A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

Last updated: October 29, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Post-polycythemia Vera Myelofibrosis

Thrombosis

Myelofibrosis

Treatment

Bomedemstat

Clinical Study ID

NCT06351631
3543-017
MK-3543-017
U1111-1294-8621
2023-506996-89
2023-506996-89-00
  • Ages > 18
  • All Genders

Study Summary

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 remission.

No hypothesis testing will be conducted in this study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary ofMerck & 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 theIMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receivingclinical 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 safelytolerating bomedemstat, and must be receiving clinical benefit from its use in theestimation of the investigator

  • Is not currently on a dose hold

  • Participant must be able to swallow oral medication and follow instructions forat-home dosing of bomedemstat

Exclusion

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 dosesexcluding suspensions or holds as assigned by the investigator

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Bomedemstat
Phase: 3
Study Start date:
May 23, 2024
Estimated Completion Date:
December 04, 2034

Connect with a study center

  • Royal Prince Alfred Hospital ( Site 1003)

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Royal North Shore Hospital ( Site 1001)

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital ( Site 1003)

    Camperdown 2172563, New South Wales 2155400 2050
    Australia

    Active - Recruiting

  • Royal North Shore Hospital ( Site 1001)

    St Leonards 8029783, New South Wales 2155400 2065
    Australia

    Active - Recruiting

  • Sunshine Coast Hematology and Oncology Clinic ( Site 1006)

    Buderim, Queensland 4556
    Australia

    Site Not Available

  • Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)

    Southport, Queensland 4215
    Australia

    Site Not Available

  • Sunshine Coast Hematology and Oncology Clinic ( Site 1006)

    Buderim 2173605, Queensland 2152274 4556
    Australia

    Active - Recruiting

  • Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)

    Southport 2148928, Queensland 2152274 4215
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)

    Adelaide 2078025, South Australia 2061327 5000
    Australia

    Active - Recruiting

  • Monash Health ( Site 1004)

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Monash Health ( Site 1004)

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Active - Recruiting

  • Queen Mary Hospital ( Site 1601)

    Hksar,
    Hong Kong

    Site Not Available

  • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703)

    Alessandria, Ancona 15121
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703)

    Alessandria 3183299, Ancona 15121
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi ( Site 2700)

    Firenze, Toscana 50134
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi ( Site 2700)

    Florence 3176959, Tuscany 3165361 50134
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo ( Site 2703)

    Alessandria, 15121
    Italy

    Active - Recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702)

    Bologna, 40138
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702)

    Bologna 3181928, 40138
    Italy

    Active - Recruiting

  • Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701)

    Varese, 21100
    Italy

    Site Not Available

  • Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701)

    Varese 3164699, 21100
    Italy

    Active - Recruiting

  • Aotearoa Clinical Trials ( Site 1400)

    Auckland, 2025
    New Zealand

    Site Not Available

  • North Shore Hospital-Department of Haematology ( Site 1401)

    Auckland, 0622
    New Zealand

    Site Not Available

  • Aotearoa Clinical Trials ( Site 1400)

    Auckland 2193733, 2025
    New Zealand

    Site Not Available

  • North Shore Hospital-Department of Haematology ( Site 1401)

    Auckland 2193733, 0622
    New Zealand

    Site Not Available

  • Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402)

    London, Hammersmith And Fulham W12 0HS
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402)

    London 2643743, Hammersmith and Fulham W12 0HS
    United Kingdom

    Active - Recruiting

  • Boston Pilgrim Hospital ( Site 3403)

    Boston, Lincolnshire PE21 9QS
    United Kingdom

    Site Not Available

  • Boston Pilgrim Hospital ( Site 3403)

    Boston 2655138, Lincolnshire PE21 9QS
    United Kingdom

    Active - Recruiting

  • Guy's & St Thomas' NHS Foundation Trust ( Site 3401)

    London, London, City Of SE1 9RT
    United Kingdom

    Active - Recruiting

  • University College London Hospital ( Site 3400)

    London, London, City Of NW1 2PG
    United Kingdom

    Active - Recruiting

  • Guy's & St Thomas' NHS Foundation Trust ( Site 3401)

    London 2643743, London, City of SE1 9RT
    United Kingdom

    Active - Recruiting

  • University College London Hospital ( Site 3400)

    London 2643743, London, City of NW1 2PG
    United Kingdom

    Active - Recruiting

  • University of Michigan ( Site 6000)

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan ( Site 6000)

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • DUHS Duke Blood Cancer Center ( Site 6005)

    Durham, North Carolina 27705
    United States

    Site Not Available

  • DUHS Duke Blood Cancer Center ( Site 6005)

    Durham 4464368, North Carolina 4482348 27705
    United States

    Active - Recruiting

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)

    Columbus, Ohio 43210
    United States

    Site Not Available

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

  • UPMC Hillman Cancer Center ( Site 6004)

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • UPMC Hillman Cancer Center ( Site 6004)

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Active - Recruiting

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