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

Imago BioSciences

Status and phase

Completed

Phase 2

Conditions

Essential Thrombocythemia

Treatments

Drug: Bomedemstat

Study type

Interventional

Funder types

Industry

Identifiers

NCT04254978

IMG-7289-CTP-201

MK-3543-003 (Other Identifier)

2019-003659-13 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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