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A Phase 1 Study of LY5830966 in Participants With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Oct 15, 2026 → Jun 2027
Primary endpoint reworded 2 of 3 changed
See other at-risk trials from Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Record History

  1. Start date moved earlier from Oct 23, 2024 to Oct 3, 2024 Site details revised at 3 of 21 sites Show 1 more changeShow less
    • Site details revised at 3 of 21 sites
  2. Primary completion pushed from Oct 15, 2026 to Jun 2027 Primary endpoint(s) modified · Sponsor changed: Ajax Therapeutics, Inc. to Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company · Enrollment increased: 76 → 256 participants · 8 more Show 11 more changesShow less
    • Primary endpoint(s) modified
    • Sponsor changed: Ajax Therapeutics, Inc. to Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
    • Enrollment increased: 76 → 256 participants
    • Completion pushed from Feb 15, 2027 to Dec 2028
    • Interventions modified
    • Trial arms changed: 7 → 10
    • Eligibility criteria expanded, about 229 words
    • Secondary endpoints revised (8)
    • Site details revised at 2 of 21 sites
    • Study title revised
    • Study description expanded, about 3 words
  3. Trial sites expanded: 16 → 21 locationsv22
  4. Study sites: 15 to 16v21
  5. Study sites: 14 to 15v20
Show 18 earlier versionsHide 18 earlier versions
  1. Study sites: 13 to 14v19
  2. Study sites: 12 to 13v18
  3. Site contacts updated at 1 of 12 sitesv17
  4. Eligibility criteria expanded, about 15 wordsv16 See this version in full on ClinicalTrials.gov ↗
  5. Site contacts updated at 3 of 12 sitesv15
  6. Site details revised at 1 of 12 sitesv14
  7. Site details revised at 1 of 12 sitesv13
  8. Study sites: 11 to 12v12
  9. Site details revised at 1 of 11 sitesv11
  10. Site details revised at 1 of 11 sitesv10
  11. Site details revised at 1 of 11 sitesv9
  12. Site details revised at 1 of 11 sitesv8
  13. Start date changed from estimate of Oct 2024 to Oct 23, 2024 Site details revised at 3 of 11 sitesv7 Show 1 more changeShow less
    • Site details revised at 3 of 11 sites
  14. Trial status: Not Yet Recruiting to Recruiting Start date: Jul 15, 2024 to Oct 2024 · Primary completion date: Aug 15, 2026 to Oct 15, 2026 · Site details revised at 11 of 11 sitesv6 Show 3 more changesShow less
    • Start date: Jul 15, 2024 to Oct 2024
    • Primary completion date: Aug 15, 2026 to Oct 15, 2026
    • Site details revised at 11 of 11 sites
  15. Study sites: 9 to 11v5
  16. Eligibility criteria revised Study description revised · Site contacts updated at 9 of 9 sitesv4 Show 2 more changesShow less
    • Study description revised
    • Site contacts updated at 9 of 9 sites

    See this version in full on ClinicalTrials.gov ↗

  17. Study sites: 0 to 9 Eligibility criteria shortened, about 2 wordsv3 Show 1 more changeShow less
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  18. Secondary endpoints revised (8) Study description expanded, about 14 wordsv2 Show 1 more changeShow less
    • Study description expanded, about 14 words

    See this version in full on ClinicalTrials.gov ↗

  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.
J8G-MC-JDIA (AJX-101) is a first-in-human (FIH), phase 1, non-randomized, multi-center, open-label clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK), clinical activity and changes in biomarkers of an orally administered type II Janus Kinase 2 (JAK2) inhibitor, LY5830966, in participants with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor.
Trial Details
NCT Number NCT06343805
Lead Sponsor Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Conditions Primary Myelofibrosis
Enrollment 256 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov