A Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Polycythemia Vera (IMG-7289-CTP-203/MK-3543-004)
Completed · Phase 2
Conditions studied: Polycythemia Vera
In brief
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.
Key facts
- Study ID
- NCT05558696
- Run by
- Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
- People needed
- 20
- Starts
- 2023-09-07
- Expected to finish
- 2025-07-10
- Last updated by the study team
- 2026-05-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- BRCR Global ( Site 0120) — Plantation, Florida, United States
- Hematology Oncology of the North Shore ( Site 0104) — Skokie, Illinois, United States
- University of Michigan Comprehensive Cancer Center ( Site 0008) — Ann Arbor, Michigan, United States
- Comprehensive Cancer Centers of Nevada - Peak ( Site 0118) — Las Vegas, Nevada, United States
- Duke University Medical Center ( Site 0016) — Durham, North Carolina, United States
- Ohio State University Comprehensive Cancer Center ( Site 0103) — Columbus, Ohio, United States
- OHSU Knight Cardiovascular Institute Cardiology Clinic - South Waterfront ( Site 0102) — Portland, Oregon, United States
- Huntsman Cancer Hospital at the University of Utah ( Site 0119) — Salt Lake City, Utah, United States
- Sunshine Coast Hematology and Oncology Clinic (Site 0506) — Sunshine Coast, Queensland, Australia
- Monash Medical Centre ( Site 0006) — Clayton, Victoria, Australia
- Royal Perth Hospital ( Site 0504) — Perth, Western Australia, Australia
- Gloucestershire Royal Hospital ( Site 0205) — Gloucester, England, United Kingdom
- United Lincolnshire Hospitals NHS Trust ( Site 0204) — Lincoln, Great Britain, United Kingdom
- Imperial College London ( Site 0025) — London, Great Britain, United Kingdom
- Boston Pilgrim Hospital ( Site 0207) — Boston, Lincolnshire, United Kingdom
- Guys and St Thomas NHS Foundation Trust - Guys Hospital ( Site 0020) — London, London, City of, United Kingdom
- Royal Gwent Hospital ( Site 0201) — Newport, Wales, United Kingdom
Full record on ClinicalTrials.gov
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