J&J’s Nipocalimab Advances to Phase III After Positive Lupus Trial

Johnson & Johnson’s autoimmune therapy nipocalimab has delivered positive results in the Phase IIb JASMINE trial, demonstrating clinically meaningful efficacy in systemic lupus erythematosus (SLE). The study met its primary endpoint, with a statistically significant increase in the proportion of patients achieving an SLE Responder Index-4 (SRI-4) response at 24 weeks compared with placebo.

Key secondary and exploratory endpoints, including measures of disease activity, flare timing and safety, were also met, according to the company. J&J said the findings suggest nipocalimab could help reduce reliance on long-term steroid use, which is linked to poor quality of life and organ damage. The drug’s safety profile was consistent with earlier studies, with no new safety concerns observed.

Nipocalimab is the first neonatal Fc receptor (FcRn) blocker to show meaningful efficacy in SLE and will now advance to Phase III trials. If approved, it will enter a competitive market dominated by GSK’s Benlysta and AstraZeneca’s Saphnelo.

11-01-2026