R668-AD-1652, Investigate the Efficacy and Safety of Dupilumab
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab Administered Concomitantly with Topical Corticosteroids in Patients, ≥6 Years to <12 Years Of Age, with Severe Atopic Dermatitis
IRAS ID
231118
Contact name
Michael Cork
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2016-004997-16
Duration of Study in the UK
0 years, 9 months, 22 days
Research summary
This study is a phase III randomised double-blind placebo-controlled trial for children aged between 6 and 12 years of age who have a diagnosis of severe Atopic Dermatitis (AD).
The study involves, Dupilumab which is a type of drug called a “monoclonal antibody.” An antibody is a special kind of protein that the immune system normally makes to fight bacteria and viruses. Scientists can now make antibodies in the laboratory and produce them for the treatment of many different diseases. IL4 and IL13 are proteins that have been found at higher levels in the blood of patients with AD and it is believed they might play a role in the development of this disease. The study drug blocks a protein called IL4 receptor alpha (IL4a), which is required for IL4 and IL3 activity on cells that are thought to play a role in Atopic Dermatitis.
Participants will be randomised to receive either: Dupilumab every 2 weeks, at a dose stratified by weight, Dupilumab every 4 weeks or Placebo, alongside topical corticosteroids. As this study is randomised, double blind, parallel group, placebo controlled study neither the patient, their parent nor study doctor will know which treatment the participant is receiving . Both safety and efficacy of Dupilumab will be assessed.
The study will last 33 weeks; 5 weeks screening, 16 weeks treatment and 12 weeks follow-up. Alternatively, if participants take part in the Open-Label Extension (R668-AD-1434), they will participate for 21 weeks and go in to the next study rather than the follow up period for this study.
This study will include 240 participants in 37 research sites in 6 countries, with 80 participants in each of the 3 groups. Eligible patients will be between 6 and 12 years old with severe AD and fit other specific criteria.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0426
Date of REC Opinion
15 Dec 2017
REC opinion
Favourable Opinion