Liberty AD SOLO
Research type
Research Study
Full title
A PHASE 3 CONFIRMATORY STUDY INVESTIGATING THE EFFICACY AND SAFETY OF DUPILUMAB MONOTHERAPY ADMINISTERED TO ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
IRAS ID
166291
Contact name
Sheetal Dyall
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2014-002619-40
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND 107969, Investigational New Drug
Duration of Study in the UK
0 years, 10 months, 5 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. Atopic dermatitis is a chronic condition; it typically improves and then flares (worsens) periodically. It is often associated with other allergic disorders, asthma e.g. Atopic dermatitis is typically treated with moisturisers and prescription ointments. There are treatments that can relieve the symptoms of atopic dermatitis. But the condition cannot be cured. Regeneron Pharmaceuticals, Inc. is developing dupilumab for the treatment of moderate-to-severe atopic dermatitis in participants intolerant, of or not adequately controlled with topical treatments. The main purpose of this research study is to determine the effectiveness of dupilumab when administered subcutaneously (given as an injection under the skin) in reducing the signs and symptoms of atopic dermatitis, when compared to a placebo (an inactive substance that looks like dupilumab but has no drug or any other active ingredient).
Participants will be assigned by chance (randomised) to receive dupilumab or placebo to one of the 3 study groups:
• Dupilumab weekly: starting dose of 2 injections on Day 1, followed by a weekly dose of one injection.
• Dupilumab once every other week: starting dose of 2 injections on Day 1, then one injection will be given every other week, alternating with placebo once every other week.
• Placebo: starting dose of placebo (2 injections) on Day 1, followed by one placebo injection weekly.
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 7 months. About 600 adult participants will be enrolled in this study at approximately 160 study sites globally.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0005
Date of REC Opinion
19 Jan 2015
REC opinion
Favourable Opinion