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Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bomedemstat (MK-3543) Versus Hydroxyurea in Cytoreductive Therapy Naïve Essential Thrombocythemia Participants

NCT06456346•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and an indication for cytoreductive therapy regardless of age or risk status
•Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis
•Has received no prior cytoreductive treatment for their ET
•Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy

Exclusion Criteria

•History of any illness/impairment of gastrointestinal function that might interfere with drug absorption
•History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
•HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
•Has an active infection requiring systemic therapy
•Has had a major surgery \<4 weeks prior to first dose of study intervention or has not recovered from side effects of major surgery \>4 weeks prior to first dose

Locations (166)

Palo Verde Cancer Specialists ( Site 0052)

Glendale, Arizona, United States

Los Angeles Cancer Network ( Site 0025)

Glendale, California, United States

Stanford Cancer Center ( Site 0024)

Palo Alto, California, United States

Exempla Lutheran Medical Center ( Site 0014)

Golden, Colorado, United States

Yale University School of Medicine ( Site 0051)

New Haven, Connecticut, United States

Parkview Research Center at Parkview Regional Medical Center ( Site 0006)

Fort Wayne, Indiana, United States

University of Michigan ( Site 0003)

Ann Arbor, Michigan, United States

Optum Care Cancer Center ( Site 0053)

Las Vegas, Nevada, United States

Levine Cancer Institute ( Site 0009)

Charlotte, North Carolina, United States

Duke University Health System (DUHS) ( Site 0012)

Durham, North Carolina, United States

Key Dates

Start Date

July 16, 2024

Primary Completion Date

September 28, 2027

Completion Date

March 24, 2028

Last Updated

March 20, 2026

Enrollment

300

ESTIMATED participants

Conditions

Essential Thrombocythemia

Interventions

Bomedemstat

DRUG

Hydroxyurea

DRUG

Bomedemstat placebo

DRUG

Hydroxyurea placebo

DRUG

Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@msd.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

Inclusion Criteria

Exclusion Criteria

A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)

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