drugset / Trial / NCT06456346

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

NCT06456346

Phase 3 Active not recruiting 300 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-07-16
Primary completion
2027-09-28
Completion
2028-03-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Bomedemstat Small molecule Oral
Comparator Hydroxyurea Other / unclassified Oral