A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bomedemstat in Patients With Polycythemia Vera (PV)
A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bomedemstat in Patients With Polycythemia Vera (PV)
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.
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 participant reported outcome measures were designated as exploratory.
Per protocol, participants who derived clinical benefit (no progressive disease) and safely tolerated drug may have qualified for enrollment into the bomedemstat extension study (NCT06351631).
Inclusion Criteria:
Exclusion Criteria:
Ann Arbor, Michigan 48109, United States
Portland, Oregon 97239-4503, United States
Salt Lake City, Utah 84112, United States
London, London, City of SE1 9RT, United Kingdom