A Phase 3 study to assess Nemolizumab in Atopic Dermatitis
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis
IRAS ID
275229
Contact name
Andrew Pink
Contact email
Sponsor organisation
Galderma S.A.
Eudract number
2019-001887-31
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
117122, IND Number
Duration of Study in the UK
2 years, 7 months, 1 days
Research summary
This study is a phase 3, randomised, double-blind, placebo controlled study of nemolizumab for adults and adolescents with Atopic Dermatitis (AD). AD is a chronic inflammatory skin disease estimated to affect between 10% and 20% of the population, and up to 25% of children.
The main purpose of the study is to assess the safety and effect of nemolizumab in adults and adolescents who have not responded well to topical AD medications (applied directly to a part of the body).
The study will include approximately 750 participants in multiple sites worldwide. Each participant will have a two in three chance of receiving the study drug. Participants will apply a moisturiser once daily for the duration of the study.
Participants will receive a loading dose of 60 mg nemolizumab or placebo at Day 1. During the 16-week initial treatment period, 30 mg nemolizumbab or placebo will be administered by subcutaneous (SC, injection into fat underneath the skin) once every 4 weeks. If participants respond to treatment, they will continue to a 28-week maintenance phase where they will receive placebo or nemolizumab every four weeks, or nemolizumab every 8 weeks. All participants, even if they do not respond to the initial treatment phase, may be eligible for an extension study.
Other study procedures include, physical examination, blood and urine samples, vital signs and ECG.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0031
Date of REC Opinion
26 Jun 2020
REC opinion
Further Information Favourable Opinion