argenx ends Phase 3 Sjögren's study
- argenx (NASDAQ:ARGX) will discontinue its Phase 3 UNITY study of subcutaneous efgartigimod in adults with moderate-to-severe Sjögren's disease.
- An independent monitoring committee recommended stopping the trial for futility after an interim analysis showed the study could not meet its primary endpoint.
- argenx plans a detailed analysis after database lock to understand the outcome and inform future Sjögren's research.
argenx (NASDAQ:ARGX) will discontinue its Phase 3 UNITY study of subcutaneous efgartigimod in adults with moderate-to-severe Sjögren's disease after an interim analysis found the trial could not meet its primary endpoint.
The primary endpoint measured the change from baseline in systemic disease activity at Week 48 using clinESSDAI, a clinical index used to assess Sjögren's disease activity.
An Independent Data Monitoring Committee recommended stopping the UNITY study for futility after reviewing interim data and determining that the primary endpoint could not be achieved.
UNITY was designed as a randomized, double-blind and placebo-controlled study, with patients assigned equally to weekly subcutaneous efgartigimod or placebo and an open-label extension included in the program.
argenx said safety findings remained consistent with efgartigimod's established profile and no new safety signals were identified.
After the study closes and the database is locked, argenx plans to conduct an in-depth analysis of the UNITY results to better understand why the trial did not meet its objective.
The company said findings from that review may provide information for future research involving Sjögren's disease and the potential use of efgartigimod in related development programs.
