Dupilumab for adult patients with moderate to severe atopic dermatitis
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled study to demonstrate the efficacy and long-term safety of Dupilumaab in adult patients with moderate-to-severe Atopic Dermatitis
IRAS ID
151694
Contact name
Christopher Griffiths
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2013-003254-24
Research summary
Atopic dermatitis, also known as eczema is a medical condition that causes the skin to become itchy, red, dry, thickened and cracked. The exact cause of eczema is unknown but it’s thought to be linked to overactive responses by body’s immune system to an irritant. It is this response that causes the symptoms of eczema.
The common treatments for eczema include moisturising creams that are typically applied daily to hydrate the skin and topical corticosteroids used to reduce itching, swelling and redness.
The main purpose of this research study is to determine the effectiveness of subcutaneously (just under the skin) administered dupilumab (the study drug) in reducing the signs and symptoms of eczema compared to placebo treatment (a placebo is an inactive substance containing no medicine) in patients with moderate to severe eczema. Other objectives of this study include collecting long term safety data (64 weeks) in patients treated with two different doses of dupilumab. Participants will be randomly assigned (like the flip of a coin) to one of the following treatment groups:
- Group 1: Starting dose of 400 mg followed by a 200 mg subcutaneous injection weekly for 51 weeks.
- Group 2: Starting dose of 600 mg followed by a 300 mg subcutaneous injection every other week through week 51.
- Group 3: Starting dose of placebo followed by a placebo subcutaneous injection every week through week 51.Participants will be invited to take part in this study if they have moderate to severe eczema that has not responded to daily administration of a moderately potent topical corticosteroid.
This is a double−blind, placebo-controlled study meaning that neither the participant nor the study doctor will know which medication is being given.
Approximately 450 participants are expected to participate in this study at approximately 150 sites worldwide. This study is sponsored by the pharmaceutical company, Regeneron Pharmaceuticals, Inc.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/0200
Date of REC Opinion
30 May 2014
REC opinion
Further Information Favourable Opinion