A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025) | NCT07722611

NCT07722611

Overview

NCT ID: NCT07722611
Lead Sponsor: Merck Sharp & Dohme LLCINDUSTRY
Official Title: A Phase 2/3, Randomized, Open-label, Active-comparator-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543) Versus Best Available Therapy in Participants With Polycythemia Vera Who Have an Inadequate Response to or Are Intolerant to Hydroxyurea
Brief Summary: 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.
Conditions: Polycythemia Vera

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 23, 2026Actual
Start Date: Sep 21, 2026Estimated
Primary Completion Date: Jun 25, 2032Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

Study Type: Interventional
Phase: Phase 2Phase 3
Enrollment: 380Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: No data available
Locations: No data available

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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