Amgen's Dazodalibep Shows Promise in Sjögren's Disease Trial
Amgen has announced positive results from its Phase 3 trial of dazodalibep in treating Sjögren's disease. The trial, OASIZ 301, met its primary endpoint of reducing systemic disease activity at Week 48.
The randomized, double-blind trial tested dazodalibep against a placebo in adults with moderate-to-severe systemic disease. Amgen reported that ESSDAI improvement appeared by Week 4 and persisted through Week 48, but did not disclose how many patients were enrolled or completed the primary assessment.
The company listed dryness, fatigue, joint symptoms, and an ESSDAI response threshold among secondary measures, without reporting their outcomes. Those results will show whether the change in systemic activity extends to the symptoms that patients experience, and whether the primary result is consistent across measures.