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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504865-21-00

Acronym

MK-3543-006

Enrollment

155

Registered

2024-03-26

Start date

2024-04-15

Completion date

Unknown

Last updated

2025-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Thrombocythemia patients who have an inadequate response to or are intolerant of hydroxyurea

Brief summary

Durable Clinicohematologic Response (DCHR) Rate

Detailed description

Change from Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 Individual Fatigue Symptom Item Score, Change from Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Fatigue SF-7a Total Fatigue Score, Change from Baseline in Total Symptom Score as Measured on the MFSAF v4.0, Duration of Clinicohematologic Response (DOCHR), Duration of Hematologic Remission (DOHR), Percentage of Participants with Thrombotic Events, Percentage of Participants with Major Hemorrhagic Events, Disease Progression Rate, Number of Participants with An Adverse Event (AE), Number of Participants Discontinuing from Study Therapy Due to an AE

Interventions

DRUGMK-3543

DRUGBUSULFAN

DRUGPEGINTERFERON ALFA-2A

DRUGRUXOLITINIB

DRUGANAGRELIDE HYDROCHLORIDE MONOHYDRATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Durable Clinicohematologic Response (DCHR) Rate	—

Secondary

Measure	Time frame
Change from Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 Individual Fatigue Symptom Item Score, Change from Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Fatigue SF-7a Total Fatigue Score, Change from Baseline in Total Symptom Score as Measured on the MFSAF v4.0, Duration of Clinicohematologic Response (DOCHR), Duration of Hematologic Remission (DOHR), Percentage of Participants with Thrombotic Events, Percentage of Participants with Major Hemorrhagic Events, Disease Progression Rate, Number of Participants with An Adverse Event (AE), Number of Participants Discontinuing from Study Therapy Due to an AE	—

Measure

Time frame

—

Countries

Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026