Phase 3
N=941
Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
Moderate-to-Severe Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT03985943 ↗Enrolled (actual)
941
Serious AEs
1.5%
Results posted
Aug 2024
Primary outcome: Primary: Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): Intent-To-Treat (ITT) Population — 24.6; 35.6 percentage of participants — p=0.0003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Nemolizumab (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): Intent-To-Treat (ITT) Population |
24.6; 35.6 | 0.0003 sig |
| PRIMARY Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a >= 2-point Reduction): Severe Pruritus Population |
21.4; 35.5 | 0.0002 sig |
| PRIMARY Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population |
29.0; 43.5 | <0.0001 sig |
| PRIMARY Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at 16: Severe Pruritus Population |
23.8; 41.6 | <0.0001 sig |
| SECONDARY Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population |
17.8; 42.7 | <0.0001 sig |
| 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 |
18.6; 46.1 | <0.0001 sig |
| SECONDARY Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population |
11.2; 30.6 | <0.0001 sig |
| SECONDARY Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population |
7.6; 27.8 | <0.0001 sig |
| SECONDARY Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population |
19.9; 37.9 | <0.0001 sig |
| SECONDARY Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population |
22.4; 42.1 | <0.0001 sig |
| SECONDARY Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population |
6.5; 27.4 | <0.0001 sig |
| 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 |
7.1; 28.3 | <0.0001 sig |
| SECONDARY Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population |
3.7; 16.0 | <0.0001 sig |
| SECONDARY Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population |
2.9; 12.6 | <0.0001 sig |
| SECONDARY Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population |
3.1; 17.7 | <0.0001 sig |
| 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 |
3.8; 20.7 | <0.0001 sig |
| SECONDARY Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population |
1.2; 4.5 | 0.0064 sig |
| 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 |
1.9; 6.2 | 0.0177 sig |
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.
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 visit.
- 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, example, monoclonal antibody) or to any of the study drug excipients.
- Any clinically significant issue, based on investigator judgement.
Data sourced from ClinicalTrials.gov (NCT03985943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.