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Phase 3 study of nipocalimab in adults with moderate to severe systemic lupus erythematosus
2025-523552-31-00Phase 3Authorised
- Sponsor
- Janssen Pharmaceutical
- Start
- May 2026
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
- Countries
- 32
01
Overview
Phase 3, randomised, double-blind trial in systemic lupus erythematosus (SLE) comparing Nipocalimab with Placebo (2 arms). Primary endpoint: Systemic lupus erythematosus responder index (SRI)-4 composite response. Planned start May 2026; status: authorised.
02
Drugs
nipocalimab
03
Conditions
systemic lupus erythematosus (SLE)
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