Amgen (NASDAQ:AMGN) issued an 8-K on October 27, 2026, announcing plans to present Phase 3 OASIZ-301 trial results for dazodalibep in Sjogren's disease, along with additional data across its rare and autoimmune disease portfolio, at ACR Convergence 2026.

Key Highlights

  • Phase 3 OASIZ-301 primary endpoint met: Both dazodalibep dosing regimens showed statistically significant reductions in ESSDAI score at Week 48 compared with placebo.
  • ESSDAI changes: Least-squares mean change from baseline was -5.6 points (every four weeks; adjusted p<0.001) and -5.2 points (every 12 weeks; adjusted p=0.010), versus -3.8 points for placebo.
  • Patient-reported dryness improved: The every-four-weeks regimen showed statistically significant improvement on both the ESSPRI dryness score (-2.50 vs. -1.33 for placebo; adjusted p<0.001) and the DASPRI dryness score (-1.98 vs. -1.05 for placebo; adjusted p<0.001).
  • Early treatment effect: According to the filing, disease activity improvements were observed as early as four weeks.
  • Baseline disease burden: Patients enrolled with an average ESSDAI score of 10.2.
  • No FDA-approved therapies exist: The filing states there are currently no approved therapies for Sjogren's disease.
  • Additional portfolio data: Long-term UPLIZNA data in IgG4-RD and real-world evidence for KRYSTEXXA and TAVNEOS are also being presented at ACR Convergence 2026.

Dazodalibep OASIZ-301 Data and Amgen's ACR Convergence 2026 Presentations

According to the filing, Amgen announced plans to present late-breaking results from its Phase 3 OASIZ-301 study of dazodalibep at ACR Convergence 2026. The study is described as "a Phase 3, randomized, double-blind, placebo-controlled study" evaluating dazodalibep in patients with Sjogren's disease with moderate-to-severe systemic disease activity (ESSDAI of 5 or higher), with an enrollment of approximately 621 patients. The primary endpoint was change from baseline in ESSDAI score at Week 48. The filing reports that patients entered the study with an average ESSDAI score of 10.2.

The filing reports that both dazodalibep dosing regimens - 1,500 mg every four weeks and 3,000 mg every 12 weeks - "demonstrated statistically significant and clinically meaningful reductions in systemic disease activity compared with placebo." The every-four-weeks regimen also met the key secondary endpoint of patient-reported dryness, with improvements measured by both the ESSPRI and DASPRI dryness scores. The filing states that treatment-emergent adverse events, serious adverse events, and treatment-emergent adverse events leading to discontinuation "were observed at similar rates across treatment groups." Dazodalibep is characterized in the filing as "a potential first-in-class CD40L antagonist fusion protein."

Beyond dazodalibep, the filing describes a broad program at ACR Convergence 2026 covering UPLIZNA (inebilizumab-cdon) in IgG4-related disease, including data from the Phase 3 MITIGATE open-label extension, as well as real-world evidence studies for KRYSTEXXA (pegloticase) in uncontrolled gout and TAVNEOS (avacopan) in ANCA-associated vasculitis. The company also disclosed that the companion Phase 3 study OASIZ 303, evaluating dazodalibep in patients with high symptom burden and low systemic disease activity, "is expected to complete in Q4 2026."

What Was Disclosed

Amgen disclosed Phase 3 OASIZ-301 trial results showing dazodalibep met its primary and key secondary endpoints in Sjogren's disease, and announced a series of additional data presentations across its rare and autoimmune disease portfolio at ACR Convergence 2026.