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

Phase 2

Completed

Conditions: Thrombocythemia, Essential
Primary Myelofibrosis

Interventions: Drug: Bomedemstat

Registration Number: NCT05223920

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

Brief Summary: 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').

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experience an Adverse Event (AE)	Up to ~32 months	An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who experienced an AE is presented.
Percentage of Participants Who Discontinue Study Intervention Due to an AE	Up to ~32 months	An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who discontinued study intervention due to an AE is presented.
Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF.	Baseline and Days 169, 339, 509, 679, 849 and 924	Mean Spleen volume reduction (mL) in participants with MF as measured by central laboratory imaging analysis of MRI (or CT where applicable) approximately every 48 weeks. Per protocol only participants with MF were analyzed for this outcome measure. The change in spleen volume from baseline is presented.
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events	Baseline and Days 29, 57, 85, 113, 141, 169, 198, 226, 254, 282, 310, 338, 367, 395, 423, 451, 479, 507, 536, 564, 592, 620, and 648	Blood samples were taken at designated time points to determine platelet count. Percentage of participants with ET who achieve a reduction of platelet counts to \<= 400 K/uL (400 x 10\^9/L) in the absence of new thromboembolic events is presented.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (19): 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
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University of Miami Leonard M. Miller
🇺🇸Miami, Florida, United States