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RecruitingPhase 3

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

Merck Sharp & Dohme LLC · NCT06351631

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
400
US sites recruiting
4
Study start
May 23, 2024
Record last updated
April 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:

  • Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;
  • Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission.

No hypothesis testing will be conducted in this study.

Being studied: Bomedemstat

Conditions: Thrombocythemia, Essential; Primary Myelofibrosis; Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis; Polycythemia Vera

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of Michigan ( Site 6000)

    Ann Arbor, MI 48109

    Site contact: Study Coordinator · 734-763-4695

  • DUHS Duke Blood Cancer Center ( Site 6005)

    Durham, NC 27705

    Site contact: Study Coordinator · 919-668-1608

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)

    Columbus, OH 43210

    Site contact: Study Coordinator · 888-577-8839

  • UPMC Hillman Cancer Center ( Site 6004)

    Pittsburgh, PA 15232

    Site contact: Study Coordinator · 412-864-6627

Study contacts (from the official record)

  • Toll Free Number · 1-888-577-8839 · Trialsites@msd.com
A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017) (NCT06351631) | Bored Studies