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A Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Polycythemia Vera (IMG-7289-CTP-203/MK-3543-004)
Sponsor: Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Summary
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.
Official title: A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bomedemstat in Patients With Polycythemia Vera (PV)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-09-07
Completion Date
2025-07-10
Last Updated
2026-05-07
Healthy Volunteers
No
Conditions
Interventions
Bomedemstat
Oral capsule
Locations (17)
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