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Clinical trial

A Phase 3 Multi-center Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children (Age 2 to <12 Years) and Infants (Age 6 Months to <2 Years) With Moderate-to-severe Atopic Dermatitis. The Trial is Randomized, Double-blind, Placebo-controlled, and Parallel-group for Children (Age 2 to <12 Years) and Open-label and Single-group for Infants (Age 6 Months to <2 Years)

NCT06311682 is registered in ClinicalTrials.gov with LEO Pharma as lead sponsor.

NCT NCT06311682
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3 Multi-center Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children (Age 2 to <12 Years) and Infants (Age 6 Months to <2 Years) With Moderate-to-severe Atopic Dermatitis. The Trial is Randomized, Double-blind, Placebo-controlled, and Parallel-group for Children (Age 2 to <12 Years) and Open-label and Single-group for Infants (Age 6 Months to <2 Years)
Lead sponsor
LEO Pharma
Phase
Phase 3
Overall status
Recruiting
Start date
June 10, 2024
Completion date
April 28, 2028
Enrollment
195 (estimated)
Sites
72

Conditions

As the registry lists them; a condition with its own page is linked.

atopic dermatitis