Purpose of this Study
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.
Who Can Participate?
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.
- 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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes
What is Involved?
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.
- 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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
Lindsay
Rein
Protocol Number
PRO00112278
NCT ID
NCT05558696
Phase
II
Enrollment Status
OPEN TO ACCRUAL