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Amgen Reports Topline P-III (OASIZ 301) Trial Data on Dazodalibep for Systemic Sjögren’s Disease

Shots:

  • Amgen has reported topline P-III (OASIZ 301) trial results evaluating dazodalibep vs PBO in adults (n=~621) with Sjögren’s disease with mod. to sev. systemic disease activity (ESSDAI ≥ 5)
  • Trial met its 1EP, showing statistically significant & clinically meaningful improvement at Wk. 48, as measured by the ESSDAI, with benefits seen as early as Wk. 4, which were sustained through Wk. 48
  • Detailed OASIZ 301 data are expected to be presented at an upcoming meeting, while the P-III (OASIZ 303) study of dazodalibep in mod. to sev. symptomatic Sjögren’s disease is expected to complete in Q4’26

Ref:  PRnewswire  |   Image: Amgen  |  Press Release

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