Ecztra 7 (ECZema TRAlokinumab trial no. 7)
Research type
Research Study
Full title
A phase 3 study investigating the efficacy, safety, and tolerability of tralokinumab administered to adult subjects with severe atopic dermatitis who are not adequately controlled with or have contraindications to oral cyclosporine A.
IRAS ID
252607
Contact name
Christina Roensholt
Contact email
Sponsor organisation
Leo Pharma A/S
Eudract number
2018-000747-76
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
The purpose of this trial is to test if the trial drug, tralokinumab, is better than placebo (‘dummy treatment’) at treating severe atopic dermatitis (AD, a type of eczema) in an AD patient population not adequately controlled with or having contraindications to oral cyclosporine A. This will be judged by assessments that rate the severity and extent of AD, itch and several other symptoms, as well as general health status and quality of life. Side effects are also evaluated.
AD is a chronic skin disease that may affect up to 20% of children and up to 10% of adults. Patients with severe AD have widespread skin lesions, itch, poor quality of life and a higher risk of skin infections.
Tralokinumab is an antibody, a type of a biological drug, which binds to a human protein called IL-13. IL-13 is involved in the body’s immune responses to fight diseases. By binding to IL-13, tralokinumab may improve or clear the symptoms of AD.
In this trial, tralokinumab will be compared with placebo, which is a ‘dummy treatment’ similar to tralokinumab except that it does not have any drug or active ingredients in it. Which patient is treated with which of these 2 treatments is chosen at random (like flipping a coin). This allows the treatments to be compared more fairly. Participants in the trial will have a 50% chance of receiving tralokinumab and a 50% chance of receiving placebo. Neither the participant nor the trial doctor will know which treatment the participant is receiving. Both treatments will be given as injections. In addition, a steroid cream is provided, to be applied on the skin as needed.
The trial will consist of a 2-6 week screening period, a treatment period of 26 weeks and a 14 week off-treatment follow-up period. This trial is funded by LEO Pharma and will be carried out in NHS hospitals throughout England
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0383
Date of REC Opinion
19 Feb 2019
REC opinion
Further Information Favourable Opinion