Amgen's Sjögren's Drug Met Its Main Trial Goal. How Well, the Company Has Not Said.

Amgen said on Sept. 22, 2026, that a Phase 3 trial of its experimental drug dazodalibep met its main goal in adults with Sjögren's disease, and did not say by how much.

Sjögren's disease is an autoimmune condition that reaches well past the dryness it is known for. Amgen describes profound fatigue, chronic pain, major organ involvement and a raised risk of lymphoma among its effects, calls it the second most common autoimmune rheumatic disease, and states that no medicine is approved for it.

The trial, OASIZ 301, randomized about 621 adults with moderate-to-severe systemic disease to dazodalibep or a placebo, with neither the patients nor their doctors told which they received. Its primary endpoint was the change in ESSDAI, a standard score of disease activity across organ systems, from the start of treatment to week 48. Amgen says that endpoint was met, describes the improvement as statistically significant and clinically meaningful, and says it appeared as early as week 4 and held to the end of the trial.

No effect size has been released. Amgen's release gives no figure for how far ESSDAI scores moved, and says the company plans to present detailed data at an upcoming medical meeting. A met endpoint is not an approval, and the release states that dazodalibep is not approved by the U.S. Food and Drug Administration. Amgen calls the drug a potential first-in-class blocker of CD40L, a signal immune cells use to activate one another.

On safety, Amgen reports that the side effects seen more often with the drug than with placebo were nose and throat infections, urinary tract infections, high blood pressure and reactions to the infusion, and that these were generally mild to moderate. It says dropouts because of side effects were low and evenly spread between the two groups.

A second trial in the program, OASIZ 303, tests dazodalibep in patients who have heavy symptoms but low systemic disease activity. Amgen expects it to finish in the fourth quarter of 2026.