Amgen reports positive Phase 3 dazodalibep trial results

Amgen announced positive topline results on Sept. 22, 2026, from the Phase 3 OASIZ 301 study evaluating dazodalibep in adults with moderate-to-severe systemic Sjögren's disease. The trial enrolled approximately 621 patients.

The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement at Week 48 based on the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI). Improvements appeared as early as Week 4 and lasted through Week 48. There are currently no FDA-approved systemic medicines for the disease.

The most common adverse events with an incidence of at least 5% and reported more frequently than placebo were nasopharyngitis, urinary tract infections, hypertension, and infusion-related reactions. Discontinuations due to adverse events remained low, with no observed imbalances in thromboembolic events or opportunistic infections.

Amgen plans to present detailed data at an upcoming medical meeting. In addition, the company expects to complete the Phase 3 OASIZ 303 study evaluating dazodalibep in moderate-to-severe symptomatic Sjögren's disease in the fourth quarter of 2026.