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

Imago BioSciences

Status and phase: Completed; Phase 2

Conditions: Polycythemia Vera

Treatments: Drug: Bomedemstat

Study type: Interventional

Funder types: Industry

Identifiers

NCT05558696

MK-3543-004 (Other Identifier)

3543-004

IMG-7289 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Bomedemstat

Experimental group

Description:

Participants will receive bomedemstat daily for 36 weeks and may qualify for additional treatment through Week 52 if deriving clinical benefit.

Treatment:

Drug: Bomedemstat