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Comparing bomedemstat to the best available therapy for essential thrombocythemia

A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543/IMG-7289) Versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia Who Have an Inadequate Response to or Are Intolerant of Hydroxyurea

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06079879

This study is testing a new treatment called bomedemstat to see if it works better than the best current options for people with essential thrombocythemia who haven't had success with hydroxyurea.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment340 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionsruxolitinib
Locations163 sites (Glendale, Arizona and 162 other locations)
Trial IDNCT06079879 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of bomedemstat (MK-3543) in comparison to the best available therapy (BAT) for patients with essential thrombocythemia (ET) who have not responded adequately to or are intolerant of hydroxyurea. The primary hypothesis is that bomedemstat will demonstrate a superior durable clinicohematologic response (DCHR) compared to BAT. Participants will be monitored for their response to treatment and any adverse effects. The study aims to provide a new therapeutic option for patients struggling with existing treatments.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with essential thrombocythemia who have had an inadequate response to or intolerance of hydroxyurea.

Not a fit: Patients who have not been diagnosed with essential thrombocythemia or those who have not experienced issues with hydroxyurea may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective option for patients with essential thrombocythemia who do not respond to hydroxyurea.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific treatment is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms (confirmed by a central pathologist)
* 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 a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance
* Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive therapy
* Has a platelet count \> 450 × 10\^9/L (450k /μL) assessed up to 72 hours before first dose of study intervention
* Has an absolute neutrophil count (ANC) ≥0.75 × 10\^9/L assessed up to 72 hours before first dose of study intervention
* Participants may have received up to 3 prior ET-directed cytoreductive agents including hydroxyurea

Exclusion Criteria:

* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or lysine demethylase or monoamine oxidase inhibitor (LSDi or MAOi) or the chosen best available therapy (including anagrelide, interferon alfa/pegylated interferon, ruxolitinib, or busulfan) that contraindicates participation
* History of any illness/impairment of GI function that might interfere with drug absorption (eg, chronic diarrhea or history of gastric bypass surgical procedure), confound the study results or pose an additional risk to the individual by participation in the study
* Evidence at the time of Screening of increased risk of bleeding
* History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
* Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Where this trial is running

Glendale, Arizona and 162 other locations

+113 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 → Find more trials like this →
Conditions Essential Thrombocythemiaessential thrombocythemiaETbomedemstatIMG-7289
Last reviewed 2026-06-13 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.