Amgen Announces Its Phase 3 OASIZ 301 Trial Of Dazodalibep To Treat Sjogren's Disease Meets Primary Endpoint, Shows Improvement In Systemic Disease Activity At Week 48

Amgen (NASDAQ:AMGN) today announced positive topline results from the Phase 3 OASIZ 301 study evaluating dazodalibep in adults with Sjögren's disease and moderate-to-severe systemic disease activity.

The study met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement at Week 48, as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI). Notably, improvements in ESSDAI were observed as early as Week 4 with treatment with dazodalibep, which were sustained through Week 48 of the study. ESSDAI is a validated clinical tool used to assess systemic disease activity across organ systems in patients with Sjögren's disease.