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A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease

Study acronym: INDIGO
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Sep 30, 2022 to Jan 9, 2023 Primary completion date changed from estimate of Nov 15, 2025 to Nov 13, 2025v36 Show 1 more changeShow less
    • Primary completion date changed from estimate of Nov 15, 2025 to Nov 13, 2025
  2. Re-verified, no change to tracked fieldsv35
  3. Eligibility criteria revised Study description expanded, about 25 wordsv34 Show 1 more changeShow less
    • Study description expanded, about 25 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study description revisedv33 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 112 to 65 Primary completion date: Nov 14, 2025 to Nov 15, 2025 · Completion date: Dec 31, 2027 to Feb 15, 2029 · Study description revised · 1 morev32 Show 4 more changesShow less
    • Primary completion date: Nov 14, 2025 to Nov 15, 2025
    • Completion date: Dec 31, 2027 to Feb 15, 2029
    • Study description revised
    • Collaborators expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

Show 30 earlier versionsHide 30 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 200 to confirmed 194 · Study sites: 108 to 112 · Primary completion date: Oct 31, 2025 to Nov 14, 2025 · 2 morev31 Show 5 more changesShow less
    • Enrollment target: estimated 200 to confirmed 194
    • Study sites: 108 to 112
    • Primary completion date: Oct 31, 2025 to Nov 14, 2025
    • Completion date: Dec 31, 2026 to Dec 31, 2027
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 92 to 108v30
  3. Study sites: 84 to 92v29
  4. Study sites: 53 to 84v28
  5. Study sites: 52 to 53v27
  6. Study sites: 39 to 52v26
  7. Study sites: 31 to 39v25
  8. Study sites: 30 to 31v24
  9. Study sites: 29 to 30v23
  10. Study sites: 28 to 29v22
  11. Study sites: 27 to 28v21
  12. Study sites: 26 to 27v20
  13. Study sites: 25 to 26v19
  14. Study sites: 24 to 25v18
  15. Study sites: 14 to 24v17
  16. Study sites: 15 to 14v16
  17. Study sites: 13 to 15v15
  18. Study sites: 12 to 13v14
  19. Study sites: 11 to 12v13
  20. Study sites: 10 to 11v12
  21. Study sites: 9 to 10v11
  22. Study sites: 8 to 9v10
  23. Study sites: 7 to 8v9
  24. Study sites: 5 to 7v8
  25. Study sites: 4 to 5v7
  26. Study sites: 3 to 4v6
  27. Study sites: 2 to 3v5
  28. Site details revised at 1 of 2 sitesv4
  29. Site details revised at 1 of 2 sitesv3
  30. Study sites: 1 to 2v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)
Trial Details
NCT Number NCT05662241
Lead Sponsor Zenas BioPharma (USA), LLC
Collaborators: Bristol-Myers Squibb
Conditions IgG4 Related Disease
Enrollment 194 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov