At a glance
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A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Administered Concomitantly With Topical Corticosteroids in Patients, ≥6 Years to <12 Years of Age, With Severe Atopic Dermatitis
In Brief
A Phase 3 clinical trial evaluating Dupilumab, Matching Placebo, and 2 other interventions for Dermatitis, Atopic. Completed, enrolled 367 participants across 61 sites in 6 countries.
Detailed Summary
The main objective of the trial is to demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in participants ≥6 years to \<12 years of age with severe atopic dermatitis (AD). The secondary objective is to assess the safety of dupilumab administered concomitantly with TCS in patients ≥6 years to \<12 years of age with severe AD.
Study Details
Timeline
Interventions
Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous (SC)
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)
All participants are required to initiate treatment with a medium potency TCS using a standardized regimen. It is recommended that participants use triamcinolone acetonide 0.1% cream, fluocinolone acetonide 0.025% cream, or clobetasone butyrate 0.05%.
All participants should apply moisturizers throughout the study. All types of moisturizers are permitted, but participants may not initiate treatment with prescription moisturizers. Participants may continue using stable doses of such moisturizers if initiated before the screening visit.