NCT05558696

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

A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bomedemstat in Patients With Polycythemia Vera (PV)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Polycythemia Vera

Interventions

Type	Name	Description
DRUG	Bomedemstat	Oral tablet

Timeline

• Start date: 2023-09-07
• Primary completion: 2025-03-24
• Completion: 2025-07-10
• First posted: 2022-09-28
• Last updated: 2025-07-29

Locations

17 sites across 3 countries: United States, Australia, United Kingdom

Regulatory

• FDA-regulated drug study