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

Actively Recruiting

Phase 3

Age: 6Months - 11Years

All Genders

NCT06311682

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

Led by LEO Pharma · Updated on 2026-03-20

195

Participants Needed

Research Sites

202 weeks

Total Duration

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Who Can Participate

Age: 6Months - 11Years

All Genders

Eligibility Criteria

You may qualify if you...

Age 6 months to <12 years at screening
Body weight at least 9 kg at screening
Diagnosis of atopic dermatitis by Hanifin and Rajka criteria
History of atopic dermatitis for at least 12 months if aged 6 years or older, or at least 3 months if aged 6 months to under 6 years
Inadequate response to mid-strength topical corticosteroids within 6 months before screening
Atopic dermatitis affecting 10% or more of body surface area at screening and baseline
Eczema Area and Severity Index (EASI) score of 16 or higher at screening and baseline
Investigator's Global Assessment (IGA) score of 3 or higher at screening and baseline
Worst itch score of 4 or higher for children aged 6 years or older, or scratch observation score of 4 or higher for children under 6 years during the week before baseline

You will not qualify if you...

Use of topical corticosteroids, calcineurin inhibitors, phosphodiesterase-4 inhibitors, or Janus kinase inhibitors within 1 week before baseline
Use of bleach baths within 1 week before baseline
Treatment with systemic immunosuppressive, immunomodulating drugs, or systemic corticosteroids (excluding inhaled, ophthalmic, or intranasal) within 4 weeks before baseline
Use of tanning beds or phototherapy within 4 weeks before baseline
Vaccination with live or non-live vaccines within 30 days before baseline
Active skin conditions that could confuse the diagnosis or interfere with treatment assessment, such as seborrheic dermatitis, skin infection, scabies, cutaneous T cell lymphoma, or psoriasis
Active chronic or acute infection requiring systemic antibiotic, antiviral, antifungal, or antiprotozoal treatment within 2 weeks before baseline
History or current infection with hepatitis B or C, or positive hepatitis B or C test at screening

AI-Screening