REG-argenx Provides Update on Phase 3 UNITY Study of Efgartigimod SC in Sjögren's Disease
argenx is discontinuing the Phase 3 UNITY study of efgartigimod SC in moderate-to-severe Sjögren's disease after the IDMC recommended stopping for futility at interim analysis. The IDMC concluded the study cannot meet its primary endpoint of clinESSDAI change at Week 48; safety remained consistent with efgartigimod's established profile with no new signals. Sjögren's was a major label-expansion opportunity for the VYVGART franchise; the company will analyze full data post database lock.
Key figures
- Drug Name
- efgartigimod SC (efgartigimod alfa and hyaluronidase-qvfc)
- Phase Of Trial
- Phase 3
- Indication
- Sjögren's disease
- Study name
- UNITY
- Stop reason
- futility at interim analysis per IDMC
- Primary endpoint
- change from baseline in clinESSDAI at Week 48
AI analysis
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