drugset / Trial / NCT06079879
A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response (DCHR).
Timeline
- Start
- 2023-12-31
- Primary completion
- 2027-07-30
- Completion
- 2028-08-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anagrelide | Small molecule | — | Oral |
| Subject | Bomedemstat | Small molecule | 50 mg | Oral |
| Comparator | Busulfan | Small molecule | — | Oral |
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | Peginterferon alfa-2b | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | Ruxolitinib | Small molecule | — | Oral |
| Comparator | interferon alfa | Protein / enzyme biologic | — | Subcutaneous |