argenx Stops Phase 3 UNITY Sjögren’s Study After Futility Review
Published in Drugs development & discovery, Immunology.
Publication and announcement date: October 8, 2026.
argenx announced that it will discontinue UNITY, its phase 3 study of subcutaneous efgartigimod in adults with moderate-to-severe Sjögren’s disease. An independent monitoring committee recommended stopping after an interim analysis concluded that the trial could not meet its primary endpoint.
UNITY used a randomized, double-blind, placebo-controlled design, with weekly treatment allocated 1:1 and an open-label extension. The primary measure was change in systemic disease activity using clinESSDAI at week 48.
The company reported no new safety signals and said safety remained consistent with the drug’s established profile. It plans further analysis after study closure and database lock.
The reason for stopping was futility regarding efficacy, rather than a newly identified safety problem. Detailed results have not yet been released. This outcome concerns the Sjögren’s indication and does not establish failure across every condition in which efgartigimod is studied or used.
Source: argenx release, October 8, 2026.