Clinical trial · Interventional
A Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Polycythemia Vera (IMG-7289-CTP-203/MK-3543-004)
A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bomedemstat in Patients With Polycythemia Vera (PV)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of the orally administered lysine-specific demethylase 1 (LSD1) inhibitor bomedemstat, in participants with polycythemia vera (PV). At Week 36 of dosing, participants will be assessed for eligibility to receive additional treatment through Week 52. Participants deriving clinical benefit and safely tolerating bomedemstat will qualify for continued treatment at the Investigator's discretion.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycythemia Vera | Polycythemia Vera | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bomedemstat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bomedemstat
- description
- Participants will receive bomedemstat daily for 36 weeks and may qualify for additional treatment through Week 52 if deriving clinical benefit.
- interventionNames
- Drug: Bomedemstat
Primary outcomes (3)
- measure
- Number of Participants With Adverse Events (AEs)
- timeFrame
- Up to approximately 52 weeks
- description
- An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with one or more AEs are reported.
- measure
- Number of Participants Who Discontinued Study Intervention Due to AEs
- timeFrame
- Up to approximately 52 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Has a diagnosis of Polycythemia Vera per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms * Has a bone marrow fibrosis score of Grade 0 or Grade 1 * Has failed at least one standard cytoreductive therapy to lower hematocrit * Has a life expectancy \>36 weeks * Has discontinued prior cytoreductive therapy for 2 weeks (4 weeks for interferon) prior to study drug initiation Exclusion Criteria: * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater * Has unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1) * Has an uncontrolled active infection * Has a known human immunodeficiency virus (HIV) infection or active Hepatitis A, Hepatitis B or Hepatitis C virus infection * Has evidence of increased risk of bleeding, including known bleeding disorders * Is pregnant or lactating
References
Publications (0)
Data not yet available