Actively Recruiting
Phase 3 Study of Tralokinumab with Topical Corticosteroids for Moderate-to-Severe Atopic Dermatitis in Children 2 to under 12 years and Infants 6 months to under 2 years
Led by LEO Pharma · Updated on 2026-07-07
195
Participants Needed
72
Research Sites
79 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether tralokinumab given as subcutaneous injections along with topical corticosteroids TCS is safe and effective for treating moderate-to-severe atopic dermatitis AD in children and infants. The trial involves two age groups children aged 2 to under 12 years and infants aged 6 months to under 2 years. Children are randomized to receive either tralokinumab plus TCS or placebo plus TCS, while infants receive open-label tralokinumab plus TCS. This Phase 3 trial will last up to four years with visits every two weeks during the first year and every six weeks thereafter, including some phone visits.
CONDITIONS
Brief Title
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
Research Team
C
Clinical Disclosure
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