argenx Provides Update on Phase 3 UNITY Study of Efgartigimod SC in Sjögren's Disease
An independent monitoring committee recommended stopping the study for futility after an interim analysis found it unlikely to meet its primary endpoint.
TL;DR
- argenx said it will discontinue the Phase 3 UNITY study of subcutaneous efgartigimod in adults with moderate-to-severe Sjögren's disease.
- The company said an independent monitoring committee recommended stopping for futility because the trial was unlikely to meet its primary endpoint.
- The company reported no new safety signals; a separate Phase 2 celiac-disease result was positive but does not reverse the UNITY outcome.
argenx said it will discontinue UNITY, a Phase 3 study testing subcutaneous efgartigimod in adults with moderate-to-severe Sjögren’s disease. BioPharma Dive and Investing.com also reported the halt and the company’s explanation. [1][2][3] [1] [2] [3]
The company said an independent data monitoring committee recommended stopping the trial for futility after an interim analysis. The committee concluded that the study was unlikely to meet its primary endpoint; the company did not present the interim efficacy dataset in the cited announcement. [1][2] [1] [2]
argenx said safety was consistent with the established profile of efgartigimod and that no new safety signals were identified. BioPharma Dive reported that a separate Phase 2 study of FB102 in celiac disease met its primary endpoint, a distinct program from UNITY. [1][2] [1] [2]
The decision removes this Phase 3 Sjögren’s study from the program, but the announcement does not establish why the interim result missed the endpoint or how it affects other efgartigimod indications. Further detail on the interim analysis and the company’s broader development plans remains limited. [1][2][3] [1] [2] [3]
Why it matters
The stop is a late-stage clinical setback for an attempted expansion of an existing autoimmune therapy; the separate celiac result belongs to another drug program and should not be conflated with it.
Editor's note
The futility determination is attributed to the independent monitoring committee and company release. No investment or treatment advice.