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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3543-003 | Other Identifier | Merck | |
| 2019-003659-13 | EudraCT Number |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bomedemstat | Experimental | Bomedemstat administered daily for 169 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bomedemstat | Drug | Oral administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Up to day 169 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Jacksonville | Florida | 32209 | United States | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41758981 | Result | Gill H, Palandri F, Ross DM, Gothert JR, Cochrane T, Larsen SR, Halpern AB, Shortt J, Rossetti JM, Liang J, Marchetti M, Wilson AJ, Innes AJ, Hanna M, Vianelli N, Stevenson WS, Vannucchi AM, Kleppe M, Flynn J, Natsoulis G, Harrison CN, Rienhoff HY Jr. Phase 2 study of the lysine-specific demethylase 1 inhibitor bomedemstat for essential thrombocythemia. Blood Adv. 2026 May 26;10(10):3494-3504. doi: 10.1182/bloodadvances.2025017575. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bomedemstat | Bomedemstat was administered daily for 169 consecutive days of the initial treatment period. After completing 169 days of treatment, qualifying participants continued into additional treatment periods of 169 days each, for as long as the participant continued to derive clinical benefit. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Treatment Period (ITP) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 9, 2020 | Mar 6, 2024 |
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Multi-center, open-label
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| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Local Institution | New York | New York | 10021 | United States |
| Local Institution | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Local Institution | Pittsburgh | Pennsylvania | 15232 | United States |
| Local Institution | Seattle | Washington | 98109 | United States |
| Local Institution | Herston | Brisbane | Australia |
| Local Institution | Camperdown | New South Wales | Australia |
| Local Institution | St Leonards | New South Wales | 2065 | Australia |
| Local Institution | Southport | Queensland | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Local Institution | Clayton | Victoria | 3168 | Australia |
| Department of Hematology and Stem Cell Transplantation, West German Cancer Center (WTZ) | Essen | 45147 | Germany |
| Local Institution | Jena | Germany |
| Local Institution | Hong Kong | Hong Kong |
| Local Institution | Alessandria | Italy |
| Local Institution | Bologna | Italy |
| CRIMM; Centro Ricerca e Innovazione delle Malattia Mieloproliferative, Azienda ospedaliera Universitaria Careggi | Florence | 50139 | Italy |
| Local Institution | Varese | Italy |
| Local Institution | Auckland | New Zealand |
| Middlemore Hospital | Auckland | New Zealand |
| Local Institution | London | NW1 | United Kingdom |
| Guys and St Thomas Hospital | London | SE1 9RT | United Kingdom |
| Local Institution | London | W12 | United Kingdom |
| Local Institution | Oxford | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| Additional Treatment Period (ATP) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bomedemstat | Bomedemstat administered daily for 169 consecutive days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who were enrolled in the study and received at least 1 dose of study drug | Posted | Count of Participants | Participants | Up to approximately 30 months |
|
|
| ||||||||||||||||||||||||||
| Primary | 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. | All participants who were enrolled in the study and received at least one dose of study drug | Posted | Count of Participants | Participants | Up to approximately 28 months |
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| |||||||||||||||||||||||||||
| Primary | 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. | All participants who were enrolled in the study, received at least one dose of study drug, and had a non-missing baseline and at least 1 non-missing post-baseline efficacy assessment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to day 169 |
|
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Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bomedemstat | Bomedemstat was administered daily for 169 consecutive days of the initial treatment period. After completing 169 days of treatment, qualifying patients continued into additional treatment periods of 169 days each, as long as the participant continued to derive clinical benefit. | 2 | 73 | 27 | 73 | 72 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Chronic gastritis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ileal ulcer | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Pneumonia aspiration | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Haematoma muscle | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dyspnoea paroxysmal nocturnal | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Rotator cuff repair | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
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| Vasculitis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Large intestine polyp | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment | General disorders and administration site conditions |
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| Influenza like illness | General disorders | MedDRA 23.0 | Systematic Assessment | General disorders and administration site conditions |
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| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment | General disorders and administration site conditions |
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| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Iron deficiency | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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The Lead/Coordinating Investigator will have the right to submit for publication any results arising from the study subject to the terms and conditions of the Clinical Trial and Confidentiality Disclosure Agreements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 21, 2020 | Mar 6, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013920 | Thrombocythemia, Essential |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| C000730033 | bomedemstat |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or not reported |
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| Aboriginal |
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