Argenx SE (Euronext & Nasdaq: ARGX) announced it will discontinue the Phase III UNITY trial of subcutaneous (SC) efgartigimod in adults with moderate-to-severe Sjögren's disease after an independent data monitoring committee recommended stopping the study for futility. An interim analysis indicated that the trial would not meet its primary endpoint of improvement in systemic disease activity at Week 48.
The randomized, double-blind study evaluated weekly efgartigimod SC against placebo, with efficacy assessed using the clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI). Argenx did not disclose quantitative efficacy results and reported no new safety signals. The company plans to analyze the complete dataset following trial closure.
The setback follows encouraging results from the smaller Phase II RHO study, in which 45.5% of efgartigimod-treated patients achieved a response on the composite CRESS endpoint at Week 24, compared with 11.1% receiving placebo. However, the study enrolled only 34 patients and used a different primary endpoint from UNITY. Efgartigimod is an FcRn inhibitor marketed as VYVGART and VYVGART Hytrulo for generalized myasthenia gravis and, in its subcutaneous formulation, chronic inflammatory demyelinating polyneuropathy.