- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06351631
A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
May 2, 2024 updated by: Merck Sharp & Dohme LLC
A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study
The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:
- Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;
- Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission.
No hypothesis testing will be conducted in this study.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
400
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Is from a bomedemstat study sponsored by Imago Biosciences, Inc. (a subsidiary of Merck & Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready.
- Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator
- ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator
- Be able to initiate study intervention on Day 1 of the extension study (ie, not currently on a dose hold)
- Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat
Exclusion Criteria:
- Has received prohibited concomitant medications
- Ongoing or planned participation in another investigational study
- Has noncompliance in prior bomedemstat study receiving <90% of assigned doses excluding suspensions or holds as assigned by the investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bomedemstat
Participants will receive oral capsules of bomedemstat once daily for up to 10 years, with the starting dose as the same dose that the participant was on at the time of transition from the feeder study.
|
10, 15, 20, and 50 mg oral capsules
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants with one or more adverse events (AEs)
Time Frame: Up to ~10 years
|
An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational 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 bomedemstat under this protocol until completion of the study.
The percentage of participants with AEs will be presented.
|
Up to ~10 years
|
Percentage of participants who discontinued study treatment due to an AE
Time Frame: Up to ~10 years
|
An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational 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 bomedemstat under this protocol until completion of the study.
The percentage of participants who discontinued study treatment due to an AE will be presented.
|
Up to ~10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
For participants with ET or PV: Duration of clinicohematologic response
Time Frame: Up to ~10 years
|
For participants who showed durable clinicohematologic response (DCHR) in their feeder studies, duration of clinicohematologic response is defined as the time from the first documented evidence of confirmed reduction of platelet and white blood cell (WBC) count until confirmed increase of platelet and WBC counts to above acceptable threshold, thrombotic or major hemorrhagic events or disease progression to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
The duration of clinicohematologic response will be reported.
|
Up to ~10 years
|
For participants with ET or PV: Duration of hematologic remission
Time Frame: Up to ~10 years
|
For participants who showed confirmed hematologic remission in their feeder studies, duration of hematologic remission is defined as the time from the first documented evidence of confirmed reduction of platelet and WBC count until confirmed increase of platelet and WBC counts to above acceptable threshold.
The duration of hematologic remission will be reported.
|
Up to ~10 years
|
For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML
Time Frame: Up to ~10 years
|
Disease Progression is defined as the transformation to post-ET myelofibrosis (ET participants only), post-PV myelofibrosis (PV participants only), spleen volume increase ≥25% (MF participants only), myelodysplastic syndrome, or acute myeloid leukemia as assessed by the investigator.
The percentage of participants with transformation to MF or MDS/AML will be reported.
|
Up to ~10 years
|
For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML
Time Frame: Up to ~10 years
|
Spleen volume will be assessed by magnetic resonance imaging (MRI) (or computed tomography [CT] where applicable) at pre-specified timepoints.
The percentage of participants with worsening of splenomegaly or transformation to MDS/AML will be reported.
|
Up to ~10 years
|
For participants with MF, ET, or PV: Percentage of participants with thrombotic events
Time Frame: Up to ~10 years
|
Thrombotic events are defined as: new or recurrent acute myocardial infarction; unstable angina; stroke; transient ischemic attack (TIA); deep venous thrombosis (DVT); pulmonary embolism (PE); thrombotic digital ischemia; other thrombotic events such as peripheral limb ischemia or Budd-Chiari syndrome that are assessed to be due to underlying PV; other vascular occlusive events such as symptoms of cardiac, abdominal or peripheral limb ischemia supported by objective evidence of vessel disease and/or ischemia.
The percentage of participants with thrombotic events will be presented.
|
Up to ~10 years
|
For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events
Time Frame: Up to ~10 years
|
Hemorrhagic events are defined as: Major Bleeding (MB) Events such as fatal bleeding, and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 2 g/dL or more, or leading to transfusion of 2 or more units of whole blood or red cells; Clinically Relevant Non-Major Bleeding (CRNMB) Events Leading to hospitalization or increased level of care or clinically important, prompting a face-to-face medical evaluation.
The percentage of participants with major hemorrhagic events will be presented.
|
Up to ~10 years
|
For participants with MF, ET, or PV: Event-Free Survival (EFS)
Time Frame: Up to ~10 years
|
EFS is defined as the time from feeder study randomization (if randomized feeder study) or first dose (if nonrandomized feeder study) to the first documented occurrence of thrombotic or major hemorrhagic event or disease progression as assessed by the investigator, or death due to any cause, whichever occurs first.
EFS will be reported.
|
Up to ~10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp and Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 21, 2024
Primary Completion (Estimated)
December 4, 2034
Study Completion (Estimated)
December 4, 2034
Study Registration Dates
First Submitted
April 2, 2024
First Submitted That Met QC Criteria
April 2, 2024
First Posted (Actual)
April 8, 2024
Study Record Updates
Last Update Posted (Actual)
May 6, 2024
Last Update Submitted That Met QC Criteria
May 2, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Myeloproliferative Disorders
- Blood Coagulation Disorders
- Blood Platelet Disorders
- Bone Marrow Neoplasms
- Hematologic Neoplasms
- Primary Myelofibrosis
- Thrombocytosis
- Thrombocythemia, Essential
- Polycythemia Vera
- Polycythemia
Other Study ID Numbers
- 3543-017
- 2023-506996-89 (Other Identifier: EU CT)
- U1111-1294-8621 (Other Identifier: UTN)
- MK-3543-017 (Other Identifier: Merck ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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