04:08 AM EDT, 09/11/2024 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) and Sanofi ( SNY ) said Wednesday that a confirmatory phase 3 study of Dupixent met primary and key secondary goals in treating patients with uncontrolled, biologic-naive chronic spontaneous urticaria receiving background therapy with antihistamines.
The study showed that Dupixent added to standard-of-care reduced itch severity from baseline by 8.64-point versus a 6.10-point reduction with placebo.
The company said the treatment also reduced urticaria activity severity by 15.86 points from baseline versus 11.21 points with placebo.
The safety results were also generally consistent with the known safety profile of Dupixent in its approved dermatological indications, the company said.
Separately, Dupixent's pivotal trial evaluating its efficacy and safety in treating adults with moderate-to-severe bullous pemphigoid met primary and all key secondary endpoints.
The study showed that 20% of patients on Dupixent experienced sustained disease remission at 36 weeks compared with 4% for placebo.
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