Amgen Reports Positive Phase 3 Dazodalibep Results: Sjögren

Thousand Oaks, California, U.S., November 11, 2026

Phase 3 OASIZ-301 Trial Demonstrates Significant Improvements

The OASIZ-301 study was a randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to evaluate the efficacy and safety of dazodalibep in adults with moderate-to-severe systemic Sjögren’s disease. The study enrolled approximately 648 participants, providing an important assessment of the investigational therapy across a substantial patient population. The primary endpoint evaluated changes in systemic disease activity using the European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index (ESSDAI) at Week 48. According to the reported findings, both evaluated dosing regimens achieved the primary endpoint, demonstrating statistically significant reductions in systemic disease activity compared with placebo. Patients receiving 1,500 mg of dazodalibep every four weeks experienced a least-squares mean reduction of 5.6 points in ESSDAI score from baseline, compared with 3.8 points in the placebo group. This represented a placebo-adjusted difference of 1.8 points, with an adjusted p-value below 0.001. The second regimen, involving 3,000 mg every 12 weeks, produced a 5.2-point reduction compared with 3.8 points for placebo, representing a difference of 1.4 points and an adjusted p-value of 0.010. Improvements were observed as early as Week 4 and continued through Week 48, indicating sustained treatment effects throughout the study period.

Dazodalibep Shows Potential to Improve Patient Symptoms

Beyond reducing systemic disease activity, the clinical findings also highlighted improvements in symptoms that frequently affect people living with Sjögren’s disease. One of the most important findings was the improvement in patient-reported dryness among participants receiving the 1,500 mg every-four-weeks regimen. At Week 48, this treatment demonstrated statistically significant improvements compared with placebo in dryness measurements assessed using the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) and the Diary for Assessing Sjögren’s Patient Reported Index (DASPRI). The placebo-adjusted differences were -1.17 points for the ESSPRI dryness domain and -0.93 points for the DASPRI dryness domain, with adjusted p-values below 0.001 for both measurements. Additional analyses also indicated improvements in overall symptom scores, stimulated salivary flow and several disease activity domains. These findings are important because Sjögren’s disease can cause persistent dry eyes and mouth, fatigue, joint pain and complications involving other organs. The disease may also affect the lungs, kidneys and nervous system, making effective treatment particularly challenging. The ability to address both systemic disease activity and patient-experienced symptoms could represent a meaningful advancement in future treatment approaches.

CD40L Targeting and Safety Findings Support Further Development

Dazodalibep is a potential first-in-class CD40L antagonist fusion protein developed to regulate immune system activation. Its mechanism involves disrupting interactions between T cells, B cells, glandular epithelial cells and other antigen-presenting cells that contribute to autoimmune activity. By targeting CD40L-mediated immune signaling, the investigational therapy aims to address important biological mechanisms involved in Sjögren’s disease rather than focusing exclusively on individual symptoms. The reported safety findings showed that the most common adverse events occurring at a higher rate with dazodalibep than placebo included nasopharyngitis, urinary tract infections, hypertension and infusion-related reactions. These events were generally mild to moderate in severity. Serious adverse events and treatment discontinuations due to adverse events were balanced across the three treatment groups. The company also reported no imbalance in thromboembolic events or opportunistic infections, while malignancy rates remained low and comparable across the groups. Amgen continues to advance its broader Phase 3 development programme for dazodalibep, including the OASIZ-303 study evaluating patients with high symptom burden and lower systemic disease activity. The positive OASIZ-301 findings strengthen the clinical development programme and provide further evidence supporting the investigation of CD40L-targeted treatment in autoimmune diseases. Although dazodalibep remains investigational and is not currently approved for Sjögren’s disease, these results represent an encouraging step toward addressing a significant unmet medical need. Further clinical evaluation and regulatory review will be important in determining its potential role in future treatment strategies.

Source: Amgen press release