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Research type
Research Study
Full title
A Phase 3, randomised, double-blind, placebo-Controlled study Investigating the efficacy and safety of multiple dupilumab dose regimens administered as monotherapy for maintaining treatment response in patients with atopic dermatitis.
IRAS ID
151920
Contact name
Michael J Cork
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2014-003384-38
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND 107969, Investigational New Drug
Duration of Study in the UK
1 years, 5 months, 17 days
Research summary
Atopic dermatitis, also known as eczema, is a medical condition that causes the skin to become itchy, red, dry, thickened, and cracked. Eczema typically improves and then worsens periodically and is often associated with other allergic disorders such as asthma. Eczema is typically treated with moisturisers and prescription ointments. There are treatments that can relieve the symptoms of eczema, but the condition cannot be cured. Regeneron Pharmaceuticals, Inc. is developing dupilumab for the treatment of moderate-to-severe eczema in participants intolerant, of or not adequately controlled with topical treatments. The main purpose of this research study is to determine which dose of dupilumab administered subcutaneously (given as an injection under the skin) maintains the reduction of symptoms of eczema achieved by an initial treatment in a previous study, when compared to a placebo. A placebo is an inactive substance that looks like dupilumab but has no drug or any other active ingredient.
Participants that have completed an initial treatment study will be eligible to take part. Participants will be assigned by chance (randomised) to receive dupilumab or placebo to one of the 4 study groups:
• Dupilumab weekly (if the participant received dupilumab every week on the initial study), or every two weeks (if they received dupilumab every other week)
• Dupilumab every four weeks:
• Dupilumab every eight weeks
• Placebo
Participants will receive placebo during weeks when dupilumab is not administered.
This is a randomised, double-blind, placebo-controlled, parallel group study, meaning that neither the participant nor the study doctor will know whether the participant is receiving dupilumab or placebo. However in an emergency the exact treatment received can be identified.
Participants will be expected to be in the study for about 11 months. About 440 adult participants will be enrolled in this study at approximately 300 study sites globally.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0243
Date of REC Opinion
13 Jul 2015
REC opinion
Further Information Favourable Opinion