Phase 2b JASMINE trial of nipocalimab demonstrates positive results for treatment of systemic lupus erythematosus

Johnson & Johnson announced positive topline results from its Phase 2 randomized placebo-controlled JASMINE study. The drug therapy, nipocalimab, met its primary endpoint and multiple key secondary and exploratory endpoints in adults with systemic lupus erythematosus (SLE). Nipocalimab is an Fc receptor (FcRn) blocker and the results mark the first positive clinical data for an investigational neonatal FcRn blocker in active SLE. The therapy was generally well tolerated, with a safety profile consistent with prior monoclonal antibody studies and no new safety signals were identified, including steroid sparing potential.

At 24 weeks, trial participants demonstrated a significant improvement in SLE Responder Index (SRI-4) response compared to placebo. The randomized, double-blind, placebo-controlled study enrolled 228 adults with active SLE in a 52-week, multicenter, dose-ranging design.

Full results from the JASMINE study will be presented at a future medical congress. Based on these positive topline results, Johnson & Johnson plans to initiate a Phase 3 program for nipocalimab in SLE. Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about treatments being studied for lupus.

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