GS29250 Treble Study - Evaluation of Lebrikizumab in Atopic Dermatitis
Research type
Research Study
Full title
A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF LEBRIKIZUMAB IN PATIENTS WITH PERSISTENT MODERATE TO SEVERE ATOPIC DERMATITIS THAT IS INADEQUATELY CONTROLLED BY TOPICAL CORTICOSTEROIDS
IRAS ID
173398
Contact name
Head, EU/ROW Regulatory Affairs
Contact email
Sponsor organisation
Hoffmann LaRoche
Eudract number
2014-000049-56
Duration of Study in the UK
1 years, 7 months, 23 days
Research summary
The purpose of this study is to find out whether or not lebrikizumab is beneficial for adult patients (18 -75 years) with moderate or severe atopic dermatitis inadequately controlled by Topical corticosteroids (TCS).
Lebrikizumab is an antibody. An antibody is a protein that attaches to a specific target in the body and prevents it from interacting with other proteins in the body. Lebrikizumab attaches to interleukin-13 (IL-13 for short), which many doctors believe plays an important part in atopic dermatitis. Lebrikizumab is a given as a subcutaneous injection. After it is injected, lebrikizumab attaches to and blocks IL 13 from working. Blocking IL-13 might help to reduce the rash severity and extent of the rash and symptoms such as itchiness. Lebrikizumab is an experimental drug, and is also being studied in clinical trials to see if it is beneficial in patients who have asthma or idiopathic pulmonary fibrosis (a scarring disease of the lung).
This study will examine whether or not lebrikizumab reduces the severity of rash in patients with atopic dermatitis who still have moderate to severe rash and symptoms even though they are being treated with steroid creams. We also hope to learn whether lebrikizumab treatment will improve the symptoms of atopic dermatitis and patients’ quality of life. To find a treatment approach that provides the best benefit with the fewest negative effects and to know how much study drug is needed for this, two different doses of lebrikizumab in 3 different dosing schedules will be tested against placebo. The patients will be required to apply steroid creams throughout the 22 week study period. After completing a 2 week run in period, they will be randomised to one of 4 arms receiving an injection 3 times over a 12 week period. Then follows a 8 week follow up period.REC name
South Central - Oxford C Research Ethics Committee
REC reference
15/SC/0217
Date of REC Opinion
22 Jun 2015
REC opinion
Further Information Favourable Opinion