Amgen reports positive Phase 3 results for Sjögren's disease drug
+1 new source since this summary was written
Amgen reported on November 11, 2026 that both dazodalibep dosing regimens met the primary endpoint in the Phase 3 OASIZ-301 trial for Sjögren's disease. At Week 48, the 1,500 mg every four weeks regimen reduced ESSDAI scores by 5.6 points versus 3.8 points for placebo, while the 3,000 mg every 12 weeks regimen reduced scores by 5.2 points versus 3.8 points for placebo. The 1,500 mg regimen also improved patient-reported dryness, and full results are scheduled for presentation at ACR Convergence 2026.
Why it matters
Dazodalibep remains investigational, so the results do not establish an approved treatment or a regulatory filing timetable. Amgen said the findings support advancing a broader Phase 3 program, including the ongoing OASIZ-303 study.
Key facts
- 1At Week 48, the 1,500 mg every four weeks regimen produced a least-squares mean ESSDAI reduction of 5.6 points from baseline versus 3.8 points for placebo, a difference of 1.8 points with adjusted p<0.001. prnewswire.com
- 2At Week 48, the 3,000 mg every 12 weeks regimen produced an ESSDAI reduction of 5.2 points from baseline versus 3.8 points for placebo, a difference of 1.4 points with adjusted p=0.010. prnewswire.com
- 3The 1,500 mg every four weeks regimen produced placebo-adjusted least-squares mean differences of −1.17 points on the ESSPRI dryness domain and −0.93 points on the DASPRI dryness domain, with adjusted p<0.001 for both. prnewswire.com
- 4OASIZ-301 evaluated 648 patients over 48 weeks, with each dazodalibep treatment group including 217 patients. finance.yahoo.com
- 5Serious adverse events and discontinuations due to adverse events were balanced across the three treatment groups, and no imbalance in thromboembolic events or opportunistic infections was observed. prnewswire.com
- 6Amgen plans to present the full OASIZ-301 results in a late-breaking session at ACR Convergence 2026. prnewswire.com
Open questions
- Amgen has not provided a regulatory submission timetable for dazodalibep in Sjögren's disease.
Summary written by AlphAI AI Desk from 10 of 10 sources. Not investment advice. Figures are as stated by the linked sources.