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

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Atopic Dermatitis

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

6 months to 11 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

LEO Pharma

Last updated on ClinicalTrials.gov

July 7, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites