An Open-label Extension Study to Assess the Long-Term Safety and Efficacy of Dupilumab in Patients ≥6 Months to <18 Years of Age with Atopic Dermatitis
Research type
Research Study
Full title
An Open-label Extension Study to Assess the Long-Term Safety and Efficacy of Dupilumab in Patients ≥6 Months to <18 Years of Age with Atopic Dermatitis
IRAS ID
189251
Contact name
Michael J Cork
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2015-001396-40
Duration of Study in the UK
2 years, 11 months, 3 days
Research summary
Regeneron Pharmaceuticals, Inc. is conducting a Phase 3 study of the investigational drug, dupilumab in children aged 6-17years old with moderate to severe atopic dermatitis (AD), also commonly known as eczema. 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 Atopic Dermatitis.
This study is a phase 3, extension study (an extension to R668-AD-1412 phase 2 study) being conducted to determine whether dupilumab is safe long-term in children suffering from AD and establish a safe dose for dupilumab in children who have previously completed a clinical study with dupilumab in patients with AD. For this purpose, blood testing will be done as part of this study to measure the amount of study drug in the body of children and how long it stays in their body and to help us understand whether dupilumab has any beneficial effects on the disease in children suffering from atopic dermatitis .This study will provide new information on the effects of dupilumab in patients with AD, especially in children, suffering from this disease.
This study will include about 80 children (6 yrs. to 17 yrs. old) at about 20 research centres in European countries and last for approximately 120 weeks, excluding the screening period.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0443
Date of REC Opinion
11 Dec 2015
REC opinion
Further Information Favourable Opinion