Johnson & Johnson’s nipocalimab reduced disease activity in lupus patients in the Phase 2 JASMINE trial, with sustained benefits through one year and stronger responses in autoantibody‑positive patients, supporting ongoing Phase 3 development.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
Johnson & Johnson reported positive Phase 2 results for nipocalimab in adults with moderate-to-severe systemic lupus erythematosus (SLE), with the investigational FcRn blocker meeting its primary endpoint and demonstrating sustained disease control through 52 weeks. The study also showed stronger responses in patients with lupus-associated autoantibodies, supporting ongoing Phase 3 development.
The findings, presented in a late-breaking session at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress, provide the first proof-of-concept evidence that neonatal Fc receptor (FcRn) blockade can reduce disease activity in SLE.
Targeting a Key Driver of Lupus
SLE is a chronic autoimmune disease in which immunoglobulin G (IgG) autoantibodies attack healthy tissues, causing inflammation and damage in organs including the skin, joints, kidneys, heart, lungs, and brain. Despite available therapies, many patients continue to experience disease activity, flares, and progressive organ damage.
Nipocalimab selectively blocks FcRn, reducing circulating IgG autoantibodies and immune complexes that contribute to lupus pathology. By lowering pathogenic antibodies while preserving important immune functions, the therapy targets a fundamental driver of disease.
JASMINE Trial Results
JASMINE (NCT04882878) enrolled 228 adults aged 18 to 65 years with active moderate-to-severe SLE who had not responded adequately to at least one standard treatment. Participants received intravenous nipocalimab at 5 mg/kg or 15 mg/kg, or placebo, every two weeks alongside background therapy.
The study met its primary endpoint at Week 24. Among patients receiving nipocalimab 15 mg/kg, 53.5% achieved an SLE Responder Index-4 (SRI-4) response compared with 46.7% of patients receiving placebo.
Benefits were more pronounced in the predefined autoantibody-positive subgroup, which represents approximately 80% of patients with SLE. At Week 52, 58.2% of autoantibody-positive patients treated with nipocalimab achieved an SRI-4 response versus 36.1% with placebo. Lupus Low Disease Activity State (LLDAS) was achieved by 38.9% of treated patients compared with 18.0% of placebo recipients.
Across the overall study population, 53.6% of patients receiving nipocalimab achieved an SRI-4 response at Week 52 compared with 39.7% receiving placebo. LLDAS was achieved by 37.5% and 20.5% of patients, respectively.
The safety profile was consistent with previous nipocalimab studies, with no new safety signals identified. The most common adverse events were nasopharyngitis, headache, urinary tract infection, and nausea.
Advancing Toward Phase 3
Richard Furie, M.D., Chief of the Division of Rheumatology at Northwell Health and a JASMINE investigator, said the sustained improvements across disease activity measures and reductions in pathogenic IgG autoantibodies support further investigation of nipocalimab in SLE.
Johnson & Johnson highlighted the particularly strong responses observed in autoantibody-positive patients, reinforcing the therapeutic rationale for FcRn blockade in lupus.
Nipocalimab received FDA Fast Track designation for SLE in January 2026. The ongoing Phase 3 GARDENIA study is currently enrolling patients and will determine whether the efficacy and safety findings from JASMINE can support future regulatory submissions and establish a new targeted treatment option for adults with moderate-to-severe SLE.
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About the Writer
Sana Jamil Khan (LinkedIn) is a B. Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.