml) | Standard Deviation 5.06 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 8 | 15.07 (ug/ml) | Standard Deviation 6.383 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 2 | 13.56 (ug/ml) | Standard Deviation 3.886 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 8 | 7.92 (ug/ml) | Standard Deviation 3.263 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 17 | 16.79 (ug/ml) | Standard Deviation 6.677 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 12 | 9.22 (ug/ml) | Standard Deviation 4.116 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 24 | 11.07 (ug/ml) | Standard Deviation 3.918 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 16 | 10.13 (ug/ml) | Standard Deviation 4.515 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 1 | 8.49 (ug/ml) | Standard Deviation 3.331 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 2 | 7.57 (ug/ml) | Standard Deviation 2.947 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 4 | 5.09 (ug/ml) | Standard Deviation 2.176 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Baseline | 0.00 (ug/ml) | Standard Deviation 0 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 1) | Week 20 | 10.68 (ug/ml) | Standard Deviation 3.715 |
Secondary
Serum KY1005 Concentration Assessed Throughout the Study (Part 2)
Time frame: Baseline and at weeks 24, 25, 28, 32, 36, 40, 44, 48, & 52
Population: This analysis was conducted for Part 2 and includes participants who took at least one dose of KY1005. Only those participants with data available at specified timepoints are reported
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 48 | 41.43 (ug/ml) | Standard Deviation 14.214 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 32 | 44.41 (ug/ml) | Standard Deviation 11.438 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 44 | 40.91 (ug/ml) | Standard Deviation 12.068 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 40 | 45.19 (ug/ml) | Standard Deviation 19.921 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 52 | 38.88 (ug/ml) | Standard Deviation 11.526 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 25 | 73.54 (ug/ml) | Standard Deviation 30.68 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 36 | 43.11 (ug/ml) | Standard Deviation 18.965 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 28 | 51.50 (ug/ml) | Standard Deviation 25.454 |
| 250 mg (500 mg LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 24 | 45.13 (ug/ml) | Standard Deviation 15.842 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 28 | 17.59 (ug/ml) | Standard Deviation 9.09 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 24 | 36.68 (ug/ml) | Standard Deviation 17.544 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 32 | 8.86 (ug/ml) | Standard Deviation 5.074 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 48 | 0.58 (ug/ml) | Standard Deviation 0.507 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 36 | 5.41 (ug/ml) | Standard Deviation 3.876 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 52 | 0.56 (ug/ml) | Standard Deviation 1.112 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 25 | 36.54 (ug/ml) | Standard Deviation 20.508 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 40 | 2.42 (ug/ml) | Standard Deviation 1.66 |
| 250 mg (no LD) KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 44 | 1.04 (ug/ml) | Standard Deviation 0.908 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 28 | 46.15 (ug/ml) | Standard Deviation 15.782 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 40 | 43.79 (ug/ml) | Standard Deviation 15.955 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 52 | 45.59 (ug/ml) | Standard Deviation 22.447 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 25 | 71.25 (ug/ml) | Standard Deviation 16.294 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 24 | 45.00 (ug/ml) | Standard Deviation 14.568 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 48 | 43.63 (ug/ml) | Standard Deviation 22.188 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 32 | 41.50 (ug/ml) | Standard Deviation 13.681 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 44 | 46.98 (ug/ml) | Standard Deviation 24.015 |
| 125 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 36 | 51.42 (ug/ml) | Standard Deviation 18.946 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 32 | 12.54 (ug/ml) | Standard Deviation 5.943 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 28 | 25.22 (ug/ml) | Standard Deviation 10.235 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 36 | 7.80 (ug/ml) | Standard Deviation 4.413 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 48 | 1.40 (ug/ml) | Standard Deviation 1.727 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 25 | 34.71 (ug/ml) | Standard Deviation 14.551 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 52 | 0.55 (ug/ml) | Standard Deviation 0.573 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 44 | 2.62 (ug/ml) | Standard Deviation 2.193 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 24 | 43.17 (ug/ml) | Standard Deviation 19.752 |
| 62.5 mg KY1005 (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 40 | 4.54 (ug/ml) | Standard Deviation 2.929 |
| Placebo (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 36 | 22.28 (ug/ml) | Standard Deviation 18.101 |
| Placebo (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 24 | 19.03 (ug/ml) | Standard Deviation 9.612 |
| Placebo (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 25 | 31.07 (ug/ml) | Standard Deviation 16.115 |
| Placebo (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 28 | 20.12 (ug/ml) | Standard Deviation 11.82 |
| Placebo (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 32 | 20.99 (ug/ml) | Standard Deviation 12.614 |
| Placebo (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 40 | 19.09 (ug/ml) | Standard Deviation 11.479 |
| Placebo (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 44 | 16.43 (ug/ml) | Standard Deviation 7.302 |
| Placebo (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 48 | 17.80 (ug/ml) | Standard Deviation 9.065 |
| Placebo (Part 1) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 52 | 22.60 (ug/ml) | Standard Deviation 8.225 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 40 | 1.68 (ug/ml) | Standard Deviation 1.669 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 32 | 4.57 (ug/ml) | Standard Deviation 2.463 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 44 | 0.82 (ug/ml) | Standard Deviation 0.863 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 28 | 10.03 (ug/ml) | Standard Deviation 4.697 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 48 | 0.42 (ug/ml) | Standard Deviation 0.483 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 25 | 17.57 (ug/ml) | Standard Deviation 7.504 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 24 | 19.48 (ug/ml) | Standard Deviation 7.791 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 36 | 2.85 (ug/ml) | Standard Deviation 2.275 |
| Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 52 | 0.19 (ug/ml) | Standard Deviation 0.289 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 36 | 13.38 (ug/ml) | Standard Deviation 2.128 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 40 | 10.95 (ug/ml) | Standard Deviation 1.35 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 28 | 9.56 (ug/ml) | Standard Deviation 3.485 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 32 | 9.40 (ug/ml) | Standard Deviation 1.749 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 48 | 11.12 (ug/ml) | Standard Deviation 1.825 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 25 | 15.90 (ug/ml) | Standard Deviation 2.443 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 52 | 12.03 (ug/ml) | Standard Deviation 3.775 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 24 | 11.60 (ug/ml) | Standard Deviation 1.383 |
| 62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 44 | 11.25 (ug/ml) | Standard Deviation 2.607 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 36 | 1.77 (ug/ml) | Standard Deviation 1.018 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 25 | 10.36 (ug/ml) | Standard Deviation 5.145 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 52 | 0.11 (ug/ml) | Standard Deviation 0.129 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 40 | 0.96 (ug/ml) | Standard Deviation 0.748 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 48 | 0.25 (ug/ml) | Standard Deviation 0.305 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 44 | 0.57 (ug/ml) | Standard Deviation 0.554 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 32 | 3.32 (ug/ml) | Standard Deviation 1.588 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 24 | 11.10 (ug/ml) | Standard Deviation 5.24 |
| Placebo Re-randomized From the 62.5 mg Arm (Part 2) | Serum KY1005 Concentration Assessed Throughout the Study (Part 2) | Week 28 | 6.66 (ug/ml) | Standard Deviation 2.584 |