argenx will discontinue the Phase 3 UNITY study of efgartigimod in Sjögren’s disease after an interim futility review found the trial unlikely to meet its primary endpoint.
Written By: Anamika Koshti, PharmD
Reviewed By: Pharmacally Editorial Team
argenx SE announced on October 8, 2026, that it will discontinue the Phase 3 UNITY study (NCT06684847) evaluating subcutaneous efgartigimod in adults with moderate-to-severe Sjögren’s disease. The decision followed a recommendation from an Independent Data Monitoring Committee (IDMC) after an interim analysis found that the study was unable to meet its primary endpoint. According to argenx, safety remained consistent with the known profile of efgartigimod, with no new safety signals identified.
What the Interim Analysis Revealed, and What Remains Unknown
argenx has not disclosed the interim efficacy values, the number of patients included in the analysis, or the statistical basis for the futility recommendation. The company also did not specify when the interim analysis was conducted.
UNITY began on January 15, 2025. Its registry record, last verified in April 2026, listed July 2027 as the estimated primary completion date. The discontinuation therefore comes well before the study’s planned primary completion.
Luc Truyen, MD, PhD, Chief Medical Officer at argenx, said the company was disappointed, particularly for patients seeking treatments that could change the course of Sjögren’s disease. He described the condition as one of the most heterogeneous and complicated diseases in immunology. Following study closure and database lock, argenx plans to conduct a full analysis of the data and share what it learns with the Sjögren’s community.
How UNITY Was Designed to Test FcRn Blockade
UNITY was a randomized, double-blind, placebo-controlled, multicenter Phase 3 study with an open-label extension. It enrolled adults with primary Sjögren’s disease who met the 2016 ACR/EULAR classification criteria, were positive for anti-Ro/SSA autoantibodies, and had active systemic disease defined by a clinical EULAR Sjögren’s Syndrome Disease Activity Index (clinESSDAI) score of at least 6 while receiving stable standard of care.
The primary endpoint was the change from baseline in clinESSDAI at Week 48. Key secondary measures included the proportion of patients achieving low disease activity, defined by a clinESSDAI score below 5; response according to the Sjögren’s Tool for Assessing Response (STAR); patient-reported symptoms assessed using the Diary of Sjögren’s Symptoms Assessment (DiSSA); and safety and tolerability.
Efgartigimod is an antagonist of the neonatal Fc receptor (FcRn) that reduces circulating IgG, including pathogenic IgG autoantibodies. The UNITY program was designed to test whether this approach could reduce systemic disease activity in patients with active, anti-Ro/SSA-positive Sjögren’s disease.
A Second Efgartigimod SC Program Stopped for Futility
UNITY follows the discontinuation of argenx’s UplighTED studies in thyroid eye disease in December 2025. The Phase 3 studies, NCT06307626 and NCT06307613, were also discontinued following a prespecified interim analysis and an IDMC recommendation, with no change reported in the known safety profile.
The UNITY decision does not change the existing approved indications for VYVGART Hytrulo, which remains approved for generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
Other Sjögren’s Programs Continue to Advance
The UNITY discontinuation comes as other targeted therapies for Sjögren’s disease continue to advance. Novartis is developing ianalumab, Amgen is evaluating dazodalibep, and Johnson & Johnson is advancing nipocalimab, another FcRn blocker. Other programs, including therapies targeting TYK2 and additional immune pathways, are also being studied in the disease.
The continued development of these programs provides important context for the UNITY outcome, but the available information does not support drawing conclusions about the broader treatment landscape from the argenx result alone. In particular, the outcome of UNITY should not be interpreted as evidence that FcRn blockade as a class is ineffective in Sjögren’s disease, as nipocalimab has reported positive Phase 2 data in the condition.
Because argenx has not released the UNITY efficacy data, the futility decision cannot yet establish whether the outcome was driven by the molecule, trial design, patient population, or underlying disease biology.
Reference
argenx Provides Update on Phase 3 UNITY Study of Efgartigimod SC in Sjögren’s Disease, argenx, 08 October 2026
A Study of the Efficacy and Safety of Efgartigimod in Patients with Primary Sjögren’s Syndrome (Unity), ClinicalTrials.gov ID NCT06684847
About the Writer
Anamika Koshti (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, and evidence-based medicine. She has authored peer-reviewed publications on Alzheimer’s disease and PCOS, presented research at national conferences, and gained hands-on experience in medical content development and clinical data interpretation. She is committed to translating complex medical research into accurate, accessible content for healthcare professionals and patients.