Imago_IMG-7289-CTP-203_Ph2 Bomedemstat in PV (Polycythemia Vera) - Clinical Trial

What is the Purpose of this Study?

Treatment

We are doing this study to find the most effective, safe dose of an experimental drug called Bomedemstat (the study drug). We want to know how well this study drug works in people with PV.

What is the Condition Being Studied?
Objective

Polycythemia Vera (PV)

Who Can Participate in the Study?

Key Eligibility

Adults ages 18+ who:
- Are diagnosed with Polycythemia Vera
- Have bone marrow fibrosis score of Grade 0 or Grade 1
- Have failed at least one standard of cytoreductive therapy to lower hematocrit (failure is the equivalent of resistance or intolerance).

For more information about who can join this study, please contact the study team at 919-660-7262.

Age Group
Adults

What is Involved?

Description

If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
- Have a physical exam
- Have spleen palpation
- Have a heart scan (ECG)
- Have blood draws

After the screening period, you will take the study drug by mouth once a day at the same time each day.

When you complete 36 weeks of dosing, if your study doctor decides you are benefiting, you may continue to receive the study drug.

Study Details

Full Title
A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bomedemstat in Patients with Polycythemia Vera
Principal Investigator
Hematologic Oncologist
Protocol Number
IRB: PRO00112278
NCT: NCT05558696
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment