Successful Phase 3 Clinical Trial
Amgen’s Dazodalibep Meets Primary Phase 3 Endpoint in Sjögren’s Disease Trial
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Key Points
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Amgen said some patients began seeing benefits from dazodalibep as early as four weeks into treatment.
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The OASIZ 301 trial enrolled 651 participants with moderate-to-severe systemic Sjögren’s disease, and its primary endpoint was the change from baseline in the ESSDAI disease-severity score at Week 48.
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Amgen’s separate Phase 3 OASIZ 303 study is evaluating patients with high symptom burden but low systemic disease activity and is expected to conclude in the fourth quarter of 2026.
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Most adverse events were mild to moderate, with few participants discontinuing treatment, according to Amgen’s trial update.
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Amgen discontinued a separate Sjögren’s disease candidate, AMG 329, after weak Phase 2 results; that molecule is distinct from dazodalibep, so the earlier setback does not directly determine the Phase 3 outcome.
Amgen's experimental drug dazodalibep has cleared a major hurdle, meeting the primary goal of its Phase 3 trial in adults with moderate-to-severe systemic Sjögren's disease. The trial showed statistically significant improvement in disease activity after 48 weeks compared with placebo, Yahoo Finance reported. This breakthrough matters because systemic Sjögren's — a chronic autoimmune condition that attacks moisture-producing glands — has no FDA-approved treatment specifically targeting disease activity.
Amgen enrolled 651 participants in the OASIZ 301 trial and measured results using the ESSDAI disease-severity score. Some patients began improving as early as four weeks into treatment, and most adverse events were mild to moderate, Clinical Trials Arena reported. The company still needs regulatory approval and is running a second Phase 3 study expected to finish in late 2026.
A Treatment for a Disease With No Cure
Sjögren's disease affects the immune system, causing it to attack glands that produce saliva and tears. Patients suffer from dry mouth, dry eyes, and joint pain that gets worse over time. Yahoo Finance noted that dazodalibep represents the first potential cure targeting the underlying disease activity itself, not just symptom relief. This fills a critical gap in treatment options.
Early Signs of Patient Improvement
In the OASIZ 301 trial, the primary endpoint measured change in the ESSDAI disease-severity score at week 48. Clinical Trials Arena reported that some patients saw benefits starting just four weeks into treatment. Few participants quit the trial due to side effects, and most who experienced adverse events had only mild to moderate symptoms. This safety profile strengthens dazodalibep's chances with regulators.
Second Trial Targets Different Patient Group
Amgen is running a parallel Phase 3 study called OASIZ 303 that focuses on patients with high symptom burden but low systemic disease activity. Clinical Trials Arena reported this trial is expected to conclude in the fourth quarter of 2026. The two-pronged approach tests dazodalibep in different patient populations, broadening its potential market if both succeed.
Past Setback Does Not Determine This Drug's Fate
Amgen previously abandoned AMG 329, a different Sjögren's candidate, after weak Phase 2 results. But dazodalibep is a distinct molecule with a different mechanism of action. Yahoo Finance noted that the earlier failure does not predict dazodalibep's outcome. In fact, the current positive Phase 3 data suggests this compound may succeed where its predecessor fell short.
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