Amgen reports positive top-line results from the Phase 3 OASIZ 301 study of dazodalibep in adults with Sjögren’s disease and moderate to severe systemic disease activity.
The study reached its primary endpoint with a statistically significant and clinically meaningful improvement in disease activity after 48 weeks, as measured by ESSDAI. Improvements were observed as early as week 4 and persisted through week 48.
The study included approximately 621 patients. The most common adverse events occurring more frequently with dazodalibep than placebo included nasopharyngitis, urinary tract infection, hypertension and infusion-related reactions.
Amgen plans to present detailed data at an upcoming medical meeting. The Phase 3 OASIZ 303 study is expected to be completed during the fourth quarter-
