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

NCT06456346 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-22

No results posted yet for this study

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

DRUG

Bomedemstat

Oral capsule

DRUG

Hydroxyurea

Oral capsule

DRUG

Bomedemstat placebo

Oral capsule placebo

DRUG

Hydroxyurea placebo

Oral capsule placebo

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-16
Primary Completion
2027-09-28
Completion
2028-03-24
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06456346 on ClinicalTrials.gov