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A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Minor Enrollment closed, study ongoing
    • Site details revised at 15 of 15 sites
    v11
  2. Minor Study sites: 14 to 15v10
  3. Minor Study sites: 12 to 14v9
  4. Minor Study sites: 11 to 12v8
  5. Minor Study sites: 10 to 11v7
Show 5 earlier versionsHide 5 earlier versions
  1. Minor Study sites: 8 to 10v6
  2. Minor Study sites: 7 to 8v5
  3. Notable Enrollment target: 20 to 60
    • Study sites: 5 to 7
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: 13 to 14
    v4
  4. Minor Site details revised at 4 of 5 sitesv3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Jun 2025 to Aug 12, 2025
    • Eligibility criteria expanded, about 8 words
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 open-label, multicenter, within-participant dose escalation study examining up to 2 dose levels of DISC-3405 will assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of DISC-3405 in participants with polycythemia vera (PV).
Trial Details
NCT Number NCT06985147
Lead Sponsor Disc Medicine, Inc
Conditions
(from sponsor)
Polycythemia Vera (PV)
Related terms Polycythemia Vera
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov