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Actively Recruiting

Phase 3
Age: 6Months - 11Years
All Genders
ID06311682

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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