OLE- Open Label Extension
Research type
Research Study
Full title
An open label study of Dupilumab in patients with atopic dermatitis who participated in previous Dupilumab clinical trials.
IRAS ID
174975
Contact name
Lesley Lockhart
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2013-001449-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
107969, IND number
Duration of Study in the UK
2 years, 9 months, 20 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 (applied to the skin). This study is being conducted to determine the safety of dupilumab with the main purpose of this study to collect long term safety data on adult participants with moderate to severe eczema who have previously been treated with dupilumab.
Participants that have completed an initial treatment study will be eligible to take part. Participants will receive treatment with 300 mg dupilumab weekly for up to 2 years.
This is an open label study, meaning that the participant and the study doctor will know how much drug the participant is receiving. There will be an initial screening period of up to 4 weeks, followed by up to 2 years of treatment and an End of Study Visit. There will be up to 25 scheduled visits in total.
About 800 adult participants will be enrolled in this study at approximately 400 study sites globally.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0287
Date of REC Opinion
19 Aug 2015
REC opinion
Further Information Favourable Opinion