A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
ConditionPolycythemia Vera (PV)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDisc Medicine, Inc
About this trial
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
Qualifiers
Aged 18 years or older at the time of signing the informed consent form (ICF).
Meet revised 2022 World Health Organization (WHO) criteria for the diagnosis of PV.
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).
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.
Disqualifiers
Clinically significant laboratory abnormalities at Screening.
Participants who require phlebotomy at HCT levels <45%.
Clinically significant thrombosis (eg, deep vein thrombosis or splenic vein thrombosis) within 2 months prior to study treatment.
Clinically significant active or chronic bleeding, considered meaningful in consultation with the medical monitor, within 6 months prior to study treatment.
Trial design
Treatments tested in this trial
- DISC-3405
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov