A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
Thrombocythemia, Essential · Primary Myelofibrosis · Myelofibrosis · Post-polycythemia Vera Myelofibrosis · Post-essential Thrombocythemia Myelofibrosis · Polycythemia Vera
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 3
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 400 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:
- Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;
- Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic response.
No hypothesis testing will be conducted in this study.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck \& Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready
- Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator
- ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic response, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator
- Is not currently on a dose hold
- Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat
Exclusion Criteria:
- Has received prohibited concomitant medications
- Ongoing or planned participation in another investigational study
- Has noncompliance in prior bomedemstat study receiving \<90% of assigned doses excluding suspensions or holds as assigned by the investigator
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Bomedemstat
Participants will receive oral capsules of bomedemstat once daily for up to 10 years, with the starting dose as the same dose that the participant was on at the time of transition from the feeder study.
Drug: Bomedemstat
Bomedemstat DRUG
10, 15, 20, and 50 mg oral capsules
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Percentage of participants with one or more adverse events (AEs)
Time frame: Up to ~10 years
An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants with AEs will be presented.
Percentage of participants who discontinued study treatment due to an AE
Time frame: Up to ~10 years
An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who discontinued study treatment due to an AE will be presented.
Secondary measures
For participants with ET: Duration of durable clinicohematologic response
Time frame: Up to ~10 years
For participants who demonstrate durable clinicohematologic response (DCHR) in their feeder study, duration of durable clinicohematologic response (DODCHR) is defined as the time from the first documented evidence of confirmed reduction of platelet and white blood cell (WBC) counts until confirmed increase of platelet and WBC counts to above acceptable threshold, thrombotic or major hemorrhagic events, or disease progression to myelofibrosis (MF), myelodysplastic syndrome (MDS), or acute myeloid leukemia (AML). DODCHR will be reported.
For participants with ET or PV: Duration of clinicohematologic response
Time frame: Up to ~10 years
For participants who showed clinicohematologic response in their feeder study, duration of clinicohematologic response is defined as the time from the first documented evidence of confirmed reduction of platelet and WBC count until confirmed increase of platelet and WBC counts to above acceptable threshold, thrombotic or major hemorrhagic events or disease progression to MF, MDS, or AML, or phlebotomy (PV participants only). The duration of clinicohematologic response will be reported.
For participants with ET or PV: Duration of hematologic response
Time frame: Up to ~10 years
For participants who showed confirmed hematologic response in their feeder study, duration of hematologic response is defined as the time from the first documented evidence of confirmed reduction of platelet and WBC count until confirmed increase of platelet and WBC counts to above acceptable threshold, or phlebotomy (PV participants only). The duration of hematologic response will be reported.
For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML
Time frame: Up to ~10 years
Disease Progression is defined as the transformation to post-ET myelofibrosis (ET participants only), post-PV myelofibrosis (PV participants only), spleen volume increase ≥25% (MF participants only), myelodysplastic syndrome, or acute myeloid leukemia as assessed by the investigator. The percentage of participants with transformation to MF or MDS/AML will be reported.
For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML
Time frame: Up to ~10 years
Spleen volume will be assessed by magnetic resonance imaging (MRI) (or computed tomography \[CT\] where applicable) at pre-specified timepoints. The percentage of participants with worsening of splenomegaly or transformation to MDS/AML will be reported.
For participants with MF, ET, or PV: Percentage of participants with thrombotic events
Time frame: Up to ~10 years
Thrombotic events are defined as: new or recurrent acute myocardial infarction; unstable angina; stroke; transient ischemic attack (TIA); deep venous thrombosis (DVT); pulmonary embolism (PE); thrombotic digital ischemia; other thrombotic events such as peripheral limb ischemia or Budd-Chiari syndrome that are assessed to be due to underlying PV; other vascular occlusive events such as symptoms of cardiac, abdominal or peripheral limb ischemia supported by objective evidence of vessel disease and/or ischemia. The percentage of participants with thrombotic events will be presented.
For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events
Time frame: Up to ~10 years
Hemorrhagic events are defined as: Major Bleeding (MB) Events such as fatal bleeding, and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 2 g/dL or more, or leading to transfusion of 2 or more units of whole blood or red cells; Clinically Relevant Non-Major Bleeding (CRNMB) Events Leading to hospitalization or increased level of care or clinically important, prompting a face-to-face medical evaluation. The percentage of participants with major hemorrhagic events will be presented.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (21)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
21 locations
University of Michigan ( Site 6000)Ann Arbor, Michigan, United StatesRecruiting
DUHS Duke Blood Cancer Center ( Site 6005)Durham, North Carolina, United StatesRecruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)Columbus, Ohio, United StatesRecruiting
UPMC Hillman Cancer Center ( Site 6004)Pittsburgh, Pennsylvania, United StatesRecruiting
Royal Prince Alfred Hospital ( Site 1003)Camperdown, New South Wales, AustraliaRecruiting
Royal North Shore Hospital ( Site 1001)St Leonards, New South Wales, AustraliaRecruiting
Sunshine Coast Hematology and Oncology Clinic ( Site 1006)Buderim, Queensland, AustraliaRecruiting
Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)Southport, Queensland, AustraliaRecruiting
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)Adelaide, South Australia, AustraliaRecruiting
Monash Health ( Site 1004)Clayton, Victoria, AustraliaRecruiting
Queen Mary Hospital ( Site 1601)Hksar, Hong KongActive, not recruiting
Azienda Ospedaliera Universitaria Careggi ( Site 2700)Florence, Tuscany, ItalyRecruiting
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703)Alessandria, ItalyRecruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702)Bologna, ItalyRecruiting
Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701)Varese, ItalyRecruiting
North Shore Hospital-Department of Haematology ( Site 1401)Auckland, New ZealandActive, not recruiting
Aotearoa Clinical Trials ( Site 1400)Auckland, New ZealandActive, not recruiting
Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402)London, Hammersmith and Fulham, United KingdomRecruiting
Boston Pilgrim Hospital ( Site 3403)Boston, Lincolnshire, United KingdomRecruiting
University College London Hospital ( Site 3400)London, London, City of, United KingdomRecruiting
Guy's & St Thomas' NHS Foundation Trust ( Site 3401)London, London, City of, United KingdomRecruiting
Study team and timeline
- Lead sponsor
- Merck Sharp & Dohme LLC
- Study start
- May 23, 2024 Actual
- Primary completion
- Dec 4, 2034 Estimated
- Study completion
- Dec 4, 2034 Estimated
- First posted
- Apr 8, 2024 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026