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INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

StatusCompleted
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Study completion date changed from estimate of Nov 26, 2027 to Sep 8, 2026 · Eligibility criteria expanded, about 21 words · Secondary endpoints: details revised at 3 of 15 entries · 2 more Show 5 more changesShow less
    • Study completion date changed from estimate of Nov 26, 2027 to Sep 8, 2026
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 3 of 15 entries
    • Site details revised at 1 of 34 sites
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv45
  3. Results first posted: May 12, 2026 Secondary endpoints revised (15)v44 Show 1 more changeShow less
    • Secondary endpoints revised (15)

    See this version in full on ClinicalTrials.gov ↗

  4. Primary endpoints: 1 to 5 Secondary endpoints revised (15)v43 Show 1 more changeShow less
    • Secondary endpoints revised (15)

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv42
Show 40 earlier versionsHide 40 earlier versions
  1. Completion date: Oct 15, 2025 to Nov 26, 2027v41
  2. Re-verified, no change to tracked fieldsv40
  3. Primary completion date changed from estimate of Nov 28, 2025 to Apr 1, 2025 Completion date: Jun 30, 2026 to Oct 15, 2025v39 Show 1 more changeShow less
    • Completion date: Jun 30, 2026 to Oct 15, 2025
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 206 to confirmed 84 · Site details revised at 34 of 34 sitesv38 Show 2 more changesShow less
    • Enrollment target: estimated 206 to confirmed 84
    • Site details revised at 34 of 34 sites
  5. Site details revised at 1 of 34 sitesv37
  6. Site details revised at 1 of 34 sitesv36
  7. Site details revised at 1 of 34 sitesv35
  8. Site details revised at 2 of 34 sitesv34
  9. Enrollment target: 100 to 206 Primary completion date: Apr 30, 2024 to Nov 28, 2025 · Completion date: Apr 30, 2024 to Jun 30, 2026 · Eligibility criteria expanded, about 37 words · 2 morev33 Show 5 more changesShow less
    • Primary completion date: Apr 30, 2024 to Nov 28, 2025
    • Completion date: Apr 30, 2024 to Jun 30, 2026
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints revised (15)
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  10. Site details revised at 1 of 34 sitesv32
  11. Study sites: 35 to 34v31
  12. Study sites: 34 to 35v30
  13. Study sites revised (34)v29 See this version in full on ClinicalTrials.gov ↗
  14. Study sites: 35 to 34v28
  15. Study sites: 32 to 35v27
  16. Site details revised at 1 of 32 sitesv26
  17. Site details revised at 1 of 32 sitesv25
  18. Re-verified, no change to tracked fieldsv24
  19. Site details revised at 1 of 32 sitesv23
  20. Study sites revised (32)v22 See this version in full on ClinicalTrials.gov ↗
  21. Study sites: 30 to 32v21
  22. Study sites revised (30)v20 See this version in full on ClinicalTrials.gov ↗
  23. Study sites: 26 to 30v19
  24. Study sites: 25 to 26v18
  25. Study sites: 23 to 25v17
  26. Primary completion date: Sep 21, 2023 to Apr 30, 2024 Study sites: 22 to 23 · Completion date: Oct 2, 2023 to Apr 30, 2024v16 Show 2 more changesShow less
    • Study sites: 22 to 23
    • Completion date: Oct 2, 2023 to Apr 30, 2024
  27. Study sites: 21 to 22v15
  28. Completion date: Sep 21, 2023 to Oct 2, 2023 Study sites revised (21)v14 Show 1 more changeShow less
    • Study sites revised (21)

    See this version in full on ClinicalTrials.gov ↗

  29. Study sites: 20 to 21 Primary and study completion dates: Dec 5, 2023 to Sep 21, 2023v13 Show 1 more changeShow less
    • Primary and study completion dates: Dec 5, 2023 to Sep 21, 2023
  30. Primary and study completion dates: Dec 2, 2023 to Dec 5, 2023 Site details revised at 2 of 20 sitesv12 Show 1 more changeShow less
    • Site details revised at 2 of 20 sites
  31. Study sites: 19 to 20v11
  32. Study sites: 18 to 19v10
  33. Primary and study completion dates: Dec 21, 2023 to Dec 2, 2023 Site details revised at 1 of 18 sitesv9 Show 1 more changeShow less
    • Site details revised at 1 of 18 sites
  34. Site details revised at 1 of 18 sitesv8
  35. Study sites: 14 to 18 Primary and study completion dates: Nov 2, 2023 to Dec 21, 2023v7 Show 1 more changeShow less
    • Primary and study completion dates: Nov 2, 2023 to Dec 21, 2023
  36. Primary completion date: Oct 15, 2022 to Nov 2, 2023 Study sites: 6 to 14 · Completion date: Feb 23, 2024 to Nov 2, 2023 · Secondary endpoints revised (15)v6 Show 3 more changesShow less
    • Study sites: 6 to 14
    • Completion date: Feb 23, 2024 to Nov 2, 2023
    • Secondary endpoints revised (15)

    See this version in full on ClinicalTrials.gov ↗

  37. Completion date: Oct 15, 2022 to Feb 23, 2024 Start date changed from estimate of Feb 15, 2021 to Mar 19, 2021 · Site details revised at 1 of 6 sitesv5 Show 2 more changesShow less
    • Start date changed from estimate of Feb 15, 2021 to Mar 19, 2021
    • Site details revised at 1 of 6 sites
  38. Trial status: Not Yet Recruiting to Recruiting Start date: Dec 15, 2020 to Feb 15, 2021 · Site details revised at 6 of 6 sitesv4 Show 2 more changesShow less
    • Start date: Dec 15, 2020 to Feb 15, 2021
    • Site details revised at 6 of 6 sites
  39. Start date: Oct 15, 2020 to Dec 15, 2020v3
  40. Start date: Aug 19, 2020 to Oct 15, 2020 Study sites: 0 to 6 · Secondary endpoints: details revised at 12 of 15 entriesv2 Show 2 more changesShow less
    • Study sites: 0 to 6
    • Secondary endpoints: details revised at 12 of 15 entries
  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
Myelofibrosis
175 trials monitored
See 8 trials at risk
This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion.
Trial Details
NCT Number NCT04455841
Lead Sponsor Incyte Corporation
Conditions Anemia, Post-essential Thrombocythemia Myelofibrosis, Post-polycythemia Vera Myelofibrosis
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov