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

NCT ID: NCT05223920

Last Updated: 2025-09-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2024-08-22

Brief Summary

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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').

Detailed Description

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Conditions

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Thrombocythemia, Essential Primary Myelofibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bomedemstat

All participants will receive bomedemstat via oral capsule daily for 169 days with additional treatment continuing in patients deriving clinical benefit.

Group Type EXPERIMENTAL

Bomedemstat

Intervention Type DRUG

Capsule (oral)

Interventions

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Bomedemstat

Capsule (oral)

Intervention Type DRUG

Other Intervention Names

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IMG-7289 MK-3543

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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University of Miami Leonard M. Miller

Miami, Florida, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

UMPC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Site Status

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Site Status

Gold Coast Hospital and Health Service

Southport, Queensland, Australia

Site Status

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Universittsklinikum Essen

Essen, , Germany

Site Status

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Ospedale di Circolo-a Fondazione Macchi

Varese, VA, Italy

Site Status

Azienda Ospedaliera SS. Antonio

Alessandria, , Italy

Site Status

Azienda Ospedaliero-Universitaria Careggi - S.O.D. Ematologia (CRIMM)

Florence, , Italy

Site Status

Azienda Ospedaliero Universitaria di Bologna

Pavia, , Italy

Site Status

Middlemore Clinical Trials

Papatoetoe, Aukland, New Zealand

Site Status

Waitemata District Health Board

Takapuna, Aukland, New Zealand

Site Status

University College London Hospitals NHS Foundation Trust

London, , United Kingdom

Site Status

Guy's and Saint Thomas' NHS Foundation Trus

London, , United Kingdom

Site Status

Countries

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United States Australia Germany Hong Kong Italy New Zealand United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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MK-3543-005

Identifier Type: OTHER

Identifier Source: secondary_id

IMG-7289

Identifier Type: OTHER

Identifier Source: secondary_id

2021-002452-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IMG-7289-CTP-202

Identifier Type: -

Identifier Source: org_study_id

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