THOUSAND OAKS (dpa-AFX) - Amgen, Inc. (AMGN) announced Tuesday positive topline results from the Phase 3 OASIZ 301 study evaluating dazodalibep in adults with Sjogren's disease and moderate-to-severe systemic disease activity.
The study met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement at Week 48, as measured by the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI).
Notably, improvements in ESSDAI were observed as early as Week 4 with treatment with dazodalibep, which were sustained through Week 48 of the study. ESSDAI is a validated clinical tool used to assess systemic disease activity across organ systems in patients with Sjogren's disease.
Sjogren's disease is a systemic heterogeneous autoimmune disease that affects the entire body. There are currently no FDA-approved medicines for Sjogren's disease. These results support the potential for a new, highly differentiated treatment option for people living with a debilitating autoimmune disease.
Amgen added that the Phase 3 OASIZ 303 study of dazodalibep in moderate-to-severe symptomatic Sjogren's disease is expected to complete in the fourth quarter of 2026.
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