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AMGEN ANNOUNCES POSITIVE PHASE 3 RESULTS FOR DAZODALIBEP IN SJÖGREN'S DISEASE

AMGN
  • Amgen announced positive results from the Phase 3 OASIZ-301 study of dazodalibep, the only global Phase 3 trial to show clinically meaningful improvements in systemic disease activity & patient-reported symptoms for Sjögren's disease.
  • Both dazodalibep dosing regimens (1,500 mg every four weeks & 3,000 mg every 12 weeks) met the primary endpoint at Week 48 by demonstrating statistically significant reductions in systemic disease activity compared to placebo as measured by the ESSDAI score.
  • Improvements in systemic disease activity were observed as early as Week 4 & sustained through Week 48, with the 1,500 mg every four weeks regimen showing a 5.6-point reduction vs 3.8 points for placebo, & the 3,000 mg every 12 weeks regimen showing a 5.2-point reduction vs 3.8 points for placebo.
  • The 1,500 mg every four weeks regimen significantly improved patient-reported dryness at Week 48, with placebo-adjusted least-squares mean differences of -1.17 points on the ESSPRI dryness domain & -0.93 points on the DASPRI dryness domain.
  • Additional analyses showed greater proportions of patients achieved clinically meaningful reductions of at least 3, 5, or 7 points on the ESSDAI, exceeded 1.5-point improvements in total ESSPRI scores, & met STAR response criteria which combines patient-reported symptoms with objective disease activity measures.
  • Dazodalibep-treated patients showed greater increases in stimulated salivary flow compared to placebo, & consistent improvements were observed across ESSDAI domain-level responses including constitutional, glandular, articular, lymphadenopathy, cutaneous, & biological manifestations.
  • Common adverse events (≥5% incidence) reported at higher rates with dazodalibep included nasopharyngitis, urinary tract infection, hypertension, & infusion-related reactions, which were generally mild to moderate in nature.
  • Serious adverse events, discontinuations due to adverse events, thromboembolic events, opportunistic infections, & malignancy rates were balanced across all treatment groups with no observed imbalances.
  • Dazodalibep is a potential first-in-class CD40L antagonist fusion protein designed to target immune activation by disrupting interactions between T cells, glandular epithelial cells, B cells, & other antigen-presenting cells.
  • The OASIZ-301 study evaluated efficacy & safety in 648 patients with moderate-to-severe systemic disease activity (ESSDAI ≥ 5), while Amgen is also conducting OASIZ-303 for patients with high symptom burden & low systemic disease activity, & the OASIZ-304 long-term extension study.
  • Full results will be presented during the late-breaking session (LB22) at the American College of Rheumatology (ACR) Convergence 2026.
  • There are currently no FDA-approved treatments for Sjögren's disease, & this study represents an important advance for a disease that remains widely underrecognized with significant unmet medical needs.
Company
Amgen
Keywords
Amgen