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Johnson & Johnson Reports Positive Phase 2 Results for Nipocalimab in SLE Study

Key highlights
  • The JASMINE study involved 228 adult participants with active SLE.
  • The study met its primary endpoint at Week 24 with statistical significance.
  • Nipocalimab's safety profile was consistent with previous studies.
  • A Phase 3 program for nipocalimab has been initiated.

Study Overview

Johnson & Johnson announced positive results from the Phase 2b JASMINE study, which evaluated nipocalimab in adults with systemic lupus erythematosus (SLE). The study met its primary endpoint, showing a statistically significant response compared to placebo at Week 24.

Key Findings

The JASMINE study also achieved key secondary and exploratory endpoints, indicating nipocalimab's potential for steroid sparing. The safety and tolerability profile of nipocalimab was consistent with previous Phase 2 studies, with no new safety signals identified.

Study Design

JASMINE is a 52-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study involving 228 adult participants with active SLE. It is the first positive study of an FcRn blocker for treating active SLE.

Future Plans

Following these results, a Phase 3 program for nipocalimab has been initiated. Full results from the JASMINE study will be presented at a future medical congress.