Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporine A is Not Medically Advisable

Conditions

• Moderate-to-severe Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nemolizumab — DRUG
  Participants will receive loading dose of 60 milligram (2×30 mg) subcutaneous (SC) injection of nemolizumab at baseline. Thereafter 30 mg nemolizumab will be administered via single SC injection once in 4 week (Q4W) up to week 12.
• CD14152 placebo — DRUG
  Participants will receive loading dose of 60 mg (2×30 mg) SC injection of placebo at baseline. Thereafter 30 mg placebo will be administered via single SC injection Q4W up to week 12.

Study Details

The primary objective of this study is to investigate the efficacy of nemolizumab administered in combination with topical background therapy (topical corticosteroids \[TCS\] with or without topical calcineurin inhibitors \[TCI\]) in adult participants with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with or are not advised to use oral cyclosporine A (CsA) for medical reasons. The secondary objective is to investigate the safety of nemolizumab in adult participants with moderate-to-severe AD who are not adequately controlled with or are not advised to use oral CsA for medical reasons. The study will be carried out in up to 70 different locations across Europe.

Key Dates

Start date

Jan 31, 2023

Status verified

Sep 2021

Primary completion

Jul 31, 2023

Completion

Jul 31, 2023

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nemolizumab
• Experimental: Placebo

Primary Outcome Measure

Proportion of Participants with Eczema Area and Severity Index-75 (EASI-75) (≥ 75% Improvement in EASI from Baseline) at Week 16 [ Time Frame: Week 16 ]