Recruiting
Phase 2
Phase 3

Bomedemstat vs. Usual Treatments

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07722611

Conditions

Polycythemia Vera

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bomedemstat

Ruxolitinib

Ropeginterferon alfa-2b

Study Details

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

Study ID

NCT07722611

Start date

Oct 21, 2026

Status verified date

Oct, 2026

Completion date

Nov 30, 2032

Anticipated

Primary completion date

Jun 25, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

380 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bomedemstat

Participants will receive bomedemstat daily for up to approximately 52 weeks. Per protocol, dosage may be adjusted within specified time parameters for each participant to achieve and maintain protocol-specified platelet and hematocrit target ranges. Eligible participants who do not discontinue study treatment at Week 52, may continue to receive study treatment.

active comparator: Best Available Therapy (BAT)

Participants will receive either ropeinterferon alfa-2b or ruxolitinib as determined by investigator. All participants will be treated per respective approved product labels for up to approximately 52 weeks.

Interventions

Bomedemstat

Oral Capsule

Ruxolitinib

Oral Tablet

Ropeginterferon alfa-2b

Subcutaneous Solution

Primary outcome measure

  • Clinicohematologic Response (CHR) Rate [ Time Frame: Up to approximately Week 52 ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@merck.com

Locations

University of Virginia ( Site 5031)

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Study Coordinator

434-924-9333

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.