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NCT Number: NCT05223920

An Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)

This is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat administered orally once daily in participants with a Myeloproliferative Neoplasm (MPN) who participated in a prior bomedemstat study such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 (NCT03136185) and IMG-7289-CTP-201/MK-3543-003 (NCT04254978) (referred to hereafter as 'feeder studies').

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Key information

Conditions

Thrombocythemia, Essential Blood Coagulation Disorders Blood Platelet Disorders Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Myeloproliferative Disorders Primary Myelofibrosis Thrombocytosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

include, but are not limited to:

  • Has completed at least one Treatment Period (TP) in a prior bomedemstat Myeloproliferative Neoplasms (MPN) protocol (such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 (NCT03136185) and IMG-7289-CTP-201/MK-3543-003) (NCT04254978).
  • In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat.

Exclusion criteria

Exclusion criteria

include, but are not limited to:

  • Ongoing participation in another investigational study (except observational studies).
  • A history of non-compliance in a prior bomedemstat study (excluding dose suspensions that were medically warranted).
  • Current use of a prohibited medication (e.g., romiplostim).
  • Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's safety, ability to give informed consent, or comply with the trial protocol.
  • Is pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
  • Women of childbearing potential (WOCBP) and fertile men unwilling to agree to use an approved method of contraception from time of enrollment until 14 days after last bomedemstat dose.

Treatment and study plan

Bomedemstat

Drug

Capsule (oral)

Other names: IMG-7289, MK-3543

Primary outcomes

  1. Percentage of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to ~32 months

    An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who experienced an AE is presented.

  2. Percentage of Participants Who Discontinue Study Intervention Due to an AE

    Time frame: Up to ~32 months

    An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who discontinued study intervention due to an AE is presented.

  3. Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF.

    Time frame: Baseline and Days 169, 339, 509, 679, 849 and 924

    Mean Spleen volume reduction (mL) in participants with MF as measured by central laboratory imaging analysis of MRI (or CT where applicable) approximately every 48 weeks. Per protocol only participants with MF were analyzed for this outcome measure. The change in spleen volume from baseline is presented.

  4. Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events

    Time frame: Baseline and Days 29, 57, 85, 113, 141, 169, 198, 226, 254, 282, 310, 338, 367, 395, 423, 451, 479, 507, 536, 564, 592, 620, and 648

    Blood samples were taken at designated time points to determine platelet count. Percentage of participants with ET who achieve a reduction of platelet counts to <= 400 K/uL (400 x 10^9/L) in the absence of new thromboembolic events is presented.

Sponsors and collaborators

Lead sponsor

Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

Industry

Registry information

Official study title

A Multi-Center, Open Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Patients With Myeloproliferative Neoplasms (MPNs) Enrolled in a Prior Bomedemstat Clinical Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 4, 2022
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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