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Comparing bomedemstat and hydroxyurea for treating essential thrombocythemia

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

PHASE3 · Merck Sharp & Dohme LLC · NCT06456346

This study is testing if a new drug called bomedemstat works better than hydroxyurea for treating essential thrombocythemia in people who haven't had treatment before.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC (industry)
Locations170 sites (Glendale, Arizona and 169 other locations)
Trial IDNCT06456346 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of bomedemstat compared to hydroxyurea in patients with essential thrombocythemia who have not previously received cytoreductive therapy. The primary objective is to determine if bomedemstat provides a superior durable clinicohematologic response compared to hydroxyurea. Participants will be monitored for their response to treatment and any adverse effects. The study includes both active treatments and placebo groups to ensure robust results.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with essential thrombocythemia who require cytoreductive therapy and have not received prior treatment.

Not a fit: Patients with gastrointestinal impairments that could interfere with drug absorption may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with essential thrombocythemia.

How similar studies have performed: Previous studies have shown promise in using similar approaches for treating myeloproliferative neoplasms, but this specific comparison is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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
* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
* Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable

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

Where this trial is running

Glendale, Arizona and 169 other locations

+120 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Essential Thrombocythemia, essential thrombocythemia, ET, bomedemstat, IMG-7289

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.