Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003)

Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)73 enrolled

Overview

This is a Phase 2b open label study of an orally administered LSD1 inhibitor, Bomedemstat (MK-3543, formerly called IMG-7289), in patients with essential thrombocythemia. This study investigates the following: * The safety and tolerability of Bomedemstat * The pharmacodynamic effect of Bomedemstat

This is a Phase 2 multi-center, open-label study evaluating the safety, efficacy and pharmacodynamics of Bomedemstat administered orally once daily in patients with essential thrombocythemia (ET). Patients will be dosed with Bomedemstat for 169 consecutive days in the Initial Treatment Period (ITP). Qualifying patients may continue to receive Bomedemstat in the Additional Treatment Period (ATP). Safety will be evaluated by clinical assessments of safety parameters i.e., safety laboratory testing, adverse event reporting, physical examination and vital sign assessments. Pharmacodynamics will be evaluated by hematology assessment, patient reported symptom burden, change in spleen size by palpation and other measures. To ensure safety, a Safety Advisory Board will perform periodic reviews of safety parameters and pharmacodynamic markers.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Essential Thrombocythemia

Interventions

BomedemstatDRUG

Oral administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms. * Requires treatment in order to lower platelet count based on patient age over 60 or history of thrombosis. * Have failed at least one standard therapy * Must have discontinued ET therapy at least 1 week (4 weeks for interferon) prior to study drug initiation. Exclusion Criteria: * Has undergone major surgery ≤4 weeks prior to starting study drug or has not recovered from side effects of such surgery. * Unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1). * Uncontrolled active infection. * Current use of prohibited medications * Known HIV infection or active Hepatitis B or Hepatitis C virus infection * Other hematologic/biochemistry requirements, as per protocol * Use of investigational agent within last 14 days * Pregnant or lactating females

Locations (26)

Local Institution

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Number of Participants Who Experienced an Adverse Event (AE)

An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during the 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 participant from the time of first dose with study treatment until completion of the study. The number of participants who experienced an AE is reported.

Time frame: Up to approximately 30 months

Number 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 the 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 study treatment until completion of the study. The number of participants who discontinued study treatment due to an AE is reported.

Time frame: Up to approximately 28 months

Percentage of Participants With Platelet Count ≤400 k/μL at Day 169

Blood samples were collected at pre-specified timepoints to determine platelet counts. The percentage of participants who achieved reduction in platelet count to ≤400k/μL in the absence of new thrombolytic events is reported.

Time frame: Up to day 169

Data from ClinicalTrials.gov

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