NCT06985147 A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
| NCT ID | NCT06985147 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Disc Medicine, Inc |
| Condition | Polycythemia Vera (PV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-08-12 |
| Primary Completion | 2027-02 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 years or older at the time of signing the informed consent form (ICF). 2. Meet revised 2022 World Health Organization (WHO) criteria for the diagnosis of PV. 3. Complete blood count values at Screening of HCT \<45% or HCT \<48% if followed by a phlebotomy within 2 weeks, white blood cells 4000/μL to 20,000/μL (inclusive), and platelets 100,000/μL to 1,000,000/μL (inclusive). 4. At least 3 phlebotomies in 26 weeks before Screening or at least 5 phlebotomies in 52 weeks before Screening. At least 1 phlebotomy must be within the 12 weeks prior to Screening. 5. Participants receiving cytoreductive therapy must have been taking for at least 6 months and be on a stable PV therapy regimen for at least 2 months for hydroxyurea, interferon or ruxolitinib with no anticipated need for dose adjustments during the study, or have decreasing dose (with medical monitor approval). 6. Participants treated with phlebotomy alone must have stopped cytoreductive therapy 6 mont