Atopic Dermatitis
Conditions
Keywords
AD, eczema, skin diseases, biologics
Brief summary
A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.
Interventions
DRUGKHK4083
Anti-OX40 Monoclonal Antibody KHK4083
DRUGPlacebo
Matching placebo
Sponsors
Kyowa Kirin Co., Ltd.
Kyowa Kirin, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
subcutaneous administration
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Voluntarily signed informed consent to participate in the study; * Chronic AD, according to American Academy of Dermatology Consensus Criteria or the local diagnostic criteria, that has been present for at least 1 year before screening; * EASI score ≥16 at screening and baseline; * IGA score ≥3 (moderate) at both screening and baseline; * BSA ≥10% at both screening and baseline; * Documented recent history (within 1 year prior to screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).
Exclusion criteria
* Current or past history of clinically significant illness(es) deemed by the Investigator to be likely to affect the study conduct and assessments. Examples include, but are not limited to, clinically significant cardiovascular (e.g., New York Heart Association \[NYHA\] Class III or IV), uncontrolled diabetes (HbA1c ≥9%), liver (e.g., Child-Pugh class B or C), renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders; * Any of the following laboratory abnormalities at screening: * Serum creatinine: \>1.5 mg/dL * AST or ALT: ≥2.5 times the upper limit of normal (ULN) * Neutrophil count: \<1.5×10³/μL * Other laboratory abnormalities that may affect the completion or evaluation of the study, as judged by the Investigator; * Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | Baseline to Week 16 | In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression total score of 4 elements of eczema × area score of eczema will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | Baseline to Week 16 | In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression total score of 4 elements of eczema × area score of eczema will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score. |
| Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score | Baseline to Week 16 | In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as A in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as B in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as C in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition. |
| Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score | Baseline to Week 16 | In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as A in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as B in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as C in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition. |
| Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16 | Baseline to Week 16 | In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA) | Baseline to Week 16 | The Investigator will calculate the percentage (%) of the total body surface area affected by AD. |
| Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score | Baseline to Week 16 | The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being no itch and 10 being the worst itch imaginable. |
| Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score | Baseline to Week 16 | The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being no itch and 10 being the worst itch imaginable. |
| Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score | Baseline to Week 16 | Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10). |
| Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score | Baseline to Week 16 | Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10). |
| Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI) | Baseline to Week 16 | DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired. |
| EASI Score at Each Time Point | 56 Weeks | In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression total score of 4 elements of eczema × area score of eczema will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score. |
| Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | Baseline to Week 16 | In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression total score of 4 elements of eczema × area score of eczema will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score. |
| Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | 56 Weeks | Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10). |
| Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | 56 Weeks | In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). |
| SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | 56 Weeks | In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as A in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as B in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as C in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition. |
| Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | 56 Weeks | In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as A in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as B in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as C in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition. |
| Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | 56 Weeks | In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe) |
| Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | 56 Weeks | The Investigator will calculate the percentage (%) of the total body surface area affected by AD. |
| Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | 56 Weeks | The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being no itch and 10 being the worst itch imaginable. |
| Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | 56 Weeks | The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being no itch and 10 being the worst itch imaginable. |
| Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | 56 Weeks | Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10). |
| Dermatology Life Quality Index (DLQI) at Each Time Point | 56 Weeks | DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired. |
| Percent Change From Baseline in EASI Score at Each Time Point | 56 Weeks | In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression total score of 4 elements of eczema × area score of eczema will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score. |
Countries
Canada, Germany, Japan, United States
Participant flow
Recruitment details
The screening period began in September 2018. A total of 61 sites in four countries (Canada, Germany, Japan, and the United States) screened 351 patients and enrolled 274. The screening period closed in September 2019.
Pre-assignment details
In Treatment Period A, randomized subjects received either study drug or placebo for 18 weeks. In Treatment Period B, the patients randomized to the placebo arm received study drug for 18 weeks. There was no treatment change for patients randomized to study drug arms. One subject who was randomized to the 600 mg Q4W group did not receive any study drug due to consent withdrawal before the start of the treatment. They are not included in baseline or any of the analysis sets.
Participants by arm
| Arm | Count |
|---|---|
| KHK4083 150 mg SC Q4W Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34. | 54 |
| KHK4083 600 mg SC Q4W Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34. | 53 |
| KHK4083 300 mg SC Q2W Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34. | 55 |
| KHK4083 600 mg SC Q2W Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34. | 54 |
| Placebo/KHK4083 600 mg Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34. | 57 |
| Total | 273 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 | 7 | 3 | 13 |
| Overall Study | Ineligibility | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 4 | 0 | 1 | 4 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 2 | 2 |
| Overall Study | Non-Compliance with Study Drug | 1 | 1 | 2 | 1 | 4 |
| Overall Study | Physician Decision | 2 | 2 | 2 | 2 | 4 |
| Overall Study | Protocol Deviation | 4 | 4 | 3 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 5 | 5 | 5 | 9 |
Baseline characteristics
| Characteristic | Total | KHK4083 600 mg SC Q4W | KHK4083 300 mg SC Q2W | KHK4083 600 mg SC Q2W | KHK4083 150 mg SC Q4W | Placebo/KHK4083 600 mg |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 2 Participants | 4 Participants | 5 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 255 Participants | 51 Participants | 51 Participants | 49 Participants | 52 Participants | 52 Participants |
| Age, Continuous | 38.0 years | 38.9 years | 37.5 years | 37.3 years | 37.4 years | 38.7 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 263 Participants | 51 Participants | 54 Participants | 53 Participants | 51 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 175 Participants | 32 Participants | 37 Participants | 33 Participants | 36 Participants | 37 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 6 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 | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 84 Participants | 20 Participants | 16 Participants | 20 Participants | 14 Participants | 14 Participants |
| Region of Enrollment Canada | 25 participants | 5 participants | 5 participants | 4 participants | 4 participants | 7 participants |
| Region of Enrollment Germany | 33 participants | 8 participants | 6 participants | 7 participants | 7 participants | 5 participants |
| Region of Enrollment Japan | 159 participants | 30 participants | 33 participants | 32 participants | 32 participants | 32 participants |
| Region of Enrollment United States | 56 participants | 10 participants | 11 participants | 11 participants | 11 participants | 13 participants |
| Sex: Female, Male Female | 113 Participants | 22 Participants | 24 Participants | 24 Participants | 17 Participants | 26 Participants |
| Sex: Female, Male Male | 160 Participants | 31 Participants | 31 Participants | 30 Participants | 37 Participants | 31 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 53 | 0 / 55 | 0 / 54 | 0 / 57 |
| other Total, other adverse events | 47 / 54 | 50 / 53 | 48 / 55 | 51 / 54 | 46 / 57 |
| serious Total, serious adverse events | 4 / 54 | 1 / 53 | 4 / 55 | 1 / 54 | 2 / 57 |
Outcome results
Primary
Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression total score of 4 elements of eczema × area score of eczema will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Time frame: Baseline to Week 16
Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set. Those 6 subjects had no evaluable EASI score after the start of IP administration until Week 16.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| KHK4083 150 mg SC Q4W | Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | -48.33 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | -49.72 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | -61.07 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | -57.35 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | -15.01 percentage of score change |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
Secondary
Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression total score of 4 elements of eczema × area score of eczema will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Time frame: Baseline to Week 16
Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set. Those 6 subjects had no evaluable EASI score after the start of IP administration until Week 16.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KHK4083 150 mg SC Q4W | Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | achieved EASI-90 at Week 16 | 10 Participants |
| KHK4083 150 mg SC Q4W | Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | Achieved EASI-50 at Week 16 | 30 Participants |
| KHK4083 150 mg SC Q4W | Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | achieved EASI-75 at Week 16 | 23 Participants |
| KHK4083 600 mg SC Q4W | Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | achieved EASI-90 at Week 16 | 6 Participants |
| KHK4083 600 mg SC Q4W | Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | Achieved EASI-50 at Week 16 | 31 Participants |
| KHK4083 600 mg SC Q4W | Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | achieved EASI-75 at Week 16 | 21 Participants |
| KHK4083 300 mg SC Q2W | Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | achieved EASI-90 at Week 16 | 19 Participants |
| KHK4083 300 mg SC Q2W | Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | achieved EASI-75 at Week 16 | 28 Participants |
| KHK4083 300 mg SC Q2W | Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | Achieved EASI-50 at Week 16 | 36 Participants |
| KHK4083 600 mg SC Q2W | Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | achieved EASI-75 at Week 16 | 21 Participants |
| KHK4083 600 mg SC Q2W | Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | achieved EASI-90 at Week 16 | 10 Participants |
| KHK4083 600 mg SC Q2W | Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | Achieved EASI-50 at Week 16 | 35 Participants |
| Placebo/KHK4083 600 mg | Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | Achieved EASI-50 at Week 16 | 17 Participants |
| Placebo/KHK4083 600 mg | Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | achieved EASI-90 at Week 16 | 2 Participants |
| Placebo/KHK4083 600 mg | Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16 | achieved EASI-75 at Week 16 | 6 Participants |
Secondary
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe)
Time frame: 56 Weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 18 | 10 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 56 | 12 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 26 | 13 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 20 | 13 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 24 | 14 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 22 | 13 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 48 | 8 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 4 | 1 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 1 | 0 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 44 | 12 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 6 | 2 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 8 | 5 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 40 | 10 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 10 | 6 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 36 | 18 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 12 | 9 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 34 | 16 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 14 | 8 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 52 | 10 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 32 | 14 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 15 | 10 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 2 | 0 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 30 | 13 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 16 | 10 Participants |
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 28 | 11 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 32 | 13 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 18 | 8 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 10 | 4 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 26 | 14 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 56 | 18 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 36 | 14 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 20 | 9 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 48 | 21 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 24 | 10 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 2 | 0 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 28 | 12 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 22 | 12 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 12 | 6 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 52 | 19 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 4 | 1 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 34 | 11 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 44 | 16 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 15 | 7 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 16 | 8 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 6 | 2 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 14 | 5 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 8 | 2 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 1 | 0 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 40 | 17 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 30 | 12 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 4 | 0 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 1 | 0 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 2 | 1 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 6 | 1 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 8 | 2 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 10 | 6 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 12 | 12 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 14 | 11 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 15 | 9 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 16 | 16 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 18 | 16 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 20 | 15 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 22 | 18 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 24 | 20 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 26 | 25 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 28 | 23 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 30 | 22 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 32 | 24 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 34 | 24 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 36 | 27 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 40 | 19 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 44 | 25 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 48 | 20 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 52 | 18 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 56 | 13 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 56 | 14 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 8 | 2 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 32 | 23 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 40 | 13 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 15 | 8 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 1 | 0 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 4 | 3 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 6 | 2 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 44 | 16 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 12 | 4 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 52 | 15 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 2 | 1 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 34 | 20 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 22 | 14 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 30 | 17 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 16 | 10 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 20 | 14 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 48 | 18 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 24 | 12 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 10 | 2 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 28 | 14 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 18 | 12 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 36 | 19 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 26 | 18 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 14 | 4 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 26 | 4 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 1 | 0 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 28 | 3 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 15 | 2 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 30 | 4 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 14 | 2 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 32 | 5 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 12 | 1 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 34 | 7 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 10 | 1 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 52 | 10 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 36 | 8 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 8 | 0 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 6 | 0 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 40 | 7 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 4 | 1 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 44 | 11 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 2 | 0 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 56 | 9 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 22 | 3 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 20 | 3 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 24 | 3 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 18 | 1 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 48 | 9 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point | Achievement of IGA Score at Week 16 | 1 Participants |
Secondary
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16
In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: Baseline to Week 16
Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| KHK4083 150 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16 | 10 Participants |
| KHK4083 600 mg SC Q4W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16 | 8 Participants |
| KHK4083 300 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16 | 16 Participants |
| KHK4083 600 mg SC Q2W | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16 | 10 Participants |
| Placebo/KHK4083 600 mg | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16 | 1 Participants |
Secondary
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%).
Time frame: 56 Weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 30 | 30 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 10 | 26 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 36 | 31 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 12 | 28 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 20 | 24 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 14 | 31 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 15 | 30 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 36 | 27 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 34 | 31 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 16 | 30 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 18 | 32 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 20 | 33 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 22 | 32 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 32 | 30 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 24 | 32 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 40 | 23 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 26 | 31 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 28 | 30 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 12 | 13 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 44 | 21 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 48 | 19 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 16 | 23 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 52 | 16 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 22 | 27 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 10 | 11 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 56 | 15 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 4 | 2 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 8 | 11 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 8 | 4 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 56 | 18 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 10 | 7 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 24 | 25 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 6 | 5 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 12 | 9 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 1 | 0 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 14 | 6 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 15 | 11 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 4 | 6 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 2 | 0 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 16 | 10 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 26 | 25 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 18 | 9 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 2 | 0 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 20 | 14 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 18 | 22 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 22 | 16 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 24 | 14 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 15 | 19 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 1 | 0 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 26 | 14 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 28 | 26 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 28 | 15 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 30 | 14 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 32 | 16 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 34 | 19 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 52 | 17 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 36 | 18 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 30 | 24 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 40 | 15 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 44 | 14 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 48 | 19 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 6 | 2 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 48 | 14 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 52 | 12 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 32 | 23 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 44 | 23 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 56 | 13 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 1 | 1 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 2 | 5 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 4 | 10 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 14 | 17 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 40 | 24 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 6 | 12 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 34 | 23 Participants |
| KHK4083 150 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 8 | 18 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 56 | 21 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 34 | 27 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 36 | 34 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 4 | 0 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 10 | 29 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 6 | 5 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 15 | 6 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 10 | 3 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 28 | 14 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 12 | 31 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 1 | 0 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 15 | 18 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 16 | 21 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 28 | 26 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 14 | 31 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 8 | 3 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 48 | 32 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 34 | 36 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 56 | 25 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 15 | 30 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 2 | 0 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 32 | 29 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 30 | 18 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 2 | 7 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 16 | 31 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 40 | 34 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 36 | 30 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 16 | 6 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 44 | 24 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 18 | 32 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 48 | 21 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 2 | 1 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 32 | 35 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 12 | 4 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 20 | 32 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 18 | 11 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 20 | 21 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 8 | 21 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 22 | 34 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 6 | 1 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 12 | 14 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 32 | 17 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 26 | 29 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 24 | 34 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 14 | 17 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 44 | 31 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 20 | 14 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 52 | 33 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 26 | 31 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 24 | 28 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 40 | 28 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 30 | 35 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 1 | 2 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 28 | 33 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 4 | 0 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 6 | 17 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 52 | 24 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 22 | 15 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 34 | 15 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 22 | 29 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 44 | 27 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 18 | 21 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 1 | 0 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 30 | 26 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 24 | 14 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 48 | 30 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 56 | 24 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 4 | 9 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 10 | 11 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 14 | 6 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 52 | 30 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 8 | 7 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 36 | 19 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 26 | 16 Participants |
| KHK4083 600 mg SC Q4W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 40 | 19 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 40 | 29 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 48 | 28 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 4 | 1 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 6 | 3 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 22 | 30 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 36 | 36 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 8 | 7 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 40 | 23 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 6 | 12 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 56 | 16 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 15 | 25 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 10 | 8 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 12 | 10 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 4 | 6 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 44 | 24 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 1 | 0 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 30 | 32 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 14 | 16 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 24 | 34 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 2 | 11 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 15 | 17 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 2 | 3 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 44 | 29 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 2 | 0 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 16 | 19 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 48 | 22 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 18 | 15 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 20 | 17 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 26 | 34 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 22 | 20 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 1 | 0 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 52 | 17 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 24 | 26 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 4 | 14 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 6 | 22 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 26 | 26 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 56 | 17 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 10 | 32 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 34 | 30 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 56 | 13 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 12 | 34 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 28 | 25 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 34 | 35 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 14 | 33 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 12 | 24 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 15 | 33 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 30 | 25 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 16 | 36 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 32 | 37 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 28 | 33 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 18 | 34 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 36 | 33 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 52 | 23 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 20 | 36 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 22 | 36 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 32 | 27 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 24 | 39 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 18 | 26 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 30 | 36 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 26 | 35 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 28 | 34 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 40 | 27 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 8 | 29 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 20 | 26 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 34 | 27 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 44 | 29 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 16 | 28 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 10 | 17 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 14 | 25 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 48 | 28 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 1 | 7 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 32 | 31 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 52 | 22 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 36 | 28 Participants |
| KHK4083 300 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 8 | 10 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 1 | 1 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 18 | 27 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 20 | 27 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 22 | 30 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 24 | 29 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 26 | 33 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 28 | 32 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 30 | 32 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 32 | 35 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 34 | 31 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 36 | 31 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 40 | 26 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 44 | 25 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 48 | 24 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 52 | 22 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 4 | 2 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 6 | 2 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 8 | 4 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 56 | 17 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 10 | 5 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 12 | 5 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 14 | 8 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 15 | 8 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 1 | 0 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 16 | 10 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 18 | 13 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 20 | 14 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 22 | 17 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 24 | 16 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 26 | 20 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 28 | 17 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 30 | 24 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 32 | 25 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 34 | 24 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 36 | 21 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 40 | 18 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 44 | 20 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 2 | 2 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 48 | 18 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 52 | 19 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 56 | 15 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 1 | 3 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 2 | 8 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 4 | 11 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 6 | 20 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 8 | 24 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 10 | 26 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 12 | 27 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 14 | 34 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 15 | 31 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 16 | 35 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 18 | 36 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 20 | 39 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 22 | 41 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 24 | 40 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 26 | 39 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 28 | 38 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 30 | 39 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 32 | 38 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 34 | 35 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 36 | 36 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 40 | 30 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 44 | 29 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 48 | 26 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 52 | 24 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 56 | 20 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 2 | 3 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 4 | 7 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 6 | 8 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 8 | 11 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 10 | 13 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 12 | 16 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 14 | 17 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 15 | 18 Participants |
| KHK4083 600 mg SC Q2W | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 16 | 21 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 32 | 19 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 36 | 23 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 4 | 2 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 2 | 3 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 1 | 1 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 30 | 18 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 40 | 20 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 52 | 11 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 48 | 11 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 56 | 8 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 28 | 17 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 44 | 18 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 44 | 12 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 40 | 13 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 36 | 13 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 20 | 17 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 48 | 16 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 34 | 11 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 32 | 11 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 30 | 8 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 14 | 5 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 52 | 17 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 28 | 5 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 26 | 6 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 26 | 17 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 56 | 16 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 24 | 6 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 22 | 5 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 20 | 3 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 1 | 0 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 18 | 3 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 16 | 2 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 1 | 0 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 24 | 11 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 2 | 0 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 15 | 3 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 14 | 2 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 12 | 26 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 22 | 11 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 4 | 1 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 10 | 1 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 56 | 14 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 8 | 0 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 16 | 6 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 6 | 2 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 6 | 0 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 4 | 0 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-90 at Week 2 | 0 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 15 | 7 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 8 | 3 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 52 | 14 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 48 | 15 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 44 | 17 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 20 | 8 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 10 | 5 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 40 | 17 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 36 | 20 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 28 | 21 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 26 | 21 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 24 | 19 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 34 | 19 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 30 | 21 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 22 | 19 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 18 | 16 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 16 | 17 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 18 | 8 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 32 | 21 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 15 | 15 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 14 | 12 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 12 | 13 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-75 at Week 12 | 4 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 34 | 20 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 10 | 10 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 8 | 10 Participants |
| Placebo/KHK4083 600 mg | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | Achievement of EASI-50 at Week 6 | 5 Participants |
Secondary
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
The Investigator will calculate the percentage (%) of the total body surface area affected by AD.
Time frame: 56 Weeks
Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 52 | -49.7 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 16 | -31.9 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 15 | -31.9 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 14 | -29.8 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 10 | -24.5 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 12 | -27.4 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 44 | -50.8 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 40 | -49.0 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 36 | -44.6 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 2 | -2.6 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 48 | -46.6 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 34 | -44.4 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 32 | -44.0 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 30 | -41.4 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 4 | -6.7 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 56 | -45.6 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 28 | -41.2 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 26 | -38.3 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 24 | -37.7 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 6 | -13.7 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 1 | -0.5 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 22 | -39.3 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 20 | -35.9 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 18 | -34.6 percentage of total BSA involvement |
| KHK4083 150 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 8 | -18.6 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 10 | -22.6 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 1 | -1.4 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 2 | -3.8 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 4 | -4.0 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 6 | -11.2 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 8 | -19.3 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 12 | -26.4 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 14 | -29.4 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 15 | -29.3 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 16 | -29.6 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 18 | -32.7 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 20 | -34.8 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 22 | -38.3 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 24 | -39.0 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 26 | -42.1 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 28 | -43.1 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 30 | -45.5 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 32 | -46.5 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 34 | -45.1 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 36 | -48.1 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 40 | -50.6 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 44 | -47.9 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 48 | -52.7 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 52 | -51.9 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 56 | -47.2 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 2 | -6.4 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 26 | -46.4 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 8 | -21.4 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 32 | -48.3 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 4 | -10.7 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 56 | -53.8 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 28 | -45.8 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 44 | -53.5 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 1 | -0.4 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 30 | -46.2 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 48 | -53.9 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 20 | -39.7 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 15 | -35.1 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 40 | -51.6 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 6 | -16.9 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 14 | -33.6 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 22 | -40.6 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 18 | -35.5 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 52 | -53.7 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 10 | -26.0 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 36 | -50.3 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 24 | -42.9 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 16 | -35.5 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 34 | -50.7 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 12 | -31.1 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 30 | -47.2 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 16 | -28.9 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 18 | -29.6 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 6 | -12.1 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 20 | -34.6 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 44 | -50.8 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 22 | -38.3 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 24 | -40.6 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 4 | -5.6 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 26 | -42.0 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 28 | -42.8 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 2 | -1.9 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 48 | -53.7 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 32 | -48.2 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 34 | -49.0 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 52 | -55.8 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 36 | -48.0 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 1 | -0.1 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 56 | -58.6 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 10 | -20.7 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 12 | -22.2 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 40 | -51.1 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 14 | -24.4 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 8 | -17.2 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 15 | -25.6 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 6 | -4.0 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 44 | -47.5 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 56 | -45.9 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 36 | -40.8 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 16 | -14.1 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 14 | -10.2 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 4 | -2.2 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 15 | -12.2 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 10 | -4.8 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 22 | -18.5 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 20 | -13.3 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 2 | 0.1 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 28 | -29.6 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 30 | -32.1 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 18 | -13.1 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 40 | -46.6 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 26 | -26.9 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 12 | -4.9 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 32 | -39.6 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 52 | -48.6 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 48 | -46.2 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 24 | -21.1 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 8 | -4.4 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 34 | -41.2 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | Change in % BSA at Week 1 | -1.2 percentage of total BSA involvement |
Secondary
Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI)
DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.
Time frame: Baseline to Week 16
Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| KHK4083 150 mg SC Q4W | Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI) | -2.59 score on a scale |
| KHK4083 600 mg SC Q4W | Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI) | -4.66 score on a scale |
| KHK4083 300 mg SC Q2W | Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI) | -6.28 score on a scale |
| KHK4083 600 mg SC Q2W | Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI) | -4.93 score on a scale |
| Placebo/KHK4083 600 mg | Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI) | 0.19 score on a scale |
Secondary
Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression total score of 4 elements of eczema × area score of eczema will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Time frame: Baseline to Week 16
Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set. Those 6 subjects had no evaluable EASI score after the start of IP administration until Week 16.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KHK4083 150 mg SC Q4W | Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | -22.5 score on a scale | Standard Deviation 14.7 |
| KHK4083 600 mg SC Q4W | Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | -20.7 score on a scale | Standard Deviation 14.3 |
| KHK4083 300 mg SC Q2W | Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | -23.3 score on a scale | Standard Deviation 9 |
| KHK4083 600 mg SC Q2W | Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | -19.9 score on a scale | Standard Deviation 11.8 |
| Placebo/KHK4083 600 mg | Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | -9.8 score on a scale | Standard Deviation 13 |
Secondary
Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA)
The Investigator will calculate the percentage (%) of the total body surface area affected by AD.
Time frame: Baseline to Week 16
Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| KHK4083 150 mg SC Q4W | Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA) | -22.86 percentage of total BSA involvement |
| KHK4083 600 mg SC Q4W | Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA) | -21.48 percentage of total BSA involvement |
| KHK4083 300 mg SC Q2W | Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA) | -27.92 percentage of total BSA involvement |
| KHK4083 600 mg SC Q2W | Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA) | -25.04 percentage of total BSA involvement |
| Placebo/KHK4083 600 mg | Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA) | -7.87 percentage of total BSA involvement |
Secondary
Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being no itch and 10 being the worst itch imaginable.
Time frame: Baseline to Week 16
Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| KHK4083 150 mg SC Q4W | Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score | -2.04 score on a scale |
| KHK4083 600 mg SC Q4W | Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score | -3.02 score on a scale |
| KHK4083 300 mg SC Q2W | Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score | -3.60 score on a scale |
| KHK4083 600 mg SC Q2W | Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score | -2.81 score on a scale |
| Placebo/KHK4083 600 mg | Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score | -1.31 score on a scale |
Secondary
Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as A in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as B in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as C in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Time frame: Baseline to Week 16
Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| KHK4083 150 mg SC Q4W | Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score | -23.71 score on a scale |
| KHK4083 600 mg SC Q4W | Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score | -23.86 score on a scale |
| KHK4083 300 mg SC Q2W | Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score | -30.44 score on a scale |
| KHK4083 600 mg SC Q2W | Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score | -27.65 score on a scale |
| Placebo/KHK4083 600 mg | Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score | -8.09 score on a scale |
Secondary
Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Time frame: Baseline to Week 16
Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| KHK4083 150 mg SC Q4W | Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score | -1.09 score on a scale |
| KHK4083 600 mg SC Q4W | Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score | -1.93 score on a scale |
| KHK4083 300 mg SC Q2W | Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score | -2.59 score on a scale |
| KHK4083 600 mg SC Q2W | Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score | -2.00 score on a scale |
| Placebo/KHK4083 600 mg | Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score | -0.01 score on a scale |
Secondary
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.
Time frame: 56 Weeks
Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 40 | 3.7 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 18 | 6.7 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Baseline | 13.4 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 52 | 4.1 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 10 | 8.0 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 36 | 5.1 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 16 | 7.6 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 32 | 5.8 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 15 | 7.5 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 12 | 7.6 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 28 | 6.8 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 48 | 4.6 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 1 | 14.1 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 22 | 6.3 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 14 | 7.4 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 4 | 12.5 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 2 | 12.6 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 34 | 5.3 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 30 | 6.0 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 20 | 6.7 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 6 | 11.3 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 26 | 6.7 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 56 | 5.1 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 44 | 3.5 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 24 | 6.8 score on a scale |
| KHK4083 150 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 8 | 9.7 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 26 | 5.2 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 28 | 5.0 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 4 | 12.7 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 36 | 4.5 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 30 | 4.4 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 32 | 5.3 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Baseline | 12.6 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 34 | 5.3 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 6 | 10.2 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 52 | 3.1 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 8 | 8.9 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 10 | 8.0 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 56 | 3.4 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 12 | 7.2 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 48 | 3.1 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 14 | 6.9 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 1 | 12.8 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 15 | 6.2 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 16 | 6.1 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 44 | 3.7 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 18 | 6.7 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 20 | 6.2 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 40 | 4.8 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 22 | 5.8 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 2 | 12.6 score on a scale |
| KHK4083 600 mg SC Q4W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 24 | 5.4 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 16 | 4.7 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 56 | 2.8 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 30 | 3.9 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 8 | 7.1 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 26 | 3.7 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 18 | 4.9 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Baseline | 12.0 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 6 | 7.1 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 40 | 3.3 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 52 | 3.7 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 24 | 4.3 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 20 | 5.0 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 34 | 2.9 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 2 | 10.7 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 32 | 3.6 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 36 | 2.9 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 14 | 5.1 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 22 | 4.3 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 12 | 5.8 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 48 | 3.2 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 28 | 3.3 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 15 | 4.4 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 1 | 11.2 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 44 | 3.3 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 10 | 7.1 score on a scale |
| KHK4083 300 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 4 | 10.2 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 44 | 3.3 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Baseline | 13.8 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 1 | 12.7 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 4 | 11.2 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 6 | 9.6 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 8 | 9.0 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 10 | 8.3 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 12 | 7.8 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 14 | 7.2 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 15 | 5.9 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 16 | 6.7 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 18 | 6.6 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 20 | 5.6 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 22 | 5.3 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 24 | 5.1 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 26 | 5.2 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 28 | 4.4 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 30 | 4.0 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 32 | 3.5 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 34 | 3.7 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 36 | 3.6 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 40 | 3.7 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 2 | 12.7 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 48 | 2.9 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 52 | 3.8 score on a scale |
| KHK4083 600 mg SC Q2W | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 56 | 4.7 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 36 | 4.4 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 22 | 8.6 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 20 | 8.8 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 18 | 9.5 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 1 | 12.2 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 40 | 4.1 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 26 | 7.5 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 16 | 9.8 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 15 | 10.3 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Baseline | 11.9 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 44 | 1.9 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 14 | 10.1 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 12 | 9.7 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 10 | 10.6 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 2 | 12.3 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 48 | 3.1 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 8 | 11.4 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 6 | 10.7 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 4 | 13.3 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 32 | 6.1 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 56 | 3.2 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 34 | 4.9 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 30 | 6.9 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 28 | 6.6 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 24 | 8.0 score on a scale |
| Placebo/KHK4083 600 mg | Dermatology Life Quality Index (DLQI) at Each Time Point | DLQI Score at Week 52 | 3.3 score on a scale |
Secondary
EASI Score at Each Time Point
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression total score of 4 elements of eczema × area score of eczema will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Time frame: 56 Weeks
Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 34 | 5.9 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 2 | 31.7 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 26 | 8.2 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 18 | 10.5 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 24 | 9.4 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 20 | 10.0 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 22 | 8.9 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 48 | 6.5 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 4 | 27.3 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 1 | 33.0 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 44 | 3.5 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 52 | 3.1 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 6 | 24.7 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 40 | 4.1 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 8 | 20.3 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 56 | 4.2 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 36 | 5.6 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 10 | 16.5 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 12 | 14.7 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Baseline | 33.2 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 14 | 12.6 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 32 | 6.4 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 15 | 10.8 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 30 | 6.5 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 28 | 7.7 score on a scale |
| KHK4083 150 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 16 | 10.8 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 32 | 5.2 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 8 | 17.6 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 26 | 6.8 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 48 | 3.0 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 36 | 4.8 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 18 | 11.0 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 2 | 27.6 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 24 | 7.4 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 14 | 12.6 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 52 | 2.9 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 20 | 9.5 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Baseline | 32.5 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 22 | 7.5 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 10 | 15.8 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 1 | 29.5 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 44 | 5.8 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 28 | 6.8 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 4 | 26.3 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 34 | 5.8 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 15 | 12.6 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 12 | 13.9 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 30 | 6.1 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 6 | 21.6 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 56 | 4.7 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 40 | 3.8 score on a scale |
| KHK4083 600 mg SC Q4W | EASI Score at Each Time Point | EASI Score at Week 16 | 11.8 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 34 | 2.6 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Baseline | 31.6 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 1 | 28.6 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 2 | 25.6 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 4 | 22.4 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 6 | 17.6 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 8 | 15.2 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 10 | 12.9 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 12 | 10.5 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 14 | 9.8 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 15 | 9.0 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 16 | 8.0 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 18 | 8.7 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 20 | 7.2 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 22 | 6.5 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 24 | 5.0 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 26 | 4.3 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 28 | 4.7 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 30 | 4.1 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 32 | 2.9 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 36 | 2.1 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 40 | 2.7 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 44 | 1.5 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 48 | 1.6 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 52 | 2.2 score on a scale |
| KHK4083 300 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 56 | 2.4 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 14 | 12.1 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 26 | 5.8 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 6 | 19.6 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 52 | 2.3 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 32 | 3.3 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 40 | 3.1 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 15 | 11.6 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 4 | 23.4 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 12 | 14.9 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Baseline | 31.1 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 44 | 3.1 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 1 | 29.4 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 2 | 27.2 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 10 | 16.1 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 34 | 3.4 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 20 | 8.1 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 56 | 2.8 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 22 | 6.0 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 30 | 3.8 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 8 | 17.3 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 18 | 10.6 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 48 | 2.5 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 24 | 6.2 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 28 | 4.8 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 36 | 3.5 score on a scale |
| KHK4083 600 mg SC Q2W | EASI Score at Each Time Point | EASI Score at Week 16 | 11.1 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 18 | 22.2 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 26 | 10.8 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 15 | 20.6 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 28 | 9.8 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 14 | 22.7 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 30 | 8.4 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 12 | 23.6 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 32 | 6.3 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 10 | 25.5 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 34 | 5.7 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 8 | 25.8 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 52 | 2.6 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 36 | 6.3 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 6 | 27.9 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Baseline | 29.2 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 4 | 28.8 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 40 | 5.5 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 2 | 28.1 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 44 | 2.8 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 1 | 28.5 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 20 | 20.8 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 56 | 3.2 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 22 | 16.6 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 48 | 3.2 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 24 | 15.9 score on a scale |
| Placebo/KHK4083 600 mg | EASI Score at Each Time Point | EASI Score at Week 16 | 20.4 score on a scale |
Secondary
Percent Change From Baseline in EASI Score at Each Time Point
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression total score of 4 elements of eczema × area score of eczema will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Time frame: 56 Weeks
Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 24 | -71.7 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 56 | -87.4 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 10 | -51.5 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 36 | -84.5 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 16 | -67.0 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 52 | -90.4 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 15 | -67.1 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 12 | -56.7 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 32 | -82.5 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 48 | -84.5 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 2 | -6.7 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 28 | -78.7 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 14 | -62.5 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 4 | -19.6 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 6 | -28.8 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 22 | -74.3 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 34 | -83.6 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 40 | -88.0 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 30 | -80.8 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 20 | -69.7 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 44 | -89.1 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 1 | -2.5 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 8 | -40.3 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 26 | -75.3 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 18 | -67.1 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 6 | -32.5 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 28 | -77.5 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 1 | -9.5 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 30 | -81.1 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 32 | -82.7 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 34 | -80.5 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 40 | -86.9 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 8 | -45.5 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 36 | -83.5 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 52 | -92.2 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 10 | -51.9 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 12 | -58.4 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 48 | -90.8 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 14 | -62.1 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 15 | -62.2 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 2 | -14.3 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 16 | -63.2 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 44 | -81.7 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 18 | -66.1 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 20 | -70.6 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 56 | -88.3 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 22 | -75.6 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 24 | -75.5 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 4 | -19.4 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 26 | -78.2 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 2 | -18.4 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 4 | -26.4 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 8 | -52.2 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 24 | -85.3 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 18 | -75.5 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 52 | -93.2 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 1 | -8.5 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 6 | -43.4 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 26 | -86.3 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 20 | -79.0 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 36 | -93.0 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 34 | -91.3 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 28 | -84.8 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 22 | -80.8 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 14 | -71.1 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 56 | -90.3 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 12 | -68.3 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 48 | -94.3 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 32 | -90.5 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 15 | -74.1 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 40 | -91.7 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 44 | -94.8 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 10 | -60.4 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 30 | -87.3 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 16 | -77.2 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 10 | -48.2 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 1 | -7.0 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 2 | -15.6 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 4 | -24.6 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 6 | -35.8 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 8 | -42.1 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 12 | -50.9 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 14 | -61.5 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 15 | -62.6 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 16 | -63.6 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 18 | -63.9 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 20 | -74.4 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 22 | -79.4 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 24 | -80.4 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 26 | -81.0 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 28 | -83.9 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 30 | -86.5 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 32 | -87.9 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 34 | -87.1 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 36 | -87.2 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 40 | -88.4 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 44 | -88.5 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 48 | -91.6 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 52 | -92.4 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 56 | -90.4 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 26 | -70.1 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 24 | -49.7 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 22 | -49.3 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 4 | -8.5 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 40 | -82.3 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 18 | -32.6 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 16 | -37.4 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 15 | -35.3 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 2 | -2.6 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 44 | -86.7 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 14 | -32.1 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 12 | -29.5 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 10 | -21.1 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 1 | -2.9 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 48 | -85.0 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 20 | -37.9 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 8 | -19.2 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 6 | -11.1 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 32 | -82.4 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 56 | -88.3 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 34 | -81.8 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 30 | -74.5 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 28 | -70.6 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 52 | -90.2 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in EASI Score at Each Time Point | EASI Score % Change at Week 36 | -82.2 percentage of score change |
Secondary
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being no itch and 10 being the worst itch imaginable.
Time frame: 56 Weeks
Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 40 | -61.7 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 30 | -56.1 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 56 | -60.2 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 32 | -58.3 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 6 | -22.1 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 36 | -59.7 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 34 | -60.9 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 1 | -2.9 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 8 | -28.1 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 10 | -37.0 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 52 | -57.1 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 12 | -37.9 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 2 | -12.2 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 14 | -43.9 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 15 | -41.7 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 48 | -56.7 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 16 | -39.9 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 18 | -45.8 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 20 | -46.6 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 4 | -16.8 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 44 | -59.2 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 22 | -48.0 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 24 | -48.9 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 26 | -52.4 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 28 | -50.3 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 22 | -52.1 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 52 | -70.1 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 10 | -36.9 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 40 | -52.8 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 12 | -37.9 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 26 | -52.2 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 14 | -45.1 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 2 | -1.7 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 48 | -69.3 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 15 | -43.6 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 24 | -53.3 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 16 | -44.1 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 1 | 2.5 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 28 | -56.2 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 30 | -64.3 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 36 | -60.9 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 18 | -44.5 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 32 | -61.4 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 56 | -67.2 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 44 | -70.6 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 34 | -58.1 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 6 | -26.0 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 4 | -8.3 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 20 | -49.2 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 8 | -25.5 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 32 | -70.5 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 18 | -52.1 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 20 | -56.5 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 28 | -73.7 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 10 | -43.5 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 22 | -66.2 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 1 | -3.4 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 4 | -18.8 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 36 | -72.3 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 12 | -49.0 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 44 | -77.1 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 48 | -74.0 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 56 | -75.7 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 52 | -72.9 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 14 | -52.7 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 30 | -69.4 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 24 | -66.7 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 40 | -70.2 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 6 | -32.5 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 15 | -57.8 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 2 | -11.9 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 26 | -71.2 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 8 | -37.3 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 34 | -72.8 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 16 | -57.4 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 10 | -32.1 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 22 | -53.6 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 1 | -12.2 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 2 | -11.8 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 4 | -17.3 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 6 | -26.0 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 8 | -31.0 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 12 | -36.0 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 14 | -36.0 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 15 | -42.6 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 16 | -45.7 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 18 | -42.9 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 20 | -49.7 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 24 | -51.4 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 26 | -54.0 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 28 | -57.1 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 30 | -60.0 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 32 | -60.9 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 34 | -57.5 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 36 | -60.5 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 40 | -60.7 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 44 | -68.4 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 48 | -68.3 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 52 | -60.3 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 56 | -65.6 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 26 | -39.3 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 24 | -33.7 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 22 | -20.9 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 4 | 14.0 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 40 | -67.0 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 20 | -25.1 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 18 | -29.3 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 16 | -20.4 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 2 | 12.9 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 44 | -75.2 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 15 | -16.3 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 14 | -13.5 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 12 | -16.0 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 1 | 2.6 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 48 | -69.7 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 10 | -14.3 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 8 | -8.8 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 6 | 5.2 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 56 | -82.1 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 34 | -63.1 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 32 | -63.6 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 30 | -48.4 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 28 | -45.4 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 52 | -80.3 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score % Change at Week 36 | -64.0 percentage of score change |
Secondary
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as A in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as B in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as C in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Time frame: 56 Weeks
Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 12 | -41.68 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 20 | -51.55 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 14 | -44.39 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 48 | -64.22 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 18 | -47.48 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 16 | -50.07 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 2 | -7.37 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 40 | -69.85 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 52 | -70.53 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 10 | -39.55 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 36 | -65.54 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 56 | -70.50 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 15 | -48.84 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 34 | -64.71 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 32 | -64.78 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 1 | -1.28 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 30 | -63.35 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 4 | -13.51 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 28 | -58.86 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 6 | -19.34 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 26 | -58.23 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 8 | -31.63 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 24 | -53.96 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 44 | -74.31 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 22 | -54.91 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 1 | -4.08 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 12 | -38.06 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 40 | -66.90 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 20 | -49.39 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 18 | -46.42 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 44 | -67.86 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 14 | -41.69 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 30 | -62.81 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 2 | -9.14 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 16 | -43.47 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 15 | -42.54 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 48 | -74.60 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 26 | -59.24 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 22 | -55.22 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 10 | -34.22 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 36 | -63.75 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 4 | -12.97 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 52 | -76.82 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 28 | -58.76 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 34 | -61.29 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 8 | -29.29 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 56 | -74.01 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 24 | -56.56 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 6 | -23.76 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 32 | -62.61 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 2 | -9.05 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 8 | -32.82 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 44 | -80.96 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 48 | -81.00 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 52 | -77.96 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 56 | -80.81 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 1 | -7.03 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 4 | -19.60 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 6 | -30.52 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 10 | -42.53 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 12 | -49.86 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 14 | -53.03 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 15 | -55.95 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 16 | -58.24 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 18 | -56.06 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 20 | -58.91 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 22 | -62.02 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 24 | -68.56 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 26 | -68.82 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 28 | -68.19 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 30 | -72.05 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 32 | -74.40 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 34 | -75.43 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 36 | -75.38 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 40 | -75.95 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 44 | -70.81 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 20 | -54.95 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 10 | -34.32 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 36 | -64.60 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 22 | -58.18 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 8 | -29.34 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 24 | -56.63 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 6 | -29.34 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 48 | -74.06 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 26 | -58.19 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 4 | -15.77 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 28 | -59.99 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 2 | -10.37 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 30 | -64.57 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 1 | -5.75 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 40 | -64.59 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 32 | -67.09 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 56 | -71.83 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 34 | -66.43 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 15 | -44.36 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 52 | -71.47 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 16 | -47.00 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 14 | -42.09 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 18 | -48.32 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 12 | -35.85 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 2 | -0.47 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 15 | -23.19 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 20 | -27.64 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 10 | -13.14 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 30 | -49.89 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 18 | -21.87 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 56 | -74.51 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 22 | -32.18 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 8 | -12.34 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 14 | -19.05 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 36 | -60.63 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 48 | -71.99 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 24 | -34.10 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 6 | -12.34 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 32 | -57.60 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 12 | -15.56 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 52 | -76.93 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 26 | -47.60 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 4 | -1.98 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 40 | -66.66 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 44 | -71.50 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 16 | -23.26 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 28 | -50.43 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 34 | -59.75 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score % Change at Week 1 | -4.54 percentage of score change |
Secondary
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Time frame: 56 Weeks
Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 10 | -29.8 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 24 | -53.1 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 48 | -60.0 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 6 | 6.2 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 36 | -64.9 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 12 | -37.1 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 28 | -48.7 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 56 | -65.9 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 22 | -45.0 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 34 | -61.1 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 14 | -34.5 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 44 | -65.7 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 8 | -11.7 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 20 | -44.4 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 32 | -60.0 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 15 | -41.9 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 2 | -0.7 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 52 | -73.2 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 26 | -46.5 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 30 | -58.1 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 16 | -38.4 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 40 | -71.6 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 4 | 4.9 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 1 | 6.6 percentage of score change |
| KHK4083 150 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 18 | -42.2 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 28 | -54.4 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 18 | -48.7 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 4 | 12.1 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 26 | -55.5 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 20 | -48.4 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 56 | -69.7 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 24 | -53.3 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 22 | -45.1 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 48 | -70.2 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 6 | -7.1 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 44 | -71.4 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 8 | -10.8 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 40 | -50.7 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 10 | -31.9 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 2 | 12.6 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 36 | -45.1 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 12 | -13.4 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 1 | 14.2 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 34 | -66.0 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 14 | -38.4 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 52 | -87.0 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 32 | -45.6 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 15 | -28.1 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 30 | -63.3 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 16 | -10.9 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 28 | -80.4 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 1 | 29.8 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 2 | 12.0 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 4 | 11.9 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 6 | -18.3 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 8 | -27.3 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 10 | -41.3 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 12 | -54.8 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 14 | -49.6 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 15 | -60.9 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 16 | -63.4 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 18 | -66.9 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 20 | -72.3 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 22 | -75.1 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 24 | -67.3 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 26 | -75.5 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 30 | -77.4 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 32 | -78.0 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 34 | -82.5 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 36 | -81.9 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 40 | -81.0 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 44 | -88.5 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 48 | -84.9 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 52 | -61.9 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 56 | -82.2 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 56 | -75.9 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 8 | -31.8 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 32 | -65.8 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 40 | -67.8 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 15 | -46.6 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 2 | -6.7 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 6 | -25.5 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 1 | -15.7 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 44 | -79.6 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 12 | -38.9 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 52 | -71.1 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 4 | -11.2 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 34 | -64.8 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 48 | -78.9 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 30 | -67.1 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 22 | -56.1 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 16 | -48.5 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 10 | -36.1 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 24 | -52.5 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 28 | -58.8 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 20 | -50.0 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 36 | -64.7 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 14 | -44.0 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 26 | -57.1 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 18 | -38.9 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 26 | -39.4 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 16 | 0.7 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 28 | -38.9 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 15 | 13.7 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 30 | -45.6 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 14 | 14.5 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 32 | -55.3 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 12 | 4.5 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 34 | -51.7 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 10 | 11.7 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 52 | -69.3 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 36 | -56.2 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 8 | 13.5 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 1 | 51.3 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 40 | -57.2 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 6 | 33.6 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 44 | -65.3 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 4 | 49.6 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 56 | -71.3 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 22 | -2.3 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 20 | 9.1 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 48 | -74.4 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 24 | -5.5 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 18 | 8.1 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score % Change at Week 2 | 60.3 percentage of score change |
Secondary
Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being no itch and 10 being the worst itch imaginable.
Time frame: Baseline to Week 16
Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| KHK4083 150 mg SC Q4W | Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score | -25.57 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score | -34.38 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score | -47.99 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score | -36.83 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score | -6.18 percentage of score change |
Secondary
Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as A in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as B in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as C in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Time frame: Baseline to Week 16
Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| KHK4083 150 mg SC Q4W | Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score | -34.86 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score | -35.13 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score | -46.69 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score | -40.76 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score | -11.90 percentage of score change |
Secondary
Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Time frame: Baseline to Week 16
Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| KHK4083 150 mg SC Q4W | Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score | -8.19 percentage of score change |
| KHK4083 600 mg SC Q4W | Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score | -7.02 percentage of score change |
| KHK4083 300 mg SC Q2W | Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score | -41.58 percentage of score change |
| KHK4083 600 mg SC Q2W | Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score | -33.17 percentage of score change |
| Placebo/KHK4083 600 mg | Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score | -46.54 percentage of score change |
Secondary
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being no itch and 10 being the worst itch imaginable.
Time frame: 56 Weeks
Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 28 | 3.7 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 22 | 4.0 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 15 | 4.4 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 56 | 2.8 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 20 | 4.0 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 16 | 4.6 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Baseline | 7.7 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 40 | 2.8 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 48 | 3.2 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 1 | 7.3 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 36 | 3.1 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 2 | 6.8 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 34 | 3.1 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 4 | 6.4 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 18 | 4.2 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 6 | 6.0 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 44 | 2.9 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 32 | 3.2 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 8 | 5.4 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 30 | 3.3 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 10 | 4.9 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 26 | 3.7 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 12 | 4.8 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 52 | 2.8 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 24 | 4.0 score on a scale |
| KHK4083 150 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 14 | 4.5 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 4 | 6.2 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 22 | 3.1 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 12 | 4.2 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Baseline | 7.7 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 15 | 3.8 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 32 | 2.7 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 20 | 3.2 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 10 | 4.7 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 6 | 5.4 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 16 | 3.6 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 56 | 2.3 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 18 | 3.7 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 40 | 2.9 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 26 | 3.0 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 30 | 2.5 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 14 | 3.7 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 1 | 7.3 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 48 | 2.2 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 36 | 2.5 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 8 | 5.2 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 24 | 3.2 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 2 | 7.0 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 44 | 2.4 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 34 | 2.8 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 28 | 3.1 score on a scale |
| KHK4083 600 mg SC Q4W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 52 | 2.0 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 32 | 2.0 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Baseline | 7.3 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 1 | 6.8 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 2 | 6.3 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 4 | 5.7 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 6 | 4.7 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 8 | 4.4 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 10 | 4.0 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 12 | 3.6 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 14 | 3.3 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 15 | 2.9 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 16 | 2.8 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 18 | 3.3 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 20 | 2.9 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 22 | 2.3 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 24 | 2.2 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 26 | 2.0 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 28 | 1.8 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 30 | 2.1 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 34 | 1.9 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 36 | 1.8 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 40 | 2.1 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 44 | 1.6 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 48 | 1.7 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 52 | 1.9 score on a scale |
| KHK4083 300 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 56 | 1.9 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 28 | 3.1 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 44 | 2.3 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 1 | 6.8 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 26 | 3.3 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 56 | 2.4 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 36 | 2.8 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 30 | 2.9 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Baseline | 7.6 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 24 | 3.6 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 52 | 2.9 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 40 | 2.8 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 6 | 5.5 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 10 | 5.1 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 18 | 4.2 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 4 | 6.2 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 32 | 2.7 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 15 | 4.2 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 8 | 5.2 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 20 | 3.7 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 16 | 4.1 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 2 | 6.8 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 14 | 4.6 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 48 | 2.2 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 22 | 3.5 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 34 | 3.0 score on a scale |
| KHK4083 600 mg SC Q2W | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 12 | 4.7 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 12 | 5.8 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 24 | 4.3 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 10 | 5.8 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 44 | 1.6 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 26 | 4.1 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 8 | 6.0 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 6 | 6.5 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 56 | 1.3 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 30 | 3.5 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 4 | 7.1 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 32 | 2.9 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 2 | 7.1 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 34 | 2.7 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 1 | 6.9 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Baseline | 7.2 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 36 | 2.6 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 48 | 1.8 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 40 | 2.4 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 28 | 3.5 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 18 | 5.2 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 15 | 5.3 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 16 | 5.2 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 20 | 4.8 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 14 | 5.9 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 52 | 1.4 score on a scale |
| Placebo/KHK4083 600 mg | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | Pruritis NRS Score at Week 22 | 4.8 score on a scale |
Secondary
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as A in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as B in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as C in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Time frame: 56 Weeks
Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 44 | 18.33 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 20 | 33.88 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 1 | 68.40 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 26 | 29.48 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 6 | 56.59 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 28 | 29.21 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 52 | 19.96 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 2 | 64.56 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 8 | 48.46 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 40 | 20.98 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 22 | 31.69 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 30 | 25.75 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 4 | 60.87 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 18 | 36.44 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 10 | 42.42 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 14 | 39.51 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 12 | 41.07 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 24 | 32.41 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 48 | 25.83 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 36 | 23.82 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 16 | 34.70 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 34 | 24.63 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 15 | 35.79 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 56 | 20.65 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 32 | 25.09 score on a scale |
| KHK4083 150 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Baseline | 68.67 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 26 | 27.54 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Baseline | 69.80 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 14 | 39.75 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 16 | 37.82 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 32 | 25.02 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 18 | 36.01 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 4 | 59.84 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 40 | 21.49 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 20 | 33.86 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 22 | 30.13 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 8 | 48.16 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 36 | 24.13 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 24 | 29.06 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 28 | 27.50 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 52 | 16.60 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 1 | 66.53 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 44 | 21.86 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 2 | 62.75 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 34 | 25.78 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 12 | 41.98 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 48 | 17.78 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 10 | 45.15 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 30 | 25.40 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 56 | 18.50 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 6 | 52.39 score on a scale |
| KHK4083 600 mg SC Q4W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 15 | 38.88 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 24 | 21.05 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 26 | 20.12 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 34 | 15.65 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 28 | 20.23 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 30 | 18.05 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 32 | 16.29 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 6 | 46.32 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 52 | 15.02 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 8 | 45.05 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 36 | 15.46 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 1 | 63.06 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 2 | 61.03 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 48 | 11.90 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 10 | 39.13 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 14 | 31.69 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 12 | 33.82 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 44 | 11.64 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 15 | 30.03 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 16 | 28.31 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 56 | 11.92 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 40 | 15.56 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 18 | 30.14 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 20 | 27.59 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 4 | 54.01 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 22 | 25.14 score on a scale |
| KHK4083 300 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Baseline | 68.19 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 4 | 57.01 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 22 | 28.21 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 44 | 20.08 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 56 | 19.27 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Baseline | 68.79 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 6 | 51.34 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 8 | 48.29 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 1 | 64.99 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 2 | 62.52 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 10 | 45.50 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 14 | 39.41 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 12 | 43.68 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 15 | 37.46 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 16 | 35.76 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 18 | 34.80 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 20 | 31.35 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 24 | 29.93 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 26 | 28.31 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 28 | 27.05 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 30 | 23.79 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 32 | 22.05 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 34 | 22.13 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 36 | 23.78 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 40 | 24.14 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 48 | 18.54 score on a scale |
| KHK4083 600 mg SC Q2W | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 52 | 20.46 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 34 | 27.55 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 24 | 43.55 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 22 | 45.07 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 4 | 65.20 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 36 | 26.86 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 20 | 48.17 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 18 | 51.99 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 16 | 51.80 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 52 | 15.21 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 40 | 22.27 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 12 | 57.15 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 14 | 54.68 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 44 | 17.72 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 10 | 58.85 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 8 | 59.11 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 2 | 65.31 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 15 | 51.66 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 48 | 17.54 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 1 | 62.83 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Baseline | 66.35 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 6 | 62.07 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 32 | 29.23 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 30 | 33.63 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 28 | 32.88 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 26 | 35.59 score on a scale |
| Placebo/KHK4083 600 mg | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | SCORAD Score at Week 56 | 16.91 score on a scale |
Secondary
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Time frame: 56 Weeks
Population: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 44 | 1.9 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 16 | 3.5 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 15 | 3.4 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 14 | 3.8 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 10 | 3.9 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 1 | 6.0 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 12 | 3.5 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 56 | 2.1 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 40 | 1.5 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 36 | 2.0 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 2 | 5.3 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 52 | 1.6 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 34 | 2.3 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 32 | 2.3 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 30 | 2.5 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 4 | 5.5 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Baseline | 5.9 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 28 | 3.1 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 26 | 3.1 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 24 | 2.9 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 6 | 5.3 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 48 | 2.1 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 22 | 3.1 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 20 | 3.1 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 18 | 3.6 score on a scale |
| KHK4083 150 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 8 | 4.5 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 4 | 4.7 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Baseline | 5.5 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 1 | 5.4 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 2 | 5.1 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 6 | 3.8 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 8 | 3.5 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 10 | 3.1 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 12 | 3.2 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 14 | 2.5 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 15 | 2.7 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 16 | 2.7 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 18 | 2.3 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 20 | 2.1 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 22 | 2.3 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 24 | 2.1 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 26 | 1.7 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 28 | 1.6 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 30 | 1.4 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 32 | 1.9 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 34 | 1.5 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 36 | 1.6 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 40 | 1.5 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 44 | 1.4 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 48 | 1.2 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 52 | 0.8 score on a scale |
| KHK4083 600 mg SC Q4W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 56 | 1.1 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 16 | 1.8 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 18 | 1.6 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 56 | 1.1 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 20 | 1.6 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 6 | 3.2 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 48 | 0.6 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 22 | 1.3 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 24 | 1.5 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 26 | 1.2 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 4 | 4.3 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 1 | 5.2 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 28 | 1.1 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 30 | 1.1 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 52 | 1.3 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 32 | 1.2 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 2 | 4.7 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 34 | 0.9 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 36 | 0.9 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Baseline | 5.0 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 40 | 0.8 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 10 | 2.5 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 12 | 2.1 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 44 | 0.6 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 14 | 2.5 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 15 | 1.9 score on a scale |
| KHK4083 300 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 8 | 3.0 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 40 | 1.9 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 44 | 1.4 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 28 | 2.3 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 56 | 1.5 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 12 | 3.6 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 30 | 1.9 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 2 | 5.5 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 32 | 1.9 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 15 | 3.0 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 52 | 1.9 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 34 | 2.1 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 14 | 3.3 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 36 | 2.1 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 16 | 2.9 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Baseline | 5.9 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 1 | 5.1 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 18 | 3.2 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 6 | 4.3 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 8 | 4.2 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 20 | 2.9 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 26 | 2.4 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 22 | 2.7 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 48 | 1.3 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 10 | 3.9 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 24 | 2.7 score on a scale |
| KHK4083 600 mg SC Q2W | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 4 | 5.0 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 36 | 2.0 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 26 | 3.2 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 10 | 4.6 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 56 | 0.9 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 44 | 1.1 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 16 | 4.2 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 28 | 2.7 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 2 | 5.6 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 6 | 5.0 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 40 | 2.0 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Baseline | 5.0 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 30 | 2.6 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 48 | 0.9 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 12 | 4.4 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 8 | 4.8 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 18 | 4.2 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 32 | 2.4 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 22 | 3.8 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 14 | 4.7 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 15 | 4.6 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 4 | 5.6 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 34 | 2.1 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 1 | 5.1 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 52 | 1.2 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 24 | 3.5 score on a scale |
| Placebo/KHK4083 600 mg | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | Sleep Disturbance NRS Score at Week 20 | 4.0 score on a scale |