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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Incyte

Record History

  1. Primary endpoint(s) modified Results posted: Oct 5, 2026 · Eligibility criteria expanded, about 29 words · Secondary endpoints revised (11) · 1 more Show 4 more changesShow less
    • Results posted: Oct 5, 2026
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints revised (11)
    • Site details revised at 1 of 16 sites
  2. Secondary endpoints: details revised at 4 of 11 entriesv16
  3. Primary endpoint revised Secondary endpoints: 10 to 11v15 Show 1 more changeShow less
    • Secondary endpoints: 10 to 11

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv14
  5. Primary completion date changed from estimate of Sep 30, 2025 to Aug 6, 2025v13
Show 11 earlier versionsHide 11 earlier versions
  1. Re-verified, no change to tracked fieldsv12
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 20 to confirmed 21 · Site details revised at 16 of 16 sites · Eligibility criteria shortened, about 1 wordv11 Show 3 more changesShow less
    • Enrollment target: estimated 20 to confirmed 21
    • Site details revised at 16 of 16 sites
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Study Status, Referencesv10
  4. Study sites revised (16)v9 See this version in full on ClinicalTrials.gov ↗
  5. Site details revised at 1 of 16 sitesv8
  6. Site details revised at 1 of 16 sitesv7
  7. Primary completion date: Dec 31, 2025 to Sep 30, 2025 Completion date: Dec 31, 2025 to Mar 30, 2027 · Site details revised at 4 of 16 sitesv6 Show 2 more changesShow less
    • Completion date: Dec 31, 2025 to Mar 30, 2027
    • Site details revised at 4 of 16 sites
  8. Site details revised at 2 of 16 sitesv5
  9. Start date: Jun 30, 2024 to Jul 30, 2024 Site details revised at 5 of 16 sitesv4 Show 1 more changeShow less
    • Site details revised at 5 of 16 sites
  10. Site details revised at 1 of 16 sitesv3
  11. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 16v2 Show 1 more changeShow less
    • Study sites: 0 to 16
  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.
Incyte
94 trials monitored
See 9 trials at risk
This study will be conducted to determine the clinical efficacy of axatilimab in Japanese participants with chronic graft-versus-host disease (cGVHD).
Trial Details
NCT Number NCT06263478
Lead Sponsor Incyte Biosciences Japan GK
Conditions Chronic Graft-versus-host-disease
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov