Phase II JASMINE-SLE trial of nipocalimab in SLE

Results from the phase II JASMINE-SLE (NCT04882878) trial, evaluating nipocalimab, an IgG1 FcRN blocker, in adults with active systemic lupus erythematosus (SLE), were presented by Richard A. Furie at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, June 3–6, 2026, London, UK. Patients received either nipocalimab 5 mg/kg intravenously (IV) every 2 weeks (Q2W; n = 77), nipocalimab 15 mg/kg IV Q2W (n = 76), or placebo IV Q2W (n = 75). The primary endpoint was the percentage of patients achieving SLE Responder Index 4 (SRI-4) composite response at Week 24.

Key data: At Week 24, the primary endpoint of SRI-4 composite response was achieved by 53.5% of patients receiving nipocalimab 15 mg/kg vs 46.7% of patients receiving placebo (p = 0.081); the primary endpoint was not met in the nipocalimab 5 mg/kg group. At 52 weeks, the SRI-4 composite response rates were 53.6%, 51.7%, and 39.7% in the 15 mg/kg, 5 mg/kg, and placebo groups, respectively (p = 0.020). Adverse events (AEs) of any grade were reported in 82.9%, 89.6%, and 76.0% of patients, respectively, with serious AEs (SAEs) in 13.2%, 7.8%, and 8.0% of patients.

Key learning: Nipocalimab 15 mg/kg IV Q2W achieved significant improvements in SRI-4 composite response at Week 24, with continuing efficacy through 52 weeks, and was well-tolerated in patients with active SLE. These findings provide proof of concept for FcRn blockade with nipocalimab in SLE and support further investigation in the ongoing phase III GARDENIA (NCT07438496) trial.