A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025) (NCT07722611) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025)
380 participantsStarted 2026-09-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.