NCT04254978

Brief Summary

This is a Phase 2b open label study of an orally administered LSD1 inhibitor, Bomedemstat (MK-3543, formerly called IMG-7289), in patients with essential thrombocythemia. This study investigates the following:

  • The safety and tolerability of Bomedemstat
  • The pharmacodynamic effect of Bomedemstat

Trial Health

93
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2020

Geographic Reach
7 countries

26 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

January 15, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

September 8, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2023

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 2, 2024

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

January 15, 2020

Results QC Date

March 6, 2024

Last Update Submit

April 13, 2026

Conditions

Essential Thrombocythemia

Outcome Measures

Primary Outcomes (3)

  • Number of Participants Who Experienced an Adverse Event (AE)

    An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during the study, in conjunction with the use of the drug or biologic, whether or not product related. This includes any untoward signs or symptoms experienced by the participant from the time of first dose with study treatment until completion of the study. The number of participants who experienced an AE is reported.

    Up to approximately 30 months

  • Number of Participants Who Discontinued Study Treatment Due to an AE

    An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in the study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient from the time of first dose with study treatment until completion of the study. The number of participants who discontinued study treatment due to an AE is reported.

    Up to approximately 28 months

  • Percentage of Participants With Platelet Count ≤400 k/μL at Day 169

    Blood samples were collected at pre-specified timepoints to determine platelet counts. The percentage of participants who achieved reduction in platelet count to ≤400k/μL in the absence of new thrombolytic events is reported.

    Up to day 169

Study Arms (1)

Bomedemstat

EXPERIMENTAL

Bomedemstat administered daily for 169 consecutive days

Drug: Bomedemstat

Interventions

BomedemstatDRUG

Oral administration

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

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms.
  • Requires treatment in order to lower platelet count based on patient age over 60 or history of thrombosis.
  • Have failed at least one standard therapy
  • Must have discontinued ET therapy at least 1 week (4 weeks for interferon) prior to study drug initiation.

You may not qualify if:

  • Has undergone major surgery ≤4 weeks prior to starting study drug or has not recovered from side effects of such surgery.
  • Unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1).
  • Uncontrolled active infection.
  • Current use of prohibited medications
  • Known HIV infection or active Hepatitis B or Hepatitis C virus infection
  • Other hematologic/biochemistry requirements, as per protocol
  • Use of investigational agent within last 14 days
  • Pregnant or lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Local Institution

Jacksonville, Florida, 32209, United States

Location

Local Institution

Ann Arbor, Michigan, 48109, United States

Location

Local Institution

New York, New York, 10021, United States

Location

Local Institution

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Local Institution

Pittsburgh, Pennsylvania, 15232, United States

Location

Local Institution

Seattle, Washington, 98109, United States

Location

Local Institution

Herston, Brisbane, Australia

Location

Local Institution

Camperdown, New South Wales, Australia

Location

Local Institution

St Leonards, New South Wales, 2065, Australia

Location

Local Institution

Southport, Queensland, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Local Institution

Clayton, Victoria, 3168, Australia

Location

Department of Hematology and Stem Cell Transplantation, West German Cancer Center (WTZ)

Essen, 45147, Germany

Location

Local Institution

Jena, Germany

Location

Local Institution

Hong Kong, Hong Kong

Location

Local Institution

Alessandria, Italy

Location

Local Institution

Bologna, Italy

Location

CRIMM; Centro Ricerca e Innovazione delle Malattia Mieloproliferative, Azienda ospedaliera Universitaria Careggi

Florence, 50139, Italy

Location

Local Institution

Varese, Italy

Location

Local Institution

Auckland, New Zealand

Location

Middlemore Hospital

Auckland, New Zealand

Location

Local Institution

London, NW1, United Kingdom

Location

Guys and St Thomas Hospital

London, SE1 9RT, United Kingdom

Location

Local Institution

London, W12, United Kingdom

Location

Local Institution

Oxford, United Kingdom

Location

Related Publications (1)

  • Gill H, Palandri F, Ross DM, Gothert JR, Cochrane T, Larsen SR, Halpern AB, Shortt J, Rossetti JM, Liang J, Marchetti M, Wilson AJ, Innes AJ, Hanna M, Vianelli N, Stevenson WS, Vannucchi AM, Kleppe M, Flynn J, Natsoulis G, Harrison CN, Rienhoff HY Jr. Phase 2 study of the lysine-specific demethylase 1 (LSD1) inhibitor bomedemstat for essential thrombocythemia. Blood Adv. 2026 Feb 27:bloodadvances.2025017575. doi: 10.1182/bloodadvances.2025017575. Online ahead of print.

    PMID: 41758981RESULT

Related Links

MeSH Terms

Conditions

Thrombocythemia, Essential

Interventions

bomedemstat

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombocytosisBlood Platelet DisordersMyeloproliferative DisordersBone Marrow DiseasesHemorrhagic Disorders

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme LLC
ClinicalTrialsDisclosure@merck.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
Model Details: Multi-center, open-label
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2020

First Posted

February 5, 2020

Study Start

September 8, 2020

Primary Completion

March 23, 2023

Study Completion

March 23, 2023

Last Updated

May 4, 2026

Results First Posted

April 2, 2024

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(4)IT(4)NZ(2)US(7)DE(2)AU(6)HK(1)