Moderate-to-Severe Atopic Dermatitis
Conditions
Keywords
CD14152, Nemolizumab, Atopic Dermatitis
Brief summary
The main purpose of the study was to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.
Detailed description
This was a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent subjects of age 12 years and above with moderate-to-severe AD. Eligible subjects had documented history of inadequate response to topical AD medication(s). Approximately 750 subjects were randomized in 2:1 to receive either nemolizumab or placebo, stratified by baseline disease severity (Investigator's Global Assessment (IGA) = 3, moderate; IGA = 4, severe) and peak pruritus numeric rating scale (PP NRS) severity (PP NRS \>= 7; PP NRS \< 7). A minimum of 250 subjects were randomized in each PP NRS strata. All nemolizumab-treated subjects who were clinical responders at Week 16 (i.e., the end of initial treatment \[Initial Treatment Period\]/beginning of Maintenance Period) were re-randomized (1:1:1) to different treatment regimens (nemolizumab injections Q4W or every 8 weeks (Q8W) \[with placebo injections at Weeks 20, 28, 36, and 44 to maintain the blind\] or placebo Q4W). A clinical responder was defined as a subject at Week 16 with an IGA of 0 (clear) or 1 (almost clear) or a \>=75% improvement in EASI from baseline (EASI-75). All placebo-treated subjects who responded to placebo during the Initial Treatment Period continued to receive placebo Q4W in the Maintenance Period.
Interventions
DRUGPlacebo
Placebo
DRUGNemolizumab
Nemolizumab
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Treatment
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female subjects aged greater than and equal to (\>=) 12 years at the screening visit. * Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for at least 2 years before the screening visit. * Eczema Area and Severity Index (EASI) score \>=16 at the screening and baseline visits. * Investigator Global Assessment (IGA) score \>= 3 (scale of 0 to 4) at the screening and baseline visits. * AD involvement \>= 10 percent (%) of body surface area (BSA) at screening and baseline visits. * Peak Pruritus Numerical Rating Scale (PPNRS) score of at least 4.0 at the screening and baseline visits. * Documented recent history of inadequate response to topical medications (topical corticosteroids \[TCS\] with or without Topical calcineurin inhibitors \[TCI\]). * Female subjects of childbearing potential (that is, fertile, following menarche and until becoming postmenopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection. Key
Exclusion criteria
* Body weight (\<) 30 kilograms (kg) * Exacerbation of asthma requiring hospitalization in the preceding 12 months. Uncontrolled asthma in the preceding 3 months. * Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit. * Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study. Note: Subjects with chronic,stable use of prophylactic treatment for recurrent herpes viral infection can be included in this clinical study. * History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g., monoclonal antibody) or to any of the study drug excipients. * Any clinically significant issue, based on investigator judgement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population | Week 16 | IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of atopic dermatitis (AD) and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data at Week 16 were considered non-responders. |
| Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Severe Pruritus Population | Week 16 | IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of AD and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders. |
| Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population | Week 16 | EASI-75 was defined as \>=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD(erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head & neck, upper limbs, trunk & lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders. |
| Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: Severe Pruritus Population | Week 16 | EASI-75 was defined as \>=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD(erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head & neck, upper limbs, trunk & lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population | Week 16 | The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
| Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population | Week 16 | The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
| Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population | Week 4 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
| Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: Severe Pruritus Population | Week 4 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
| Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population | Week 4 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
| Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population | Week 16 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. |
| Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population | Week 2 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
| Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population | Week 2 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
| Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population | Week 1 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
| Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: Severe Pruritus Population | Week 1 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
| Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population | Week 4 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
| Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population | Week 16 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. |
| Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population | Week 16 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
| Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population | Week 16 | The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders. |
Countries
Belgium, Bulgaria, Estonia, France, Georgia, Germany, Hungary, Italy, Poland, Singapore, United States
Participant flow
Recruitment details
The study was conducted at 136 active sites in Belgium, Bulgaria, Estonia, France, Georgia, Germany, Hungary, Italy, Poland, Singapore, and the United States from 27 June 2019 to 26 September 2022.
Pre-assignment details
A total of 787 randomized 2:1 to receive either nemolizumab or placebo.At Week 16, 235 nemolizumab treated participants were clinical responders(IGA of 0\[clear\] or 1\[almost clear\]or Eczema Area and Severity Index \[EASI\]-75) re-randomized to receive nemolizumab Q4,nemolizumab Q8W,or placebo during Maintenance Period.85 participants received placebo in Initial Treatment, responded to placebo at Week 16,re-assigned to placebo and continued to receive placebo Q4W in Maintenance Period.
Participants by arm
| Arm | Count |
|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period. | 522 |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period. | 265 |
| Total | 787 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Initial Treatment(Day 1-Week 16 Predose) | Adverse Event | 17 | 4 | 0 | 0 | 0 | 0 |
| Initial Treatment(Day 1-Week 16 Predose) | Lack of Efficacy | 3 | 0 | 0 | 0 | 0 | 0 |
| Initial Treatment(Day 1-Week 16 Predose) | Lost to Follow-up | 1 | 1 | 0 | 0 | 0 | 0 |
| Initial Treatment(Day 1-Week 16 Predose) | Physician/principal investigator decision | 1 | 0 | 0 | 0 | 0 | 0 |
| Initial Treatment(Day 1-Week 16 Predose) | Protocol Deviation | 3 | 2 | 0 | 0 | 0 | 0 |
| Initial Treatment(Day 1-Week 16 Predose) | Randomized but not Treated | 3 | 2 | 0 | 0 | 0 | 0 |
| Initial Treatment(Day 1-Week 16 Predose) | Withdrawal by Subject | 24 | 15 | 0 | 0 | 0 | 0 |
| Maintenance Period (Week 16-Week 48) | Adverse Event | 0 | 0 | 3 | 2 | 3 | 2 |
| Maintenance Period (Week 16-Week 48) | Lack of Efficacy | 0 | 0 | 2 | 2 | 3 | 3 |
| Maintenance Period (Week 16-Week 48) | Lost to Follow-up | 0 | 0 | 1 | 0 | 3 | 0 |
| Maintenance Period (Week 16-Week 48) | Other | 0 | 0 | 4 | 2 | 2 | 0 |
| Maintenance Period (Week 16-Week 48) | Physician Decision | 0 | 0 | 1 | 1 | 0 | 1 |
| Maintenance Period (Week 16-Week 48) | Re-randomized/Re-assigned but not Treated | 0 | 0 | 1 | 0 | 1 | 1 |
| Maintenance Period (Week 16-Week 48) | Withdrawal by Subject | 0 | 0 | 2 | 3 | 1 | 4 |
Baseline characteristics
| Characteristic | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 91 Participants | 41 Participants | 132 Participants |
| Age, Categorical >=65 years | 37 Participants | 15 Participants | 52 Participants |
| Age, Categorical Between 18 and 65 years | 394 Participants | 209 Participants | 603 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants | 19 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 464 Participants | 244 Participants | 708 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants | 2 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 35 Participants | 18 Participants | 53 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 20 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 458 Participants | 227 Participants | 685 Participants |
| Sex: Female, Male Female | 270 Participants | 136 Participants | 406 Participants |
| Sex: Female, Male Male | 252 Participants | 129 Participants | 381 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 519 | 0 / 263 | 0 / 79 | 0 / 77 | 0 / 77 | 0 / 84 |
| other Total, other adverse events | 71 / 519 | 40 / 263 | 17 / 79 | 11 / 77 | 26 / 77 | 16 / 84 |
| serious Total, serious adverse events | 13 / 519 | 3 / 263 | 6 / 79 | 0 / 77 | 2 / 77 | 1 / 84 |
Outcome results
Primary
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population
EASI-75 was defined as \>=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD(erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head & neck, upper limbs, trunk & lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders.
Time frame: Week 16
Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population | 42.1 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population | 30.2 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.p-value: 0.000697.5% CI: [4.6, 20.3]Cochran-Mantel-Haenszel
Primary
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: Severe Pruritus Population
EASI-75 was defined as \>=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD(erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head & neck, upper limbs, trunk & lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders.
Time frame: Week 16
Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: Severe Pruritus Population | 41.1 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: Severe Pruritus Population | 25.0 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.p-value: 0.000497.5% CI: [6.6, 26]Cochran-Mantel-Haenszel
Primary
Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population
IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of atopic dermatitis (AD) and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data at Week 16 were considered non-responders.
Time frame: Week 16
Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population | 37.7 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population | 26.0 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.p-value: 0.000697.5% CI: [4.6, 19.8]Cochran-Mantel-Haenszel
Primary
Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Severe Pruritus Population
IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of AD and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders.
Time frame: Week 16
Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Severe Pruritus Population | 36.7 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Severe Pruritus Population | 22.0 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.p-value: 0.000897.5% CI: [5.6, 24.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Time frame: Week 16
Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population | 28.4 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population | 11.3 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.p-value: <0.000197.5% CI: [10.9, 23.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Time frame: Week 16
Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population | 26.9 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population | 8.5 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.p-value: <0.000197.5% CI: [11, 25.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Time frame: Week 16
Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population | 33.5 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population | 16.2 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.p-value: <0.000197.5% CI: [10.8, 24.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Time frame: Week 16
Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population | 42.7 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population | 20.7 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.p-value: <0.000197.5% CI: [12.5, 31.4]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure.
Time frame: Week 16
Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population | 41.0 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population | 18.1 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.p-value: <0.000197.5% CI: [16.1, 30.3]Cochran-Mantel-Haenszel
Comparison: Nemolizumab 30 mg versus Placebo using multiple imputation (MI) with missing at random (MAR) assumption.p-value: <0.000197.5% CI: [21.2, 34.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure.
Time frame: Week 16
Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population | 48.4 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population | 21.3 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.p-value: <0.000197.5% CI: [17.5, 36.6]Cochran-Mantel-Haenszel
Comparison: Nemolizumab 30 mg versus Placebo using MI-MAR assumption.p-value: <0.000197.5% CI: [24.5, 42.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Time frame: Week 1
Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population | 6.7 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population | 0.4 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.p-value: <0.000197.5% CI: [3.8, 9.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: Severe Pruritus Population
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Time frame: Week 1
Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: Severe Pruritus Population | 8.5 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: Severe Pruritus Population | 0.6 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for preceding outcome measure was statistically significant at two-sided 2.5% significance level.p-value: 0.000497.5% CI: [4.2, 11.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Time frame: Week 2
Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population | 16.9 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population | 1.9 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance levelp-value: <0.000197.5% CI: [11, 19.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Time frame: Week 2
Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population | 19.3 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population | 3.0 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.p-value: <0.000197.5% CI: [10.5, 22.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Time frame: Week 4
Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population | 26.1 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population | 5.3 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.p-value: <0.000197.5% CI: [15.6, 26.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: Severe Pruritus Population
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Time frame: Week 4
Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: Severe Pruritus Population | 30.4 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: Severe Pruritus Population | 7.9 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.p-value: <0.000197.5% CI: [15, 29.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Time frame: Week 4
Population: The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population | 15.9 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population | 2.6 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.p-value: <0.000197.5% CI: [9, 17.4]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population
The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
Time frame: Week 4
Population: Severe pruritus population consisted of all randomized participants with a baseline PP NRS \>=7. Data was planned to be collected and analyzed for Initial Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population | 11.1 percentage of participants |
| Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population | 1.2 percentage of participants |
Comparison: A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.p-value: 0.000197.5% CI: [5.5, 14.3]Cochran-Mantel-Haenszel