Phase 2
Completed N=73
Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003)
Source: ClinicalTrials.gov NCT04254978 ↗Enrolled (actual)
73
Serious AEs
37.0%
Results posted
Apr 2024
Primary outcomePrimary: Number of Participants Who Experienced an Adverse Event (AE) — 73 Participants
Summary
This is a Phase 2b open label study of an orally administered LSD1 inhibitor, Bomedemstat (MK-3543, formerly called IMG-7289), in patients with essential thrombocythemia.
This study investigates the following:
* The safety and tolerability of Bomedemstat
* The pharmacodynamic effect of Bomedemstat
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced an Adverse Event (AE) |
73 | — |
| PRIMARY Number of Participants Who Discontinued Study Treatment Due to an AE |
11 | — |
| PRIMARY Percentage of Participants With Platelet Count ≤400 k/μL at Day 169 |
76.6 | <.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms.
- Requires treatment in order to lower platelet count based on patient age over 60 or history of thrombosis.
- Have failed at least one standard therapy
- Must have discontinued ET therapy at least 1 week (4 weeks for interferon) prior to study drug initiation.
Exclusion Criteria
- Has undergone major surgery ≤4 weeks prior to starting study drug or has not recovered from side effects of such surgery.
- Unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1).
- Uncontrolled active infection.
- Current use of prohibited medications
- Known HIV infection or active Hepatitis B or Hepatitis C virus infection
- Other hematologic/biochemistry requirements, as per protocol
- Use of investigational agent within last 14 days
- Pregnant or lactating females
Data sourced from ClinicalTrials.gov (NCT04254978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.