Johnson & Johnson has announced positive 52-week results from its Phase 2 JASMINE study evaluating nipocalimab in adults with moderate-to-severe Systemic Lupus Erythematosus (SLE). The monoclonal antibody met the primary endpoint of reducing disease activity at 24 weeks, as measured by the SLE Responder Index 4 (SRI-4), and demonstrated sustained disease reduction through 52 weeks based on both SRI-4 and Lupus Low Disease Activity State (LLDAS) assessments.

The findings also showed stronger responses compared with placebo plus background medication among participants who tested positive for lupus-associated autoantibodies, a group representing approximately 80 percent of people living with SLE. The results will be presented in a late-breaking session at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London and are among 38 abstracts being presented by the company across its rheumatology portfolio.

Nipocalimab is the first neonatal Fc receptor (FcRn) blocker to be studied in systemic lupus erythematosus. The therapy is designed to reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with the disease while preserving immune function. The study demonstrated a significant reduction in disease activity beyond the 24-week primary endpoint, with benefits sustained through Week 52 in the nipocalimab 15 mg/kg treatment group.

The ongoing Phase 3 GARDENIA study is currently recruiting people living with systemic lupus erythematosus. The treatment works by selectively blocking the neonatal Fc receptor, reducing circulating pathogenic IgG autoantibodies and immune complexes linked to inflammation in SLE. By lowering circulating IgG levels, including disease-causing autoantibodies, nipocalimab is intended to target the underlying cause of the disease while maintaining essential immune functions.

JASMINE is the first clinical study to demonstrate the efficacy of FcRn blockade in SLE and provides clinical, biomarker and pharmacodynamic evidence supporting the continued development of nipocalimab as a potential treatment option.

Richard Furie, Chief of the Division of Rheumatology at Northwell, said the consistent improvements across established disease activity measures and reductions in pathogenic IgG autoantibodies support further investigation of nipocalimab as a targeted treatment for people living with systemic lupus erythematosus. He noted that the 52-week findings highlight the potential of the therapy to provide long-term disease control for autoantibody-positive adults with moderate-to-severe SLE.

The study met its primary endpoint at Week 24, with 53.5 percent of patients receiving nipocalimab 15 mg/kg plus background medication achieving an SRI-4 response compared with 46.7 percent of patients receiving placebo plus background medication.

Among a predefined population of autoantibody-positive patients, SRI-4 response rates at Week 52 were 58.2 percent in the nipocalimab group compared with 36.1 percent in the placebo group. Achievement of Lupus Low Disease Activity State was also higher, at 38.9 percent versus 18.0 percent.

At Week 52, a key secondary endpoint showed that 53.6 percent of patients treated with nipocalimab 15 mg/kg achieved an SRI-4 response compared with 39.7 percent of those receiving placebo plus background medication. Additionally, 37.5 percent of patients receiving nipocalimab achieved Lupus Low Disease Activity State compared with 20.5 percent in the placebo group.

The safety profile of nipocalimab remained consistent with previous studies, and no new safety signals were identified. The most common adverse reactions reported in patients with SLE receiving the treatment were nasopharyngitis, headache, urinary tract infection and nausea.

Leonard L. Dragone, Disease Area Leader for Autoantibody and Rheumatology at Johnson & Johnson, said the JASMINE results provide important insights into the potential of nipocalimab for adults with moderate-to-severe systemic lupus erythematosus. He added that the responses observed in autoantibody-positive participants support the therapy’s potential as a targeted and immunoselective treatment designed to address the underlying drivers of the disease.

Earlier this year, nipocalimab received Fast Track Designation for SLE from the US Food and Drug Administration (FDA), while the Phase 3 GARDENIA study continues patient recruitment.