An Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)

Completed · Phase 2

Conditions studied: Thrombocythemia, Essential, Primary Myelofibrosis

In brief

This is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat administered orally once daily in participants with a Myeloproliferative Neoplasm (MPN) who participated in a prior bomedemstat study such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 (NCT03136185) and IMG-7289-CTP-201/MK-3543-003 (NCT04254978) (referred to hereafter as 'feeder studies').

Key facts

Study ID

NCT05223920

Run by

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

People needed

81

Starts

2021-12-15

Expected to finish

2024-08-22

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria include, but are not limited to:
• Has completed at least one Treatment Period (TP) in a prior bomedemstat Myeloproliferative Neoplasms (MPN) protocol (such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 (NCT03136185) and IMG-7289-CTP-201/MK-3543-003) (NCT04254978).
• In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat.

You may not qualify if…

• Exclusion Criteria include, but are not limited to:
• Ongoing participation in another investigational study (except observational studies).
• A history of non-compliance in a prior bomedemstat study (excluding dose suspensions that were medically warranted).
• Current use of a prohibited medication (e.g., romiplostim).
• Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's safety, ability to give informed consent, or comply with the trial protocol.
• Is pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
• Women of childbearing potential (WOCBP) and fertile men unwilling to agree to use an approved method of contraception from time of enrollment until 14 days after last bomedemstat dose.

Where it is running

• University of Miami Leonard M. Miller — Miami, Florida, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• UMPC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• Royal North Shore Hospital — Saint Leonards, New South Wales, Australia
• Gold Coast Hospital and Health Service — Southport, Queensland, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Universittsklinikum Essen — Essen, Germany
• Queen Mary Hospital — Hong Kong, Hong Kong
• Ospedale di Circolo-a Fondazione Macchi — Varese, VA, Italy
• Azienda Ospedaliera SS. Antonio — Alessandria, Italy
• Azienda Ospedaliero-Universitaria Careggi - S.O.D. Ematologia (CRIMM) — Florence, Italy
• Azienda Ospedaliero Universitaria di Bologna — Pavia, Italy
• Middlemore Clinical Trials — Papatoetoe, Aukland, New Zealand
• Waitemata District Health Board — Takapuna, Aukland, New Zealand
• University College London Hospitals NHS Foundation Trust — London, United Kingdom
• Guy's and Saint Thomas' NHS Foundation Trus — London, United Kingdom

Full record on ClinicalTrials.gov

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