Efgartigimod - (UNITY)

October 8, 2026: argenx SE (Euronext, NASDAQ: ARGX) said it will discontinue the Phase 3 UNITY trial of subcutaneous efgartigimod (efgartigimod alfa and hyaluronidase-qvfc) in adults with moderate-to-severe Sjögren's disease after an Independent Data Monitoring Committee recommended stopping for futility at an interim analysis. The IDMC concluded the study was unable to meet its primary endpoint. Safety was consistent with the established profile of efgartigimod, with no new safety signals.

UNITY was a randomized, double-blind, placebo-controlled, multicenter Phase 3 study with an open-label extension. Patients were randomized 1:1 to weekly efgartigimod SC or placebo. The primary endpoint was change from baseline in systemic disease activity by clinESSDAI at Week 48. Key secondary endpoints included low disease activity rate (clinESSDAI <5), STAR responder status, change in DiSSA patient-reported symptoms, and safety/tolerability.

argenx said it will analyze the data after study close and database lock to better understand the outcome and inform future Sjögren's disease research.