Amgen to unveil Phase 3 Sjögren’s disease data at ACR Convergence 2026
Amgen will present late‑breaking results from the Phase 3 OASIZ‑301 trial of dazodalibep in adults with moderate‑to‑severe Sjögren’s disease at the American College of Rheumatology Convergence 2026. The study met its primary endpoint, showing a statistically significant reduction in systemic disease activity and a meaningful improvement in patient‑reported dryness versus placebo. The data will be shown in a late‑breaking abstract on 11 Nov 2026, alongside additional long‑term and real‑world evidence for UPLIZNA, KRYSTEXXA and TAVNEOS.
Why it matters
The company says the topline results demonstrate a potential first‑in‑class therapy for a disease with no approved treatments, which could expand Amgen’s autoimmune portfolio and drive future sales. Investors should watch for regulatory filing plans and any impact on Amgen’s pipeline valuation.
Key facts
- 1The OASIZ‑301 trial enrolled approximately 621 patients, with 217 receiving dazodalibep 1,500 mg intravenously every four weeks, 217 receiving 3,000 mg intravenously every 12 weeks, and 214 receiving placebo. securities.io
- 2Patients entered the study with an average ESSDAI score of 10.2. securities.io
- 3At Week 48, the four‑week regimen reduced ESSDAI by a least‑squares mean change of –5.6 points versus –3.8 for placebo (difference –1.8, p < 0.001). securities.io
- 4The twelve‑week regimen reduced ESSDAI by a least‑squares mean change of –5.2 points versus –3.8 for placebo (difference –1.4, p = 0.010). securities.io
- 5The four‑week regimen improved patient‑reported dryness, with ESSPRI dryness score changing –2.50 versus –1.33 for placebo (p < 0.001). securities.io
- 6Adverse‑event rates were similar across all treatment arms. securities.io
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.