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    Clinical Trial Results:
    A Multi-Center, Randomized, Double-Blind, Placebo- Controlled study to investigate the efficacy and safety of 52 weeks treatment with QGE031 subcutaneous (s.c). in Asthma Patients not adequately controlled by medium- or high-dose inhaled corticosteroid (ICS) plus long acting β2-agonist (LABA) with or without oral corticosteroid (OCS)

    Summary
    EudraCT number
    		 2014-003155-57
    Trial protocol
    		 GB   HU   IT   DE   BE   ES   SK   NL   LU  
    Global end of trial date
    07 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Mar 2017
    First version publication date
    09 Mar 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CQGE031B2204
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02336425
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    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
    07 Mar 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Mar 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy of QGE031 (24 mg, 72 mg, 240 mg s.c. q4w) compared to placebo on top of standard of care (SoC) in atopic patients with asthma who were not adequately controlled by medium- or high-dose ICS plus LABA with or without OCS on the reduction in rate of severe asthma exacerbations during 52 weeks of treatment.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 A short-acting β2-agonist (SABA) (salbutamol/albuterol) was provided to patients for use as a rescue medication. For the treatment of potential anaphylactic reactions, patients were supplied epinephrine autoinjector. If an epinephrine auto-injector was not available locally, the administration of epinephrine followed local standard of care.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2015
    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
    Hungary: 3
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Japan: 2
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Slovakia: 2
    Worldwide total number of subjects
    10
    EEA total number of subjects
    7
    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)
    9
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were randomized to one of the four treatment arms.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 QGE031 240 mg
    Arm description
    		 QGE031 240 mg subcutaneous injection every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    QGE031
    Investigational medicinal product code
    QGE031
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    QGE031 240 mg subcutaneous injection every 4 weeks

    Arm title
    		 QGE031 72 mg
    Arm description
    		 QGE031 72 mg subcutaneous injection every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    QGE031
    Investigational medicinal product code
    QGE031
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    QGE031 72 mg subcutaneous injection every 4 weeks

    Arm title
    		 QGE031 24 mg
    Arm description
    		 QGE031 24 mg subcutaneous injection every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    QGE031
    Investigational medicinal product code
    QGE031
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    QGE031 24 mg subcutaneous injection every 4 weeks

    Arm title
    		 Placebo to QGE031
    Arm description
    		 Placebo subcutaneous injection every 4 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching placebo to QGE031 subcutaneous injection every 4 weeks

    Number of subjects in period 1
    		QGE031 240 mg QGE031 72 mg QGE031 24 mg Placebo to QGE031
    Started
    2
    2
    3
    3
    Completed
    0
    0
    0
    0
    Not completed
    2
    2
    3
    3
         Study terminated.
    2
    2
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    QGE031 240 mg
    Reporting group description
    		 QGE031 240 mg subcutaneous injection every 4 weeks

    Reporting group title
    QGE031 72 mg
    Reporting group description
    		 QGE031 72 mg subcutaneous injection every 4 weeks

    Reporting group title
    QGE031 24 mg
    Reporting group description
    		 QGE031 24 mg subcutaneous injection every 4 weeks

    Reporting group title
    Placebo to QGE031
    Reporting group description
    		 Placebo subcutaneous injection every 4 weeks

    Reporting group values
    		 QGE031 240 mg QGE031 72 mg QGE031 24 mg Placebo to QGE031 Total
    Number of subjects
    		 2 2 3 3 10
    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)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 2 2 2 3 9
        From 65-84 years
    		 0 0 1 0 1
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 46.5 ( 16.26 ) 47 ( 1.41 ) 53.7 ( 11.59 ) 47.7 ( 2.89 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 2 0 3 2 7
        Male
    		 0 2 0 1 3

    End points

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    End points reporting groups
    Reporting group title
    QGE031 240 mg
    Reporting group description
    		 QGE031 240 mg subcutaneous injection every 4 weeks

    Reporting group title
    QGE031 72 mg
    Reporting group description
    		 QGE031 72 mg subcutaneous injection every 4 weeks

    Reporting group title
    QGE031 24 mg
    Reporting group description
    		 QGE031 24 mg subcutaneous injection every 4 weeks

    Reporting group title
    Placebo to QGE031
    Reporting group description
    		 Placebo subcutaneous injection every 4 weeks

    Primary: QGE031 compared to placebo in atopic asthma patients on the reduction in rate of severe asthma exacerbations

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    End point title
    		 QGE031 compared to placebo in atopic asthma patients on the reduction in rate of severe asthma exacerbations [1]
    End point description
    End point type
    Primary
    End point timeframe
    Week 52
    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: Due to the small number of patients randomized, the planned statistical analysis was not performed.
    End point values
    		 QGE031 240 mg QGE031 72 mg QGE031 24 mg Placebo to QGE031
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    Units: severe asthma exacerbations
        number (not applicable)
    Notes
    [2] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [3] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [4] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [5] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    No statistical analyses for this end point

    Secondary: QGE031 compared to placebo in all asthma patients on the reduction in rate of severe asthma exacerbations

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    End point title
    		 QGE031 compared to placebo in all asthma patients on the reduction in rate of severe asthma exacerbations
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 QGE031 240 mg QGE031 72 mg QGE031 24 mg Placebo to QGE031
    Number of subjects analysed
    0 [6]
    0 [7]
    0 [8]
    0 [9]
    Units: severe asthma exacerbations
        number (not applicable)
    Notes
    [6] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [7] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [8] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [9] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    No statistical analyses for this end point

    Secondary: QGE031 compared to placebo in non-atopic asthma patients on the reduction in rate of severe asthma exacerbations

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    End point title
    		 QGE031 compared to placebo in non-atopic asthma patients on the reduction in rate of severe asthma exacerbations
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 QGE031 240 mg QGE031 72 mg QGE031 24 mg Placebo to QGE031
    Number of subjects analysed
    0 [10]
    0 [11]
    0 [12]
    0 [13]
    Units: severe asthma exacerbations
        number (not applicable)
    Notes
    [10] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [11] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [12] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [13] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    No statistical analyses for this end point

    Secondary: QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on the reduction in rate of asthma exacerbations (by severity)

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    End point title
    		 QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on the reduction in rate of asthma exacerbations (by severity)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 QGE031 240 mg QGE031 72 mg QGE031 24 mg Placebo to QGE031
    Number of subjects analysed
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    Units: asthma exacerbations
        number (not applicable)
    Notes
    [14] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [15] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [16] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [17] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    No statistical analyses for this end point

    Secondary: QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on time to first asthma exacerbations (by severity)

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    End point title
    		 QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on time to first asthma exacerbations (by severity)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 QGE031 240 mg QGE031 72 mg QGE031 24 mg Placebo to QGE031
    Number of subjects analysed
    0 [18]
    0 [19]
    0 [20]
    0 [21]
    Units: days
        median (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [18] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [19] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [20] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [21] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    No statistical analyses for this end point

    Secondary: QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on change from baseline in Asthma Control Questionnaire (ACQ)

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    End point title
    		 QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on change from baseline in Asthma Control Questionnaire (ACQ)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
    End point values
    		 QGE031 240 mg QGE031 72 mg QGE031 24 mg Placebo to QGE031
    Number of subjects analysed
    0 [22]
    0 [23]
    0 [24]
    0 [25]
    Units: score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Notes
    [22] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [23] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [24] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [25] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    No statistical analyses for this end point

    Secondary: QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on change from baseline in Asthma Control Diary (ACD)

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    End point title
    		 QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on change from baseline in Asthma Control Diary (ACD)
    End point description
    End point type
    Secondary
    End point timeframe
    Over 52 weeks (Treatment) and 20 weeks (follow-up)
    End point values
    		 QGE031 240 mg QGE031 72 mg QGE031 24 mg Placebo to QGE031
    Number of subjects analysed
    0 [26]
    0 [27]
    0 [28]
    0 [29]
    Units: score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Notes
    [26] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [27] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [28] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [29] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    No statistical analyses for this end point

    Secondary: QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on Forced Expiratory Volume in 1 second (FEV1)

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    End point title
    		 QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on Forced Expiratory Volume in 1 second (FEV1)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)
    End point values
    		 QGE031 240 mg QGE031 72 mg QGE031 24 mg Placebo to QGE031
    Number of subjects analysed
    0 [30]
    0 [31]
    0 [32]
    0 [33]
    Units: liters
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Notes
    [30] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [31] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [32] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [33] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    No statistical analyses for this end point

    Secondary: QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on Peak expiratory flow (PEF) in the morning and evening

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    End point title
    		 QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on Peak expiratory flow (PEF) in the morning and evening
    End point description
    End point type
    Secondary
    End point timeframe
    Over 52 weeks (Treatment) and 20 weeks (follow-up)
    End point values
    		 QGE031 240 mg QGE031 72 mg QGE031 24 mg Placebo to QGE031
    Number of subjects analysed
    0 [34]
    0 [35]
    0 [36]
    0 [37]
    Units: liters/minute
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Notes
    [34] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [35] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [36] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [37] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    No statistical analyses for this end point

    Secondary: QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on Total daily symptom score

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    End point title
    		 QGE031 compared to placebo in asthma patients (all and either atopic or non-atopic) on Total daily symptom score
    End point description
    End point type
    Secondary
    End point timeframe
    Over 52 weeks (Treatment) and 20 weeks (follow-up)
    End point values
    		 QGE031 240 mg QGE031 72 mg QGE031 24 mg Placebo to QGE031
    Number of subjects analysed
    0 [38]
    0 [39]
    0 [40]
    0 [41]
    Units: score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Notes
    [38] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [39] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [40] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [41] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    No statistical analyses for this end point

    Secondary: Response to QGE031 between atopic asthma and non-atopic asthma

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    End point title
    		 Response to QGE031 between atopic asthma and non-atopic asthma
    End point description
    End point type
    Secondary
    End point timeframe
    Over 52 weeks (treatment) and 20 weeks (follow up)
    End point values
    		 QGE031 240 mg QGE031 72 mg QGE031 24 mg Placebo to QGE031
    Number of subjects analysed
    0 [42]
    0 [43]
    0 [44]
    0 [45]
    Units: Participants
        number (not applicable)
    Notes
    [42] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [43] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [44] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    [45] - Due to the small number of patients randomized, the planned statistical analysis was not performed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    QGE031 240 mg
    Reporting group description
    		 QGE031 240 mg subcutaneous injection every 4 weeks

    Reporting group title
    QGE031 72 mg
    Reporting group description
    		 QGE031 72 mg subcutaneous injection every 4 weeks

    Reporting group title
    QGE031 24 mg
    Reporting group description
    		 QGE031 24 mg subcutaneous injection every 4 weeks

    Reporting group title
    Placebo to QGE031
    Reporting group description
    		 Placebo subcutaneous injection every 4 weeks

    Serious adverse events
    		 QGE031 240 mg QGE031 72 mg QGE031 24 mg Placebo to QGE031
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 QGE031 240 mg QGE031 72 mg QGE031 24 mg Placebo to QGE031
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    2 / 2 (100.00%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    Injury, poisoning and procedural complications
    Contusion
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Dysphagia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Productive cough
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Asthma
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    2
    0
    2
    Hepatobiliary disorders
    Biliary colic
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Infections and infestations
    Conjunctivitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory tract infection
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Feb 2015
    This amendment 1 was triggered by a request from the European Health Authorities as part of the VHP (Voluntary Harmonization Procedure) process. Specifically, VHP requested the clarifications for the composition and the independency of the review committees from Novartis. Accordingly this amendment provided further clarification of the two committees that were supposed to review the data from the two pre-specified interim analyses.
    17 Mar 2015
    This amendment 2 was triggered by a request from the European Health Authorities as part of the VHP (Voluntary Harmonization Procedure) process. VHP requested to change the contraception method in the exclusion criteria based on “Recommendations related to contraception and pregnancy testing in clinical trials” issued by Clinical Trial Facilitation Group on 15-Sep-2014.
    24 Apr 2015
    This amendment 3 was triggered by feasibility challenges potentially affecting the conduct of the study. The detailed changes are outlined in the study protocol

    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.
    Study was terminated due to the efficacy results from the Phase II study CQGE031B2201 (NCT01716754). Data analyses were not performed due to the very limited dataset (only 10 participants received study medication of the 440 participants planned).
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