Bomedemstat for Polycythemia Vera

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests a pill called bomedemstat for patients with polycythemia vera, a condition with too many red blood cells. The pill works by blocking an enzyme to reduce red blood cells and improve symptoms like an enlarged spleen.

Eligibility Criteria

This trial is for people with Polycythemia Vera who haven't responded well to at least one standard treatment. They should have a certain level of platelets and white blood cells, expect to live more than 36 weeks, and meet specific diagnostic criteria. Those with severe physical limitations, unresolved side effects from past treatments, certain infections or bleeding risks, pregnant or breastfeeding women, or on prohibited meds can't join.

Inclusion Criteria

My bone marrow fibrosis is minimal.

Has a life expectancy >36 weeks

I have tried at least one standard treatment to lower my blood volume without success.

+2 more

Exclusion Criteria

I have HIV or active Hepatitis B/C.

I have an ongoing infection that isn't under control.

Is pregnant or lactating

+3 more

Participant Groups

The study tests Bomedemstat (MK-3543), an oral drug that targets LSD1 enzymes in patients with Polycythemia Vera. The goal is to see if it's safe and can manage the disease by reducing blood counts, improving symptoms, and shrinking enlarged spleens within 36 weeks.

1Treatment groups

Experimental Treatment

Group I: BomedemstatExperimental Treatment1 Intervention

Participants will receive bomedemstat daily for 36 weeks and may qualify for additional treatment through Week 52 if deriving clinical benefit.