Dazodalibep meets primary endpoint in first Phase 3 study in systemic Sjogren's disease

Amgen reported positive topline results on September 22, 2026 from OASIZ 301, a Phase 3 study of dazodalibep in moderate-to-severe systemic Sjogren's disease. The study met its primary endpoint, the change from baseline in the ESSDAI score at week 48, with improvements visible from week 4. Amgen gave no effect sizes and plans to present detail at a future medical meeting, and the second Phase 3 study, OASIZ 303, is expected to complete in Q4 2026.

• Primary endpoint: change in ESSDAI score at week 48, statistically significant
• Improvement seen from week 4 and sustained through week 48
• No imbalance in thromboembolic events or opportunistic infections
• Most common adverse events were nasopharyngitis, urinary tract infection, hypertension and infusion reactions, mostly mild to moderate
• OASIZ 303 expected to complete in Q4 2026