NCT06351631

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Bomedemstat	10, 15, 20, and 50 mg oral capsules

Timeline

• Start date: 2024-05-23
• Primary completion: 2034-12-04
• Completion: 2034-12-04
• First posted: 2024-04-08
• Last updated: 2026-04-02

Locations

21 sites across 6 countries: United States, Australia, Hong Kong, Italy, New Zealand, United Kingdom

Regulatory

• FDA-regulated drug study