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Evaluating the safety and effectiveness of bomedemstat for blood disorders

A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06351631

This study is trying to see how safe and effective bomedemstat is for people with blood disorders like essential thrombocythemia and myelofibrosis who have been doing well on the treatment for at least six months.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations21 sites (Ann Arbor, Michigan and 20 other locations)
Trial IDNCT06351631 on ClinicalTrials.gov

What this trial studies

This study aims to transition participants who have been safely tolerating bomedemstat into an extension phase to gather long-term safety and efficacy data. Participants must have received at least six months of treatment with bomedemstat and show clinical benefit as assessed by the investigator. The study focuses on individuals with essential thrombocythemia and myelofibrosis who have achieved confirmed hematologic remission. No hypothesis testing will be conducted, emphasizing observational data collection.

Who should consider this trial

Good fit: Ideal candidates are individuals who have previously participated in bomedemstat studies and have shown clinical benefit while tolerating the treatment.

Not a fit: Patients who have not previously received bomedemstat or those who have not achieved hematologic remission will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable long-term safety and efficacy data for patients with specific blood disorders.

How similar studies have performed: Other studies involving bomedemstat have shown promise, indicating a potential for success in this extension phase.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck \& Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready
* Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator
* ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator
* Is not currently on a dose hold
* Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat

Exclusion Criteria:

* Has received prohibited concomitant medications
* Ongoing or planned participation in another investigational study
* Has noncompliance in prior bomedemstat study receiving \<90% of assigned doses excluding suspensions or holds as assigned by the investigator

Where this trial is running

Ann Arbor, Michigan and 20 other locations

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 Thrombocythemia, EssentialPrimary MyelofibrosisMyelofibrosisPost-polycythemia Vera MyelofibrosisPost-essential Thrombocythemia MyelofibrosisPolycythemia Vera
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.