A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis - Trial NCT06311682
Access comprehensive clinical trial information for NCT06311682 through Pure Global AI's free database. This Phase 3 trial is sponsored by LEO Pharma and is currently Not yet recruiting. The study focuses on Atopic Dermatitis. Target enrollment is 195 participants.
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Study Focus
Sponsor & Location
LEO Pharma
Timeline & Enrollment
Phase 3
May 24, 2024
Apr 28, 2028
Primary Outcome
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to 12 years at screening.,Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to 12 years at screening.
Summary
The purpose of this trial is to test whether treatment with tralokinumab (administered
 subcutaneous injections [SC]) in combination with topical corticosteroids (TCS) is safe and
 effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. 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. Infants will not receive placebo. All subjects 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. During the first 16 weeks,
 children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of
 getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will
 receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning
 that the participants will know they are receiving tralokinumab. After stopping treatment,
 all participants will enter a 4-week safety follow-up period.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06311682
Non-Device Trial