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    Clinical Trial Results:
    Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy and Pharmacodynamics of IMG-7289 in Patients with Essential Thrombocythemia

    Summary
    EudraCT number
    		 2019-003659-13
    Trial protocol
    		 DE   GB   IT  
    Global end of trial date
    23 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2024
    First version publication date
    29 Mar 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-3453-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04254978
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Imago: IMG-7289-CTP-201
    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@merck.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
    23 Mar 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Mar 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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
    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
    08 Sep 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 20
    Country: Number of subjects enrolled
    United States: 7
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    New Zealand: 6
    Country: Number of subjects enrolled
    Hong Kong: 16
    Worldwide total number of subjects
    73
    EEA total number of subjects
    16
    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)
    34
    From 65 to 84 years
    37
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 94 participants were screened for the study. Of these, 21 participants were considered as screen failures and did not enter the treatment phase of the study.

    Period 1
    Period 1 title
    Initial Treatment Period (ITP)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Bomedemstat
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bomedemstat
    Investigational medicinal product code
    Other name
    MG-7289 MK-3543
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Bomedemstat administered daily for 169 consecutive days

    Number of subjects in period 1
    		Bomedemstat
    Started
    73
    Completed
    64
    Not completed
    9
         Consent withdrawn by subject
    3
         Adverse event, non-fatal
    5
         Lack of efficacy
    1
    Period 2
    Period 2 title
    Additional Treatment Period (ATP)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Bomedemstat
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bomedemstat
    Investigational medicinal product code
    Other name
    MG-7289 MK-3543
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Bomedemstat administered daily for 169 consecutive days

    Number of subjects in period 2 [1]
    		Bomedemstat
    Started
    63
    Completed
    52
    Not completed
    11
         Consent withdrawn by subject
    3
         Physician decision
    1
         Adverse event, non-fatal
    7
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: One participant completed the initial treatment period (ITP) but did not continue into the additional treatment period (ATP)

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bomedemstat
    Reporting group description
    		 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.

    Reporting group values
    		 Bomedemstat Total
    Number of subjects
    		 73 73
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 34 34
        From 65-84 years
    		 37 37
        85 years and over
    		 2 2
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 64.8 ± 10.40 -
    Sex: Female, Male
    Units: Participants
        Female
    		 42 42
        Male
    		 31 31
    Race (Customized)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 18 18
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 3 3
        White
    		 51 51
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0
        Aboriginal
    		 1 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 1
        Not Hispanic or Latino
    		 71 71
        Unknown or Not Reported
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Bomedemstat
    Reporting group description
    		 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.
    Reporting group title
    Bomedemstat
    Reporting group description
    		 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.

    Primary: Percentage of Participants with Platelet Count ≤400k/μL

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    End point title
    		 Percentage of Participants with Platelet Count ≤400k/μL [1]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Up to day 169
    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: No between-group statistical analyses were performed for this endpoint.
    End point values
    		 Bomedemstat
    Number of subjects analysed
    64
    Units: Percentage of Participants
        number (confidence interval 95%)
    76.6 (64.3 to 86.2)
    No statistical analyses for this end point

    Primary: Number of Participants Who Experienced an Adverse Event (AE)

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    End point title
    		 Number of Participants Who Experienced an Adverse Event (AE) [2]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Up to approximately 30 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: No statistical analyses were planned for this endpoint.
    End point values
    		 Bomedemstat
    Number of subjects analysed
    73
    Units: Participants
    73
    No statistical analyses for this end point

    Primary: Number of Participants Who Discontinue Study Treatment Due to an AE

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    End point title
    		 Number of Participants Who Discontinue Study Treatment Due to an AE [3]
    End point 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 discontinued study treatment due to an AE is reported.
    End point type
    Primary
    End point timeframe
    Up to approximately 30 months
    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: No statistical analyses were planned for this endpoint.
    End point values
    		 Bomedemstat
    Number of subjects analysed
    73
    Units: Participants
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 30 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Bomedemstat
    Reporting group description
    		 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.

    Serious adverse events
    		 Bomedemstat
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 73 (36.99%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Vasculitis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Rotator cuff repair
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea paroxysmal nocturnal
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Contusion
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Traumatic haematoma
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    Anemia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Chronic gastritis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mouth haemorrhage
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ileal ulcer
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Panniculitis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chondrocalcinosis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematoma muscle
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Synovitis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Arthralgia
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 73 (4.11%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Skin infection
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypervolaemia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Bomedemstat
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    72 / 73 (98.63%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    6
    General disorders and administration site conditions
    Fatigue
    Additional description: General disorders and administration site conditions
         subjects affected / exposed
    21 / 73 (28.77%)
         occurrences all number
    35
    Influenza like illness
    Additional description: General disorders and administration site conditions
         subjects affected / exposed
    9 / 73 (12.33%)
         occurrences all number
    10
    Oedema peripheral
    Additional description: General disorders and administration site conditions
         subjects affected / exposed
    11 / 73 (15.07%)
         occurrences all number
    15
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Epistaxis
         subjects affected / exposed
    7 / 73 (9.59%)
         occurrences all number
    8
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 73 (8.22%)
         occurrences all number
    8
    Investigations
    Weight decreased
         subjects affected / exposed
    7 / 73 (9.59%)
         occurrences all number
    8
    Blood creatinine increased
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    8
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Limb injury
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Contusion
         subjects affected / exposed
    18 / 73 (24.66%)
         occurrences all number
    25
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    11 / 73 (15.07%)
         occurrences all number
    12
    Headache
         subjects affected / exposed
    12 / 73 (16.44%)
         occurrences all number
    26
    Paraesthesia
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    10
    Syncope
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Dysgeusia
         subjects affected / exposed
    43 / 73 (58.90%)
         occurrences all number
    62
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    14 / 73 (19.18%)
         occurrences all number
    35
    Neutropenia
         subjects affected / exposed
    8 / 73 (10.96%)
         occurrences all number
    12
    Thrombocytopenia
         subjects affected / exposed
    23 / 73 (31.51%)
         occurrences all number
    47
    Gastrointestinal disorders
    Gingival bleeding
         subjects affected / exposed
    6 / 73 (8.22%)
         occurrences all number
    6
    Abdominal discomfort
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Abdominal pain
         subjects affected / exposed
    6 / 73 (8.22%)
         occurrences all number
    7
    Flatulence
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Dyspepsia
         subjects affected / exposed
    6 / 73 (8.22%)
         occurrences all number
    6
    Diarrhoea
         subjects affected / exposed
    15 / 73 (20.55%)
         occurrences all number
    22
    Constipation
         subjects affected / exposed
    29 / 73 (39.73%)
         occurrences all number
    35
    Vomiting
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    5
    Nausea
         subjects affected / exposed
    10 / 73 (13.70%)
         occurrences all number
    17
    Large intestine polyp
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Haemorrhoids
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Rash
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Pruritus
         subjects affected / exposed
    14 / 73 (19.18%)
         occurrences all number
    17
    Nail disorder
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Hyperhidrosis
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Ecchymosis
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    5
    Dry skin
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    5
    Alopecia
         subjects affected / exposed
    14 / 73 (19.18%)
         occurrences all number
    17
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    9 / 73 (12.33%)
         occurrences all number
    18
    Neck pain
         subjects affected / exposed
    6 / 73 (8.22%)
         occurrences all number
    6
    Myalgia
         subjects affected / exposed
    6 / 73 (8.22%)
         occurrences all number
    6
    Muscular weakness
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    6
    Muscle spasms
         subjects affected / exposed
    6 / 73 (8.22%)
         occurrences all number
    6
    Joint effusion
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Bone pain
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    9
    Back pain
         subjects affected / exposed
    12 / 73 (16.44%)
         occurrences all number
    13
    Arthralgia
         subjects affected / exposed
    29 / 73 (39.73%)
         occurrences all number
    75
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    9
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    6
    Gastroenteritis
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    5
    Cellulitis
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    5
    COVID-19
         subjects affected / exposed
    19 / 73 (26.03%)
         occurrences all number
    19
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 73 (8.22%)
         occurrences all number
    8
    Iron deficiency
         subjects affected / exposed
    7 / 73 (9.59%)
         occurrences all number
    7
    Gout
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Mar 2020
    Amendment 1: The main purpose of the amendment was to update the inclusion and exclusion criteria and to modify the DLT criteria per FDA request.
    19 Oct 2020
    Amendment 2: The main purpose of the amendment was to increase the number of enrolled participants from 40 to 60. The amendment also updated the titration of the study treatment and clarified the adverse event reporting criteria.

    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
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    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
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