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    Clinical Trial Results:
    A 12 week, multi-center, randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of omalizumab in adult and adolescent patients with inadequately controlled severe Japanese cedar pollinosis despite the current recommended therapies Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.

    Summary
    EudraCT number
    		 2017-002154-36
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Apr 2019
    First version publication date
    24 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CIGE025F1301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03369704
    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, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy of omalizumab compared with placebo.
    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
    15 Dec 2017
    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
    Japan: 337
    Worldwide total number of subjects
    337
    EEA total number of subjects
    0
    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)
    28
    Adults (18-64 years)
    289
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 22 centers in Kanto-area of Japan.

    Pre-assignment
    Screening details
    		 337 patients were randomized

    Period 1
    Period 1 title
    Treatment epoch
    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
    		 Omalizumab
    Arm description
    		 Omalizumab administered subcutaneously for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    IGE025
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose (75 to 600 mg) and dosing frequency (every 2 or 4 weeks) of the study drug were determined by serum total IgE level (IU/mL) and body weight (kg), measured during the screening epoch.

    Arm title
    		 Placebo
    Arm description
    		 Placebo administered subcutaneously for 12 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching placebo was supplied in an open-label manner and in a 5mL glass vial.

    Number of subjects in period 1
    		Omalizumab Placebo
    Started
    162
    175
    Completed
    158
    172
    Not completed
    4
    3
         technical problems
    1
    -
         Adverse event, non-fatal
    2
    -
         Lost to follow-up
    -
    1
         Protocol deviation
    1
    -
         Lack of efficacy
    -
    2
    Period 2
    Period 2 title
    Follow-up epoch
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Omalizumab
    Arm description
    		 Omalizumab administered subcutaneously for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    IGE025
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose (75 to 600 mg) and dosing frequency (every 2 or 4 weeks) of the study drug were determined by serum total IgE level (IU/mL) and body weight (kg), measured during the screening epoch.

    Arm title
    		 Placebo
    Arm description
    		 Placebo administered subcutaneously for 12 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching placebo was supplied in an open-label manner and in a 5mL glass vial.

    Number of subjects in period 2
    		Omalizumab Placebo
    Started
    161
    174
    Completed
    160
    174
    Not completed
    1
    0
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Omalizumab
    Reporting group description
    		 Omalizumab administered subcutaneously for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered subcutaneously for 12 weeks

    Reporting group values
    		 Omalizumab Placebo Total
    Number of subjects
    		 162 175 337
    Age, Customized
    Units: Subjects
        < 15 years
    		 4 6 10
        15 <=, < 65 years
    		 149 158 307
        >= 65 years
    		 9 11 20
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.3 ( 14.31 ) 41.0 ( 15.43 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 99 97 196
        Male
    		 63 78 141
    Race/Ethnicity, Customized
    Units: Subjects
        Asians
    		 162 175 337

    End points

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    End points reporting groups
    Reporting group title
    Omalizumab
    Reporting group description
    		 Omalizumab administered subcutaneously for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered subcutaneously for 12 weeks
    Reporting group title
    Omalizumab
    Reporting group description
    		 Omalizumab administered subcutaneously for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered subcutaneously for 12 weeks

    Primary: Mean nasal symptom score

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    End point title
    		 Mean nasal symptom score
    End point description
    Nasal symptoms (sneezing, rhinorrhea and nasal congestion) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Nasal symptom score (0-12 point) consisted of score for severity of sneezing (0-4 point), rhinorrhea (0-4 point) and nasal congestion (0-4 point). Severe symptom period: The three weeks where the cumulative value of the mean daily nasal symptom score is the maximum. The three weeks must also meet one of the following criteria: 2) ≥ 70% of the period with concomitant use of fluticasone propionate is included in this three weeks. 2) ≥ 70% of this three weeks includes the period with concomitant use of fluticasone propionate. If not, severe symptom period was extended at a minimum to meet one of the criteria above.
    End point type
    Primary
    End point timeframe
    Severe symptom period
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    158
    174
    Units: score
        least squares mean (standard error)
    3.66 ( 0.151 )
    4.69 ( 0.144 )
    Statistical analysis title
    		 Nasal symptom score
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean
    Point estimate
    -1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.44
         upper limit
    		 -0.62
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.209
    Notes
    [1] - H0: Omalizumab is not different to placebo with respect to mean nasal symptom score over the severe symptom period. H1: Omalizumab is different to placebo with respect to mean nasal symptom score over the severe symptom period.

    Secondary: Mean ocular symptom score and mean nasal ocular symptom score

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    End point title
    		 Mean ocular symptom score and mean nasal ocular symptom score
    End point description
    Ocular symptoms (itchy and watery eye) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Ocular symptom score (0-8 point) consisted of score for severity of itchy eye (0-4 point) and watery eye (0-4 point). Nasal ocular symptom score consisted of nasal symptom score and ocular symptom score.
    End point type
    Secondary
    End point timeframe
    Severe symptom period
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    158
    174
    Units: Score
    least squares mean (standard error)
        Mean ocular symptom score
    2.45 ( 0.115 )
    3.32 ( 0.110 )
        Mean nasal ocular symptom score
    6.11 ( 0.240 )
    8.01 ( 0.228 )
    Statistical analysis title
    		 Nasal Ocular Symptom
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -1.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.55
         upper limit
    		 -1.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.331
    Statistical analysis title
    		 Ocular symptom
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.18
         upper limit
    		 -0.55
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.159

    Secondary: Mean nasal symptom medication score, mean ocular symptom medication score, and mean nasal ocular symptom medication score

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    End point title
    		 Mean nasal symptom medication score, mean ocular symptom medication score, and mean nasal ocular symptom medication score
    End point description
    Medication scores were given for fluticasone propionate (nasal, 2 point), fexofenadine hydrochloride (oral, 1 point), tramazoline hydrochloride (nasal, 1 point), and levocabastine hydrochloride (ocular, 1 point). Symptom medication score consisted of severe symptom period.
    End point type
    Secondary
    End point timeframe
    Severe symptom period
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    158
    174
    Units: score
    least squares mean (standard error)
        Mean nasal symptom medication score
    6.19 ( 0.166 )
    7.29 ( 0.158 )
        Mean ocular symptom medication score
    3.91 ( 0.137 )
    4.86 ( 0.130 )
        Mean nasal ocular symptom medication score
    9.10 ( 0.271 )
    11.15 ( 0.259 )
    Statistical analysis title
    		 Nasal symptom medication score
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.55
         upper limit
    		 -0.64
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.229
    Statistical analysis title
    		 Ocular symptom medication score
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.32
         upper limit
    		 -0.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.189
    Statistical analysis title
    		 Nasal ocular symptom medication score
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -2.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.78
         upper limit
    		 -1.31
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.375

    Secondary: Mean score for severity of sneezing, rhinorrhea and nasal congestion

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    End point title
    		 Mean score for severity of sneezing, rhinorrhea and nasal congestion
    End point description
    Symptoms of sneezing, rhinorrhea and nasal congestion were evaluated on a scale of 0 (none) to 4 (intense/severe).
    End point type
    Secondary
    End point timeframe
    Severe symptom period
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    158
    174
    Units: score
    least squares mean (standard error)
        Mean sneezing score
    1.15 ( 0.053 )
    1.56 ( 0.050 )
        Mean rhinorrhea score
    1.46 ( 0.063 )
    1.79 ( 0.060 )
        Mean nasal congestion score
    1.05 ( 0.058 )
    1.34 ( 0.056 )
    Statistical analysis title
    		 Sneezing score
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 -0.26
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.073
    Statistical analysis title
    		 Rhinorrhea score
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.51
         upper limit
    		 -0.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.088
    Statistical analysis title
    		 Nasal congestion score
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 -0.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.081

    Secondary: Mean score for severity of itchy and watery eye

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    End point title
    		 Mean score for severity of itchy and watery eye
    End point description
    Symptoms of itchy and watery eye were evaluated on a scale of 0 (none) to 4 (intense/severe).
    End point type
    Secondary
    End point timeframe
    Severe symptom period
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    158
    174
    Units: score
    least squares mean (standard error)
        Mean itchy eye score
    1.47 ( 0.061 )
    1.94 ( 0.058 )
        Mean watery eye score
    0.98 ( 0.063 )
    1.38 ( 0.060 )
    Statistical analysis title
    		 Itchy eye score
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.63
         upper limit
    		 -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.084
    Statistical analysis title
    		 Watery eye score
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.57
         upper limit
    		 -0.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.087

    Secondary: Mean score for impairment of daily activities

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    End point title
    		 Mean score for impairment of daily activities
    End point description
    Impairment of daily activities were evaluated on a scale of 0 (none) to 4 (intense/severe).
    End point type
    Secondary
    End point timeframe
    Severe symptom period
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    158
    174
    Units: score
        least squares mean (standard error)
    1.09 ( 0.052 )
    1.43 ( 0.050 )
    Statistical analysis title
    		 Score for impairment of daily activities
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.072

    Secondary: Number of symptom free days

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    End point title
    		 Number of symptom free days
    End point description
    Nasal symptom free days (days with all nasal symptoms are not more than mild in severity) during the severe symptom period. Ocular symptom free days (days with all ocular symptoms are not more than mild in severity) during the severe symptom period.
    End point type
    Secondary
    End point timeframe
    Severe symptom period
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    158
    174
    Units: days
        Nasal symptom free days
    15
    10
        Ocular symptom free days
    12
    6
    Statistical analysis title
    		 Nasal symptom free days
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Hodges-Lehmann Estimate
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.02
    Statistical analysis title
    		 Ocular symptom free days
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Hodges-Lehmann Estimate
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 6.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.15

    Secondary: Rescue medication free days

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    End point title
    		 Rescue medication free days
    End point description
    Number of days with no rescue medication (tramazoline hydrochloride, levocabastine hydrochloride)
    End point type
    Secondary
    End point timeframe
    Severe symptom period
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    158
    174
    Units: days
    number (not applicable)
        Nasal rescue medication free days
    27.0
    23.5
        Ocular rescue medication free days
    16.0
    11.0
        Nasal ocular rescue medication free days
    12.5
    9.0
    Statistical analysis title
    		 Nasal rescue medication score
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.011
    Method
    		 van Elteren test
    Parameter type
    		 Hodges-Lehmann Estimate
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 3.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.89
    Statistical analysis title
    		 Ocular rescue medication free days
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.074
    Method
    		 van Elteren test
    Parameter type
    		 Hodges-Lehmann Estimate
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 4.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.21
    Statistical analysis title
    		 Nasal ocular rescue medication free days
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.098
    Method
    		 van Elteren test
    Parameter type
    		 Hodges-Lehmann Estimate
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.02

    Secondary: Number of rescue medication used

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    End point title
    		 Number of rescue medication used
    End point description
    Amount number of rescue medication used (a total number of times used).
    End point type
    Secondary
    End point timeframe
    Severe symptom period
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    158
    174
    Units: Number of times used
    number (not applicable)
        Number of rescue nasal medication used
    1.0
    6.0
        Number of ocular rescue medication used
    18.5
    28.5
    Statistical analysis title
    		 Nasal rescue medication used
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.006
    Method
    		 van Elteren test
    Parameter type
    		 Hodges-Lehmann Estimate
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.5
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.15
    Statistical analysis title
    		 Ocular rescue medication used
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.012
    Method
    		 van Elteren test
    Parameter type
    		 Hodges-Lehmann Estimate
    Point estimate
    -7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12
         upper limit
    		 -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.81

    Secondary: Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ, No1) score

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    End point title
    		 Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ, No1) score
    End point description
    Nasal and eye symptoms (JRQLQ I) included 6 categories: Runny nose, Sneezing, Nasal congestion, Itchy nose, itchy eyes and watery eyes, on a 5-point scale of 0 to 4 (no symptoms to very severe symptoms). JRQLQ I score was a mean of these 6 categories. JRQLQ II included 17 items on a 5-point scale, 0 to 4 (no significant problem to very greatly). JRQLQ II scores was a mean of these 17 items. Overall face scale (JRQLQ III) evaluated overall symptoms, condition and feelings on a 5-point scale from 0 to 4 (fine to crying). Evaluation visit was defined as follows independently for each evaluation item and for each patient: 1) If there was a single visit during the severe symptom period, the visit was the evaluation visit. 2) If there were ≥ 2 visits during the severe symptom period and a) if Visit 105 was one of them, Visit 105 was the evaluation visit; b) if Visit 105 was outside the period, the closest visit to Visit 105 during the period was the evaluation visit.
    End point type
    Secondary
    End point timeframe
    Evaluation Visit
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    160
    175
    Units: Score
    least squares mean (standard error)
        Nasal and eye symptoms (JRQLQ I)
    1.27 ( 0.062 )
    1.76 ( 0.059 )
        Mean score of QoL-related questionnaire (JRQLQ II)
    0.70 ( 0.067 )
    1.20 ( 0.064 )
        Overall face scale (JRQLQ III)
    1.6 ( 0.08 )
    2.2 ( 0.07 )
    Statistical analysis title
    		 JRQLQ I
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.66
         upper limit
    		 -0.33
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.086
    Statistical analysis title
    		 JRQLQ II
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.69
         upper limit
    		 -0.33
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.093
    Statistical analysis title
    		 JRQLQ III
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 -0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1

    Secondary: Number of Participants with Anti-omalizumab antibodes

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    End point title
    		 Number of Participants with Anti-omalizumab antibodes
    End point description
    Number of participants with antibodies against the Fab and Fc region of omalizumab in serum.
    End point type
    Secondary
    End point timeframe
    Prior to first dosing (Day 1), At follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    161
    175
    Units: participants
        Anti-Fab-(pre-dose)
    0
    0
        Anti-Fab (post dose)
    0
    0
        Anti-Fc-(pre-dose)
    1
    2
        Anti-Fc-(post-dose)
    0
    2
    No statistical analyses for this end point

    Secondary: Serum trough omalizumab concentration

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    End point title
    		 Serum trough omalizumab concentration [2]
    End point description
    Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch
    End point type
    Secondary
    End point timeframe
    Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and 24 weeks after last dose
    Notes
    [2] - 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: descriptive statistics.
    End point values
    		 Omalizumab
    Number of subjects analysed
    161
    Units: μg/mL
    arithmetic mean (standard deviation)
        Day 1 (pre-dose)
    0 ( 0 )
        Day 29 (N=159)
    42.6 ( 34.8 )
        Day 57 (N=158)
    54.1 ( 42.3 )
        Day 85 (N=161)
    66.3 ( 49.0 )
        Day 225/239 (N=160)
    0.928 ( 1.11 )
    No statistical analyses for this end point

    Secondary: Free IgE and total IgE

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    End point title
    		 Free IgE and total IgE
    End point description
    Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation were conducted 20/22 weeks after 12 week-treatment epoch
    End point type
    Secondary
    End point timeframe
    Day 1, at Day 29, Day 57, Day 85 and 24 weeks after last dose
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    161
    175
    Units: ng/mL
    arithmetic mean (standard deviation)
        Free IgE (Day 1 predose)
    999 ( 999 )
    999 ( 999 )
        Free IgE (Day 29)
    21.3 ( 9.8 )
    999 ( 999 )
        Free IgE (Day 57)
    20.8 ( 10.1 )
    999 ( 999 )
        Free IgE (Day 85)
    18.6 ( 11.9 )
    999 ( 999 )
        Free IgE (Day 225/239)
    999 ( 999 )
    999 ( 999 )
        Total IgE (Day 1 pre-dose)
    524 ( 531 )
    570 ( 641 )
        Total IgE (Day 29)
    2040 ( 1620 )
    558 ( 608 )
        Total IgE (Day 57)
    2160 ( 1660 )
    640 ( 721 )
        Total IgE (Day 85)
    1960 ( 1480 )
    673 ( 775 )
        Total IgE (Day 225/239)
    702 ( 639 )
    669 ( 783 )
    No statistical analyses for this end point

    Secondary: Completely nasal symptom free patients

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    End point title
    		 Completely nasal symptom free patients
    End point description
    Completely nasal symptom free patients is the number of patients who were nasal symptom free (all nasal symptoms were not more than mild in severity) on all non-missing days and had nasal symptom scores for at least 26 days during the 30 days of severe symptom period.
    End point type
    Secondary
    End point timeframe
    Severe symptom period
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    158
    174
    Units: Patients
    13
    4
    Statistical analysis title
    		 Completely nasal symptom free patients
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.005
    Method
    		 logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.21
         upper limit
    		 9.75

    Secondary: Rescue medication score

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    End point title
    		 Rescue medication score
    End point description
    Rescue medication scores were given for tramazoline hydrochloride (nasal, 1 point) and levocabastine hydrochloride (ocular, 1 point).
    End point type
    Secondary
    End point timeframe
    Severe symptom period
    End point values
    		 Omalizumab Placebo
    Number of subjects analysed
    158
    174
    Units: score
    least squares mean (standard error)
        Nasal rescue medication score
    0.20 ( 0.024 )
    0.28 ( 0.023 )
        Ocular rescue medication score
    0.46 ( 0.029 )
    0.54 ( 0.027 )
        Nasal ocular rescue medication score
    0.66 ( 0.045 )
    0.82 ( 0.043 )
    Statistical analysis title
    		 Nasal rescue medication score
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.14
         upper limit
    		 -0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.033
    Statistical analysis title
    		 Ocular rescue medication score
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.04
    Statistical analysis title
    		 Nasal ocular rescue medication score
    Comparison groups
    Omalizumab v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 ANCOVA
    Point estimate
    -0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 -0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.063

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were collected after providing written informed consent for participation in the study until the end of the treatment epoch. Serious Adverse Events were collected until 30 days after the end of the treatment epoch.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    IGE025
    Reporting group description
    		 Eligible patients randomized to this arm received omalizumab subcutaneously for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered subcutaneously for 12 weeks

    Serious adverse events
    		 IGE025 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 175 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Testicular neoplasm
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 IGE025 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 161 (16.15%)
    21 / 175 (12.00%)
    Infections and infestations
    Influenza
         subjects affected / exposed
    4 / 161 (2.48%)
    8 / 175 (4.57%)
         occurrences all number
    4
    8
    Nasopharyngitis
         subjects affected / exposed
    15 / 161 (9.32%)
    8 / 175 (4.57%)
         occurrences all number
    15
    9
    Pharyngitis
         subjects affected / exposed
    7 / 161 (4.35%)
    5 / 175 (2.86%)
         occurrences all number
    7
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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