SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) said its experimental immune therapy nipocalimab cleared a major clinical hurdle in systemic lupus erythematosus, delivering the first positive Phase 2b results ever reported for an FcRn blocker in the chronic autoimmune disease and setting up a pivotal Phase 3 development program.
The company reported that the 228-patient JASMINE study met its primary endpoint, with a statistically significant share of treated patients achieving a clinical response at 24 weeks compared with placebo. The trial also hit key secondary and exploratory goals, including measures that suggest nipocalimab could reduce the need for long-term steroid use, a long-standing problem in lupus care.
For patients with SLE, that matters. Steroids remain a cornerstone of treatment, but years of use can cause serious side effects ranging from osteoporosis and diabetes to infections and cardiovascular disease. A therapy that controls disease activity while allowing doctors to taper steroids would mark a meaningful shift in how lupus is managed.
“These data represent the first positive results of an investigational FcRn blocker treatment in this chronic, debilitating autoantibody-driven disease,” the company said, noting that SLE affects an estimated 3 million to 5 million people worldwide, including about 450,000 in the United States.
Nipocalimab works by blocking the neonatal Fc receptor, or FcRn, a protein that helps circulate harmful autoantibodies in the bloodstream. By reducing those antibodies, the drug is designed to dial down the immune attack that drives lupus without broadly suppressing immune function.
The JASMINE trial, which runs 52 weeks, is a randomized, double-blind, placebo-controlled, dose-ranging study across multiple centers. Johnson & Johnson said the drug’s safety and tolerability were consistent with earlier Phase 2 results, with no new safety signals detected.
“Systemic lupus erythematosus is a serious autoantibody-driven disease that can impact multiple organ systems, significantly reducing health-related quality of life for millions of people,” said Leonard Dragone, disease area leader for autoantibody and rheumatology at Johnson & Johnson Innovative Medicine. He said the results highlight the need for more targeted therapies that can control disease while avoiding the long-term toxicity of steroids.
The company plans to launch a Phase 3 program based on the JASMINE data, moving nipocalimab closer to what could become one of the most significant new treatment options for lupus in years. Full study results are expected to be presented at a future medical meeting, where investors and clinicians will be watching closely to see whether the early promise holds up under deeper scrutiny.
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