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A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Incyte

Record History

  1. Site details revised at 1 of 41 sites
  2. Eligibility criteria shortened, about 10 words Secondary endpoints: details revised at 2 of 17 entries · Site details revised at 11 of 41 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 2 of 17 entries
    • Site details revised at 11 of 41 sites
  3. Primary endpoint(s) modified Eligibility criteria expanded, about 36 words · Secondary endpoints: 15 to 17 · Study sites revised (41)v20 Show 3 more changesShow less
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: 15 to 17
    • Study sites revised (41)

    See this version in full on ClinicalTrials.gov ↗

  4. Start date changed from estimate of May 31, 2026 to May 20, 2026v19
  5. Study sites: 40 to 41v18
  6. Trial sites reduced: 47 → 40 locationsv17
  7. Trial sites expanded: 42 → 47 locationsv16
  8. Trial sites expanded: 37 → 42 locationsv15
  9. Start date: Mar 31, 2026 to May 31, 2026 Study sites: 38 to 37v14 Show 1 more changeShow less
    • Study sites: 38 to 37
  10. Study sites: 37 to 38v13
  11. Study sites: 39 to 37v12
  12. Start date: Jan 31, 2026 to Mar 31, 2026 Site details revised at 1 of 39 sitesv11 Show 1 more changeShow less
    • Site details revised at 1 of 39 sites
  13. Study sites: 42 to 39v10
  14. Study sites: 39 to 42v9
  15. Study sites: 42 to 39v8
  16. Study sites: 39 to 42v7
  17. Study sites: 38 to 39v6
  18. Start date: Dec 15, 2025 to Jan 31, 2026 Study sites: 42 to 38v5 Show 1 more changeShow less
    • Study sites: 42 to 38
  19. Study sites: 38 to 42v4
  20. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 38v3 Show 1 more changeShow less
    • Study sites: 0 to 38
  21. Study title expanded, about 1 wordv2 See this version in full on ClinicalTrials.gov ↗
  22. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 compare Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
Trial Details
NCT Number NCT07124078
Lead Sponsor Incyte Corporation
Conditions Chronic Graft-versus-host-disease
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov