Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called bomedemstat or hydroxyurea in people with essential thrombocythemia (ET). We also want to know which of these options works best for most people.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with ET and appropriate for cytoreductive therapy
- Have a bone marrow fibrosis score of Grade 0 or Grade 1
- Have never received any form of cytoreductive treatment
- Are able to take hydroxyurea
What is Involved?
Description
If you decide to participate in this study, you will have a screening visit to see if you are eligible for this study.
If you are eligible to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- Group 1: you will take bomedemstat and placebo (inactive substance or "sugar pill") for hydroxyurea
- Group 2: will take hydroxyurea and placebo for bomedemstat
- Full physical examination
- 12-lead ECG
- Blood for safety assessments and urine or serum for pregnancy
- Bone marrow aspirate and biopsy
- Blood for pharmacokinetics and biomarker assessments
Study Details
Full Title
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
Clinical Study to Evaluate the Efficacy and Safety of Bomedemstat (MK-3543) versus
Hydroxyurea in Cytoreductive Therapy Naïve Essential Thrombocythemia Participants
Principal Investigator
Lindsay
Rein
Protocol Number
PRO00115732
NCT ID
NCT06456346
Phase
III
Enrollment Status
Open to Enrollment