Johnson & Johnson has announced that nipocalimab met the primary endpoint of the Phase 2 JASMINE study, demonstrating significant reduction of systemic lupus erythematosus disease activity at 24 weeks and sustained results through 52 weeks in adults with moderate-to-severe SLE. The findings were presented as a late-breaking result at the European Alliance of Associations for Rheumatology 2026 Congress in London, marking the first clinical demonstration of efficacy for FcRn blockade in SLE.
Nipocalimab is designed to selectively block the neonatal Fc receptor, reducing levels of circulating pathogenic immunoglobulin G autoantibodies and immune complexes associated with inflammation in SLE, while preserving critical immune functions. The study met its primary endpoint at Week 24, with 53.5% of patients receiving nipocalimab 15 mg/kg achieving an SRI-4 response compared with 46.7% for placebo plus background medication. At Week 52, 53.6% of nipocalimab-treated patients achieved an SRI-4 response versus 39.7% for placebo, and more patients also achieved Lupus Low Disease Activity State — 37.5% versus 20.5%. Results were particularly pronounced in autoantibody-positive patients, who represent approximately 80% of people living with SLE, with SRI-4 response rates of 58.2% versus 36.1% and LLDAS achievement of 38.9% versus 18.0% compared to placebo at Week 52.
Nipocalimab had a safety profile consistent with previous studies, with the most common adverse reactions including nasopharyngitis, headache, urinary tract infection, and nausea. The drug received FDA Fast Track Designation in SLE earlier in 2026, and the ongoing Phase 3 GARDENIA study is currently recruiting. The JASMINE study enrolled 228 adult participants across a multicenter, randomized, double-blind, placebo-controlled design, with participants randomized to receive nipocalimab at 5 or 15 mg/kg or placebo every two weeks through Week 52 in addition to background medications.
KEY QUOTES:
“The consistent improvements observed across established disease activity measures and reductions in pathogenic immunoglobulin G autoantibodies are encouraging and support the continued investigation of nipocalimab as a targeted treatment approach for people living with systemic lupus erythematosus. These 52-week findings support the potential of nipocalimab to provide disease control over time for a broad population of autoantibody-positive adult patients living with moderate-to-severe systemic lupus erythematosus, a disease in which many patients experience ongoing disease activity and risk of irreversible organ damage.”
Richard Furie, M.D., Chief of the Division of Rheumatology, Northwell
“We are especially encouraged by the responses observed in autoantibody-positive study participants. These findings support the potential of nipocalimab as a targeted, immunoselective treatment designed to address underlying drivers of systemic lupus erythematosus.”
Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson
