NCT05558696

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2023

Geographic Reach
3 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

September 7, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2025

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

September 20, 2022

Last Update Submit

July 28, 2025

Conditions

Polycythemia Vera

Keywords

polycythemia verabomedemstat

Outcome Measures

Primary Outcomes (3)

  • Number of participants with adverse events (AEs)

    An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with one or more AEs will be reported.

    Up to ~56 weeks

  • Number of participants who discontinued study intervention due to AEs

    An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to AEs will be reported.

    Up to ~52 weeks

  • Number of participants with sustained change from baseline of hematocrit to <45% without concomitant phlebotomy at Week 36

    Hematocrit will be analyzed by taking blood samples from participants at designated time points during the study. The number of participants who have achieved a sustained change from baseline of hematocrit to \<45% without concomitant phlebotomy at Week 36 will be reported.

    Baseline through Week 36

Secondary Outcomes (9)

  • Duration of reduction of hematocrit to <45% without phlebotomy

    Baseline through Week 36

  • Number of participants with platelet count ≤ 450 x 10^9/L at Week 36

    Baseline through Week 36

  • Duration of platelet count ≤ 450 x 10^9/L in participants at Week 36

    Baseline through Week 36

  • Number of participants with white blood cell (WBC) count of <10 x 10^9/L at Week 36

    Baseline through Week 36

  • Duration of white blood cell (WBC) count <10 x 10^9/L in participants at Week 36

    Baseline through Week 36

  • +4 more secondary outcomes

Study Arms (1)

Bomedemstat

EXPERIMENTAL

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

Drug: Bomedemstat

Interventions

BomedemstatDRUG

Oral tablet

Also known as: MK-3543, IMG-7289
Bomedemstat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has a diagnosis of Polycythemia Vera per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms
  • Has a bone marrow fibrosis score of Grade 0 or Grade 1
  • Has failed at least one standard cytoreductive therapy to lower hematocrit
  • Has a life expectancy \>36 weeks
  • Has discontinued prior cytoreductive therapy for 2 weeks (4 weeks for interferon) prior to study drug initiation

You may not qualify if:

  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater
  • Has unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1)
  • Has an uncontrolled active infection
  • Has a known human immunodeficiency virus (HIV) infection or active Hepatitis B or Hepatitis C virus infection
  • Has evidence of increased risk of bleeding, including known bleeding disorders
  • Is pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

BRCR Global ( Site 0120)

Plantation, Florida, 33322, United States

Location

Hematology Oncology of the North Shore ( Site 0104)

Skokie, Illinois, 60076-1264, United States

Location

University of Michigan Comprehensive Cancer Center ( Site 0008)

Ann Arbor, Michigan, 48109, United States

Location

Comprehensive Cancer Centers of Nevada - Peak ( Site 0118)

Las Vegas, Nevada, 89128, United States

Location

Duke University Medical Center ( Site 0016)

Durham, North Carolina, 27705, United States

Location

Ohio State University Comprehensive Cancer Center ( Site 0103)

Columbus, Ohio, 43203, United States

Location

OHSU Knight Cardiovascular Institute Cardiology Clinic - South Waterfront ( Site 0102)

Portland, Oregon, 97239-4503, United States

Location

Huntsman Cancer Hospital at the University of Utah ( Site 0119)

Salt Lake City, Utah, 84112, United States

Location

Sunshine Coast Hematology and Oncology Clinic (Site 0506)

Sunshine Coast, Queensland, 4556, Australia

Location

Monash Medical Centre ( Site 0006)

Clayton, Victoria, 3168, Australia

Location

Royal Perth Hospital ( Site 0504)

Perth, Western Australia, 6000, Australia

Location

Gloucestershire Royal Hospital ( Site 0205)

Gloucester, England, GL1 3NN, United Kingdom

Location

United Lincolnshire Hospitals NHS Trust ( Site 0204)

Lincoln, Great Britain, LN2 5QY, United Kingdom

Location

Imperial College London ( Site 0025)

London, Great Britain, W12 0HS, United Kingdom

Location

Boston Pilgrim Hospital ( Site 0207)

Boston, Lincolnshire, PE21 9QS, United Kingdom

Location

Guys and St Thomas NHS Foundation Trust - Guys Hospital ( Site 0020)

London, London, City of, SE1 9RT, United Kingdom

Location

Royal Gwent Hospital ( Site 0201)

Newport, Wales, NP9 2UB, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Polycythemia Vera

Interventions

bomedemstat

Condition Hierarchy (Ancestors)

Bone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesMyeloproliferative Disorders

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2022

First Posted

September 28, 2022

Study Start

September 7, 2023

Primary Completion

March 24, 2025

Study Completion

July 10, 2025

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

More information

Locations

US(8)AU(3)GB(6)