Argenx Stops Phase 3 Vyvgart Trial in Sjögren’s Disease After Monitors Find the Study Cannot Meet Its Goal

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An independent data monitoring committee reviewed an interim analysis of the UNITY trial and recommended stopping it for futility, according to an argenx statement. The company said safety was consistent with the drug’s established profile and that no new safety signals were identified.

For people living with Sjögren’s, the news means one potential new option will not arrive soon. It does not affect patients who take the drug for its approved uses, and it does not raise new safety concerns.

A futility finding means the data reviewed so far showed the study had little realistic chance of proving its main benefit, even if it ran to completion. Independent committees perform these checks so patients are not kept on an experimental treatment unlikely to help.

UNITY tested the under-the-skin version of efgartigimod, sold as Vyvgart Hytrulo, given weekly against a placebo. Its main measure was the change in systemic disease activity on a clinical scale called clinESSDAI after 48 weeks. That scale scores how the disease affects organs and body systems such as joints, lungs, glands, nerves, and blood.

Patients had to have moderate to severe primary Sjögren’s disease, test positive for anti-Ro (SSA) autoantibodies, and stay on stable standard care, according to the trial’s ClinicalTrials.gov listing and company descriptions. Secondary goals included the share of patients reaching low disease activity, a composite responder measure, and patient-reported symptoms.

The interim analysis included more than 500 of the 630 patients enrolled, analysts at William Blair told Fierce Pharma. The analysts suggested the check may have occurred at 24 weeks rather than the 48-week endpoint, though Argenx has not confirmed the timing. Full results had not been expected until the second half of 2027.

The Phase 3 trial followed a small Phase 2 study called RHO that looked promising. In that study of 31 adults, 45.5% of patients given efgartigimod improved on at least three of five measures in a composite score at 24 weeks, compared with 11.1% on placebo, Sjögren’s Syndrome News reported after the results were presented in 2025.

Small early studies can overstate a drug’s effect, especially in diseases where symptoms vary widely. William Blair analysts noted that Sjögren’s drug development has been slowed by high placebo response rates, which make it harder for any drug to show a clear difference.

“We are disappointed by this outcome, most of all for people living with Sjögren’s disease,” said Dr. Luc Truyen, Argenx’s chief medical officer. In the company’s statement, he called Sjögren’s one of the most varied and complicated diseases in immunology and said Argenx will analyze the data and share what it learns with the Sjögren’s community.

Efgartigimod blocks the neonatal Fc receptor, a protein that helps antibodies survive in the bloodstream. Lowering antibody levels is meant to reduce the immune attack in autoimmune diseases. Vyvgart Hytrulo remains approved in the United States for generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy (CIDP). In August, the drug met its main goal in a separate Phase 2/3 trial in autoimmune myositis, and Argenx plans to take those data to regulators.

Sjögren’s is a long-term autoimmune disease in which the immune system attacks the glands that make moisture in the eyes and mouth. Most patients are women, and it is most common in people in their 40s and 50s, according to MedlinePlus. Symptoms include dry eyes, dry mouth, joint and muscle pain, fatigue, and numbness or tingling.

The disease can also affect the joints, lungs, kidneys, and nerves. Diagnosis is often delayed because early symptoms are easy to mistake for aging, allergies, or medication side effects. Treatment today focuses on managing symptoms with artificial tears, saliva substitutes, medicines that increase saliva, anti-inflammatory drugs and, in severe cases, immune-suppressing medicines.

Other companies are still pursuing Sjögren’s drugs. Novartis has filed its candidate ianalumab with the FDA, which is reviewing it under priority review after granting it Breakthrough Therapy designation. Amgen reported in September that its candidate dazodalibep met the main goal of a Phase 3 trial. None of these experimental drugs is approved, and approval is not guaranteed.

People enrolled in UNITY should hear from their study site about the closeout process, including any final visits and how their care will continue. Argenx has not publicly detailed what will happen to patients in the open-label extension, so participants should ask their site investigator directly.

Patients taking Vyvgart or Vyvgart Hytrulo for myasthenia gravis or CIDP do not need to change their treatment because of this news. Anyone with concerns should talk with their neurologist rather than stopping a prescribed medicine.

People with Sjögren’s can ask a rheumatologist about current treatments and other clinical trials. Regular dental and eye care matters because chronic dryness raises the risk of cavities and eye surface damage. New shortness of breath, a persistent cough, swollen glands that do not go away, or new numbness should be checked promptly.

The next step is Argenx’s full analysis after the study closes and the database is locked. MedicalDaily will report the detailed findings once they are released.

An independent data monitoring committee reviewed interim data and concluded the trial could not meet its primary endpoint, so it recommended stopping for futility.

No. Argenx said safety was consistent with the drug’s known profile and no new safety signals were identified.

Its main goal was the change in systemic disease activity on the clinESSDAI scale after 48 weeks of weekly treatment compared with placebo.

Does this affect people taking Vyvgart for myasthenia gravis?

No. The drug remains approved for generalized myasthenia gravis and CIDP. Patients should not stop treatment without talking to their doctor.

It is a chronic autoimmune disease that attacks moisture-producing glands, causing dry eyes and mouth, fatigue, and joint pain. It can also affect internal organs.

Are there other Sjögren’s treatments in development?

Yes. Novartis has filed ianalumab with the FDA, and Amgen reported positive Phase 3 results for dazodalibep. Neither is approved yet.

Argenx will analyze the full data after study closeout and database lock and says it will share what it learns with the Sjögren’s community.