Johnson & Johnson (NYSE:JNJ) announced on Tuesday, January 6, 2026, that its Phase 2b JASMINE study of nipocalimab in adults with moderate-to-severe systemic lupus erythematosus (SLE) met its primary and key secondary endpoints.
This represents a major breakthrough, as nipocalimab is now the first investigational FcRn (neonatal Fc receptor) blocker to demonstrate clinical efficacy in this complex autoimmune disease.
The study (n=228) achieved its primary goal: a statistically significant percentage of patients achieved an SRI-4 response at Week 24 compared to placebo.
Beyond disease activity reduction, the trial yielded a high-value signal for steroid sparing—a critical need for lupus patients who often suffer from the long-term toxic effects of chronic corticosteroid use.
Meanwhile, safety remained consistent with previous nipocalimab trials, which have spanned rare diseases like myasthenia gravis and Sjögren’s disease.
Nipocalimab works by blocking the neonatal Fc receptor (FcRn), which is responsible for "recycling" IgG antibodies and keeping them in the bloodstream.
By inhibiting this process, nipocalimab accelerates the clearance of the pathogenic autoantibodies that drive lupus, essentially "washing" them out of the patient's system while leaving other parts of the immune system intact.
Based on these results, J&J confirmed it will initiate a Phase 3 program for SLE later this year.