Argenx will discontinue its Phase 3 UNITY trial of subcutaneous efgartigimod in adults with moderate-to-severe Sjögren’s disease after an interim analysis showed the study could not meet its primary endpoint.
An independent data monitoring committee recommended stopping the trial for futility. The company said safety findings remained consistent with efgartigimod’s established profile, with no new safety signals identified.
UNITY was a randomized, double-blind, placebo-controlled, multicenter study with an open-label extension. Participants received weekly subcutaneous efgartigimod or placebo in equal proportions while continuing stable background standard-of-care treatment.
The primary endpoint measured change from baseline in systemic disease activity at week 48 using the clinical EULAR Sjögren’s Syndrome Disease Activity Index, known as clinESSDAI. Secondary endpoints included achievement of low disease activity, response on the Sjögren’s Tool for Assessing Response, patient-reported symptoms, and safety and tolerability.
Eligible participants had to meet established classification criteria for primary Sjögren’s disease, test positive for anti-Ro/SSA autoantibodies and have moderate-to-severe systemic disease activity, defined as a clinESSDAI score of at least six.
After closing the study and locking its database, argenx plans to conduct a comprehensive analysis to understand the outcome. Chief Medical Officer Luc Truyen said the company would share its findings with the Sjögren’s community.
Sjögren’s is a chronic systemic autoimmune disease involving immune-mediated destruction of glands. Common symptoms include dry eyes and mouth, fatigue and joint pain.
Efgartigimod reduces circulating IgG autoantibodies by binding to the neonatal Fc receptor. Its subcutaneous formulation combines the antibody fragment with hyaluronidase to facilitate delivery beneath the skin.
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