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CompletedNCT03989349Updated Aug 14, 2024Results posted

Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

A Phase 3 interventional study of Placebo and Nemolizumab in Moderate-to-Severe Atopic Dermatitis, sponsored by Galderma R&D. Completed at 138 sites in 11 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by Galderma R&D · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
787
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Moderate-to-Severe Atopic Dermatitis

Keywords

  • CD14152
  • Nemolizumab
  • Atopic Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 787 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.

Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
787 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo administered via subcutaneous injection

    Drug: Placebo

  • Experimental
    Nemolizumab

    Nemolizumab administered via subcutaneous injection

    Drug: Nemolizumab

Interventions

  • DrugPlacebo

    Placebo

  • DrugNemolizumab

    Nemolizumab

    Also known as: CD14152

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

07

Results

Posted Aug 14, 2024

Participant flow

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.

Initial Treatment(Day 1-Week 16 Predose)
Participant flow — Initial Treatment(Day 1-Week 16 Predose)
MilestoneInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial Treatment Period (Baseline - Week 16 Predose): PlaceboMaintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4WMaintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q8WMaintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Placebo Q4WMaintenance Period (Week 16-Week 48): Placebo Q4W Re-assigned to Placebo Q4W
Started5222650000
Treated5192630000
Safety population5192630000
Completed4702410000
Not completed52240000
Withdrew: Lack of efficacy300000
Withdrew: Adverse event1740000
Withdrew: Withdrawal by subject24150000
Withdrew: Lost to follow-up110000
Withdrew: Protocol deviation320000
Withdrew: Physician/principal investigator decision100000
Withdrew: Randomized but not treated320000
Maintenance Period (Week 16-Week 48)
Participant flow — Maintenance Period (Week 16-Week 48)
MilestoneInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial Treatment Period (Baseline - Week 16 Predose): PlaceboMaintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4WMaintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q8WMaintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Placebo Q4WMaintenance Period (Week 16-Week 48): Placebo Q4W Re-assigned to Placebo Q4W
Started0079787885
Treated0078787784
Safety population0079777784
Completed0065686574
Not completed0014101311
Withdrew: Lack of efficacy002233
Withdrew: Adverse event003232
Withdrew: Withdrawal by subject002314
Withdrew: Lost to follow-up001030
Withdrew: Physician decision001101
Withdrew: Other004220
Withdrew: Re-randomized/re-assigned but not treated001011

Outcome measures

PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial Treatment Period (Baseline - Week 16 Predose): Placebo
Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Intent-To-Treat (ITT) Population37.726.0
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = 0.0006 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).) · Strata-adjusted percentage difference: 12.2 · 97.5% CI 4.6 to 19.8
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Severe Pruritus Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial Treatment Period (Baseline - Week 16 Predose): Placebo
Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: Severe Pruritus Population36.722.0
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = 0.0008 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).) · Strata-adjusted percentage difference: 14.9 · 97.5% CI 5.6 to 24.3
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial 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 Population42.130.2
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = 0.0006 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).) · Strata-adjusted percentage difference: 12.5 · 97.5% CI 4.6 to 20.3
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: Severe Pruritus Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial 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 Population41.125.0
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = 0.0004 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).) · Strata-adjusted percentage difference: 16.3 · 97.5% CI 6.6 to 26.0
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial 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 Population41.018.1
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = <0.0001 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).) · Strata-adjusted percentage difference: 23.2 · 97.5% CI 16.1 to 30.3
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = <0.0001 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).) · Strata-adjusted percentage difference: 27.8 · 97.5% CI 21.2 to 34.5The estimates are from 50 complete datasets by MI-MAR assumption.
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial 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 Population48.421.3
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = <0.0001 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].) · Strata-adjusted percentage difference: 27.1 · 97.5% CI 17.5 to 36.6
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = <0.0001 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].) · Strata-adjusted percentage difference: 33.4 · 97.5% CI 24.5 to 42.3The estimates are from 50 complete datasets by MI-MAR assumption.
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial Treatment Period (Baseline - Week 16 Predose): Placebo
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population28.411.3
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = <0.0001 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).) · Strata-adjusted percentage difference: 17.1 · 97.5% CI 10.9 to 23.3
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial Treatment Period (Baseline - Week 16 Predose): Placebo
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population26.98.5
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = <0.0001 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).) · Strata-adjusted percentage difference: 18.4 · 97.5% CI 11.0 to 25.8
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial 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 Population33.516.2
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = < 0.0001 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).) · Strata-adjusted percentage difference: 17.5 · 97.5% CI 10.8 to 24.3
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial 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 Population42.720.7
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = <0.0001 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).) · Strata-adjusted percentage difference: 21.9 · 97.5% CI 12.5 to 31.4
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial 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 Population26.15.3
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = < 0.0001 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting the randomized stratification variables (IGA severity and PP NRS).) · Strata-adjusted percentage difference: 20.9 · 97.5% CI 15.6 to 26.1
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: Severe Pruritus Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial 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 Population30.47.9
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = <0.0001 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).) · Strata-adjusted percentage difference: 22.5 · 97.5% CI 15.0 to 29.9
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial Treatment Period (Baseline - Week 16 Predose): Placebo
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population15.92.6
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = < 0.0001 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).) · Strata-adjusted percentage difference: 13.2 · 97.5% CI 9 to 17.4
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial Treatment Period (Baseline - Week 16 Predose): Placebo
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population11.11.2
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = 0.0001 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).) · Strata-adjusted percentage difference: 9.9 · 97.5% CI 5.5 to 14.3
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial 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 Population16.91.9
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = < 0.0001 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).) · Strata-adjusted percentage difference: 15.1 · 97.5% CI 11 to 19.2
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial 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 Population19.33.0
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = <0.0001 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).) · Strata-adjusted percentage difference: 16.3 · 97.5% CI 10.5 to 22.1
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial 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 Population6.70.4
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = <0.0001 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).) · Strata-adjusted percentage difference: 6.4 · 97.5% CI 3.8 to 9.1
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: Severe Pruritus Population
percentage of participantsInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial 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 Population8.50.6
Statistical analysis
  • Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg vs Initial Treatment Period (Baseline - Week 16 Predose): Placebo · Cochran-Mantel-Haenszel · p = 0.0004 (Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).) · Strata-adjusted percentage difference: 8.0 · 97.5% CI 4.2 to 11.8

Adverse events

Collected over Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg0/519 (0%)13/519 (2.5%)71/519 (13.7%)
Initial Treatment Period (Baseline - Week 16 Predose): Placebo0/263 (0%)3/263 (1.1%)40/263 (15.2%)
Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q4W0/79 (0%)6/79 (7.6%)17/79 (21.5%)
Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q8W0/77 (0%)0/77 (0%)11/77 (14.3%)
Maintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Placebo Q4W0/77 (0%)2/77 (2.6%)26/77 (33.8%)
Maintenance Period (Week 16- Week 48): Placebo Q4W Re-assigned to Placebo Q4W0/84 (0%)1/84 (1.2%)16/84 (19%)
Most frequent serious events
Showing 10 of 28
Most frequent serious events
EventInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial Treatment Period (Baseline - Week 16 Predose): PlaceboMaintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q4WMaintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q8WMaintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Placebo Q4WMaintenance Period (Week 16- Week 48): Placebo Q4W Re-assigned to Placebo Q4W
EndometriosisReproductive system and breast disorders0/5190/2630/790/771/770/84
Pulmonary embolismRespiratory, thoracic and mediastinal disorders0/5190/2630/790/771/770/84
Duodenal ulcer haemorrhageGastrointestinal disorders0/5190/2631/790/770/770/84
GastroenteritisInfections and infestations0/5190/2631/790/770/770/84
Comminuted fractureInjury, poisoning and procedural complications0/5190/2631/790/770/770/84
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders2/5190/2631/790/770/770/84
AdenomyosisReproductive system and breast disorders0/5190/2631/790/770/770/84
AsthmaRespiratory, thoracic and mediastinal disorders0/5190/2631/790/770/770/84
Post procedural haematomaInjury, poisoning and procedural complications0/5190/2630/790/770/771/84
Dermatitis atopicSkin and subcutaneous tissue disorders3/5190/2630/790/770/770/84
Most frequent other events
Most frequent other events
EventInitial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial Treatment Period (Baseline - Week 16 Predose): PlaceboMaintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q4WMaintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Q8WMaintenance Period (Week 16- Week 48): Nemolizumab 30 mg Q4W to Placebo Q4WMaintenance Period (Week 16- Week 48): Placebo Q4W Re-assigned to Placebo Q4W
COVID-19Infections and infestations14/5198/2633/794/7713/776/84
NasopharyngitisInfections and infestations19/51912/2637/793/775/776/84
Dermatitis atopicSkin and subcutaneous tissue disorders34/51915/2636/793/776/775/84
Upper respiratory tract infectionInfections and infestations6/5195/2631/792/775/772/84

Baseline characteristics

The ITT population consisted of all randomized participants.

Age, Categorical
Age, Categorical(Participants)Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial Treatment Period (Baseline - Week 16 Predose): PlaceboTotal
<=18 years9141132
Between 18 and 65 years394209603
>=65 years371552
Sex: Female, Male
Sex: Female, Male(Participants)Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial Treatment Period (Baseline - Week 16 Predose): PlaceboTotal
Female270136406
Male252129381
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial Treatment Period (Baseline - Week 16 Predose): PlaceboTotal
Hispanic or Latino441963
Not Hispanic or Latino464244708
Unknown or Not Reported14216
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mgInitial Treatment Period (Baseline - Week 16 Predose): PlaceboTotal
American Indian or Alaska Native101
Asian351853
Native Hawaiian or Other Pacific Islander101
Black or African American252045
White458227685
More than one race000
Unknown or Not Reported202
08

Study locations

138 sites
  • Galderma Investigational Site 8749
    Birmingham, Alabama 35244, United States
  • Galderma Investigational Site 8893
    Birmingham, Alabama 35244, United States
  • Galderma Investigational Site 8866
    Guntersville, Alabama 35976, United States
  • Galderma Investigational Site 8808
    Scottsdale, Arizona 85255, United States
  • Galderma Investigational Site 8906
    Bell Gardens, California 90201, United States
  • Galderma Investigational Site 8905
    Canoga Park, California 91304, United States
  • Galderma Investigational Site 8577
    Encinitas, California 92024, United States
  • Galderma Investigational Site 8673
    Garden Grove, California 92840, United States
  • Galderma Investigational Site 8683
    Los Angeles, California 90033, United States
  • Galderma Investigational Site 8907
    Newport Beach, California 92660, United States
  • Galderma Investigational Site 8799
    Ontario, California 91762, United States
  • Galderma Investigational Site 8745
    Pasadena, California 91105, United States
  • Galderma Investigational Site 8658
    San Diego, California 92123, United States
  • Galderma Investigational Site 8536
    Santa Ana, California 92705, United States
  • Galderma Investigational Site 8820
    Westminster, California 92683, United States
  • Galderma Investigational Site 8637
    Farmington, Connecticut 06030, United States
  • Galderma Investigational Site 8875
    Delray Beach, Florida 33484, United States
  • Galderma Investigational Site 8391
    Hialeah, Florida 33013, United States
  • Galderma Investigational Site 8727
    Hialeah, Florida 33016, United States
  • Galderma Investigational Site 8523
    Largo, Florida 33770, United States
  • Galderma Investigational Site 8719
    Miami, Florida 33125, United States
  • Galderma Investigational Site 8656
    Miami, Florida 33137, United States
  • Galderma Investigational Site 8704
    Miami, Florida 33155, United States
  • Galderma Investigational Site 8706
    Miami, Florida 33175, United States
  • Galderma Investigational Site 8203
    Tampa, Florida 33607, United States
  • Galderma Investigational Site 8839
    Tampa, Florida 33615, United States
  • Galderma Investigational Site 8729
    Rolling Meadows, Illinois 60008, United States
  • Galderma Investigational Site 8724
    New Albany, Indiana 47150, United States
  • Galderma Investigational Site 8554
    Detroit, Michigan 48202, United States
  • Galderma Investigational Site 8825
    Las Vegas, Nevada 89106, United States
  • Galderma Investigational Site 8506
    Hackensack, New Jersey 07601, United States
  • Galderma Investigational Site 8741
    Buffalo, New York 14221, United States
  • Galderma Investigational Site 8723
    Cortland, New York 13045, United States
  • Galderma Investigational Site 8733
    New York, New York 10022, United States
  • Galderma Investigational Site 8823
    Greensboro, North Carolina 27408, United States
  • Galderma Investigational Site 8030
    Raleigh, North Carolina 27612, United States
  • Galderma Investigational Site 8747
    Cincinnati, Ohio 45219, United States
  • Galderma Investigational Site 8212
    Portland, Oregon 97210, United States
  • Galderma Investigational Site 8721
    Pittsburgh, Pennsylvania 15213, United States
  • Galderma Investigational Site 8713
    North Charleston, South Carolina 29420, United States
  • Galderma Investigational Site 8705
    Chattanooga, Tennessee 37421, United States
  • Galderma Investigational Site 8807
    Houston, Texas 77029, United States
  • Galderma Investigational Site 8618
    Waco, Texas 76710, United States
  • Galderma Investigational Site 8003
    Webster, Texas 77598, United States
  • Galderma Investigational Site 8672
    Salt Lake City, Utah 84117, United States
  • Galderma Investigational Site 8896
    Richmond, Virginia 23219, United States
  • Galderma Investigational Site 8434
    Seattle, Washington 98105, United States
  • Galderma Investigational Site 5448
    Brussel, 1200, Belgium
  • Galderma Investigational Site 6164
    Gent, 9000, Belgium
  • Galderma Investigational Site 6038
    Leuven, 3000, Belgium
  • Galderma Investigational Site 6162
    Liège, 4000, Belgium
  • Galderma Investigational Site 6029
    Pleven, 5800, Bulgaria
  • Galderma Investigational Site 6051
    Sofia, 1407, Bulgaria
  • Galderma Investigational Site 6078
    Sofia, 1408, Bulgaria
  • Galderma Investigational Site 6102
    Sofia, 1431, Bulgaria
  • Galderma Investigational Site 6165
    Sofia, 1431, Bulgaria
  • Galderma Investigational Site 6216
    Sofia, 1528, Bulgaria
  • Galderma Investigational Site 6046
    Sofia, 1606, Bulgaria
  • Galderma Investigational Site 6080
    Sofia, 1606, Bulgaria
  • Galderma Investigational Site 6079
    Sofia, 1618, Bulgaria
  • Galderma Investigational Site 6250
    Sofia, 1784, Bulgaria
  • Galderma Investigational Site 6251
    Stara Zagora, 6000, Bulgaria
  • Galderma Investigational Site 6069
    Tallinn, 10138, Estonia
  • Galderma Investigational Site 6068
    Tallin, 10134, Estonia
  • Galderma Investigational Site 6067
    Tartu, 50417, Estonia
  • Galderma Investigational Site 6198
    Le Mans, 72037, France
  • Galderma Investigational Site 5031
    Lille, 59037, France
  • Galderma Investigational Site 6170
    Martigues, 13500, France
  • Galderma Investigational Site 6167
    Nantes, 44093, France
  • Galderma Investigational Site 5140
    Nice, 6200, France
  • Galderma Investigational Site 6133
    Paris, 75015, France
  • Galderma Investigational Site 6166
    Paris, 75475, France
  • Galderma Investigational Site 5407
    Pierre-Bénite, 69495, France
  • Galderma Investigational Site 6135
    Quimper, 29 107, France
  • Galderma Investigational Site 6197
    Toulon, 83800, France
  • Galderma Investigational Site 6169
    Toulouse, 31000, France
  • Galderma Investigational Site 6168
    Valence, 26000, France
  • Galderma Investigational Site 6238
    Tbilisi, 0159, Georgia
  • Galderma Investigational Site 6227
    Tbilisi, 0186, Georgia
  • Galderma Investigational Site 6230
    Tbilisi, 0186, Georgia
  • Galderma Investigation Site 6228
    Tbilisi, 159, Georgia
  • Galderma Investigational Site 6224
    Tbilisi, 159, Georgia
  • Galderma Investigational Site 6235
    Tbilisi, 159, Georgia
  • Galderma Investigational Site 6234
    Tbilisi, 186, Georgia
  • Galderma Investigational Site 6236
    Zugdidi, 2100, Georgia
  • Galderma Investigational Site 5482
    Aachen, 52074, Germany
  • Galderma Investigational Site 5566
    Augsburg, 86179, Germany
  • Galderma Investigational Site 6082
    Bonn, 53127, Germany
  • Galderma Investigational Site 6132
    Dresden, 01097, Germany
  • Galderma Investigational Site 6031
    Duesseldorf, 40225, Germany
  • Galderma Investigational Site 6083
    Frankfurt, 60437, Germany
  • Galderma Investigational Site 5442
    Gera, 7548, Germany
  • Galderma Investigational Site 6081
    Goettigen, 37075, Germany
  • Galderma Investigational Site 6062
    Halle, 6120, Germany
  • Galderma Investigational Site 6041
    Hamburg, 20251, Germany
  • Galderma Investigational Site 6150
    Hamburg, 20537, Germany
  • Galderma Investigational Site 6040
    Hamburg, 22391, Germany
  • Galderma Investigational Site 5469
    Heidelberg, 69120, Germany
  • Galderma Investigational Site 6086
    Kiel, 24148, Germany
  • Galderma Investigational Site 6084
    Mainz, 55131, Germany

Showing the first 100 of 138 sites across 11 countries.

09

References and documents

Study documents

  • Study protocol · Nov 17, 2021
  • Statistical analysis plan · Nov 10, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03989349
Lead sponsor
Galderma R&D
Responsible party
Sponsor
First posted
Jun 18, 2019
Start date
Jun 30, 2019
Primary completion
Feb 23, 2022
Completion
Sep 26, 2022
Results posted
Aug 14, 2024
Last update
Aug 14, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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