ECZTRA 3 (ECZema TRAlokinumab trial no. 3)
Research type
Research Study
Full title
Tralokinumab in combination with topical corticosteroids for moderate-to-severe atopic dermatitis. ECZTRA 3 (ECZema TRAlokinumab trial no. 3)
IRAS ID
237184
Contact name
Thomas Coquelle
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2017-002065-21
Duration of Study in the UK
1 years, 5 months, 23 days
Research summary
The purpose of this trial is to test if the trial drug, tralokinumab, is better than placebo (‘dummy treatment’) at treating moderate to severe atopic dermatitis (AD, a type of eczema). 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 75% chance of receiving tralokinumab and a 25% 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 32 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
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
18/YH/0012
Date of REC Opinion
14 Feb 2018
REC opinion
Further Information Favourable Opinion