Amgen's Dazodalibep Meets 48-Week ESSDAI Primary Endpoint in Phase 3 OASIZ 301 Trial in Moderate-to-Severe Systemic Sjögren's Disease
Amgen announced on September 22, 2026 that OASIZ 301, a randomized, double-blind, placebo-controlled Phase 3 trial in about 621 adults with Sjögren's disease and moderate-to-severe systemic activity (ESSDAI of 5 or higher), met its primary endpoint of change from baseline in ESSDAI at week 48. Amgen described the improvement as statistically significant and seen as early as week 4, but did not release effect sizes. The company describes dazodalibep as a potential first-in-class CD40L antagonist fusion protein. The most common adverse events were nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions; a second Phase 3 trial, OASIZ 303, is expected to complete in the fourth quarter of 2026.