A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
NCT ID: NCT06351631
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2024-05-23
2034-12-04
Brief Summary
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* 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 remission.
No hypothesis testing will be conducted in this study.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Bomedemstat
10, 15, 20, and 50 mg oral capsules
Interventions
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Bomedemstat
10, 15, 20, and 50 mg oral capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 remission, 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
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp and Dohme LLC
Locations
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University of Michigan ( Site 6000)
Ann Arbor, Michigan, United States
DUHS Duke Blood Cancer Center ( Site 6005)
Durham, North Carolina, United States
UPMC Hillman Cancer Center ( Site 6004)
Pittsburgh, Pennsylvania, United States
Royal Prince Alfred Hospital ( Site 1003)
Camperdown, New South Wales, Australia
Royal North Shore Hospital ( Site 1001)
St Leonards, New South Wales, Australia
Sunshine Coast Hematology and Oncology Clinic ( Site 1006)
Buderim, Queensland, Australia
Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)
Southport, Queensland, Australia
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)
Adelaide, South Australia, Australia
Monash Health ( Site 1004)
Clayton, Victoria, Australia
Queen Mary Hospital ( Site 1601)
Hksar, , Hong Kong
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703)
Alessandria, Ancona, Italy
Azienda Ospedaliera Universitaria Careggi ( Site 2700)
Florence, Tuscany, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702)
Bologna, , Italy
Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701)
Varese, , Italy
North Shore Hospital-Department of Haematology ( Site 1401)
Auckland, , New Zealand
Aotearoa Clinical Trials ( Site 1400)
Auckland, , New Zealand
Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402)
London, Hammersmith and Fulham, United Kingdom
Boston Pilgrim Hospital ( Site 3403)
Boston, Lincolnshire, United Kingdom
University College London Hospital ( Site 3400)
London, London, City of, United Kingdom
Guy's & St Thomas' NHS Foundation Trust ( Site 3401)
London, London, City of, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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3543-017
Identifier Type: -
Identifier Source: org_study_id
2023-506996-89-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1294-8621
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-3543-017
Identifier Type: OTHER
Identifier Source: secondary_id