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

NCT06351631 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-04-02

No results posted yet for this study

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
  • Polycythemia Vera

Interventions

DRUG

Bomedemstat

10, 15, 20, and 50 mg oral capsules

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp and Dohme LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-23
Primary Completion
2034-12-04
Completion
2034-12-04
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Hong Kong
  • Italy
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06351631 on ClinicalTrials.gov