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Sponsor: Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Conditions: Polycythemia Vera
Interventions: Bomedemstat
Countries: United States, Australia, United Kingdom
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Plantation, Florida, United States
- Skokie, Illinois, United States
- Ann Arbor, Michigan, United States
- Las Vegas, Nevada, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Salt Lake City, Utah, United States
- Sunshine Coast, Queensland, Australia
- Clayton, Victoria, Australia
- Perth, Western Australia, Australia
- Gloucester, England, United Kingdom
- Lincoln, Great Britain, United Kingdom
- London, Great Britain, United Kingdom
- Boston, Lincolnshire, United Kingdom
- London, London, City of, United Kingdom
- Newport, Wales, United Kingdom