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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

Study on Tralokinumab plus steroids for children's eczema.

Recruiting
6-11 years
All
Phase 3

In this study, researchers are testing a treatment called **tralokinumab**, given by shots under the skin (called *subcutaneous injections*), along with a cream called **topical corticosteroids (TCS)**, to help kids with a skin problem called **atopic dermatitis (AD)**. AD is a condition that makes skin red, itchy, and swollen. The study will check if these treatments are safe and help make the skin better. The study lasts up to 4 years, with visits every 2 weeks for the first year, then every 6 weeks. Some visits will be by phone.

The study is for kids aged 6 months to under 12 years. Children will get either tralokinumab + TCS or a pretend treatment (placebo) + TCS for the first 16 weeks, but everyone will know infants only get the real treatment. After 16 weeks, all kids will get tralokinumab + TCS. After the treatment stops, there’s a 4-week safety check.

  • Visits are frequent: every 2 weeks initially, then every 6 weeks.
  • Some children may receive a placebo for the first 16 weeks.
  • The trial lasts up to 4 years, with a mix of in-person and phone visits.
Study details
    Atopic Dermatitis

NCT06311682

LEO Pharma

2 March 2025

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