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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
DISC-3405
DrugDISC-3405 is administered subcutaneously.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Within-participant dose escalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment-related adverse events as assessed by CTCAE
Proportion of participants with treatment-emergent adverse events
Time frame
Up to 365 days2
Incidence of clinically abnormal vital signs
Proportion of participants with changes in vital signs
Time frame
Up to 365 days3
Incidence of clinically abnormal physical exam
Proportion of participants with changes in physical examinations
Time frame
Up to 365 days4
Incidence of clinically abnormal electrocardiograms
Proportion of participants with changes in electrocardiograms (ECGs)
Time frame
Up to 365 daysSecondary outcomes
1
Proportion of participants achieving therapeutic response, defined as absence of phlebotomy eligibility, during the maintenance period
Time frame
Up to 365 days2
Number of phlebotomies during the maintenance and optimization periods
Time frame
Up to 365 days3
Proportion of participants achieving therapeutic response, defined as absence of phlebotomy eligibility, during the optimization period
Time frame
Up to 365 days4
Proportion of participants with HCT values <45% throughout the study
Time frame
Up to 365 daysSponsors and contacts
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Source ClinicalTrials.gov