$AMGN PHASE 3 SJÖGREN’S TRIAL HITS PRIMARY ENDPOINT
Amgen says dazodalibep significantly improved systemic disease activity in patients with moderate-to-severe Sjögren’s disease, with benefits seen as early as Week 4 and sustained through Week 48.
The Phase 3 OASIZ 301 trial enrolled about 621 patients and met its primary endpoint based on the ESSDAI disease activity score.
There are currently no FDA-approved medicines for Sjögren’s disease.
A second Phase 3 study, OASIZ 303, focused on symptomatic Sjögren’s, is expected to complete in Q4.