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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
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505232-36-00
Acronym
MK-3543-007
Enrollment
153
Registered
2024-09-30
Start date
2024-11-15
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

Brief summary

Durable Clinicohematologic Response (DCHR) Rate.

Detailed description

Change From Baseline in Myelofibrosis Symptom Assessment Form version 4.0 (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 MFSAF v4.0 Total Symptom Score., Duration of Clinicohematologic Response (DOCHR)., Duration of Hematologic Remission (DOHR)., Number of Participants Who Experience Thrombotic Events., Number of Participants Who Experience Major Hemorrhagic Events., Disease Progression Rate., Number of Participants Who Experience One or More Adverse Events (AEs), Number of Participants Who Discontinue Study Intervention Due to an AE.

Interventions

DRUGPlacebo for Bomedemstat
DRUGPlacebo for hydroxycarbamide

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Durable Clinicohematologic Response (DCHR) Rate.

Secondary

MeasureTime frame
Change From Baseline in Myelofibrosis Symptom Assessment Form version 4.0 (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 MFSAF v4.0 Total Symptom Score., Duration of Clinicohematologic Response (DOCHR)., Duration of Hematologic Remission (DOHR)., Number of Participants Who Experience Thrombotic Events., Number of Participants Who Experience Major Hemorrhagic Events., Disease Progression Rate., Number of Participants Who Experience One or More Adverse Events (AEs), Number of Participants Who Discontinue Study Intervention Due to an AE.

Countries

Austria, Denmark, France, Germany, Hungary, Italy, Poland, Spain, Sweden

Outcome results

None listed

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