An 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)

IMG-7289 (Other Identifier)

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 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').

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

Bomedemstat

Experimental group

Description:

All participants will receive bomedemstat via oral capsule daily for 169 days with additional treatment continuing in patients deriving clinical benefit.

Treatment:

Drug: Bomedemstat