NCT06079879

A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)

A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543/IMG-7289) Versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia Who Have an Inadequate Response to or Are Intolerant of Hydroxyurea

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response (DCHR).

Conditions

• Essential Thrombocythemia

Interventions

Type	Name	Description
DRUG	Bomedemstat	Oral Capsule
DRUG	Anagrelide	Oral Capsule
DRUG	Busulfan	Oral Tablet
DRUG	Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b	Subcutaneous Solution
DRUG	Ruxolitinib	Oral Tablet

Timeline

• Start date: 2023-12-31
• Primary completion: 2027-07-30
• Completion: 2028-08-18
• First posted: 2023-10-12
• Last updated: 2026-03-13

Locations

161 sites across 24 countries: United States, Argentina, Australia, Belgium, Canada, China, Colombia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Netherlands, New Zealand, Poland, Portugal, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study