Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Status: Not yet recruiting

Phase of Trial: Phase III

Latest Information Update: 04 Mar 2026

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At a glance

Drugs Nipocalimab (Primary)
Indications Systemic lupus erythematosus
Focus Registrational; Therapeutic Use
Acronyms GARDENIA
Sponsors Janssen Research & Development; Johnson & Johnson

Most Recent Events

02 Mar 2026 Status changed from planning to not yet recruiting.
13 Jan 2026 New trial record

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