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

Study acronym: GARDENIA-SLE
StatusRecruiting
PhasePhase 3
Started2026-03-05
View on ClinicalTrials.gov ↗
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).

Amendment history 6 changes detected by DataLookout

2026-08-29
Trial sites expanded: 231 → 249 locations
2026-08-01
Trial sites expanded: 222 → 231 locations
2026-07-17
Trial sites expanded: 169 → 222 locations
2026-06-06
Trial sites expanded: 69 → 169 locations
2026-05-09
Trial sites expanded: 27 → 69 locations
2026-04-14
Trial sites expanded: 5 → 27 locations
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 2026-08-28