A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

NCT06351631 | Recruiting Phase 3 FDA Drug

• 4 other identifiers: 3543-0172023-506996-89-00U1111-1294-8621MK-3543-017
• Study Type: interventional
• Target: 400
• Locations: 6 countries
• Sites: 21

Brief Summary

The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:

• Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;
• Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission. No hypothesis testing will be conducted in this study.

Conditions

Primary Myelofibrosis; Thrombocythemia, Essential; Post-essential Thrombocythemia Myelofibrosis; Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Polycythemia Vera

Outcome Measures

Primary Outcomes (2)

• Percentage of participants with one or more adverse events (AEs)

  An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational 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 bomedemstat under this protocol until completion of the study. The percentage of participants with AEs will be presented.

  Up to ~10 years

• Percentage 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 an investigational 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 bomedemstat under this protocol until completion of the study. The percentage of participants who discontinued study treatment due to an AE will be presented.

  Up to ~10 years

Secondary Outcomes (6)

• For participants with ET or PV: Duration of clinicohematologic response

  Up to ~10 years

• For participants with ET or PV: Duration of hematologic remission

  Up to ~10 years

• For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML

  Up to ~10 years

• For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML

  Up to ~10 years

• For participants with MF, ET, or PV: Percentage of participants with thrombotic events

  Up to ~10 years

Study Arms (1)

Bomedemstat

EXPERIMENTAL

Participants will receive oral capsules of bomedemstat once daily for up to 10 years, with the starting dose as the same dose that the participant was on at the time of transition from the feeder study.

Drug: Bomedemstat

Interventions

Bomedemstat DRUG

10, 15, 20, and 50 mg oral capsules

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:

• Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck \& Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready
• Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator
• ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator
• Is not currently on a dose hold
• Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat

You may not qualify if:

• Has received prohibited concomitant medications
• Ongoing or planned participation in another investigational study
• Has noncompliance in prior bomedemstat study receiving \<90% of assigned doses excluding suspensions or holds as assigned by the investigator

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (21)

University of Michigan ( Site 6000)

Ann Arbor, Michigan, 48109, United States

RECRUITING

DUHS Duke Blood Cancer Center ( Site 6005)

Durham, North Carolina, 27705, United States

RECRUITING

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)

Columbus, Ohio, 43210, United States

RECRUITING

UPMC Hillman Cancer Center ( Site 6004)

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Royal Prince Alfred Hospital ( Site 1003)

Camperdown, New South Wales, 2050, Australia

RECRUITING

Royal North Shore Hospital ( Site 1001)

St Leonards, New South Wales, 2065, Australia

RECRUITING

Sunshine Coast Hematology and Oncology Clinic ( Site 1006)

Buderim, Queensland, 4556, Australia

RECRUITING

Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)

Southport, Queensland, 4215, Australia

RECRUITING

Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)

Adelaide, South Australia, 5000, Australia

RECRUITING

Monash Health ( Site 1004)

Clayton, Victoria, 3168, Australia

RECRUITING

Queen Mary Hospital ( Site 1601)

Hksar, Hong Kong

ACTIVE NOT RECRUITING

Azienda Ospedaliera Universitaria Careggi ( Site 2700)

Florence, Tuscany, 50134, Italy

RECRUITING

Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703)

Alessandria, 15121, Italy

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702)

Bologna, 40138, Italy

RECRUITING

Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701)

Varese, 21100, Italy

RECRUITING

North Shore Hospital-Department of Haematology ( Site 1401)

Auckland, 0622, New Zealand

ACTIVE NOT RECRUITING

Aotearoa Clinical Trials ( Site 1400)

Auckland, 2025, New Zealand

ACTIVE NOT RECRUITING

Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402)

London, Hammersmith and Fulham, W12 0HS, United Kingdom

RECRUITING

Boston Pilgrim Hospital ( Site 3403)

Boston, Lincolnshire, PE21 9QS, United Kingdom

RECRUITING

University College London Hospital ( Site 3400)

London, London, City of, NW1 2PG, United Kingdom

RECRUITING

Guy's & St Thomas' NHS Foundation Trust ( Site 3401)

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

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Thrombocythemia, Essential; Primary Myelofibrosis; Polycythemia Vera

Interventions

bomedemstat

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombocytosis; Blood Platelet Disorders; Myeloproliferative Disorders; Bone Marrow Diseases; Hemorrhagic Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Medical Director

  Merck Sharp and Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: May 23, 2024
• Primary Completion (Estimated): December 4, 2034
• Study Completion (Estimated): December 4, 2034
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

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