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

Last updated: April 16, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Red Blood Cell Disorders

Bone Marrow Disorder

Myelofibrosis

Treatment

Bomedemstat

Clinical Study ID

NCT06351631
3543-017
MK-3543-017
U1111-1294-8621
2023-506996-89
  • 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

    Active - Recruiting

  • Royal North Shore Hospital ( Site 1001)

    St Leonards, New South Wales 2065
    Australia

    Active - Recruiting

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

    Southport, Queensland 4215
    Australia

    Active - Recruiting

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

    Adelaide, South Australia 5000
    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

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi ( Site 2700)

    Firenze, Toscana 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

    Active - Recruiting

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

    Varese, 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

  • 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

  • University of Michigan ( Site 6000)

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center ( Site 6004)

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

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