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

Study Overview
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Brief Summary
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The main purpose of the study is 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
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This is 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 must have a documented history of inadequate response to topical AD medication(s). Approximately 750 subjects will be 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).

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

Conditions
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Moderate-to-Severe Atopic Dermatitis

Intervention / Treatment
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* Drug: Placebo
* Drug: Nemolizumab


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male or female subjects aged ≥ 12 years at the screening visit Note: Enrollment of subjects aged 12 to 17 years has been opened after the IDMC has assessed interim safety data from the phase 2 study (Protocol 116912) and provided recommendations to the sponsor, who then determined the eligibility of this age group for enrollment in the study Chronic AD that has been documented for at least 2 years EASI score ≥ 16 IGA score ≥ 3 AD involvement ≥ 10% of BSA PPNRS score of at least 4.0 at the screening and baseline visit Documented recent history of inadequate response to topical medications (TCS with or without 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 kg Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study 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 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, eg, monoclonal antibody) or to any of the study drug excipients Any clinically significant issue, based on investigator judgement

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo administered via subcutaneous injection | Drug: Placebo<br>* Placebo<br>|
| Experimental: Nemolizumab<br>Nemolizumab administered via subcutaneous injection | Drug: Nemolizumab<br>* Nemolizumab<br>* Other names: CD14152;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with an IGA success (IGA of 0 or 1) and a ≥ 2-point reduction | IGA success rate defined as the proportion of subjects who achieve an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 16. | Baseline to Week 16 | 
| Proportion of subjects with EASI-75 |  | Baseline to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with an improvement of PP NRS ≥ 4 |  | Week 16 | 
| Proportion of subjects with PP NRS < 2 |  | Week 16 | 
| Proportion of subjects with an improvement of sleep disturbance NRS (SD NRS) ≥ 4 |  | Week 16 | 
| Proportion of subjects with an improvement of PP NRS ≥ 4 |  | Week 4 | 
| Proportion of subjects with PP NRS < 2 |  | Week 4 | 
| Proportion of subjects with an improvement of PP NRS ≥ 4 |  | Week 2 | 
| Proportion of subjects with an improvement of PP NRS ≥ 4 |  | Week 1 | 
| Proportion of subjects with EASI-75 and improvement of PP NRS ≥ 4 |  | Week 16 | 
| Proportion of subjects with IGA success and improvement of PP NRS ≥ 4 |  | Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CD14152, Nemolizumab, Atopic Dermatitis