Thousand Oaks – October 29, 2026 -- Amgen's dazodalibep reduced systemic disease activity in Sjögren's disease patients by 5.6 points on the ESSDAI scale at Week 48 in the Phase 3 OASIZ-301 trial, against 3.8 points for placebo. The company will present the late-breaking data at the American College of Rheumatology (ACR) Convergence 2026.
Both dazodalibep regimens beat placebo on the primary endpoint
Patients entered OASIZ-301 with an average ESSDAI score of 10.2. The trial enrolled approximately 621 adults with moderate-to-severe systemic disease activity (ESSDAI of at least 5).
The 1,500 mg every-four-weeks regimen cut scores by a least-squares mean of 5.6 points, 1.8 points better than placebo (adjusted p<0.001). The 3,000 mg every-12-weeks regimen cut scores by 5.2 points, 1.4 points better than placebo (adjusted p=0.010). Treatment effects appeared as early as four weeks.
Four-weekly dosing also improved patient-reported dryness
The four-weekly arm met the key secondary endpoint of patient-reported dryness. On the ESSPRI dryness score, patients improved by 2.50 points versus 1.33 for placebo (adjusted p<0.001). On the DASPRI dryness score, the improvement was 1.98 versus 1.05 (adjusted p<0.001).
Treatment-emergent adverse events, serious adverse events and events leading to discontinuation occurred at similar rates across treatment groups.
No FDA-approved medicine exists for the disease
Amgen states that no FDA-approved medicines currently exist for Sjögren's disease, which it describes as the second most common autoimmune rheumatic disease. Dazodalibep is a CD40L antagonist fusion protein that disrupts interactions between T cells, glandular epithelial cells, B cells and other antigen-presenting cells.
Duke University's Dr. Teresa K. Tarrant described the rapid ESSDAI and dryness improvements as encouraging for a disease with limited treatment options.
Late-breaking presentation is set for November 11
Amgen will present the OASIZ-301 results as Late-Breaking Abstract #22 on Wednesday, November 11, from 8:45 to 9:00 a.m. ET.
Amgen adds 10 abstracts across three marketed therapies
Amgen will present three UPLIZNA (inebilizumab-cdon) posters from the Phase 3 MITIGATE open-label period in IgG4-related disease, covering long-term efficacy and safety, age subgroups, and newly diagnosed versus recurrent patients. Sessions run November 8-10.
The company will also present two TAVNEOS (avacopan) posters in ANCA-associated vasculitis and five KRYSTEXXA (pegloticase) posters in uncontrolled gout. The KRYSTEXXA posters include real-world remission durability data from a U.S. rheumatology network and analyses of immunomodulation co-therapy.
Amgen is also running OASIZ 303, a Phase 3 study in Sjögren's patients with high symptom burden and low systemic activity, which is expected to complete in Q4 2026. The OASIZ 304 open-label extension is evaluating long-term safety and tolerability for eligible participants from OASIZ 301 and 303.