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

Imago BioSciences

Status and phase

Completed

Phase 2

Conditions

Primary Myelofibrosis

Thrombocythemia, Essential

Treatments

Drug: Bomedemstat

Study type

Interventional

Funder types

Industry

Identifiers

NCT05223920

IMG-7289-CTP-202

2021-002452-37 (EudraCT Number)

MK-3543-005 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

81 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Completed at least one Treatment Period (TP) in a prior bomedemstat Myeloproliferative Neoplasm (MPN) protocol (such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 or IMG-7289-CTP-201/MK-3543-003).
In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat.

Exclusion criteria

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.
Females who are 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.