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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

Testing Tralokinumab with creams for kids with moderate-to-severe eczema.

Recruiting
6-11 years
All
Phase 3

This study tests if a new medicine, *tralokinumab*, given via subcutaneous (SC) injections, works well and is safe for kids with moderate-to-severe *atopic dermatitis* (AD), a skin condition causing red, itchy skin. This medicine will be combined with topical corticosteroids (TCS), creams used to reduce skin inflammation. The trial includes two age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. Kids will receive either tralokinumab or a placebo (a fake treatment) with TCS, while infants only receive tralokinumab with TCS. The trial will last up to 4 years, with visits every 2 weeks for the first year and every 6 weeks afterward. Some visits will be through phone calls.

  • The study lasts up to 4 years with frequent check-ups.
  • Children may receive a placebo initially, but infants receive the treatment directly.
  • Participants need to meet certain health criteria to join the study.

All participants will undergo a screening process to ensure eligibility. After stopping treatment, there is a 4-week follow-up to check on participants' safety. This study aims to improve the quality of life for children with AD.

Study details
    Atopic Dermatitis

NCT06311682

LEO Pharma

31 March 2025

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