Sanofi provides update on phase III study evaluating rilzabrutinib for the treatment of pemphigus.
Rilzabrutinib’s safety profile remained consistent with previous results and no new safety signals were identified.
The Phase III study, which is the first placebo-controlled trial of a BTK inhibitor in pemphigus, enrolled adult patients with moderate-to-severe pemphigus vulgaris or pemphigus foliaceus. The primary endpoint was complete remission from weeks 29 to 37 with minimal doses of corticosteroids (?10/mg day). Complete remission was defined as the absence of new and established skin lesions.
Results show the proportion of patients meeting the primary endpoint on rilzabrutinib was not significantly different from placebo. Sanofi is continuing to evaluate the data and plans to share detailed findings at a future medical meeting.
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