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GARDENIA-SLE
jRCT2031250789Phase 3Recruiting
- Sponsor
- Janssen Pharmaceutical
- Start
- Jun 2026
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
01
Overview
Phase 3, randomised, double-blind trial in systemic lupus erythematosus (SLE) comparing Nipocalimab with Placebo (2 arms). Primary endpoint: Percentage of participants achieving SLE Responder Index-4 composite response at Week 52. Started Jun 2026; status: recruiting.
02
Drugs
nipocalimab
03
Conditions
systemic lupus erythematosus (SLE)
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