en.Wedoany.com Reported - Johnson & Johnson presented detailed results from the Phase 2 JASMINE study of the FcRn blocker nipocalimab in moderate to severe systemic lupus erythematosus (SLE) at the 2026 European Alliance of Associations for Rheumatology (EULAR) congress. The study showed that the drug met the primary endpoint of reducing disease activity at Week 24 and demonstrated sustained effective control of disease activity over 52 weeks, with higher response rates particularly in autoantibody-positive patients. It should be noted that nipocalimab has not yet been approved by the U.S. Food and Drug Administration (FDA) for systemic lupus erythematosus.
The JASMINE study is the first global trial to confirm the clinical efficacy of FcRn blockade in systemic lupus erythematosus. Nipocalimab is an investigational immunoselective therapeutic designed to reduce circulating levels of pathogenic immunoglobulin G (IgG) autoantibodies associated with inflammation by targeting and blocking the neonatal Fc receptor (FcRn), while preserving key immune functions. The study provides clinical, biomarker, and pharmacodynamic evidence supporting the continued advancement of nipocalimab as a potential treatment option for SLE.
Study results showed that at the primary endpoint of SLE Responder Index 4 (SRI-4), 53.5% of patients receiving nipocalimab 15 mg/kg plus background therapy achieved a response at Week 24, compared to 46.7% in the placebo plus background therapy group. In the prespecified autoantibody-positive patient population, the SRI-4 response rate at Week 52 in the nipocalimab group was 58.2%, significantly higher than the 36.1% in the placebo group; additionally, 38.9% of patients in this group achieved Lupus Low Disease Activity State (LLDAS), compared to 18.0% in the control group. Among key secondary endpoints at Week 52, 53.6% of patients treated with nipocalimab 15 mg/kg achieved an SRI-4 response, versus 39.7% in the placebo group.
Dr. Richard Furie, Chief of Rheumatology at Northwell Health, stated that the consistent improvements observed across established disease activity measures, along with the reduction in pathogenic IgG autoantibodies, are encouraging and support continued investigation of nipocalimab's potential to provide long-term disease control for a broad population of autoantibody-positive adult SLE patients. The safety profile of nipocalimab was consistent with previous studies, with the most common adverse events (incidence ≥10%) including nasopharyngitis, headache, urinary tract infection, and nausea.
The Phase 2 study, designated JASMINE (NCT04882878), is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study that enrolled 228 adult patients with active SLE. Patients were randomized to receive intravenous nipocalimab 5 mg/kg, 15 mg/kg, or placebo every two weeks through Week 52, with primary results presented for the 15 mg/kg group. The primary endpoint was the SRI-4 composite response at Week 24. Based on the positive study results, nipocalimab received Fast Track designation from the U.S. FDA for SLE earlier this year, and its Phase 3 GARDENIA study is currently enrolling patients.
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