Amgen Dazodalibep data from the Phase 3 OASIZ-301 study show clinically meaningful improvements in systemic disease activity and patient-reported symptoms of Sjögren’s disease, the company announced on November 11, 2026. Amgen (NASDAQ: AMGN) described the study as the only global Phase 3 trial to demonstrate such improvements in the condition. Sjögren’s disease currently has no U.S. Food and Drug Administration (FDA)-approved treatments, according to the company.
The results build on positive topline findings that Amgen announced in September. The full dataset will be presented in a late-breaking session, labeled LB22, at the American College of Rheumatology (ACR) Convergence 2026. The announcement did not state the session date or time.
Jay Bradner, M.D., executive vice president of Research and Development, Artificial Intelligence and Data at Amgen, said the results support dazodalibep’s potential as a first-in-class treatment. He added that they strengthen the rationale for targeting CD40L-mediated immune signaling in these patients. Bradner noted that improvements in systemic disease activity appeared as early as Week 4 and were sustained through Week 48, and that Amgen intends to advance a broader Phase 3 program.
Amgen Dazodalibep Primary Endpoint: ESSDAI Reductions at Week 48
OASIZ-301 is a randomized, double-blind, placebo-controlled Phase 3 study of 648 patients with moderate-to-severe systemic disease activity, defined as an ESSDAI score of at least 5. ESSDAI is the European Alliance of Associations for Rheumatology Sjögren’s Syndrome Disease Activity Index. Patients had a mean baseline score of 10.2, and the primary endpoint was change from baseline in ESSDAI at Week 48. In this Amgen Dazodalibep trial, both dosing regimens met the primary endpoint with statistically significant reductions versus placebo.
The 1,500 mg every-four-weeks regimen (n=217) produced a least-squares mean reduction of 5.6 points, compared with 3.8 points for placebo. That is a difference of 1.8 points (adjusted p<0.001). The 3,000 mg every-12-weeks regimen (n=217) produced a 5.2-point reduction, a 1.4-point difference versus placebo (adjusted p=0.010).
ESSDAI captures disease activity across multiple organ domains, so the endpoint reflects the systemic burden of Sjögren’s disease rather than dryness alone. Amgen said a treatment effect was observed as early as Week 4 and held through Week 48. The release does not state the size of the placebo arm.
Amgen Dazodalibep Improves Patient-Reported Dryness in Sjögren’s Disease
Dryness is described in the release as a debilitating symptom of Sjögren’s disease. At Week 48, the 1,500 mg every-four-weeks regimen significantly improved patient-reported dryness compared with placebo. Placebo-adjusted least-squares mean differences were −1.17 points on the dryness domain of the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) and −0.93 points on the dryness domain of the Diary for Assessing Sjögren’s Patient Reported Index (DASPRI). Adjusted p<0.001 was reported for both. The release reports these dryness results for the every-four-weeks regimen only.
The ACR presentation for Amgen Dazodalibep will include further analyses. These cover responder rates for ESSDAI reductions of at least 3, 5 or 7 points, and total ESSPRI and DASPRI scores, where mean improvement in total ESSPRI exceeded 1.5 points with both regimens. They also cover ESSDAI domain-level responses, the composite STAR response criteria, and stimulated salivary flow, an objective measure of oral dryness. Amgen said more patients on dazodalibep than on placebo met the STAR criteria and showed greater salivary flow increases.
Ghaith Noaiseh, M.D., associate professor of Medicine at the University of Kansas Medical Center and lead investigator, called the disease complex and heterogeneous. He said patients can face dry eyes and mouth, fatigue and joint pain, as well as organ involvement in the lungs, kidneys or nervous system. He described the results as encouraging progress toward unmet needs. Janet Church, president and chief executive officer of the Sjögren’s Foundation, said continued research progress matters to patients and expressed hope that development will yield new options.
Amgen Dazodalibep Safety Profile Reported From OASIZ-301
Amgen reported the most common adverse events, those with at least 5% incidence and a higher rate on dazodalibep than placebo. They were nasopharyngitis, urinary tract infection, hypertension and infusion-related reactions, generally mild to moderate in nature. Serious adverse events and discontinuations due to adverse events were balanced across all three treatment groups.
The company also reported no imbalance in thromboembolic events or opportunistic infections across groups, and malignancy rates were low and comparable. Event-level percentages are not disclosed in the release. Amgen Dazodalibep remains an investigational candidate, and the company states that no conclusions can be drawn about its safety or effectiveness because it is not FDA-approved.
What Amgen Dazodalibep Means for the Sjögren’s Disease Pipeline
Dazodalibep is a potential first-in-class CD40L antagonist fusion protein. It is designed to target immune activation by disrupting interactions between T cells, glandular epithelial cells, B cells and other antigen-presenting cells. Amgen is studying it in two patient groups: those with moderate-to-severe systemic disease, and those with a high symptom burden and low systemic activity who suffer from dryness, fatigue or pain.
Beyond OASIZ-301, Amgen is running OASIZ-303, a Phase 3 study in patients with high symptom burden and low systemic disease activity. It is also running OASIZ-304, an open-label long-term extension for eligible participants from OASIZ-301 and OASIZ-303. Amgen notes that Sjögren’s disease is the second most common autoimmune rheumatic disease yet remains widely underrecognized.
OASIZ-301 Study Design
| Parameter | Detail |
|---|---|
| Sponsor | Amgen (NASDAQ: AMGN) |
| Drug | Dazodalibep (CD40L antagonist fusion protein) |
| Study | OASIZ-301, Phase 3 |
| Design | Randomized, double-blind, placebo-controlled |
| Population | Sjögren’s disease, moderate-to-severe systemic activity (ESSDAI ≥ 5) |
| Total enrollment | 648 |
| Mean baseline ESSDAI | 10.2 |
| Primary endpoint | Change from baseline in ESSDAI at Week 48 |
| Key secondary endpoints | Dryness, tender and swollen joints, fatigue, ESSDAI[5] response (≥5-point decrease) |
| Announcement date | November 11, 2026 |
| Presentation | ACR Convergence 2026, late-breaking session LB22 |
| ClinicalTrials.gov identifier | Not disclosed |
Primary Endpoint Results at Week 48 (ESSDAI)
| Regimen | n | LS Mean Reduction | Placebo Reduction | Difference | Adjusted p-value |
|---|---|---|---|---|---|
| 1,500 mg every 4 weeks | 217 | 5.6 points | 3.8 points | 1.8 points | <0.001 |
| 3,000 mg every 12 weeks | 217 | 5.2 points | 3.8 points | 1.4 points | 0.010 |
| Placebo arm size | Not disclosed | N/A | N/A | N/A | N/A |
