Johnson & Johnson (JNJ) reported that its investigational candidate, Nipocalimab, met the primary endpoint of reducing disease activity at 24 weeks in adults with moderate-to-severe systemic lupus erythematosus in the Phase 2 study dubbed JASMINE.
Systemic Lupus Erythematosus, or SLE, is a chronic autoimmune disease that occurs when the body's immune system attacks its own healthy tissues, leading to inflammation and damage in many parts of the body.
Nipocalimab
Nipocalimab is an investigational therapy designed to selectively block the neonatal Fc receptor (FcRn), which reduces circulating pathogenic IgG autoantibodies and immune complexes that drive inflammation in SLE.
Notably, the FDA has granted Fast Track Designation to Nipocalimab for SLE, and the firm estimates that 0.45 million people in the United States are affected by SLE. Trial Details
JASMINE is a Phase 2, multicenter, randomised, double-blind, placebo-controlled, parallel-group, dose-ranging study to evaluate Nipocalimab in 228 adult participants with active systemic lupus erythematosus.
Participants were randomised 1:1:1 to receive intravenous Nipocalimab at 5 or 15 mg/kg, or placebo every 2 weeks through week 52, in addition to protocol-permitted background medications.
The primary endpoint was the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) composite response at Week 24. In addition, pharmacodynamic effects and safety, including adverse events, were assessed through week 58.
Key Findings
- The study met its primary endpoint at week 24, and in patients receiving Nipocalimab 15 mg/kg plus background medication, 53.5% achieved an SRI-4b response, compared with 46.7% in the placebo plus background medication group.
- In a predefined autoantibody-positive patient population, SRI-4 response rates were 58.2% with SRI-4 versus 36.1% with placebo plus background medication at Week 52. - Similarly, 38.9% achieved Lupus Low Disease Activity State (LLDAS), compared with 18% on placebo plus background medication.
- In addition, at Week 52, as a key secondary endpoint, 53.6% of patients receiving Nipocalimab 15 mg/kg achieved an SRI-4b response, compared with 39.7% in the placebo plus background medication group.
- According to the firm, Nipocalimab had a safety profile consistent with previous studies, and no new safety signals were identified.
These findings will be presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London.
JNJ has traded between $149.04 and $251.71 over the last year. The stock closed Tuesday's trade at $222.89, down 0.28%.
JNJ is currently up 0.06% at $223.03 in the overnight market.
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