Amgen's Dazodalibep Cuts Sjögren's Disease Activity in Phase 3 Trial
Thousand Oaks – October 29, 2026 -- Amgen's dazodalibep reduced systemic disease activity in Sjögren's disease patients by 5.6 points on the ESSDAI scale at Week 48 in the Phase 3 OASIZ-301 trial, against 3.8 points for placebo. The company will present the late-breaking data at the American College of Rheumatology (ACR) Convergence 2026.
Both dazodalibep regimens beat placebo on the primary endpoint
Patients entered OASIZ-301 with an average ESSDAI score of 10.2. The trial enrolled approximately 621 adults with moderate-to-severe systemic disease activity (ESSDAI of at least 5).
The 1,500 mg every-four-weeks regimen cut scores by a least-squares mean of 5.6 points, 1.8 points better than placebo (adjusted p<0.001). The 3,000 mg every-12-weeks regimen cut scores by 5.2 points, 1.4 points better than placebo (adjusted p=0.010). Treatment effects appeared as early as four weeks.