A Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Polycythemia Vera (IMG-7289-CTP-203/MK-3543-004)

NCT05558696 | Completed Phase 2 Results FDA Drug

• 4 other identifiers: 3543-004MK-3543-004IMG-7289-CTP-2032022-002262-32
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 17

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.

Conditions

Polycythemia Vera

Keywords

polycythemia vera; bomedemstat

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Adverse Events (AEs)

  An AE was 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 are reported.

  Up to approximately 52 weeks

• Number of Participants Who Discontinued Study Intervention Due to AEs

  An AE was 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 discontinued study intervention due to an AE are reported.

  Up to approximately 52 weeks

• Percentage of Participants With Sustained 12-week Reduction of Hematocrit (Hct) to <45% Without Concomitant Phlebotomy by Week 36

  Hematocrit (Hct) was analyzed by taking blood samples from participants at designated time points during the study. Participants were considered responders if they achieved a sustained reduction of Hct to \<45% for 12 weeks (84 calendar days) by Week 36 AND there was no concomitant phlebotomy performed during the sustained reduction. Baseline data was defined as the data most recently collected prior to the first dose. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders was presented. The percentage of participants who achieved a sustained 12-week reduction of Hct to \<45% without concomitant phlebotomy at Week 36 are reported.

  Up to approximately 36 weeks

Secondary Outcomes (9)

• Duration of Reduction of Hematocrit (Hct) to <45% Without Phlebotomy

  Up to approximately 22 months

• Percentage of Participants With Platelet Count ≤ 450 x 10^9/L by Week 36

  Up to approximately 36 weeks

• Duration of Platelet Count ≤ 450 x 10^9/L

  Up to approximately 22 months

• Percentage of Participants With White Blood Cell (WBC) Count <10 x 10^9/L by Week 36

  Up to approximately 36 weeks

• Duration of White Blood Cell (WBC) Count <10 x 10^9/L

  Up to approximately 22 months

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

Bomedemstat DRUG

Oral capsule

Also known as: MK-3543, IMG-7289

Bomedemstat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 A, Hepatitis B or Hepatitis C virus infection
• Has evidence of increased risk of bleeding, including known bleeding disorders
• Is pregnant or lactating

Sponsors & Collaborators

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

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

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Polycythemia Vera

Interventions

bomedemstat

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: May 7, 2026
• Results First Posted: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

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