R668-AD-1424, Phase 3 , Dupilumab, Adults, Severe Atopic Dermatitis
Research type
Research Study
Full title
A PHASE 3 STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF DUPILUMAB ADMINISTERED TO ADULT PATIENTS WITH SEVERE ATOPIC DERMATITIS WHO ARE NOT ADEQUATELY CONTROLLED WITH OR ARE INTOLERANT TO ORAL CYCLOSPORINE A, OR WHEN THIS TREATMENT IS NOT MEDICALLY ADVISABLE
IRAS ID
190662
Contact name
Michael J. Cork
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2015-002653-35
Duration of Study in the UK
0 years, 10 months, 20 days
Research summary
Regeneron Pharmaceutical, Inc. is conducting a Phase 3 study of the investigational drug, dupilumab, in adults with severe atopic dermatitis (AD), also commonly known as eczema, whose AD is not adequately controlled or they are intolerant to cyclosporine A or it is not medically advised. Dupilumab 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 AD.
This study is being conducted to compare two doses of dupilumab, to placebo (an inactive substance containing no medicine) to see how well dupilumab works, how well participants tolerate it and to study dupilumab’s effectiveness and safety.
For this purpose, participants will be asked to complete questionnaires to assess how effective the drug is. Blood samples will also be taken during the study to measure the quantity of the study drug in the participants body and the duration it stays in the body. This will help us understand whether the study drug has any beneficial effects on AD in adult patients.
This study will provide new information on the effects of dupilumab in patients with severe AD.
This study will include about 330 patients with AD at about 115 research centres globally.
Study duration is approximately 32 weeks.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0538
Date of REC Opinion
9 Dec 2015
REC opinion
Favourable Opinion