Recruiting
Phase 3

Bomedemstat

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06351631

Conditions

Thrombocythemia, Essential

Primary Myelofibrosis

Myelofibrosis

Post-polycythemia Vera Myelofibrosis

Post-essential Thrombocythemia Myelofibrosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bomedemstat

Study Details

Brief summary:

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.

Conditions

Thrombocythemia, Essential

Primary Myelofibrosis

Myelofibrosis

Post-polycythemia Vera Myelofibrosis

Post-essential Thrombocythemia Myelofibrosis

Study ID

NCT06351631

Start date

May 23, 2024

Status verified date

Apr, 2026

Completion date

Dec 4, 2034

Anticipated

Primary completion date

Dec 4, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bomedemstat

Participants will receive oral capsules of bomedemstat once daily for up to 10 years, with the starting dose as the same dose that the participant was on at the time of transition from the feeder study.

Interventions

Bomedemstat

10, 15, 20, and 50 mg oral capsules

Primary outcome measure

  • Percentage of participants with one or more adverse events (AEs) [ Time Frame: Up to ~10 years ]
  • Percentage of participants who discontinued study treatment due to an AE [ Time Frame: Up to ~10 years ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

University of Michigan ( Site 6000)

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Study Coordinator

734-763-4695

DUHS Duke Blood Cancer Center ( Site 6005)

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Study Coordinator

919-668-1608

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

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Study Coordinator

888-577-8839

UPMC Hillman Cancer Center ( Site 6004)

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Study Coordinator

412-864-6627

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Apr 2, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-04-02.