At a glance
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A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Subjects With Moderate to Severe Atopic Dermatitis
In Brief
A Phase 3 clinical trial evaluating Tralokinumab and Placebo for Atopic Dermatitis. Completed, enrolled 380 participants across 66 sites in 8 countries.
Detailed Summary
Primary objective: To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD). Secondary objectives: To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared with placebo in combination with TCS. To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks.
Study Details
Timeline
Interventions
Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration.
Placebo contains the same excipients in the same concentration only lacking tralokinumab.