Amgen announced positive topline results from the phase 3 OASIZ 301 trial of dazodalibep in adults with Sjögren disease and moderate-to-severe systemic disease activity, meeting its primary endpoint with statistically significant and clinically meaningful improvement at week 48, the company announced September 22, 2026.¹ Improvements in disease activity, as measured by the EULAR Sjögren Syndrome Disease Activity Index (ESSDAI), were observed as early as week 4 and sustained through week 48.¹
Key facts
- Drug: Dazodalibep (Amgen)
- Class: CD40 ligand antagonist fusion protein (potential first-in-class)
- Indication: Sjögren disease, moderate-to-severe systemic disease activity
- Trial: Phase 3 OASIZ 301 (NCT06104124); ~621 patients, randomized, double-blind, placebo-controlled
- Primary result: ESSDAI improvement at week 48
- Onset: Improvements observed as early as week 4
- Prior data: Phase 2 showed 6.3-point vs 4.1-point ESSDAI reduction at day 169
- Regulatory status: No FDA-approved therapies currently exist Sjögren disease
- Pipeline: OASIZ 303 trial (low systemic activity population) expected to complete Q4 2026
"The results mark an important step forward for people living with Sjögren's disease, a condition with significant unmet need and no approved systemic treatment options," said Jay Bradner, MD, executive vice president of research and development, artificial intelligence and data at Amgen, in a company press release.¹ "The rapid and sustained improvement observed in systemic disease activity reinforces our confidence in dazodalibep and the broader phase 3 program as we work to deliver a new, highly differentiated option for people living with this debilitating autoimmune disease."
What did the OASIZ 301 trial evaluate?
OASIZ 301 (NCT06104124) is a phase 3, randomized, double-blind, placebo-controlled trial that enrolled approximately 621 patients with Sjögren disease and moderate-to-severe systemic disease activity, defined as an ESSDAI score of 5 or higher.¹,² The primary endpoint was change from baseline in ESSDAI score at week 48, and key secondary endpoints evaluated dryness, tender and swollen joints, fatigue, and ESSDAI response, defined as a decrease of at least 5 points from baseline. The most common adverse events occurring in 5% or more of patients and at a higher rate than placebo were nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions, generally mild to moderate in severity; discontinuations due to adverse events were low and balanced across treatment groups, and no imbalance in thromboembolic events or opportunistic infections was observed.¹
How does dazodalibep work, and what has earlier data shown?
Dazodalibep is a potential first-in-class CD40 ligand antagonist fusion protein designed to disrupt costimulatory interactions between T cells, B cells, and other antigen-presenting cells.¹ In an earlier phase 2 crossover trial in patients with moderate-to-severe systemic disease activity, dazodalibep produced a 6.3-point reduction in ESSDAI score compared with a 4.1-point reduction for placebo at day 169, and, unlike first-generation anti-CD40L monoclonal antibodies, dazodalibep has not shown a thromboembolic safety signal in clinical trials to date.³
