Amgen, the Thousand Oaks‑based biotechnology leader, announced on Nov. 11, 2026 that its experimental therapy dazodalibep achieved statistically significant improvements in systemic disease activity and patient‑reported symptoms for Sjögren’s disease in the global Phase 3 OASIZ‑301 study. The results, presented at the American College of Rheumatology Convergence 2026, represent the first Phase 3 trial to demonstrate such benefits for a condition that currently has no FDA‑approved treatments.
According to the company’s press release, the double‑blind, placebo‑controlled trial enrolled 648 patients with moderate‑to‑severe disease (baseline ESSDAI score 10.2). Both dosing regimens—1,500 mg every four weeks (n=217) and 3,000 mg every 12 weeks (n=217)—met the primary endpoint at Week 48, showing greater reductions in ESSDAI scores than placebo (1.8‑point and 1.4‑point differences, respectively; p < 0.001 and p = 0.010). Improvements were observed as early as Week 4 and persisted through the study’s end.
Patient‑reported dryness, a debilitating hallmark of Sjögren’s disease, also improved significantly with the every‑four‑weeks regimen. The placebo‑adjusted least‑squares mean differences were ‑1.17 points on the ESSPRI dryness domain and ‑0.93 points on the DASPRI dryness domain (adjusted p < 0.001), according to PR Newswire. Additional analyses showed higher proportions of patients achieving clinically meaningful ESSDAI reductions of 3, 5, or 7 points, greater increases in stimulated salivary flow, and better overall ESSPRI and DASPRI scores.
Lead investigator Dr. Ghaith Noaiseh of the University of Kansas Medical Center highlighted the trial’s significance, noting the disease’s complexity and the unmet need for effective therapies. Janet Church, CEO of the Sjögren’s Foundation, expressed encouragement about the momentum in research and optimism that continued development could bring new options to patients.
Safety data indicated that the most common adverse events (≥ 5% incidence) were nasopharyngitis, urinary‑tract infection, hypertension, and infusion‑related reactions, all generally mild to moderate. Serious adverse events and discontinuations were balanced across treatment groups, with no increase in thromboembolic events, opportunistic infections, or malignancies.
What’s next: Amgen plans to advance dazodalibep into broader Phase 3 programs and will file for regulatory review following the upcoming ACR presentation. Residents of Thousand Oaks can follow the company’s updates through its website and social‑media channels.
Sources: amgen.com, prnewswire.com
