search
Back to results

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

Primary Purpose

Essential Thrombocythemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bomedemstat
Sponsored by
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Thrombocythemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Cleveland Clinic
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Royal Adelaide Hospital
  • Local Institution
  • Department of Hematology and Stem Cell Transplantation, West German Cancer Center (WTZ)
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • CRIMM; Centro Ricerca e Innovazione delle Malattia Mieloproliferative, Azienda ospedaliera Universitaria Careggi
  • Local Institution
  • Local Institution
  • Middlemore Hospital
  • Local Institution
  • Guys and St Thomas Hospital
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bomedemstat

Arm Description

Bomedemstat administered daily for 169 consecutive days

Outcomes

Primary Outcome Measures

Number of Participants Who Experience an Adverse Event (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 experience an AE will be reported.
Number of Participants Who Discontinue 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 discontinue study treatment due to an AE will be reported.
Change From Baseline in Percentage of Participants with Platelet Count ≤400k/µL
Blood samples will be collected at pre-specified timepoints to determine platelet counts. Change from baseline in percentage of participants who achieve reduction in platelet count to ≤400k/µL in the absence of new thrombolytic events will be reported.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2020
Last Updated
June 27, 2023
Sponsor
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
search

1. Study Identification

Unique Protocol Identification Number
NCT04254978
Brief Title
Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003)
Official Title
A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy and Pharmacodynamics of IMG-7289 in Patients With Essential Thrombocythemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
March 23, 2023 (Actual)
Study Completion Date
March 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Thrombocythemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Multi-center, open-label
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bomedemstat
Arm Type
Experimental
Arm Description
Bomedemstat administered daily for 169 consecutive days
Intervention Type
Drug
Intervention Name(s)
Bomedemstat
Other Intervention Name(s)
IMG-7289, MK-3543
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Number of Participants Who Experience an Adverse Event (AE)
Description
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 experience an AE will be reported.
Time Frame
Up to approximately 30 months
Title
Number of Participants Who Discontinue Study Treatment Due to an AE
Description
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 discontinue study treatment due to an AE will be reported.
Time Frame
Up to approximately 30 months
Title
Change From Baseline in Percentage of Participants with Platelet Count ≤400k/µL
Description
Blood samples will be collected at pre-specified timepoints to determine platelet counts. Change from baseline in percentage of participants who achieve reduction in platelet count to ≤400k/µL in the absence of new thrombolytic events will be reported.
Time Frame
Baseline and up to 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Local Institution
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Local Institution
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Local Institution
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Local Institution
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Local Institution
City
Herston
State/Province
Brisbane
Country
Australia
Facility Name
Local Institution
City
Camperdown
State/Province
New South Wales
Country
Australia
Facility Name
Local Institution
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Local Institution
City
Southport
State/Province
Queensland
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Department of Hematology and Stem Cell Transplantation, West German Cancer Center (WTZ)
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Local Institution
City
Jena
Country
Germany
Facility Name
Local Institution
City
Hong Kong
Country
Hong Kong
Facility Name
Local Institution
City
Alessandria
Country
Italy
Facility Name
Local Institution
City
Bologna
Country
Italy
Facility Name
CRIMM; Centro Ricerca e Innovazione delle Malattia Mieloproliferative, Azienda ospedaliera Universitaria Careggi
City
Florence
ZIP/Postal Code
50139
Country
Italy
Facility Name
Local Institution
City
Varese
Country
Italy
Facility Name
Local Institution
City
Auckland
Country
New Zealand
Facility Name
Middlemore Hospital
City
Auckland
Country
New Zealand
Facility Name
Local Institution
City
London
ZIP/Postal Code
NW1
Country
United Kingdom
Facility Name
Guys and St Thomas Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Local Institution
City
London
ZIP/Postal Code
W12
Country
United Kingdom
Facility Name
Local Institution
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs