Amgen says Phase 3 OASIZ 301 trial meets primary endpoint for dazodalibep in systemic Sjögren's disease
Bitget2026/09/22 13:06- Amgen reported positive topline Phase 3 OASIZ 301 results for dazodalibep in moderate-to-severe systemic Sjögren's disease.
- 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.
- 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.
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