A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025)

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

Researchers are looking for new ways to treat polycythemia vera (PV). People with PV may receive treatment to lower the number of red blood cells in the blood, but the usual treatments may not work for everyone. Researchers want to learn if a trial medicine called bomedemstat, also called MK-3543, can treat PV. In this study, researchers will compare bomedemstat to 2 usual treatments for PV.

The goal of this study is to learn if more participants who take bomedemstat reach healthy blood cell counts and avoid major health problems from PV, compared to those who receive a usual treatment.

Eligibility criteria

Qualifiers

Has confirmed local diagnosis of polycythemia vera (PV) per World Health Organization (WHO) diagnostic criteria for PV

Must have discontinued prior cytoreductive therapy for condition under study for protocol specified duration

Has failed at least one prior line of cytoreductive therapy to lower hematocrit

Has a history of inadequate response, resistance to, or intolerant to hydroxyurea (HU) per protocol specified criteria

Disqualifiers

Has history of any illness/impairment of gastrointestinal (GI) function that might interfere with drug absorption

Has evidence at the time of screening of increased risk of bleeding

Has history of malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years

HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Trial design

Treatments tested in this trial

  • Bomedemstat
  • Ruxolitinib
  • Ropeginterferon alfa-2b

Treatment groups

380 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators