argenx Provides Update on Phase 3 UNITY Study of Efgartigimod SC in Sjögren's Disease
argenx will discontinue 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, concluding the trial could not meet its primary endpoint of clinESSDAI change at Week 48. Safety was consistent with efgartigimod's established profile and no new safety signals were identified; the approved VYVGART and VYVGART Hytrulo franchise in gMG and CIDP is unaffected.
Key figures
- Drug Name
- efgartigimod SC (efgartigimod alfa and hyaluronidase-qvfc)
- Phase Of Trial
- Phase 3
- Study status
- discontinued for futility after IDMC interim analysis
- Primary endpoint
- change from baseline in clinESSDAI at Week 48
- New safety signals
- No
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