Argenx has stopped a Phase 3 study testing its marketed therapy Vyvgart Hytrulo in Sjögren’s disease after an interim analysis indicated that the trial was unlikely to achieve its primary endpoint.
The Dutch biotechnology company decided to discontinue the UNITY study following a recommendation from its independent data monitoring team. The committee reviewed interim results and concluded that continuing the trial was unlikely to change its chances of meeting the study’s main objective.
UNITY was investigating Vyvgart Hytrulo, the subcutaneous version of the original FcRn antagonist Vyvgart, in adults suffering from moderate-to-severe Sjögren’s disease. Although the efficacy outlook led to the early termination, Argenx reported that investigators identified no new safety concerns associated with the treatment during the study.
The disappointing Phase 3 result differs from findings from the open-label Phase 2 RHO+ study, where patients receiving Vyvgart maintained low disease activity through to the 72nd week.
Vyvgart Hytrulo is an FcRn-targeting therapy that has already received U.S. approval for neurological conditions including generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. Argenx continues to investigate Vyvgart and Vyvgart Hytrulo across several additional diseases, including systemic sclerosis in rheumatology, Graves’ disease in endocrinology and immune thrombocytopenia in hematology.
Following the UNITY setback, Argenx plans to conduct a detailed assessment of the study data to determine what may have contributed to the result and identify information that could guide future Sjögren’s research. Argenx Chief Medical Officer Luc Truyen described Sjögren’s disease as an especially heterogeneous and complex condition within immunology, highlighting the challenges involved in developing treatments for the disease.
At presenr, there are no disease-modifying therapies specifically approved for Sjögren’s disease, which researchers estimate affects approximately 300 million people worldwide. Some biologic treatments are nevertheless used off-label in patients with substantial disease activity or organ involvement. These include rituximab, marketed by Biogen and Roche as Rituxan, and GSK’s Benlysta (belimumab), although neither therapy carries a specific indication for Sjögren’s syndrome.
The treatment landscape could soon become more competitive, however, with several potential therapies now progressing through late-stage development.
Novartis’ ianalumab has produced positive results in two Phase 3 studies within the NEPTUNUS program, positioning the company to consider U.S. regulatory filings for Sjögren’s disease.
Amgen is also advancing its candidate dazodalibep through Phase 3 development, with the OASIZ 301 study recently reporting positive results.
In China, RemeGen and Vor Bio have reported encouraging late-stage findings for telitacicept in study NCT05673993. The treatment’s prospects beyond China will depend in part on results from an ongoing Phase 3 trial being conducted in the U.S.
For Argenx, the failure of UNITY removes one potential route for expanding Vyvgart Hytrulo into Sjögren’s disease, but the company’s broader clinical program continues to test the therapy across multiple immune-mediated conditions.
However, all is not doom and gloom For Argenx – the firm’s anti-CD122 antibody FB102 tasted victory in a mid-stage celiac disease study. Argenx got the molecule through it’s $2.2B acquisition of Forte Biosciences.
Argenx has discontinued its Phase III UNITY clinical trial evaluating efgartigimod subcutaneous, marketed as Vyvgart Hytrulo, in adults with moderate-to-severe Sjögren’s disease. The decision followed an interim analysis and a recommendation from the study’s independent data monitoring committee, which concluded that the trial was unlikely to meet its primary endpoint. The company announced the decision on October 8, 2026.
The setback represents a disappointment for Argenx and for patients seeking new treatment options for this chronic autoimmune condition. Although earlier research had encouraged further investigation, the Phase III findings indicate that the treatment’s expected benefit was not sufficient to justify continuing the study as planned.
Importantly, the company reported that the treatment’s safety profile remained consistent with previous experience, with no new safety signals identified. Argenx plans to analyze the trial data to better understand the outcome and identify lessons for future research.
Why Argenx Stopped the Phase III Study
The central reason for the discontinuation was predicted efficacy failure, commonly described in clinical research as futility. This means that an interim analysis suggests a trial is unlikely to demonstrate the required treatment benefit if it continues as planned.
In this case, the monitoring committee concluded that UNITY was unlikely to meet its primary endpoint. The publicly announced decision did not establish that efgartigimod caused harm or that every potential effect of the medicine was absent.
