Clinical Trial

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Study acronym: GARDENIA-SLE
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).
Protocol Amendment History 4 changes
notable Trial sites expanded: 169 -> 222 locations 2026-07-17
notable Trial sites expanded: 69 -> 169 locations 2026-06-06
notable Trial sites expanded: 27 -> 69 locations 2026-05-09
notable Trial sites expanded: 5 -> 27 locations 2026-04-14
Trial Details
NCT Number NCT07438496
Lead Sponsor Janssen Research & Development, LLC
Conditions Lupus Erythematosus, Systemic
Enrollment 600 participants
Start Date 2026-03-05
Primary Completion 2028-12-06 (estimated)
Study Completion 2031-11-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-16