Amgen Reports Improvement of Up to 5.6 Points in Sjögren’s Activity in Phase 3 Study
Key Facts
On November 11, 2026, Amgen announced positive detailed results from the Phase 3 OASIZ-301 study of dazodalibep in adults with Sjögren’s syndrome and moderate to severe systemic activity. At week 48, the mean disease activity score fell by 5.6 points with a dose of 1,500 mg every four weeks and by 5.2 points with a dose of 3,000 mg every 12 weeks. The reduction was 3.8 points in the placebo group. The late-breaking oral presentation of the results at the ACR Convergence conference was scheduled for the same day. Dr. Teresa Tarrant of Duke University said the improvements in disease activity and patient-reported dryness were "particularly encouraging."
The mean ESSDAI score, which measures systemic disease activity, was 10.2 points when participants entered the study. The adjusted difference versus placebo was 1.8 points for the every-four-week dosing regimen, with an adjusted p-value below 0.001. The every-12-week regimen recorded a difference of 1.4 points, with an adjusted p-value of 0.010. According to the company, these results show that both regimens achieved a statistically significant improvement on the measure at week 48. The trial included adults with an ESSDAI score of at least 5, and planned enrollment was about 621 participants, in a randomized, double-blind, placebo-controlled design.
The improvement extended to patient-reported dryness measures, one of the main symptoms associated with Sjögren’s syndrome. In the every-four-week dose group, the ESSPRI dryness score fell by 2.50 points at week 48, compared with 1.33 points with placebo. The DASPRI score fell by 1.98 points with treatment, compared with 1.05 points in the control group. The adjusted p-value was below 0.001 for both dryness outcomes. When it announced the topline results, Amgen had said the improvement in ESSDAI was evident from week 4 and continued through week 48.
Amgen said rates of treatment-emergent adverse events, serious adverse events and events leading to treatment discontinuation were similar across study groups. The release did not provide detailed figures for these rates in the available results. Dazodalibep is an anti-CD40L fusion protein designed to disrupt interactions between T cells, glandular epithelial cells, B cells and other antigen-presenting cells. This mechanism targets immune pathways associated with the disease. According to the company’s release, no treatments for Sjögren’s syndrome had been approved by the U.S. Food and Drug Administration at the time it was issued.
Amgen had announced positive topline results from the study on September 22, 2026, saying then that OASIZ-301 had met its primary endpoint at week 48. The detailed results announced on November 11 add measures of response in disease activity and dryness to that initial announcement. The company is also testing the drug in OASIZ-303, a Phase 3 study targeting patients with a moderate to severe symptom burden and low systemic activity. The study was expected to be completed in the fourth quarter of 2026. The company is also conducting OASIZ-304, an open-label study to monitor long-term safety and tolerability in eligible participants from OASIZ-301 and OASIZ-303.
In share trading, EL7 data show AMGN closing at $465.23 on November 9 and November 10, 2026. The stock also recorded $478.48 on November 4, $460.28 on November 5 and $460.42 on November 6. The data therefore show no change between the November 9 and November 10 closes. These prices alone do not indicate the market’s reaction to the results presentation scheduled for November 11. OASIZ-303, which targets a different patient group, remains the next research milestone specified in the information announced by the company.