Amgen's Dazodalibep Hits Primary Endpoint in Sjögren's Disease Trial

Amgen's dazodalibep has achieved its primary endpoint in a Phase III trial of systemic Sjögren's disease, demonstrating statistically significant and clinically meaningful improvement in disease activity at Week 48. The OASIZ 301 study enrolled approximately 621 adults with moderate-to-severe systemic Sjögren's disease.

The primary endpoint was change from baseline in ESSDAI at Week 48, and Amgen reported improvements were observed as early as Week 4 and sustained through Week 48. Dazodalibep blocks the CD40L, CD40 co-stimulatory interaction between T cells and B cells.

This mechanism distinguishes it from pipeline competitors targeting downstream B cell biology, such as Novartis's ianalumab and Johnson & Johnson's nipocalimab. The most common adverse events in OASIZ 301 were nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions.