Amgen’s Phase III Sjögren’s disease trial has met its primary endpoint, marking the latest sign that the indication could be set for its first-ever drug approvals.
In the double-blind, randomised, placebo-controlled Phase III OASIZ 301 study (NCT06104124), patients treated with dazodalibep had a statistically significant and clinically meaningful reduction in systemic disease activity as per the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) after 48 weeks, with improvements observed as early as week four.
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ESSDAI is a validated clinical tool used to assess systemic disease activity across organ systems in patients with Sjögren’s disease.
The most common adverse events (AEs) were nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions, and were generally mild to moderate in nature.
“Sjögren’s disease is a complex and heterogeneous autoimmune disease, and no two people experience it in exactly the same way. It can be relentless, creating a real burden for people living with the disease and affecting their quality of life,” said Janet Church, president and CEO of the Sjögren’s Foundation.
The company plans to present detailed data from the OASIZ 301 study at an upcoming medical meeting.
The drug is also being investigated in the Phase III OASIZ 303 study (NCT06245408), a second Sjögren’s disease trial. This is expected to be completed in Q4 2026 and will help the company build its data package to file for regulatory approval, if successful.
Dazodalibep is a potential first-in-class CD40L antagonist fusion protein that is designed to target immune activation by disrupting interactions between T cells, B cells and other antigen-presenting cells. Amgen acquired the drug as part of its $27.8bn buyout of Horizon Therapeutics in 2023.
Sjögren’s disease is a systemic autoimmune disease that affects the entire body. Along with symptoms of extensive dryness, other serious manifestations may include profound fatigue, chronic pain, major organ involvement, neuropathy, and an increased risk of lymphoma. There are currently no FDA-approved medicines for Sjögren’s disease.
While Amgen’s Phase III data have put it in a good position for approval, it is not the only candidate that is showing promise in Sjögren’s disease. Novartis’ BLyS/BAFF-targeting ianalumab was granted breakthrough designation by the US Food and Drug Administration (FDA) in January 2026, with applications submitted for approval based on two successful Phase III trials. Other candidates showing promise include RemeGen’s telitacicept and Johnson & Johnson’s Imaavy (nipocalimab).
