NCT06456346

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bomedemstat (MK-3543) Versus Hydroxyurea in Cytoreductive Therapy Naïve Essential Thrombocythemia Participants

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.

Conditions

• Essential Thrombocythemia

Interventions

Type	Name	Description
DRUG	Bomedemstat	Oral capsule
DRUG	Hydroxyurea	Oral capsule
DRUG	Bomedemstat placebo	Oral capsule placebo
DRUG	Hydroxyurea placebo	Oral capsule placebo

Timeline

• Start date: 2024-07-16
• Primary completion: 2027-09-28
• Completion: 2028-03-24
• First posted: 2024-06-13
• Last updated: 2026-04-16

Locations

166 sites across 23 countries: United States, Argentina, Australia, Austria, Canada, Chile, China, Colombia, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Poland, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study