TRAPEDS 2
Research type
Research Study
Full title
A phase 3 multi-center trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids in children (age 2 to <12 years) and infants (age 6 months to <2 years) with moderate-to-severe atopic dermatitis. The trial is randomized, double-blind, placebo-controlled, and parallel-group for children (age 2 to <12 years) and open-label and single-group for infants (age 6 months to <2 years).
IRAS ID
1009664
Contact name
Semina Beg
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2023-503630-44
Clinicaltrials.gov Identifier
Research summary
The purpose of this trial is to test whether treatment with tralokinumab in combination with topical corticosteroids (TCS), which will be administered by subcutaneous (SC) injection, is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. Atopic dermatitis can also be called atopic eczema or eczema. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone. The study involves two different age groups: children aged 2 to under 12 years
and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. There will not be a placebo for infants. All subject will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial. The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive
tralokinumab + TCS for the entire treatment period, and there will be an open label treatment, meaning that the participants will know they are receiving the treatment. After stopping treatment, all participants will enter a 4-week safety follow-up period.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
24/YH/0086
Date of REC Opinion
7 Jun 2024
REC opinion
Further Information Favourable Opinion