Amgen: dazodalibep met primary endpoint in phase 3 OASIZ-301 trial in Sjögren's syndrome
In a 648-patient phase 3 trial, both dazodalibep doses lowered ESSDAI more than placebo at 48 weeks, Amgen reported. The candidate is not yet approved for Sjögren's syndrome.
Amgen announced on 11 November 2026 positive results of the phase 3 trial OASIZ-301 of dazodalibep in Sjögren's syndrome, according to ad-hoc-news.de. Both tested doses met the primary endpoint, systemic disease activity, after 48 weeks. ad-hoc-news.de
ad-hoc-news.dead-hoc-news.deOpen source ↗ The company's release is available on its investor page.
The randomized, double-blind, placebo-controlled study enrolled 648 patients with moderate to severe systemic disease activity. Activity was assessed with ESSDAI, an established index for Sjögren's syndrome; the mean baseline value was 10.2 points.
Primary endpoint results
At 1,500 mg every four weeks, mean ESSDAI fell by 5.6 points at week 48, versus 3.8 points with placebo. The difference was 1.8 points in favor of dazodalibep, with an adjusted p-value below 0.001.
The 3,000 mg dose every twelve weeks also met the primary endpoint: a decrease of 5.2 points versus 3.8 points with placebo, a difference of 1.4 points, with an adjusted p-value of 0.010. According to Amgen, the treatment effect appeared from week four and persisted to week 48. ad-hoc-news.de
ad-hoc-news.dead-hoc-news.deOpen source ↗
The monthly regimen also produced statistically significant improvements in patient-reported dryness. The placebo-adjusted change was −1.17 points on the ESSPRI dryness domain and −0.93 points on DASPRI, both with adjusted p-values below 0.001.
Safety and further studies
Amgen describes dazodalibep as a potential first-in-class agent intended to affect CD40L-mediated immune activation. The candidate is not yet approved for Sjögren's syndrome.
The most common adverse events were nasopharyngitis, urinary tract infections, hypertension and infusion-related reactions; according to Amgen, they were mostly mild to moderate. Serious events and treatment discontinuations were balanced between the groups. ad-hoc-news.de
ad-hoc-news.dead-hoc-news.deOpen source ↗
The company says further analyses will cover disease activity, patient symptoms and dry mouth. They include responder analyses at different levels of improvement, change in saliva production and a composite STAR criterion. Amgen is also running OASIZ-303, another phase 3 study in patients with high symptom burden and low systemic disease activity, and OASIZ-304, an open-label extension study of long-term safety and tolerability.
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