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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, 28-week, multicenter study with a 8 weeks follow-up period to investigate the impact of subcutaneous omalizumab on quality of life measures and on the incidence and severity of angioedema in patients with chronic spontaneous urticaria and a history of angioedema who remain symptomatic with H1-antihistamine treatment.

    Summary
    EudraCT number
    		 2011-004254-25
    Trial protocol
    		 DE  
    Global end of trial date
    09 May 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    CIGE025EDE16
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01723072
    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 AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis 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
    09 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    09 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to demonstrate the superiority of Omalizumab 300 mg versus placebo in patients with moderate to severe CSU regarding QoL measures. This was done by evaluating the change of total CU-Q2oL scores in moderate to severe CSU patients with a history of angioedema and insufficient treatment response to a high dose of nsH1-antihistamines (second line treatment: up to 4 times of the approved nsH1-antihistamine dose). Scores were calculated from baseline (visit 2) to week 28 (visit 9) with secondary objective(s).
    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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jan 2013
    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
    Germany: 91
    Worldwide total number of subjects
    91
    EEA total number of subjects
    91
    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)
    88
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Eligible study patients were randomized in a 1:1 ratio

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Omalizumab
    Arm description
    		 Omalizumab once a month via subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    IGE025
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    patients received two injections of Omalizumab 150 mg every four weeks

    Arm title
    		 Placebo
    Arm description
    		 Placebo of omalizumab once a month via subcutaneous injection
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    patients received two injections of Placebo every four weeks

    Number of subjects in period 1
    		Omalizumab Placebo
    Started
    44
    47
    Completed
    33
    26
    Not completed
    11
    21
         Consent withdrawn by subject
    7
    13
         Discon for rescue medication after wk 24
    -
    5
         Unknown
    4
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Omalizumab
    Reporting group description
    		 Omalizumab once a month via subcutaneous injection.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo of omalizumab once a month via subcutaneous injection

    Reporting group values
    		 Omalizumab Placebo Total
    Number of subjects
    		 44 47 91
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 41 47 88
        From 65-84 years
    		 3 0 3
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 44.9 ± 13.7 41.1 ± 10.6 -
    Gender, Male/Female
    Units: participants
        Male
    		 14 14 28
        Female
    		 30 33 63
    Age, Customized
    Units: Subjects
        <65 years
    		 41 47 88
        >=65 years
    		 3 0 3
    Study Specific Characteristic
    Body Mass Index group
    Units: Subjects
        <18.5
    		 0 0 0
        18.5-25
    		 20 12 32
        >25
    		 24 35 59
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 42 46 88
        Asian
    		 1 1 2
        Other
    		 1 0 1
    Study Specific Characteristic
    Units: Subjects
        Never smoked
    		 18 13 31
        Current smoker
    		 19 18 37
        Ex-smoker
    		 7 16 23
    Study Specific Characteristic
    Duration of symptoms of angioedema (usually)
    Units: Subjects
        <24 hours
    		 25 25 50
        >24 hours
    		 19 22 41
    Study Specific Characteristic
    Duration of disease group - n
    Units: Subjects
        <2
    		 13 13 26
        2-10
    		 18 27 45
        >10
    		 13 7 20
    Study Specific Characteristic
    Previous systemic corticosteroid use - n
    Units: Subjects
        No
    		 33 32 65
        Yes
    		 11 15 26
    Study Specific Characteristic
    Previous number of nsH1-n antihistamines - n
    Units: Subjects
        <=2
    		 42 40 82
        3-5
    		 2 7 9
        >5
    		 0 0 0
    Study Specific Characteristic |
    Units: years
        arithmetic mean (standard deviation)
    		 8.4 ± 9.3 7.4 ± 8.8 -
    Study Specific Characteristic |
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 27.3 ± 6.3 29 ± 5.9 -

    End points

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    End points reporting groups
    Reporting group title
    Omalizumab
    Reporting group description
    		 Omalizumab once a month via subcutaneous injection.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo of omalizumab once a month via subcutaneous injection

    Primary: Mean change from baseline using Chronic urticaria quality of life questionnaire (CU-Q2oL) total scores during the study: unadjusted analysis and ANCOVA (LOCF) (FAS)

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    End point title
    		 Mean change from baseline using Chronic urticaria quality of life questionnaire (CU-Q2oL) total scores during the study: unadjusted analysis and ANCOVA (LOCF) (FAS)
    End point description
    The CU-Q2oL is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It consists of 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Patients are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1= not at all to 5= very much). An overall score is calculated and normalized to a scale of 1 to 100.
    End point type
    Primary
    End point timeframe
    Baseline/week 28
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    44
    47
    Units: score
    arithmetic mean (standard deviation)
        V3 (week 4)
    -25.5 ± 21.3
    -6.4 ± 15.9
        V5 (week 12)
    -32.1 ± 21.8
    -12.1 ± 20.3
        V7 (week 20)
    -31.4 ± 23.7
    -16.2 ± 18.8
        V9 (week 28)
    -35.1 ± 24.2
    -13.9 ± 17.7
        Follow-up (week 36)
    -23.9 ± 23
    -14.7 ± 19.2
    Statistical analysis title
    		 CU-Q2oL Total Scores during study
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Number of angioedema burdened days by study phase (observed cases with imputation)

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    End point title
    		 Number of angioedema burdened days by study phase (observed cases with imputation)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline/week 28
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    44
    47
    Units: days
    arithmetic mean (standard deviation)
        Screening (Week -2 to -1)
    5.2 ± 3.9
    6.8 ± 4.3
        Treatment (Week 1 to 28)
    14.6 ± 19.5
    49.5 ± 50.8
        Follow-up (Week 29 to 36)
    5.8 ± 9.1
    12.8 ± 16.2
    No statistical analyses for this end point

    Secondary: Mean time interval between successive angioedema episodes of the first 15 episodes

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    End point title
    		 Mean time interval between successive angioedema episodes of the first 15 episodes
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 28
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    44
    47
    Units: days
    arithmetic mean (standard deviation)
        1st to 2nd episode (n=36/43)
    20 ± 41.63
    7.8 ± 14.29
        2nd to 3rd episode (n=30/42)
    11 ± 19.52
    7.2 ± 10.16
        3rd to 4th episode (n=28/39)
    26.4 ± 50.73
    8.3 ± 13.24
        4th to 5th episode (n=27/36)
    14.9 ± 23.87
    8.6 ± 20.44
        5th to 6th episode (n=25/34)
    14.2 ± 20.54
    13.6 ± 30.09
        6th to 7th episode (n=21/31)
    11.2 ± 22.11
    7.5 ± 11.32
        7th to 8th episode (n=15/29)
    18.1 ± 29.41
    9.1 ± 17.58
        8th to 9th episode (n=14/28)
    10.7 ± 15.05
    8 ± 12.26
        9th to 10th episode (n=11/26)
    11.4 ± 20.16
    8.7 ± 12.26
        10th to 11th episode (n=11/23)
    11.5 ± 13.02
    8.5 ± 10.41
        11th to 12th episode (n=10/21)
    8.9 ± 9.42
    9.4 ± 13.89
        12th to 13th episode (n=8/18)
    6 ± 4.47
    4.3 ± 4.43
        13th to 14th episode (n=8/18)
    3.6 ± 3.02
    7.3 ± 4.56
        14th to 15th episode (n=7/17)
    6.9 ± 9.96
    10.1 ± 11.86
    No statistical analyses for this end point

    Secondary: Change of AAS total week sum scores from baseline to week 28: unadjusted analysis and ANCOVA (observed cases with imputation)

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    End point title
    		 Change of AAS total week sum scores from baseline to week 28: unadjusted analysis and ANCOVA (observed cases with imputation)
    End point description
    A cumulative activity score, evaluated in the screening period and throughout the study. The records each evening on a daily basis symptoms of itch and hives into a patient diary.
    End point type
    Secondary
    End point timeframe
    Baseline to week 28
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    44
    47
    Units: AAS (Angioedema Activity Score)
    arithmetic mean (standard deviation)
        Diary week 4 (n=43,44)
    -17.7 ± 20
    -5 ± 18.2
        Diary week 12 (n=39,34)
    -19 ± 22.4
    -9 ± 22.8
        Diary week 20 (n=35,32)
    -21.3 ± 21.6
    -16.9 ± 21
        Diary week 28 (n=34, 32)
    -20.6 ± 21.5
    -10.8 ± 21.3
        Diary week 36 (n=-23, 16)
    -9.6 ± 18.4
    -15.3 ± 20.8
    No statistical analyses for this end point

    Secondary: Diameter: acute swelling episodes within the screening period (Week -2 to -1)

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    End point title
    		 Diameter: acute swelling episodes within the screening period (Week -2 to -1)
    End point description
    End point type
    Secondary
    End point timeframe
    week -2 to -1
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    44
    47
    Units: Number of episodes
        Acute swelling episode, Diameter <10cm
    146
    165
        Acute swelling episode, Diameter 10-20cm
    54
    99
        Acute swelling episode, Diameter >20cm
    19
    46
        unknown
    12
    15
    No statistical analyses for this end point

    Secondary: Diameter: acute swelling episodes at end of treatment (weeks 25 to 28)

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    End point title
    		 Diameter: acute swelling episodes at end of treatment (weeks 25 to 28)
    End point description
    End point type
    Secondary
    End point timeframe
    weeks 25 to 28
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    34
    25
    Units: Number of episodes
        Acute swelling episode, Diameter <10cm
    31
    76
        Acute swelling episode, Diameter 10-20cm
    0
    94
        Acute swelling episode, Diameter 20cm
    0
    24
        unknown
    0
    12
    No statistical analyses for this end point

    Secondary: Diameter: acute swelling episodes at end of follow-up(weeks 33 to 36)

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    End point title
    		 Diameter: acute swelling episodes at end of follow-up(weeks 33 to 36)
    End point description
    End point type
    Secondary
    End point timeframe
    weeks 33 to 36
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    33
    23
    Units: Number of episodes
        Acute swelling episode, Diameter <10cm
    92
    90
        Acute swelling episode, Diameter 10-20cm
    28
    58
        Acute swelling episode, Diameter >20cm
    8
    19
        unknown
    17
    18
    No statistical analyses for this end point

    Secondary: Shortness of breath: acute swelling episodes within the screening period (weeks -2 to -1)

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    End point title
    		 Shortness of breath: acute swelling episodes within the screening period (weeks -2 to -1)
    End point description
    End point type
    Secondary
    End point timeframe
    weeks -2 to -1
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    44
    47
    Units: number of episodes
        Shortness of breath: No
    203
    264
        Shortness of breath: Slightly
    13
    25
        Shortness of breath: Moderately
    7
    25
        Shortness of breath: Severely
    1
    7
        Unknown
    7
    4
    No statistical analyses for this end point

    Secondary: Shortness of breath: acute swelling episodes at end of treatment period (weeks 25 to 28)

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    End point title
    		 Shortness of breath: acute swelling episodes at end of treatment period (weeks 25 to 28)
    End point description
    End point type
    Secondary
    End point timeframe
    weeks 25 to 28
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    31
    25
    Units: Number of episodes
        Shortness of breath: No
    28
    195
        Shortness of breath: Slightly
    3
    5
        Shortness of breath: Moderately
    0
    5
        Shortness of breath: Severely
    0
    0
        Unknown
    0
    1
    No statistical analyses for this end point

    Secondary: Shortness of breath: acute swelling episodes at end of follow-up period (weeks 33 to 36)

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    End point title
    		 Shortness of breath: acute swelling episodes at end of follow-up period (weeks 33 to 36)
    End point description
    End point type
    Secondary
    End point timeframe
    weeks 33 to 36
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    33
    23
    Units: Number of episodes
        Shortness of breath: No
    28
    195
        Shortness of breath: Slightly
    3
    5
        Shortness of breath: Moderately
    0
    5
        Shortness of breath: Severely
    0
    0
        Unknown
    0
    1
    No statistical analyses for this end point

    Secondary: Change of AE-Q2oL scores from baseline to week 28: unadjusted analysis and ANCOVA (observed cases)

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    End point title
    		 Change of AE-Q2oL scores from baseline to week 28: unadjusted analysis and ANCOVA (observed cases)
    End point description
    The AE-Q2oL is a questionnaire for patients suffering from angioedema. It consists of 29 questions relevant to angioedema and its specific impact on quality of life. Patients are asked to respond how much they are troubled be each problem on a 5-point Likert scale (1= does not apply to 5= very much). An overall score is calculated and a higher score indicates lower quality of life. A negative change score (week 28 score minus baseline score) indicates improvement.
    End point type
    Secondary
    End point timeframe
    baseline to week 28
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    44
    47
    Units: AE-QoL Score
    arithmetic mean (standard deviation)
        week 4 (n=38,36)
    -26.5 ± 20.4
    -10.3 ± 21
        week 12 (n= 35, 29)
    -37.4 ± 23.8
    -20.4 ± 27.4
        week 20 (n=34,27)
    -37.1 ± 26.5
    -28.8 ± 22
        week 28 (n=34, 25)
    -41.4 ± 25.7
    -24.2 ± 24.3
        follow-up, week 36 (n=33,23)
    -27.2 ± 26.4
    -24.6 ± 23.3
    No statistical analyses for this end point

    Secondary: Rescue medication during the treatment period

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    End point title
    		 Rescue medication during the treatment period
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to 28 weeks
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    44
    47
    Units: participants
        Any rescue medication
    25
    35
        Any nsH1 - antihistamine rescue medication
    19
    27
        Any clemastine rescue medication
    12
    26
        Any corticosteroid rescue medication
    5
    13
        Betamethasone
    2
    12
        Prednisolone
    3
    3
        Prednisolone succinate
    2
    0
    No statistical analyses for this end point

    Secondary: Days of rescue medication during the treatment period

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    End point title
    		 Days of rescue medication during the treatment period
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to 28 weeks
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    44
    47
    Units: days
        Any rescue medication
    507
    787
        Any nsH1 - antihistamine rescue medication
    403
    524
        Any clemastine rescue medication
    92
    236
        Any corticosteroid rescue medication
    25
    113
    No statistical analyses for this end point

    Secondary: Days of rescue medication during the follow-up period

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    End point title
    		 Days of rescue medication during the follow-up period
    End point description
    End point type
    Secondary
    End point timeframe
    weeks 33 to 36
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    44
    47
    Units: days
        Any rescue medication
    165
    118
        Any nsH1 - antihistamine rescue medication
    158
    85
        Any clemastine rescue medication
    15
    19
        Any corticosteroid rescue medication
    0
    17
    No statistical analyses for this end point

    Secondary: Change of UAS7 total scores from baseline to week 28: unadjusted analysis and ANCOVA (observed cases)

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    End point title
    		 Change of UAS7 total scores from baseline to week 28: unadjusted analysis and ANCOVA (observed cases)
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to week 28
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    44
    47
    Units: participants
    arithmetic mean (standard deviation)
        week 4
    -12.6 ± 13.3
    -3 ± 9.4
        week 12
    -16.4 ± 14.3
    -4.4 ± 13.3
        week 20
    -15 ± 15
    -7.2 ± 14.7
        week 28
    -16.8 ± 14.8
    -6.5 ± 13.4
        follow-up, week 36
    -8.3 ± 15.3
    -6.2 ± 13.3
    No statistical analyses for this end point

    Secondary: Change of DLQI scores from baseline to week 28: unadjusted analysis and ANCOVA (observed cases)

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    End point title
    		 Change of DLQI scores from baseline to week 28: unadjusted analysis and ANCOVA (observed cases)
    End point description
    change in Dermatology Quality of Life Index scores
    End point type
    Secondary
    End point timeframe
    baseline to week 28
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    44
    46
    Units: DLQI Score
    arithmetic mean (standard deviation)
        week 4
    -8.3 ± 7.3
    -2.4 ± 6.9
        week 12
    -10.1 ± 7.5
    -3.9 ± 7.6
        week 20
    -9.5 ± 8.4
    -5.1 ± 8.3
        week 28
    -10.5 ± 8.3
    -5.6 ± 8
        follow-up, week 36
    -6.8 ± 8.6
    -5.4 ± 8.3
    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
    17.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Omalizumab
    Reporting group description
    		 Omalizumab

    Serious adverse events
    		 Placebo Omalizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 47 (4.26%)
    4 / 44 (9.09%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament injury
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Omalizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 47 (59.57%)
    16 / 44 (36.36%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 44 (2.27%)
         occurrences all number
    3
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 47 (8.51%)
    4 / 44 (9.09%)
         occurrences all number
    5
    8
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    4 / 47 (8.51%)
    0 / 44 (0.00%)
         occurrences all number
    6
    0
    Diarrhoea
         subjects affected / exposed
    5 / 47 (10.64%)
    3 / 44 (6.82%)
         occurrences all number
    6
    4
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    6 / 47 (12.77%)
    1 / 44 (2.27%)
         occurrences all number
    10
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 47 (8.51%)
    0 / 44 (0.00%)
         occurrences all number
    4
    0
    Back pain
         subjects affected / exposed
    3 / 47 (6.38%)
    3 / 44 (6.82%)
         occurrences all number
    4
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 47 (27.66%)
    9 / 44 (20.45%)
         occurrences all number
    17
    13

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Sep 2012
    Issued before study start) was primarily written to address new legal requirements regarding market access, requiring provision of longer term data from the most diseased burdened patients. However, following feedback from participating centers, it became clear that this particular patient group was rare and difficult to recruit. Therefore, the amendment introduced the following changes: - Study population was reduced from 150 to 70 patients and, accordingly, the number of participating centers from 30 to 25. -For sample size calculation, acceptable power was reduced from 90 % to 84 % on a 2-sided, 5 % significance level. -Patients prematurely withdrawing the study were included in the FAS analysis. New additional patients were allowed to be enrolled to meet the target sample size of 70 evaluable (PP) patients.-Only one active arm (Omalizumab 300 mg) was compared to placebo; elimination of 150 mg Omalizumab arm. -Due to changes in the manufacturing process the study medication was delivered open-label, but the study itself remained double-blinded. The wording was changed accordingly. Changes were necessary to describe packaging of study drug. -Addition of MID-CU-Q2oL as explorative objective. Accordingly, an additional patient and physician questionnaire was included. Weekly UAS7 score was changed to twice-daily evaluation (US-system) to allow comparability with other globally available data-sets from phase III trials.

    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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