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    Clinical Trial Results:
    A Multicenter, Open-Label Extension Study of WVE-210201 in Patients Previously Enrolled in WVE-DMDX51-001

    Summary
    EudraCT number
    2018-000975-34
    Trial protocol
    GB   FR   NL   BE   IT  
    Global end of trial date
    20 Jan 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Sep 2020
    First version publication date
    13 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    WVE-DMDX51-002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Wave Life Sciences UK Limited
    Sponsor organisation address
    1 Chamberlain Square CS, Birmingham, United Kingdom, B3 3AX
    Public contact
    Chief Medical Officer, Wave Life Sciences, +617 949-2900, info@wavelifesci.com
    Scientific contact
    Chief Medical Officer, Wave Life Sciences, +617 949-2900, info@wavelifesci.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
    18 Feb 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of WVE-210201
    Protection of trial subjects
    Written informed consent from each patient or patient’s parent(s) or legal guardian(s), if applicable, and written assent from each patient, if applicable, were obtained before any study-specific screening or baseline period evaluations were performed. The anonymity of participating patients was maintained to the extent required by applicable laws and in accordance with current HIPAA standards. This study was designed and monitored in accordance with Sponsor procedures, which complied with the ethical principles of Good Clinical Practice (GCP) as required by the major regulatory authorities, and in accordance with the Declaration of Helsinki. The unblinded, independent Safety Monitoring Committee (SMC) reviewed aggregate safety data periodically and unblinded, aggregate safety data periodically and on an ad hoc basis should any emergent safety concerns have arisen during the course of the study. Recommendations based on these reviews were to be provided to the Sponsor
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    14 Aug 2018
    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
    Canada: 1
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    United States: 10
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    France: 5
    Worldwide total number of subjects
    37
    EEA total number of subjects
    26
    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)
    33
    Adolescents (12-17 years)
    4
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted in 6 countries (Belgium, France, Italy, United Kingdom, Canada and United States from 14 August 2018 to 20 January 2020).

    Pre-assignment
    Screening details
    The patients successfully completed the Phase I study (WVE-DMDX51-001) were eligible to participate in this open-label extension study (OLE study). They were re-evaluated for certain eligibility criteria. Patients started screening for this OLE study after a minimum of 2 weeks from the last follow-up visit in the Phase I study.

    Period 1
    Period 1 title
    Period 1 (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    This is an open-label study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    1 mg/kg WVE-210201
    Arm description
    Dose at enrollment, 1 mg/kg WVE-210201 administered via IV infusion
    Arm type
    Experimental

    Investigational medicinal product name
    suvodirsen
    Investigational medicinal product code
    WVE-210201
    Other name
    Pharmaceutical forms
    Powder for infusion, Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received weekly IV infusions of suvodirsen. WVE-210201 was provided either as a lyophilized powder or as an isotonic solution for dilution for infusion.

    Arm title
    2 mg/kg WVE-210201
    Arm description
    Dose at enrollment, 2 mg/kg WVE-210201 administered via IV infusion
    Arm type
    Experimental

    Investigational medicinal product name
    suvodirsen
    Investigational medicinal product code
    WVE-210201
    Other name
    Pharmaceutical forms
    Solution for infusion, Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received weekly IV infusions of suvodirsen. WVE-210201 was provided either as a lyophilized powder or as an isotonic solution for dilution for infusion.

    Arm title
    3.5 mg/kg WVE-210201
    Arm description
    Dose at enrollment, 3.5 mg/kg WVE-210201 administered via IV infusion
    Arm type
    Experimental

    Investigational medicinal product name
    suvodirsen
    Investigational medicinal product code
    WVE-210201
    Other name
    Pharmaceutical forms
    Solution for infusion, Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received weekly IV infusions of suvodirsen. WVE-210201 was provided either as a lyophilized powder or as an isotonic solution for dilution for infusion.

    Arm title
    5 mg/kg WVE-210201
    Arm description
    Dose at enrollment, 5 mg/kg WVE-210201 administered via IV infusion
    Arm type
    Experimental

    Investigational medicinal product name
    suvodirsen
    Investigational medicinal product code
    WVE-210201
    Other name
    Pharmaceutical forms
    Powder for infusion, Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received weekly IV infusions of suvodirsen. WVE-210201 was provided either as a lyophilized powder or as an isotonic solution for dilution for infusion.

    Number of subjects in period 1
    1 mg/kg WVE-210201 2 mg/kg WVE-210201 3.5 mg/kg WVE-210201 5 mg/kg WVE-210201
    Started
    14
    5
    5
    13
    Completed Dose Modification Visit
    13
    5
    0
    0
    Target Dose 3.5 mg/kg
    1
    4
    0
    0
    Target Dose 5 mg/kg
    12
    1
    0
    0
    Completed
    0
    0
    0
    0
    Not completed
    14
    5
    5
    13
         Physician decision
    1
    -
    -
    -
         Study Terminated by Sponsor
    13
    5
    5
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1 mg/kg WVE-210201
    Reporting group description
    Dose at enrollment, 1 mg/kg WVE-210201 administered via IV infusion

    Reporting group title
    2 mg/kg WVE-210201
    Reporting group description
    Dose at enrollment, 2 mg/kg WVE-210201 administered via IV infusion

    Reporting group title
    3.5 mg/kg WVE-210201
    Reporting group description
    Dose at enrollment, 3.5 mg/kg WVE-210201 administered via IV infusion

    Reporting group title
    5 mg/kg WVE-210201
    Reporting group description
    Dose at enrollment, 5 mg/kg WVE-210201 administered via IV infusion

    Reporting group values
    1 mg/kg WVE-210201 2 mg/kg WVE-210201 3.5 mg/kg WVE-210201 5 mg/kg WVE-210201 Total
    Number of subjects
    14 5 5 13 37
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0
        Children (2-11 years)
    12 4 5 12 33
        Adolescents (12-17 years)
    2 1 0 1 4
        Adults (18-64 years)
    0 0 0 0 0
        From 65-84 years
    0 0 0 0 0
        85 years and over
    0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    0 0 0 0 0
        Male
    14 5 5 13 37
    Subject analysis sets

    Subject analysis set title
    Safety population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All patients who received at least 1 dose of WVE-210201

    Subject analysis sets values
    Safety population
    Number of subjects
    37
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    33
        Adolescents (12-17 years)
    4
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    37

    End points

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    End points reporting groups
    Reporting group title
    1 mg/kg WVE-210201
    Reporting group description
    Dose at enrollment, 1 mg/kg WVE-210201 administered via IV infusion

    Reporting group title
    2 mg/kg WVE-210201
    Reporting group description
    Dose at enrollment, 2 mg/kg WVE-210201 administered via IV infusion

    Reporting group title
    3.5 mg/kg WVE-210201
    Reporting group description
    Dose at enrollment, 3.5 mg/kg WVE-210201 administered via IV infusion

    Reporting group title
    5 mg/kg WVE-210201
    Reporting group description
    Dose at enrollment, 5 mg/kg WVE-210201 administered via IV infusion

    Subject analysis set title
    Safety population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All patients who received at least 1 dose of WVE-210201

    Primary: Number of Patients who Experienced a Serious TEAE

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    End point title
    Number of Patients who Experienced a Serious TEAE [1]
    End point description
    An SAE was defined as any event that resulted in death, was immediately life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect not present at Screening. Important medical events that did not result in death, were life threatening, or required hospitalization were considered SAEs when, based upon appropriate medical judgment, they jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed in this definition. No patients were withdrawn due to a serious or intolerable AE that in the Investigator’s opinion required discontinuation of study drug. 3 patients experienced severe adverse events (2 in 3.5 mg/kg WVE-210201 arm and 1 in 5 mg/kg WVE-210201 arm). This may include patients whose doses were modified.
    End point type
    Primary
    End point timeframe
    Day 1 to Early Termination
    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 statistical analysis has been used.
    End point values
    1 mg/kg WVE-210201 2 mg/kg WVE-210201 3.5 mg/kg WVE-210201 5 mg/kg WVE-210201
    Number of subjects analysed
    14
    5
    5
    13
    Units: Subjects
    number (not applicable)
        Number of Patients who Experienced an SAE
    0
    0
    1
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to Early Termination
    Adverse event reporting additional description
    For the patients who had a dose modification during the course of the study, events that occurred prior to dose modification are counted in the dose arm that the patient received at the time of enrollment, and events that occurred after dose modification are counted in the dose arm that the patient received after dose modification.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    1 mg/kg WVE-210201
    Reporting group description
    1 mg/kg WVE-210201 administered via IV infusion

    Reporting group title
    2 mg/kg WVE-210201
    Reporting group description
    2 mg/kg WVE-210201 administered via IV infusion

    Reporting group title
    3.5 mg/kg WVE-210201
    Reporting group description
    3.5 mg/kg WVE-210201 administered via IV infusion.

    Reporting group title
    5 mg/kg WVE-210201
    Reporting group description
    5 mg/kg WVE-210201 administered via IV infusion

    Serious adverse events
    1 mg/kg WVE-210201 2 mg/kg WVE-210201 3.5 mg/kg WVE-210201 5 mg/kg WVE-210201
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    5 / 26 (19.23%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glutamate dehydrogenase increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    4 / 26 (15.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    2 / 26 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    1 mg/kg WVE-210201 2 mg/kg WVE-210201 3.5 mg/kg WVE-210201 5 mg/kg WVE-210201
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 14 (100.00%)
    5 / 5 (100.00%)
    10 / 10 (100.00%)
    26 / 26 (100.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    3 / 26 (11.54%)
         occurrences all number
    1
    0
    5
    13
    Haematoma
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypertension
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Pallor
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Catheter site erythema
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Chest discomfort
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    5
    Chest pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    3 / 26 (11.54%)
         occurrences all number
    1
    0
    0
    9
    Chills
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    2 / 10 (20.00%)
    4 / 26 (15.38%)
         occurrences all number
    0
    0
    4
    8
    Fatigue
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    2 / 10 (20.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    3
    4
    Feeling abnormal
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Feeling cold
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Hyperthermia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infusion site erythema
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Infusion site papule
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    2
    Malaise
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    1
    Pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    1
    0
    0
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    2
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    6 / 10 (60.00%)
    22 / 26 (84.62%)
         occurrences all number
    1
    0
    29
    113
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    3 / 10 (30.00%)
    5 / 26 (19.23%)
         occurrences all number
    0
    0
    3
    7
    Dyspnoea
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    1 / 26 (3.85%)
         occurrences all number
    1
    0
    1
    4
    Epistaxis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypoxia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    3 / 26 (11.54%)
         occurrences all number
    2
    0
    0
    3
    Oropharyngeal pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 5 (20.00%)
    2 / 10 (20.00%)
    4 / 26 (15.38%)
         occurrences all number
    0
    1
    2
    5
    Sneezing
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sputum discoloured
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Throat irritation
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    1 / 26 (3.85%)
         occurrences all number
    2
    0
    1
    1
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Mood altered
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Restlessness
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Sleep disorder
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood fibrinogen increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Blood lactic acid increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Blood pressure increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Body temperature increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    1
    3
    C-reactive protein increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Complement factor C3 increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    0
    2
    Ejection fraction decreased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    1
    2
    Glutamate dehydrogenase increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    2 / 10 (20.00%)
    4 / 26 (15.38%)
         occurrences all number
    0
    0
    3
    4
    Heart rate increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    1
    Monocyte count increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Neutrophil count increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Protein urine present
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    4
    Troponin I increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Troponin increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    White blood cell count increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    0
    2
    Arthropod sting
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fall
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    2 / 10 (20.00%)
    9 / 26 (34.62%)
         occurrences all number
    1
    0
    2
    14
    Heat exhaustion
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Laceration
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Ligament sprain
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Limb injury
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    1
    2
    Procedural pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    2 / 10 (20.00%)
    6 / 26 (23.08%)
         occurrences all number
    0
    0
    2
    6
    Skin abrasion
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Soft tissue injury
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Wound complication
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Wound secretion
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Cyanosis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Palpitations
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Sinus tachycardia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Tachycardia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    7 / 26 (26.92%)
         occurrences all number
    0
    0
    0
    31
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    2 / 10 (20.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Dysstasia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 5 (20.00%)
    6 / 10 (60.00%)
    14 / 26 (53.85%)
         occurrences all number
    4
    1
    37
    58
    Lethargy
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tympanic membrane hyperaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 5 (20.00%)
    2 / 10 (20.00%)
    6 / 26 (23.08%)
         occurrences all number
    2
    1
    6
    14
    Abdominal pain upper
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    4 / 10 (40.00%)
    4 / 26 (15.38%)
         occurrences all number
    1
    0
    4
    7
    Defaecation urgency
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    3 / 10 (30.00%)
    8 / 26 (30.77%)
         occurrences all number
    0
    0
    9
    8
    Dysphagia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Food poisoning
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Loose tooth
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Nausea
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    8 / 26 (30.77%)
         occurrences all number
    1
    0
    2
    17
    Stomatitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    3 / 10 (30.00%)
    14 / 26 (53.85%)
         occurrences all number
    1
    0
    3
    46
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eczema
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    0
    1
    Erythema
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 5 (40.00%)
    0 / 10 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Livedo reticularis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    0
    2
    Pruritus
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    1
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 5 (20.00%)
    2 / 10 (20.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    1
    2
    5
    Rash erythematous
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Rash pruritic
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    9
    Urticaria
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    1
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Back pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    2 / 10 (20.00%)
    5 / 26 (19.23%)
         occurrences all number
    0
    0
    3
    5
    Haemarthrosis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    0
    7
    Musculoskeletal pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Osteoporosis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    6 / 26 (23.08%)
         occurrences all number
    1
    0
    1
    11
    Infections and infestations
    Asymptomatic bacteriuria
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    1
    0
    0
    2
    Candida infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Cystitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    1
    0
    0
    4
    Influenza
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    2 / 10 (20.00%)
    2 / 26 (7.69%)
         occurrences all number
    1
    0
    4
    2
    Rhinitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 5 (20.00%)
    0 / 10 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin bacterial infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Tinea infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    3 / 26 (11.54%)
         occurrences all number
    0
    0
    0
    3
    Wound infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    1 / 10 (10.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    1
    6
    Dehydration
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Insulin resistance
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 May 2018
    Amendment 3.0, dated 25 May 2018 - Addition of liquid formulation of WVE-210201
    01 Aug 2018
    Amendment 5.0, dated 01 August 2018 - Baseline needle biopsy collection was removed and end-of-treatment needle biopsy was clarified.
    22 Jan 2019
    Amendment 6.0, dated 22 January 2019 - Study was extended from 14 weeks to 96 weeks. Dose modification to the highest tolerated doses (3.5 and 5 mg/kg) was added.

    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.
    Not applicable
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