Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003)

April 13, 2026 updated by: Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy and Pharmacodynamics of IMG-7289 in Patients With Essential Thrombocythemia

This is a Phase 2b open label study of an orally administered LSD1 inhibitor, Bomedemstat (MK-3543, formerly called IMG-7289), in patients with essential thrombocythemia.

This study investigates the following:

  • The safety and tolerability of Bomedemstat
  • The pharmacodynamic effect of Bomedemstat

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 2 multi-center, open-label study evaluating the safety, efficacy and pharmacodynamics of Bomedemstat administered orally once daily in patients with essential thrombocythemia (ET). Patients will be dosed with Bomedemstat for 169 consecutive days in the Initial Treatment Period (ITP). Qualifying patients may continue to receive Bomedemstat in the Additional Treatment Period (ATP).

Safety will be evaluated by clinical assessments of safety parameters i.e., safety laboratory testing, adverse event reporting, physical examination and vital sign assessments. Pharmacodynamics will be evaluated by hematology assessment, patient reported symptom burden, change in spleen size by palpation and other measures.

To ensure safety, a Safety Advisory Board will perform periodic reviews of safety parameters and pharmacodynamic markers.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Brisbane
      • Herston, Brisbane, Australia
        • Local Institution
    • New South Wales
      • Camperdown, New South Wales, Australia
        • Local Institution
      • St Leonards, New South Wales, Australia, 2065
        • Local Institution
    • Queensland
      • Southport, Queensland, Australia
        • Local Institution
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Local Institution
  • Germany
      • Essen, Germany, 45147
        • Department of Hematology and Stem Cell Transplantation, West German Cancer Center (WTZ)
      • Jena, Germany
        • Local Institution
  • Hong Kong
      • Hong Kong, Hong Kong
        • Local Institution
  • Italy
      • Alessandria, Italy
        • Local Institution
      • Bologna, Italy
        • Local Institution
      • Florence, Italy, 50139
        • CRIMM; Centro Ricerca e Innovazione delle Malattia Mieloproliferative, Azienda ospedaliera Universitaria Careggi
      • Varese, Italy
        • Local Institution
  • New Zealand
      • Auckland, New Zealand
        • Middlemore Hospital
      • Auckland, New Zealand
        • Local Institution
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guys and St Thomas Hospital
      • London, United Kingdom, NW1
        • Local Institution
      • London, United Kingdom, W12
        • Local Institution
      • Oxford, United Kingdom
        • Local Institution
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Local Institution
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Local Institution
    • New York
      • New York, New York, United States, 10021
        • Local Institution
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Local Institution
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution
    • Washington
      • Seattle, Washington, United States, 98109
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms.
  • Requires treatment in order to lower platelet count based on patient age over 60 or history of thrombosis.
  • Have failed at least one standard therapy
  • Must have discontinued ET therapy at least 1 week (4 weeks for interferon) prior to study drug initiation.

Exclusion Criteria:

  • Has undergone major surgery ≤4 weeks prior to starting study drug or has not recovered from side effects of such surgery.
  • Unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1).
  • Uncontrolled active infection.
  • Current use of prohibited medications
  • Known HIV infection or active Hepatitis B or Hepatitis C virus infection
  • Other hematologic/biochemistry requirements, as per protocol
  • Use of investigational agent within last 14 days
  • Pregnant or lactating females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bomedemstat
Bomedemstat administered daily for 169 consecutive days
Drug: Bomedemstat
Oral administration
Other Names:
  • IMG-7289
  • MK-3543

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experienced an Adverse Event (AE)
Time Frame: Up to approximately 30 months
An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during the study, in conjunction with the use of the drug or biologic, whether or not product related. This includes any untoward signs or symptoms experienced by the participant from the time of first dose with study treatment until completion of the study. The number of participants who experienced an AE is reported.
Up to approximately 30 months
Number of Participants Who Discontinued Study Treatment Due to an AE
Time Frame: Up to approximately 28 months
An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in the study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient from the time of first dose with study treatment until completion of the study. The number of participants who discontinued study treatment due to an AE is reported.
Up to approximately 28 months
Percentage of Participants With Platelet Count ≤400 k/μL at Day 169
Time Frame: Up to day 169
Blood samples were collected at pre-specified timepoints to determine platelet counts. The percentage of participants who achieved reduction in platelet count to ≤400k/μL in the absence of new thrombolytic events is reported.
Up to day 169

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2020

Primary Completion (Actual)

March 23, 2023

Study Completion (Actual)

March 23, 2023

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

February 2, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMG-7289-CTP-201
  • MK-3543-003 (Other Identifier: Merck)
  • 2019-003659-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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