Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

Study Overview
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Brief Summary
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Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description

Detailed Description
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Long-term study to assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe AD

Official Title
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A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) 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: Nemolizumab


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal 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 effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection. Key Exclusion Criteria: Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject. Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study. Body weight < 30 kg 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. Subjects may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) Any clinically significant issue, based 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 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 |
| --- | --- | --- |
| Incidence and Severity of TEAEs |  | Baseline to Week 200 | 
| Incidence of Serious TEAEs |  | Baseline to Week 200 | 
| Incidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the Study |  | Baseline to Week 200 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants with IGA score = 0-1 at Each Visit |  | Baseline to Week 200 | 
| Proportion of Participants with EASI-75 at Each Visit |  | Baseline to Week 200 | 
| Change and Percent Change From Baseline in Overall Eczema Area and Severity Index (EASI) Score at Each Visit | EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity will be assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score can range from 0 to 72 with higher scores representing greater severity of atopic dermatitis. | Baseline to Week 200 | 
| Proportion of Participants with IGA ≤ 2 at Each Visit |  | Baseline to Week 200 | 
| Change and Percent Change From Baseline in SCORAD Score at Each Visit |  | Baseline to Week 200 | 
| Change and Percent Change From Baseline in Participant-Reported Pruritus Using 10-cm VAS (SCORAD Sub-Component) |  | Baseline to Week 200 | 
| Change and Percent Change From Baseline in Participant-Reported Sleep Loss Using 10-cm VAS (SCORAD Sub-Component) |  | Baseline to Week 200 | 
| Proportion of Participants Reporting Low Disease Activity State Based on PGAD at Each Visit |  | Baseline to Week 200 | 
| Proportion of Participants Satisfied with Study Treatment Based on PGAT at each visit |  | Baseline to Week 200 | 
| Change from Baseline in Dermatology Life Quality Index (DLQI) |  | Baseline to Week 200 | 
| Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Total Score at Each Visit Through Week 200 |  | Baseline to Week 200 | 
| Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Each Visit Through Week 200 |  | Baseline to Week 200 | 
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) for Each Subscale at Each Visit Through Week 200 |  | Baseline to Week 200 | 
| Change From Baseline in Work Productivity and Activity Impairment: Atopic Dermatitis (WPAI:AD) for Each Subscale at Each Visit Through Week 200 |  | Baseline to Week 200 | 
| Change From Baseline in EuroQoL 5-Dimension (EQ-5D) at Each Visit Through Week 200 |  | Baseline to Week 200 | 
| Proportion of Participants Receiving Any Rescue Therapy by Rescue Treatment Type at Any Visit During the Treatment Period |  | Baseline to Week 200 | 
| Time to First Relapse |  | Baseline to Week 200 | 
| Duration of Remission |  | Baseline to Week 200 | 
| Time to Permanent Study Drug Discontinuation |  | Baseline to Week 200 |