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

Study acronym: GARDENIA-SLE
StatusRecruiting
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC
    • Trial sites expanded: 249 → 260 locations
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (9)
  2. Trial sites expanded: 231 → 249 locationsv9
  3. Trial sites expanded: 222 → 231 locationsv8
  4. Trial sites expanded: 169 → 222 locations
    • Eligibility criteria expanded, about 3 words
    v7
  5. Trial sites expanded: 69 → 169 locationsv6
  6. Trial sites expanded: 27 → 69 locationsv5
  7. Trial sites expanded: 5 → 27 locationsv4
  8. Study sites: 3 to 5
    • Start date changed from estimate of Apr 3, 2026 to Mar 5, 2026
    v3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 3
    v2
  10. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Johnson & Johnson
289 trials monitored
See 16 trials at risk
Lupus (SLE)
667 trials monitored
See 27 trials at risk
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).
Trial Details
NCT Number NCT07438496
Lead Sponsor Janssen Research & Development, LLC
Conditions
(from sponsor)		 Lupus Erythematosus, Systemic
Related terms Lupus Erythematosus, Systemic
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov