Positive phase 3 results raise hopes for Sjögren's disease treatment

Clinical takeaway: For patients with moderate-to-severe systemic Sjögren's disease, positive phase 3 results position dazodalibep as a potential future treatment option in a field with no approved disease-modifying therapies. Pending full data release and regulatory review, these findings may signal a meaningful shift in how systemic Sjögren's disease is managed.

Amgen announced that the phase 3 OASIZ 301 trial met its primary endpoint, with dazodalibep producing a statistically significant and clinically meaningful improvement in systemic disease activity compared with placebo at 48 weeks, as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI). Improvements were observed as early as week 4 and were sustained throughout the study.

Despite being one of the most common autoimmune rheumatic diseases, Sjögren's disease currently has no FDA-approved disease-modifying therapies. Patients often experience severe dryness, fatigue, pain, neuropathy, organ involvement, and an increased risk of lymphoma, leaving clinicians with limited treatment options. Positive phase 3 results therefore represent a potentially important step toward the first approved therapy specifically targeting the disease process.

Dazodalibep is a first-in-class CD40L antagonist fusion protein designed to interrupt immune signaling between T cells, B cells, and antigen-presenting cells. The safety profile was generally consistent with earlier studies, with mostly mild-to-moderate adverse events and low discontinuation rates. No imbalance in thromboembolic events or opportunistic infections was reported.

Detailed findings have not yet been released or peer reviewed. Amgen plans to present the full data at a forthcoming medical meeting. Meanwhile, the phase 3 OASIZ 303 study, evaluating dazodalibep in patients with high symptom burden but lower systemic disease activity, is expected to complete later in 2026. If positive, the results could support broader development of CD40L-targeted therapies across different Sjögren's disease populations.

Source: Amgen. (2026 Sep 22). Amgen Announces Positive Topline Phase 3 Results For Dazodalibep In Moderate-To-Severe Systemic Sjögren's Disease