Argenx Sjögren's Trial Halt Ends UNITY Study
Argenx Sjögren's trial halt after an IDMC futility recommendation ends the UNITY Phase 3 study and creates a negative near-term outlook for the stock.
KEY TAKEAWAYS
- An IDMC recommended stopping UNITY for futility, prompting argenx to discontinue the Phase 3 study.
- argenx reported safety consistent with efgartigimod SC and no new safety signals were identified.
- argenx will complete study close and database lock, then conduct a comprehensive analysis to understand UNITY's outcome.
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Argenx SE said on Oct. 8, 2026, it will discontinue its Phase 3 UNITY study of efgartigimod SC in adults with moderate-to-severe Sjögren’s disease after an Independent Data Monitoring Committee (IDMC) recommended stopping the trial for futility following an interim analysis.
IDMC Recommendation and Study Discontinuation
The IDMC, an external trial oversight body, reviewed the interim data and concluded that the UNITY study could not meet its primary endpoint. This finding led argenx to halt the late-stage program. The company emphasized the IDMC’s conclusion in its announcement.
Study Design, Safety, and Next Steps
UNITY’s primary endpoint measured the change from baseline in systemic disease activity at Week 48 using the clinical EULAR Sjögren’s Syndrome Disease Activity Index (clinESSDAI). The randomized, double-blind, placebo-controlled, multicenter trial included an open-label extension. Patients were assigned 1:1 to receive weekly subcutaneous efgartigimod or placebo during the blinded period. The formulation evaluated was identified as efgartigimod alfa and hyaluronidase-qvfc.
argenx reported that safety remained consistent with the drug’s established profile and no new safety signals emerged. The company plans to complete study close and database lock, then conduct a comprehensive analysis to understand the UNITY outcome and generate insights for future Sjögren’s disease research. The IDMC’s recommendation effectively ends the program’s immediate path to a late-stage efficacy readout, shifting focus to data review and planning next steps.
“The IDMC concluded that the UNITY study is unable to meet its primary endpoint,” argenx said.
