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    Clinical Trial Results:
    A randomized, double-blind, placebo- and comparator-controlled study evaluating the effect of multiple doses of QGE031 compared to omalizumab in asthma induced by allergen bronchial provocation

    Summary
    EudraCT number
    		 2012-003350-84
    Trial protocol
    		 SE  
    Global end of trial date
    28 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    25 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CQGE031B2203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01703312
    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
    28 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effects of treatment every two weeks with 240 mg QGE031 versus omalizumab in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline
    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. Subjects were permitted use of rescue short-acting beta-2 agonists no more than twice a week with the exception of use for exercise induced symptoms. Should subjects have developed more frequent symptoms of asthma or an exacerbation of asthma during the study, whether spontaneously or as a result of allergen challenge, they were instructed to use short acting beta-2 agonists for relief of symptoms. The investigator was permitted to prescribe inhaled and, if necessary, oral steroids with or without long-acting beta-2 agonists to regain control of asthma.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Nov 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 35
    Country: Number of subjects enrolled
    Sweden: 2
    Worldwide total number of subjects
    37
    EEA total number of subjects
    2
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    37
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study consisted of up to a 28-day screening period (Day -31 to Day -4).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: QGE031 24 mg
    Arm description
    		 QGE031 24 mg or matching placebo, subcutaneous, q2 weeks x 6 doses
    Arm type
    		 Experimental

    Investigational medicinal product name
    QGE031
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    QGE031 120 mg per 1 mL liquid in vial, used to prepare the active subcutaneous injection

    Investigational medicinal product name
    Matching placebo for QGE031
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    QGE031 0 mg per 1 mL liquid in vial, used to prepare placebo subcutaneous injection

    Arm title
    		 Cohort 2: QGE031 72 mg
    Arm description
    		 QGE031 72 mg or matching placebo, subcutaneous, q2 weeks x 6 doses
    Arm type
    		 Experimental

    Investigational medicinal product name
    QGE031
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    QGE031 120 mg per 1 mL liquid in vial, used to prepare the active subcutaneous injection

    Investigational medicinal product name
    Matching placebo for QGE031
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    QGE031 0 mg per 1 mL liquid in vial, used to prepare placebo subcutaneous injection

    Arm title
    		 Cohort 3: QGE031 240 mg
    Arm description
    		 QGE031 240 mg or matching placebo, subcutaneous, q2 weeks x 6 doses
    Arm type
    		 Experimental

    Investigational medicinal product name
    QGE031
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    QGE031 120 mg per 1 mL liquid in vial, used to prepare the active subcutaneous injection

    Investigational medicinal product name
    Matching placebo for QGE031
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    QGE031 0 mg per 1 mL liquid in vial, used to prepare placebo subcutaneous injection

    Arm title
    		 Cohort 4: Omalizumab
    Arm description
    		 Omalizumab or matching placebo, subcutaneous, q2 weeks x 6 doses or q4 weeks x 3 doses
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Omalizumab or matching placebo, subcutaneous, q2 weeks x 6 doses or q4 weeks x 3 doses

    Investigational medicinal product name
    Matching placebo for Omalizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Omalizumab or matching placebo, subcutaneous, q2 weeks x 6 doses or q4 weeks x 3 doses

    Arm title
    		 Placebo
    Arm description
    		 During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses).
    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
    r matching placebo, subcutaneous, q2 weeks x 6 doses or q4 weeks x 3 doses

    Number of subjects in period 1
    		Cohort 1: QGE031 24 mg Cohort 2: QGE031 72 mg Cohort 3: QGE031 240 mg Cohort 4: Omalizumab Placebo
    Started
    8
    8
    8
    6
    7
    Randomized
    8
    8
    8
    6
    7
    Completed
    7
    8
    8
    6
    6
    Not completed
    1
    0
    0
    0
    1
         Consent withdrawn by subject
    1
    -
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: QGE031 24 mg
    Reporting group description
    		 QGE031 24 mg or matching placebo, subcutaneous, q2 weeks x 6 doses

    Reporting group title
    Cohort 2: QGE031 72 mg
    Reporting group description
    		 QGE031 72 mg or matching placebo, subcutaneous, q2 weeks x 6 doses

    Reporting group title
    Cohort 3: QGE031 240 mg
    Reporting group description
    		 QGE031 240 mg or matching placebo, subcutaneous, q2 weeks x 6 doses

    Reporting group title
    Cohort 4: Omalizumab
    Reporting group description
    		 Omalizumab or matching placebo, subcutaneous, q2 weeks x 6 doses or q4 weeks x 3 doses

    Reporting group title
    Placebo
    Reporting group description
    		 During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses).

    Reporting group values
    		 Cohort 1: QGE031 24 mg Cohort 2: QGE031 72 mg Cohort 3: QGE031 240 mg Cohort 4: Omalizumab Placebo Total
    Number of subjects
    		 8 8 8 6 7 37
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 8 8 8 6 7 37
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 26.3 ( 1.83 ) 32.3 ( 15.08 ) 34.4 ( 11.84 ) 33 ( 11.88 ) 30.1 ( 12.77 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 5 4 4 6 25
        Male
    		 2 3 4 2 1 12

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: QGE031 24 mg
    Reporting group description
    		 QGE031 24 mg or matching placebo, subcutaneous, q2 weeks x 6 doses

    Reporting group title
    Cohort 2: QGE031 72 mg
    Reporting group description
    		 QGE031 72 mg or matching placebo, subcutaneous, q2 weeks x 6 doses

    Reporting group title
    Cohort 3: QGE031 240 mg
    Reporting group description
    		 QGE031 240 mg or matching placebo, subcutaneous, q2 weeks x 6 doses

    Reporting group title
    Cohort 4: Omalizumab
    Reporting group description
    		 Omalizumab or matching placebo, subcutaneous, q2 weeks x 6 doses or q4 weeks x 3 doses

    Reporting group title
    Placebo
    Reporting group description
    		 During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses).

    Subject analysis set title
    QGE031 240mg vs. Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    One efficacy objective to compare the effects between QGE031 240 mg and Placebo.

    Subject analysis set title
    QGE031 72mg vs. Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    One efficacy objective to compare the effects between QGE031 72 mg and Placebo.

    Subject analysis set title
    QGE031 24mg vs. Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    One efficacy objective to compare the effects between QGE031 24 mg and Placebo.

    Subject analysis set title
    Omalizumab vs. Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    One efficacy objective to compare the effects between Omalizumab and Placebo.

    Primary: Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second

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    End point title
    		 Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second [1]
    End point description
    The end point is not reporting statistics for all the arms in the baseline period
    End point type
    Primary
    End point timeframe
    6, 12, and 18 weeks
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only select arms are reporting data for the measure. Values are not provided in other arms for this measure.
    End point values
    		 Cohort 3: QGE031 240 mg Cohort 4: Omalizumab
    Number of subjects analysed
    8
    6
    Units: ratio
    geometric mean (geometric coefficient of variation)
        Week 6
    6.58 ( 0.848 )
    7.761 ( 0.848 )
        Week 12
    24.762 ( 2.969 )
    8.339 ( 2.969 )
        Week 18
    5.118 ( 1.707 )
    2.999 ( 1.707 )
    Statistical analysis title
    		 Ratio of Geometric Means
    Comparison groups
    Cohort 4: Omalizumab v Cohort 3: QGE031 240 mg
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.1
    Method
    		 linear mixed effects model
    Confidence interval
    Notes
    [2] - inferential

    Secondary: Ratio of Geometric Means of QGE031 doses and omalizumab vs. Placebo at 12 weeks of treatment

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    End point title
    		 Ratio of Geometric Means of QGE031 doses and omalizumab vs. Placebo at 12 weeks of treatment
    End point description
    Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1) following treatment with placebo and various doses of QGE031.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 QGE031 240mg vs. Placebo QGE031 72mg vs. Placebo QGE031 24mg vs. Placebo Omalizumab vs. Placebo
    Number of subjects analysed
    15
    15
    15
    13
    Units: ratio
    geometric mean (geometric coefficient of variation)
        Test
    24.762 ( 16.081 )
    22.796 ( 14.804 )
    2.781 ( 1.806 )
    8.339 ( 5.416 )
        Reference
    1.54 ( 16.081 )
    1.54 ( 14.804 )
    1.54 ( 1.806 )
    1.54 ( 5.416 )
    No statistical analyses for this end point

    Secondary: Plasma QGE031 concentrations at week 24

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    End point title
    		 Plasma QGE031 concentrations at week 24 [3]
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only select arms are reporting data for the measure. Values are not provided in other arms for this measure.
    End point values
    		 Cohort 1: QGE031 24 mg Cohort 2: QGE031 72 mg Cohort 3: QGE031 240 mg
    Number of subjects analysed
    7
    8
    8
    Units: µg/mL
        arithmetic mean (standard deviation)
    0 ( 0 )
    0.567 ( 0.689 )
    1.91 ( 1.1 )
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events or other safety concerns

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    End point title
    		 Number of participants with adverse events or other safety concerns
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Cohort 1: QGE031 24 mg Cohort 2: QGE031 72 mg Cohort 3: QGE031 240 mg Cohort 4: Omalizumab Placebo
    Number of subjects analysed
    8
    8
    8
    6
    7
    Units: participants
        number (not applicable)
    8
    5
    7
    3
    6
    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
    16.1
    Reporting groups
    Reporting group title
    Cohort 1 QGE031 24mg
    Reporting group description
    		 Cohort 1 QGE031 24mg

    Reporting group title
    Cohort 2 QGE031 72mg
    Reporting group description
    		 Cohort 2 QGE031 72mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Cohort 4 Omalizumab
    Reporting group description
    		 Cohort 4 Omalizumab

    Reporting group title
    Cohort 3 QGE031 240mg
    Reporting group description
    		 Cohort 3 QGE031 240mg

    Serious adverse events
    		 Cohort 1 QGE031 24mg Cohort 2 QGE031 72mg Placebo Cohort 4 Omalizumab Cohort 3 QGE031 240mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1 QGE031 24mg Cohort 2 QGE031 72mg Placebo Cohort 4 Omalizumab Cohort 3 QGE031 240mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 8 (100.00%)
    5 / 8 (62.50%)
    6 / 7 (85.71%)
    3 / 6 (50.00%)
    7 / 8 (87.50%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Injection site bruising
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Injection site erythema
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    1
    0
    0
    5
    Injection site pruritus
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    3
    Injection site urticaria
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Injection site warmth
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    0
    0
    3
    Pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 8 (25.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
         occurrences all number
    2
    1
    0
    1
    1
    Cough
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    3 / 8 (37.50%)
         occurrences all number
    1
    0
    0
    0
    3
    Nasal congestion
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    1
    0
    0
    2
    Wheezing
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Arthropod bite
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Contusion
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Injection related reaction
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Fall
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Laceration
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Ligament sprain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Cardiac disorders
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    2 / 8 (25.00%)
         occurrences all number
    0
    0
    0
    1
    3
    Dizziness
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Eye pruritus
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    0
    2
    Nausea
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rash generalised
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Solar dermatitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    0
    1
    Back pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    0
    0
    1
    Patellofemoral pain syndrome
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Tenosynovitis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Influenza
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    5 / 8 (62.50%)
    2 / 8 (25.00%)
    0 / 7 (0.00%)
    3 / 6 (50.00%)
    1 / 8 (12.50%)
         occurrences all number
    6
    2
    0
    3
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Tooth abscess
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    0
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 8 (25.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Iron deficiency
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Dec 2012
    • Changed contraception requirement for WOCBP from highly effective to effective due to enhanced peri-and post-natal development preclinical data since the original submission of this protocol. • Screening bronchial provocation procedures were modified as follows: late phase assessment made optional; sputum collection and post-allergen methacholine challenge made not mandatory. • The language of Section 4.4 (Exclusion criteria), Section 5.5.8 (Concomitant treatment) and Section 5.5.9 (Prohibited treatment) of the protocol was amended to be internally consistent and consistent with the AllerGen SOPs. • Removed collection of blood for allergen-specific T cells and dendritic cell subsets from Section 6.6 of the protocol. • Updated blood log to reflect volumes collected by the tubes contained in central lab kits. Total blood volume decreased due to the removal of biomarker collection (allergen-specific T cells and dendritic cell subsets).

    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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