Johnson & Johnson: nipocalimab lowers SLE disease activity in Phase 2 JASMINE study
- Primary endpoint met at Week 24: SRI‑4 response 53.5% with nipocalimab 15 mg/kg versus 46.7% with placebo plus background medication.
- In autoantibody‑positive patients at Week 52, SRI‑4 rates were 58.2% vs 36.1% and LLDAS was 38.9% vs 18.0% versus placebo.
- Overall Week 52 results: SRI‑4 53.6% with nipocalimab vs 39.7% with placebo; LLDAS achieved by 37.5% vs 20.5%.
- Safety consistent with prior studies; no new signals identified and most common adverse reactions (≥10%) were nasopharyngitis, headache, urinary tract infection and nausea.
Key results
The Phase 2 JASMINE study met its primary endpoint at Week 24: 53.5% of patients receiving nipocalimab 15 mg/kg plus protocol‑permitted background medication achieved an SRI‑4 response versus 46.7% for placebo plus background medication. At Week 52, 53.6% of nipocalimab patients achieved SRI‑4 versus 39.7% for placebo. In a predefined autoantibody‑positive subgroup, responses were larger: SRI‑4 58.2% vs 36.1% and LLDAS 38.9% vs 18.0% at Week 52. Overall LLDAS at Week 52 was 37.5% for nipocalimab versus 20.5% for placebo.
Mechanism and significance
Nipocalimab is an FcRn blocker designed to reduce circulating IgG autoantibodies and immune complexes implicated in SLE. JASMINE is reported as the first clinical study to demonstrate proof‑of‑concept efficacy for FcRn blockade in SLE and includes pharmacodynamic and biomarker evidence supporting further evaluation.
Safety and next steps
No new safety signals were identified; the most common adverse reactions (≥10%) were nasopharyngitis, headache, urinary tract infection and nausea. Nipocalimab received FDA Fast Track designation for SLE earlier this year, the Phase 3 GARDENIA study is currently recruiting, and these Phase 2 findings were presented as a late‑breaking abstract at EULAR 2026.
Source: J&J