Amgen says Phase 3 OASIZ 301 trial meets primary endpoint for dazodalibep in systemic Sjögren's disease
AMGN•Safety and next steps
Safety profile showed mostly mild-to-moderate adverse events; discontinuations were low and balanced, with no thromboembolic or opportunistic infection imbalance.
Detailed data will be presented at a medical meeting; Phase 3 OASIZ 303 is expected to complete in Q4 2026.
Phase 3 trial meets primary endpoint
Amgen reported positive topline Phase 3 OASIZ 301 results for dazodalibep in moderate-to-severe systemic Sjögren's disease.
The trial met the primary endpoint, showing a statistically significant, clinically meaningful ESSDAI improvement at Week 48 versus placebo.
ESSDAI benefit emerged by Week 4, then held through Week 48, supporting differentiation in a disease with no FDA-approved medicines.
