A Study of Bomedemstat (MK-3543) in Participants With Polycythemia Vera (MK-3543-004)

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.

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 B or Hepatitis C virus infection
Has evidence of increased risk of bleeding, including known bleeding disorders
Is pregnant or lactating

Additional locations may be listed on ClinicalTrials.gov for NCT05558696.

See trial information on ClinicalTrials.gov for a list of participating sites.

With Amendment 3, after all ongoing participants have reached 52 weeks of treatment,

eligible participants may transition to a bomedemstat extension study if available. With

Amendment 4, all secondary PK and patient reported outcome measures were designated as

exploratory.

Trial PhasePhase II

Trial Typetreatment

Lead OrganizationImago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

Primary ID3543-004
Secondary IDsNCI-2023-08587, IMG-7289, MK-3543-004
ClinicalTrials.gov IDNCT05558696

A Study of Bomedemstat (MK-3543) in Participants With Polycythemia Vera (MK-3543-004)

Inclusion Criteria

Exclusion Criteria

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A Study of Bomedemstat (MK-3543) in Participants With Polycythemia Vera (MK-3543-004)

Description

Eligibility Criteria

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Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

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