A Phase 2, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DISC-3405 in Participants With Polycythemia Vera (PV)
Disc Medicine, Inc
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. Part…
Interventions
- DrugDISC-3405
DISC-3405 is administered subcutaneously.
Locations (14)
- Mayo Clinic in ArizonaPhoenix, Arizona
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- UCLA HealthLos Angeles, California
- Keck Medicine of USC - Cancer Clinic- Newport BeachNewport Beach, California
- Mayo Clinic in FloridaJacksonville, Florida
- Mayo Clinic in MinnesotaRochester, Minnesota