What is bomedemstat studying for blood disorders like essential thrombocythemia and polycythemia vera?

Bomedemstat is being studied to collect long-term safety and effectiveness data for people with certain blood disorders who have been using the drug. Researchers are evaluating how well the treatment is tolerated and its impact over time. This study is sponsored by Merck Sharp & Dohme LLC and focuses on ongoing monitoring rather than testing new hypotheses.

Who may be eligible for this blood disorder clinical trial?

Adults 18 years and older who have previously participated in a bomedemstat study may be eligible. Participants must be safely tolerating bomedemstat and receiving benefit, with some needing confirmed blood count remission. There are no gender restrictions. Please review eligibility criteria for more details.

Is there any cost to participate in this blood disorder clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06351631

A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for Participants From Prior Bomedemstat Clinical Studies

Led by Merck Sharp & Dohme LLC · Updated on 2026-04-02

400

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to collect long-term safety and efficacy data for participants who have been using bomedemstat and are benefiting from it, or have achieved blood count remission in certain conditions. The study includes individuals with essential thrombocythemia ET, polycythemia vera PV, and myelofibrosis MF who have previously been in earlier bomedemstat trials. It does not involve hypothesis testing but focuses on extended monitoring. Participants will take oral bomedemstat capsules once daily for up to 10 years. The dose they start with will be the same as they used in their previous study before transitioning into this extension. This allows continuous assessment of the effects and safety of the medication over a long period. During the study, participants will be closely monitored for adverse events and any reasons for stopping treatment due to side effects. For those with ET or PV, the duration of their clinical response and remission will be tracked, as well as any progression to more severe conditions. Other outcomes include the frequency of blood clots and bleeding events. Participant involvement may last up to about 10 years, with regular assessments and safety checks throughout.

CONDITIONS

Brief Title

A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants must have been part of a bomedemstat study sponsored by Imago BioSciences, Inc. or Merck Sharp & Dohme LLC
Must have received at least 6 months of bomedemstat treatment in the IMG-7289-202/MK-3543-005 study while tolerating it safely and benefiting clinically
ET and PV participants from other feeder studies must have achieved confirmed hematologic remission and be safely tolerating bomedemstat with clinical benefit
Must not currently be on a dose hold
Must be able to swallow oral medication and follow home dosing instructions

You will not qualify if you...

Use of prohibited medications during the study
Participation in another investigational study ongoing or planned
Noncompliance in prior bomedemstat study with less than 90% of assigned doses taken, excluding suspensions or holds assigned by the investigator

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