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

Starting soon · Phase 2/Phase 3

Conditions studied: Polycythemia Vera

In brief

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.

Key facts

Study ID: NCT07722611
Run by: Merck Sharp & Dohme LLC
People needed: 380
Starts: 2026-09-21
Expected to finish: 2032-11-30
Last updated by the study team: 2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

The main inclusion criteria include but are not limited to the following:
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
Has no evidence of splenomegaly and no symptoms attributable to splenomegaly, including early satiety, left upper quadrant discomfort, or splenic pain
Has locally assessed bone marrow (BM) fibrosis score of Grade 0 or Grade 1 as per modified version of the European Consensus Criteria for Grading Myelofibrosis
Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy (ART)
Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable
Participants must be able to swallow oral medication and follow instructions for at home dosing of bomedemstat

You may not qualify if…

The main exclusion criteria include but are not limited to the following:
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
Is currently receiving anticancer therapy
Has an active infection requiring systemic therapy
Has had major surgical procedure ≤4 weeks before first dose of study intervention or has not recovered from side effects of major surgical procedure

Full record on ClinicalTrials.gov

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