IRB #

STUDY00019144

Title

A Two-Part, Randomized, Open-label, Multicenter, Phase 2a/2b
Study of the Efficacy, Safety, and Pharmacokinetics of KRT-232
Compared to Ruxolitinib in Patients with Phlebotomy-Dependent
Polycythemia Vera

Principal Investigator

Uma Borate

Study Purpose

In this study, we will learn about a drug called KRT-232. KRT-232 will be called “the study drug”. This is the first study the study drug is used for participants with polycythemia vera (PV). This study will evaluate how well tolerated the study drug is when given to participants with PV, and whether the study drug can improve your PV. The study drug has been given to about 170 participants with different cancers and disorders (other than PV). Some of these studies are ongoing.

The study drug is a small molecule inhibitor and can reverse a mechanism through which unhealthy or tumor cells can survive and grow. This study will test if the study drug can restore the function of your healthy bone marrow cells and reduce the symptoms of your PV.

Medical Condition(s)

Polycthemia vera

Eligibility Criteria

Eligible subjects must meet the following:
-Be at least 18 years or older,
-Have been diagnosed with polycythemia vera, and
-You are dependent on phlebotomy (removal of blood from a vein) to maintain the amount of red blood cells in your body.

Age Range

18 - n/a

Healthy Volunteers Needed

No

Duration of Participation

If you participate in the study, the amount of time you will be on study treatment or be followed up for health information as part of the study depends on how you respond to the study treatment.

You will continue study drug treatment until your PV worsens or until you can no longer tolerate study drug treatment. If you stop study drug treatment, your investigator will continue to follow-up with you to see how well you are and discuss with you if treatment outside of this study is necessary. You will be contacted approximately every 12 weeks from your last dose of study drug.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Kartos Therapeutics, Inc.

Recruitment End

01/01/2028

Compensation Provided

No


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