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Phase 2 JASMINE Study Shows Nipocalimab Reduces Disease Activity in Adults with Systemic Lupus Erythematosus

Pharmaceutical company Johnson & Johnson announced new late-breaking results from its Phase 2 JASMINE study showing that investigational therapy nipocalimab significantly reduced disease activity in adults living with moderate-to-severe systemic lupus erythematosus (SLE). These findings were presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress and build on previously reported positive topline results from the study.
Nipocalimab is designed to selectively block the neonatal Fc receptor (FcRn), reducing levels of circulating pathogenic immunoglobulin (IgG) autoantibodies and immune complexes associated with inflammation in SLE. The Phase 2 JASMINE study evaluated 228 adults with active SLE with IV nipocalimab over 52 weeks. Participants receiving the therapy experienced significant improvements in disease activity compared with placebo and met key secondary and exploratory endpoints. Treatment with nipocalimab 15 mg/kg showed better results than placebo on the SRI-4 measure at both week 24 (53.5% vs 46.7%) and week 52 (53.6% vs 39.7%). At week 52, more participants on 15 mg/kg reached low disease activity (LLDAS: 37.5% vs 20.5%), meeting treat-to-target goals that include prednisone doses ≤7.5 mg/day. Among autoantibody-positive participants, differences were even greater (SRI-4: 58.2% vs 36.1%; LLDAS: 38.9% vs 18.0%), and no new safety issues were observed.
The Lupus Foundation of America previously reported on the development of nipocalimab, including the positive Phase 2b JASMINE topline results announced in January 2026, and the U.S. Food and Drug Adminstration's Fast Track Designation for the therapy in March. 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.

