Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44358   clinical trials with a EudraCT protocol, of which   7384   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Multi-Center, Open Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Patients with Myeloproliferative Neoplasms (MPNs) Enrolled in a Prior Bomedemstat Clinical Study

    Summary
    EudraCT number
    		 2021-002452-37
    Trial protocol
    		 DE   IT  
    Global end of trial date
    22 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Sep 2025
    First version publication date
    03 Sep 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IMG-7289-CTP-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05223920
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IMG-7289-CTP-202: Imago Bio, 3543-005: MSD
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@msd.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Aug 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Aug 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat administered orally once daily in patients with a Myeloproliferative Neoplasm (MPN) who participated in a prior bomedemstat study such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 (NCT03136185) and IMG-7289-CTP-201/MK-3543-003 (NCT04254978) (referred to hereafter as ‘feeder studies’).
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Dec 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 10 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 15
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Hong Kong: 27
    Country: Number of subjects enrolled
    Italy: 15
    Country: Number of subjects enrolled
    New Zealand: 5
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    United States: 9
    Worldwide total number of subjects
    81
    EEA total number of subjects
    17
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    37
    From 65 to 84 years
    42
    85 years and over
    2

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants with Myeloproliferative Neoplasms (MPNs) who participated in a prior bomedemstat study such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 (NCT03136185) and IMG-7289-CTP-201/MK-3543-003 (NCT04254978) (referred to hereafter as ‘feeder studies’) were included in the recruitment.

    Pre-assignment
    Screening details
    		 Participants were assigned to either the Essential thrombocythemia (ET) arm or Myelofibrosis (MF) arm based on prior diagnosis.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Essential thrombocythemia (ET)
    Arm description
    		 Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant’s underlying MPN.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bomedemstat
    Investigational medicinal product code
    Other name
    IMG-7289 MK-3543
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    As titrated per participant

    Arm title
    		 Myelofibrosis (MF)
    Arm description
    		 Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant’s underlying MPN.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bomedemstat
    Investigational medicinal product code
    Other name
    IMG-7289 MK-3543
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    As titrated per participant

    Number of subjects in period 1
    		Essential thrombocythemia (ET) Myelofibrosis (MF)
    Started
    52
    29
    Completed
    0
    0
    Not completed
    52
    29
         Adverse event, serious fatal
    2
    -
         Physician decision
    1
    2
         Consent withdrawn by subject
    1
    6
         Adverse event, non-fatal
    6
    3
         Transferred to Ext Study MK-3543-017 (NCT06351631)
    29
    7
         Subject decision
    1
    -
         Sponsor decision
    11
    9
         Disease Progression
    1
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Essential thrombocythemia (ET)
    Reporting group description
    		 Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant’s underlying MPN.

    Reporting group title
    Myelofibrosis (MF)
    Reporting group description
    		 Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant’s underlying MPN.

    Reporting group values
    		 Essential thrombocythemia (ET) Myelofibrosis (MF) Total
    Number of subjects
    		 52 29 81
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 24 13 37
        From 65-84 years
    		 26 16 42
        85 years and over
    		 2 0 2
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 65.8 ( 11.01 ) 65.3 ( 9.68 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 29 14 43
        Male
    		 23 15 38
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 14 15 29
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 3 1 4
        White
    		 35 13 48
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 1 2
        Not Hispanic or Latino
    		 51 28 79
        Unknown or Not Reported
    		 0 0 0
    Baseline Spleen Volume by Magnetic resonance imaging/computerized tomography (MRI/CT) in mL
    Baseline spleen volume was measured for myelofibrosis participants via MRI/CT scan in milliliters (mL).
    Units: mL
        median (full range (min-max))
    		 9999 (9999 to 9999) 835.21 (98.88 to 3085.92) -
    Baseline Platelet Counts in thousands per microliter (k/uL)
    Baseline platelet count measured in K/uL was obtained for both ET and MF participants.
    Units: K/uL
        arithmetic mean (standard deviation)
    		 380.4 ( 207.44 ) 190.5 ( 209.64 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Essential thrombocythemia (ET)
    Reporting group description
    		 Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant’s underlying MPN.

    Reporting group title
    Myelofibrosis (MF)
    Reporting group description
    		 Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant’s underlying MPN.

    Primary: Percentage of Participants who Experience an Adverse Event (AE)

    		 Close Top of page
    End point title
    		 Percentage of Participants who Experience an Adverse Event (AE) [1]
    End point description
    An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The analysis population includes all participants who received at least one dose of study intervention. The percentage of participants who experienced an AE is presented.
    End point type
    Primary
    End point timeframe
    Up to ~32 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analysis was planned for this outcome measure.
    End point values
    		 Essential thrombocythemia (ET) Myelofibrosis (MF)
    Number of subjects analysed
    52
    29
    Units: Percentage of Participants
        number (not applicable)
    98.1
    100.0
    No statistical analyses for this end point

    Primary: Percentage of Participants who Discontinue Study Intervention Due to an AE

    		 Close Top of page
    End point title
    		 Percentage of Participants who Discontinue Study Intervention Due to an AE [2]
    End point description
    An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The analysis population includes all participants who received at least one dose of study intervention. The percentage of participants who discontinued study intervention due to an AE is presented.
    End point type
    Primary
    End point timeframe
    Up to ~32 months
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analysis was planned for this outcome measure.
    End point values
    		 Essential thrombocythemia (ET) Myelofibrosis (MF)
    Number of subjects analysed
    52
    29
    Units: Percentage of Participants
        number (not applicable)
    15.4
    10.3
    No statistical analyses for this end point

    Primary: Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants with MF.

    		 Close Top of page
    End point title
    		 Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants with MF. [3]
    End point description
    Mean Spleen volume reduction (mL) in participants with MF as measured by central laboratory imaging analysis of MRI (or CT where applicable) approximately every 48 weeks. The modified intent to treat (mITT) population included all participants who were enrolled in the study, received at least 1 dose of study intervention, and who had a nonmissing baseline and at least 1 nonmissing postbaseline efficacy assessment. Participants were analyzed according to treatment received in the study. Per protocol only participants with MF were analyzed for this outcome measure. The change in spleen volume from baseline is presented.
    End point type
    Primary
    End point timeframe
    Baseline and Days 169, 339, 509, 679, 849 and 924
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analysis was planned for this outcome measure.
    End point values
    		 Essential thrombocythemia (ET) Myelofibrosis (MF)
    Number of subjects analysed
    0 [4]
    29
    Units: mL
    arithmetic mean (standard deviation)
        Day 169
    ( )
    -101.570 ( 92.6876 )
        Day 339
    ( )
    -67.645 ( 249.0079 )
        Day 509
    ( )
    -5.920 ( 143.1692 )
        Day 679
    ( )
    -61.000 ( 396.2520 )
        Day 849
    ( )
    -38.840 ( 9999 )
        Day 924
    ( )
    80.575 ( 10.3308 )
    Notes
    [4] - Per protocol only participants with MF were analyzed for this outcome measure.
    No statistical analyses for this end point

    Primary: Percentage of Participants with ET who Achieve a Reduction of Platelet Counts to <= 400 k/uL (400 x 109/L) in the Absence of New Thromboembolic Events

    		 Close Top of page
    End point title
    		 Percentage of Participants with ET who Achieve a Reduction of Platelet Counts to <= 400 k/uL (400 x 109/L) in the Absence of New Thromboembolic Events [5]
    End point description
    Blood samples were taken at designated time points to determine platelet count. The modified intent to treat (mITT) population included all participants who were enrolled in the study, received at least 1 dose of study intervention, and who had a nonmissing baseline and at least 1 nonmissing postbaseline efficacy assessment. Per protocol only participants with ET were analyzed for this outcome measure. Participants were analyzed according to treatment received in the study. Percentage of participants with ET who achieve a reduction of platelet counts to <= 400 k/uL (400 x 109/L) in the absence of new thromboembolic events is presented.
    End point type
    Primary
    End point timeframe
    Baseline and Days 29, 57, 85, 113, 141, 169, 198, 226, 254, 282, 310, 338, 367, 395, 423, 451, 479, 507, 536, 564, 592, 620, and 648
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol no statistical analysis was planned for this outcome measure.
    End point values
    		 Essential thrombocythemia (ET) Myelofibrosis (MF)
    Number of subjects analysed
    52
    0 [6]
    Units: Percentage of participants
    number (confidence interval 95%)
        Day 29
    77.1 (62.7 to 88.0)
    ( to )
        Day 57
    72.9 (58.2 to 84.7)
    ( to )
        Day 85
    72.0 (57.5 to 83.8)
    ( to )
        Day 113
    78.4 (64.7 to 88.7)
    ( to )
        Day 141
    91.8 (80.4 to 97.7)
    ( to )
        Day 169
    89.4 (76.9 to 96.5)
    ( to )
        Day 198
    86.7 (73.2 to 94.9)
    ( to )
        Day 226
    81.8 (67.3 to 91.8)
    ( to )
        Day 254
    79.5 (64.7 to 90.2)
    ( to )
        Day 282
    75.0 (59.7 to 86.8)
    ( to )
        Day 310
    81.4 (66.6 to 91.6)
    ( to )
        Day 338
    83.7 (69.3 to 93.2)
    ( to )
        Day 367
    76.2 (60.5 to 87.9)
    ( to )
        Day 395
    78.0 (62.4 to 89.4)
    ( to )
        Day 423
    80.0 (64.4 to 90.9)
    ( to )
        Day 451
    82.1 (66.5 to 92.5)
    ( to )
        Day 479
    75.7 (58.8 to 88.2)
    ( to )
        Day 507
    96.2 (80.4 to 99.9)
    ( to )
        Day 536
    94.7 (74.0 to 99.9)
    ( to )
        Day 564
    86.7 (59.5 to 98.3)
    ( to )
        Day 592
    72.7 (39.0 to 94.0)
    ( to )
        Day 620
    85.7 (42.1 to 99.6)
    ( to )
        Day 648
    83.3 (35.9 to 99.6)
    ( to )
    Notes
    [6] - Per protocol only participants with ET were analyzed for this outcome measure.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Death and adverse events up to ~32 months
    Adverse event reporting additional description
    All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Myelofibrosis (MF)
    Reporting group description
    		 Participants with MF received bomedemstat daily as an oral capsule with dose-titration contingent on the titration assessment performed every 169 days. The daily dose of bomedemstat was titrated for each patient to a dose that reduces platelets to the underlying MPN’s target range.

    Reporting group title
    Essential thrombocythemia (ET)
    Reporting group description
    		 Participants with ET received bomedemstat daily as an oral capsule with dose-titration contingent on the titration assessment performed every 169 days. The daily dose of bomedemstat was titrated for each patient to a dose that reduces platelets to the underlying MPN’s target range.

    Serious adverse events
    		 Myelofibrosis (MF) Essential thrombocythemia (ET)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 29 (41.38%)
    19 / 52 (36.54%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Reproductive system and breast disorders
    Heavy menstrual bleeding
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphonia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood potassium increased
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wellens' syndrome
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune thrombocytopenia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 52 (5.77%)
         occurrences causally related to treatment / all
    1 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytosis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingival bleeding
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 52 (5.77%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis B
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Myelofibrosis (MF) Essential thrombocythemia (ET)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 29 (96.55%)
    45 / 52 (86.54%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 52 (7.69%)
         occurrences all number
    2
    7
    Haematoma
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 52 (5.77%)
         occurrences all number
    3
    5
    Hypotension
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 52 (1.92%)
         occurrences all number
    2
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 52 (3.85%)
         occurrences all number
    5
    2
    Fatigue
         subjects affected / exposed
    2 / 29 (6.90%)
    7 / 52 (13.46%)
         occurrences all number
    2
    8
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 52 (5.77%)
         occurrences all number
    1
    3
    Oedema peripheral
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 52 (5.77%)
         occurrences all number
    3
    4
    Peripheral swelling
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 52 (1.92%)
         occurrences all number
    2
    1
    Pyrexia
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 52 (3.85%)
         occurrences all number
    3
    2
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 29 (13.79%)
    4 / 52 (7.69%)
         occurrences all number
    5
    4
    Dyspnoea
         subjects affected / exposed
    1 / 29 (3.45%)
    5 / 52 (9.62%)
         occurrences all number
    1
    6
    Epistaxis
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 52 (7.69%)
         occurrences all number
    2
    4
    Pulmonary hypertension
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    Investigations
    Urinary occult blood
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 52 (3.85%)
         occurrences all number
    2
    2
    Blood creatinine increased
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    0
    8
    SARS-CoV-2 test positive
         subjects affected / exposed
    4 / 29 (13.79%)
    1 / 52 (1.92%)
         occurrences all number
    4
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    6 / 29 (20.69%)
    4 / 52 (7.69%)
         occurrences all number
    13
    4
    Fall
         subjects affected / exposed
    1 / 29 (3.45%)
    5 / 52 (9.62%)
         occurrences all number
    1
    6
    Head injury
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    4 / 29 (13.79%)
    2 / 52 (3.85%)
         occurrences all number
    5
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 29 (13.79%)
    8 / 52 (15.38%)
         occurrences all number
    4
    8
    Dysgeusia
         subjects affected / exposed
    4 / 29 (13.79%)
    3 / 52 (5.77%)
         occurrences all number
    5
    3
    Headache
         subjects affected / exposed
    3 / 29 (10.34%)
    7 / 52 (13.46%)
         occurrences all number
    3
    7
    Blood and lymphatic system disorders
    Increased tendency to bruise
         subjects affected / exposed
    4 / 29 (13.79%)
    2 / 52 (3.85%)
         occurrences all number
    4
    2
    Anaemia
         subjects affected / exposed
    7 / 29 (24.14%)
    10 / 52 (19.23%)
         occurrences all number
    16
    11
    Neutropenia
         subjects affected / exposed
    2 / 29 (6.90%)
    4 / 52 (7.69%)
         occurrences all number
    2
    5
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 52 (0.00%)
         occurrences all number
    4
    0
    Thrombocytosis
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    0
    5
    Thrombocytopenia
         subjects affected / exposed
    12 / 29 (41.38%)
    6 / 52 (11.54%)
         occurrences all number
    27
    13
    Polycythaemia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 52 (0.00%)
         occurrences all number
    4
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    0
    3
    Eye disorders
    Blepharitis
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 52 (3.85%)
         occurrences all number
    2
    2
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    0
    3
    Abdominal pain
         subjects affected / exposed
    0 / 29 (0.00%)
    4 / 52 (7.69%)
         occurrences all number
    0
    9
    Chronic gastritis
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    Constipation
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 52 (5.77%)
         occurrences all number
    4
    5
    Diarrhoea
         subjects affected / exposed
    7 / 29 (24.14%)
    5 / 52 (9.62%)
         occurrences all number
    8
    10
    Vomiting
         subjects affected / exposed
    0 / 29 (0.00%)
    5 / 52 (9.62%)
         occurrences all number
    0
    6
    Epigastric discomfort
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 52 (1.92%)
         occurrences all number
    2
    1
    Gingival bleeding
         subjects affected / exposed
    7 / 29 (24.14%)
    3 / 52 (5.77%)
         occurrences all number
    14
    3
    Haemorrhoids
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 52 (1.92%)
         occurrences all number
    2
    1
    Mouth haemorrhage
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 52 (1.92%)
         occurrences all number
    3
    1
    Mouth ulceration
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 52 (5.77%)
         occurrences all number
    2
    3
    Nausea
         subjects affected / exposed
    1 / 29 (3.45%)
    6 / 52 (11.54%)
         occurrences all number
    1
    6
    Rectal haemorrhage
         subjects affected / exposed
    5 / 29 (17.24%)
    0 / 52 (0.00%)
         occurrences all number
    10
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    0
    3
    Petechiae
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 52 (0.00%)
         occurrences all number
    3
    0
    Pruritus
         subjects affected / exposed
    3 / 29 (10.34%)
    8 / 52 (15.38%)
         occurrences all number
    4
    8
    Alopecia
         subjects affected / exposed
    0 / 29 (0.00%)
    5 / 52 (9.62%)
         occurrences all number
    0
    6
    Ecchymosis
         subjects affected / exposed
    4 / 29 (13.79%)
    1 / 52 (1.92%)
         occurrences all number
    7
    1
    Skin lesion
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 52 (1.92%)
         occurrences all number
    2
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 29 (10.34%)
    5 / 52 (9.62%)
         occurrences all number
    4
    5
    Arthritis
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 52 (3.85%)
         occurrences all number
    2
    2
    Arthralgia
         subjects affected / exposed
    14 / 29 (48.28%)
    15 / 52 (28.85%)
         occurrences all number
    21
    24
    Bone pain
         subjects affected / exposed
    6 / 29 (20.69%)
    0 / 52 (0.00%)
         occurrences all number
    7
    0
    Pain in extremity
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 52 (7.69%)
         occurrences all number
    1
    4
    Osteoarthritis
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 52 (5.77%)
         occurrences all number
    1
    5
    Neck pain
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 52 (5.77%)
         occurrences all number
    1
    3
    Myalgia
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    0
    4
    Muscle spasms
         subjects affected / exposed
    2 / 29 (6.90%)
    4 / 52 (7.69%)
         occurrences all number
    2
    4
    Joint swelling
         subjects affected / exposed
    4 / 29 (13.79%)
    2 / 52 (3.85%)
         occurrences all number
    4
    2
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 29 (0.00%)
    7 / 52 (13.46%)
         occurrences all number
    0
    8
    Oral herpes
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 29 (13.79%)
    4 / 52 (7.69%)
         occurrences all number
    4
    4
    Cellulitis
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 52 (5.77%)
         occurrences all number
    3
    3
    COVID-19
         subjects affected / exposed
    11 / 29 (37.93%)
    6 / 52 (11.54%)
         occurrences all number
    15
    6
    Bronchitis
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 52 (3.85%)
         occurrences all number
    2
    2
    Wound infection
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    0
    3
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 29 (13.79%)
    4 / 52 (7.69%)
         occurrences all number
    5
    6
    Metabolism and nutrition disorders
    Iron deficiency
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 52 (1.92%)
         occurrences all number
    4
    1
    Hyperuricaemia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    Hyperkalaemia
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 52 (1.92%)
         occurrences all number
    4
    1
    Decreased appetite
         subjects affected / exposed
    4 / 29 (13.79%)
    2 / 52 (3.85%)
         occurrences all number
    5
    2

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jan 2024
    Amendment 1 was made to address non-Merck protocol template. The rationale is further supported by acquisition of Imago BioSciences, Inc. by Merck & Co., Inc. This conversion resulted only in an entity name change and update to the address.
    08 Mar 2024
    Amendment 2 was made to address study extension where participants from this study were eligible to enroll in another bomedemstat extension study at any point before this study ended.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Sep 04 20:34:55 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA