Dupilumab enters Phase III trial for treatment of Atopic Dermatitis- Sanofi+ Regeneron
Sanofi and Regeneron Pharmaceuticals, Inc announced that the first patients have been dosed in a Phase III clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe Atopic Dermatitis (AD) that is not adequately controlled with topical AD medications.
LIBERTY AD CHRONOS the first trial in the Phase III clinical program for dupilumab, is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks. Secondary objectives of the study will evaluate the long-term safety and efficacy of dupilumab up to 52 weeks. The trial will enroll approximately 700 adult patients. The LIBERTY AD Phase III clinical program will consist of at least five trials of patients with moderate-to-severe AD at sites worldwide.