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Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003)
Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003)

NCT04254978

CompletedPhase 2

Sponsor: Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

Conditions: Essential Thrombocythemia

Interventions: Bomedemstat

Countries: United States, Australia, Germany, Hong Kong, Italy, New Zealand, United Kingdom

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (26)
  • Jacksonville, Florida, United States
  • Ann Arbor, Michigan, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Seattle, Washington, United States
  • Herston, Brisbane, Australia
  • Camperdown, New South Wales, Australia
  • St Leonards, New South Wales, Australia
  • Southport, Queensland, Australia
  • Adelaide, South Australia, Australia
  • Clayton, Victoria, Australia
  • Essen, Germany
  • Jena, Germany
  • Hong Kong, Hong Kong
  • Alessandria, Italy
  • Bologna, Italy
  • Florence, Italy
  • Varese, Italy
  • Auckland, New Zealand
  • Auckland, New Zealand
  • London, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • Oxford, United Kingdom