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    Clinical Trial Results:
    A multicenter, randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of omalizumab in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine therapy 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
    		 2016-002273-35
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jul 2018
    First version publication date
    11 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CIGE025E2306
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02329223
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Dec 2015
    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 and / or 150 mg injected subcutaneously every 4 weeks in patients with refractory CSU receiving concomitant H1 antihistamine (H1AH) therapy with respect to a reduction from baseline in the weekly itch severity score at Week 12, compared to 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
    09 Dec 2014
    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: 105
    Country: Number of subjects enrolled
    Korea, Republic of: 113
    Worldwide total number of subjects
    218
    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)
    1
    Adolescents (12-17 years)
    3
    Adults (18-64 years)
    202
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were randomly assigned to the 3 treatment groups in a 1:1:1 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, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Omalizumab 300 mg
    Arm description
    		 Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    IGE025
    Other name
    Xolair
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.

    Arm title
    		 Omalizumab 150 mg
    Arm description
    		 Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    IGE025
    Other name
    Xolair
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.

    Arm title
    		 Placebo
    Arm description
    		 Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
    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
    Participants received placebo subcutaneously every 4 weeks during the 12 week treatment period.

    Number of subjects in period 1
    		Omalizumab 300 mg Omalizumab 150 mg Placebo
    Started
    73
    71
    74
    Full Analysis Set
    73
    70
    74
    Safety Set
    73
    71
    74
    Completed
    72
    68
    68
    Not completed
    1
    3
    6
         Consent withdrawn by subject
    1
    2
    5
         Physician decision
    -
    -
    1
         Adverse event, non-fatal
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Omalizumab 300 mg
    Reporting group description
    		 Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.

    Reporting group title
    Omalizumab 150 mg
    Reporting group description
    		 Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.

    Reporting group values
    		 Omalizumab 300 mg Omalizumab 150 mg Placebo Total
    Number of subjects
    		 73 71 74 218
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 1 0 1
        Adolescents (12-17 years)
    		 2 0 1 3
        Adults (18-64 years)
    		 66 69 67 202
        From 65-84 years
    		 5 1 6 12
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 44.6 ( 14.86 ) 43.6 ( 12.24 ) 42.5 ( 14.26 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 40 43 48 131
        Male
    		 33 28 26 87

    End points

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    End points reporting groups
    Reporting group title
    Omalizumab 300 mg
    Reporting group description
    		 Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.

    Reporting group title
    Omalizumab 150 mg
    Reporting group description
    		 Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.

    Primary: Change From Baseline (BL) in Weekly Itch Severity Score at Week 12

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    End point title
    		 Change From Baseline (BL) in Weekly Itch Severity Score at Week 12
    End point description
    The weekly itch severity score is a component of the Urticaria Activity Score 7 (UAS7) composite score. The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score from baseline indicates improvement.
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Omalizumab 300 mg Omalizumab 150 mg Placebo
    Number of subjects analysed
    73
    70
    74
    Units: Units on a scale
        least squares mean (standard error)
    -10.22 ( 0.571 )
    -8.8 ( 0.591 )
    -6.51 ( 0.581 )
    Statistical analysis title
    		 Change from BL in weekly itch severity score
    Comparison groups
    Omalizumab 300 mg v Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Mixed Models with repeated measures
    Parameter type
    		 Mean difference (net)
    Point estimate
    -3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.31
         upper limit
    		 -2.098
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.815
    Statistical analysis title
    		 Change from BL in weekly itch severity score
    Comparison groups
    Omalizumab 150 mg v Placebo
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.006
    Method
    		 Mixed Model with repeated measure(MMRM)
    Parameter type
    		 Mean difference (net)
    Point estimate
    -2.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.921
         upper limit
    		 -0.654
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.828

    Secondary: Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12

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    End point title
    		 Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12
    End point description
    The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Omalizumab 300 mg Omalizumab 150 mg Placebo
    Number of subjects analysed
    73
    70
    74
    Units: Units on a scale
        least squares mean (standard error)
    -22.44 ( 1.243 )
    -18.79 ( 1.288 )
    -13.9 ( 1.265 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Weekly Number of Hives Score at Week 12

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    End point title
    		 Change From Baseline in the Weekly Number of Hives Score at Week 12
    End point description
    The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Omalizumab 300 mg Omalizumab 150 mg Placebo
    Number of subjects analysed
    73
    70
    74
    Units: Units on a scale
        least squares mean (standard error)
    -12.17 ( 0.742 )
    -10.04 ( 0.769 )
    -7.41 ( 0.756 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a UAS7 Score ≤ 6 at Week 12

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    End point title
    		 Percentage of Participants With a UAS7 Score ≤ 6 at Week 12
    End point description
    The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Omalizumab 300 mg Omalizumab 150 mg Placebo
    Number of subjects analysed
    73
    70
    74
    Units: Percentage of participants
        number (not applicable)
    57.5
    42.9
    18.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12

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    End point title
    		 Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12
    End point description
    The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score from baseline indicates a reduction in hive size.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Omalizumab 300 mg Omalizumab 150 mg Placebo
    Number of subjects analysed
    73
    70
    74
    Units: Units on a scale
        least squares mean (standard error)
    -10.71 ( 0.684 )
    -9.3 ( 0.709 )
    -6.27 ( 0.696 )
    No statistical analyses for this end point

    Secondary: Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12

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    End point title
    		 Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12
    End point description
    Weekly itch severity score MID response is defined as a reduction from baseline in AUS7 of >=5 points.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Omalizumab 300 mg Omalizumab 150 mg Placebo
    Number of subjects analysed
    73
    70
    74
    Units: Percentage of participants
        number (not applicable)
    87.7
    68.6
    55.4
    No statistical analyses for this end point

    Secondary: Percentage of Complete Responders (UAS7 = 0) at Week 12

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    End point title
    		 Percentage of Complete Responders (UAS7 = 0) at Week 12
    End point description
    Complete responders are defined as participants who achieved AUS7 = 0.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Omalizumab 300 mg Omalizumab 150 mg Placebo
    Number of subjects analysed
    73
    70
    74
    Units: Percentage of participants
        number (not applicable)
    35.6
    18.6
    4.1
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12

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    End point title
    		 Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12
    End point description
    The DLQI is a 10-item dermatology-specific health-related quality of life measure. Participants rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Omalizumab 300 mg Omalizumab 150 mg Placebo
    Number of subjects analysed
    71
    69
    74
    Units: Units on a scale
        least squares mean (standard error)
    -8.4 ( 0.52 )
    -7.2 ( 0.53 )
    -5.3 ( 0.52 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with production of anti-omalizumab antibody

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    End point title
    		 Percentage of Participants with production of anti-omalizumab antibody [1]
    End point description
    Serum samples were collected for anti-omalizumab antibody testing.
    End point type
    Secondary
    End point timeframe
    Week 24
    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: The placebo group does not apply to this end point.
    End point values
    		 Omalizumab 300 mg Omalizumab 150 mg
    Number of subjects analysed
    68
    64
    Units: Percentage of participants
    number (not applicable)
        Conclusive results (n=64,63)
    0
    0
        Inconclusive results (n=4,1)
    9999
    9999
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    IGE025 300 mg
    Reporting group description
    		 IGE025 300 mg

    Reporting group title
    IGE025 150 mg
    Reporting group description
    		 IGE025 150 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 IGE025 300 mg IGE025 150 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 73 (4.11%)
    3 / 71 (4.23%)
    0 / 74 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    LIMB TRAUMATIC AMPUTATION
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SPINAL CORD INJURY
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLECYSTITIS CHRONIC
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ASTHMA
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    PNEUMONIA
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DIABETES MELLITUS
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 IGE025 300 mg IGE025 150 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 73 (43.84%)
    25 / 71 (35.21%)
    29 / 74 (39.19%)
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    2 / 73 (2.74%)
    1 / 71 (1.41%)
    0 / 74 (0.00%)
         occurrences all number
    2
    1
    0
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    3 / 73 (4.11%)
    3 / 71 (4.23%)
    5 / 74 (6.76%)
         occurrences all number
    7
    3
    6
    MIGRAINE
         subjects affected / exposed
    2 / 73 (2.74%)
    0 / 71 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    4
    0
    0
    SOMNOLENCE
         subjects affected / exposed
    2 / 73 (2.74%)
    0 / 71 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    2
    0
    1
    Gastrointestinal disorders
    CONSTIPATION
         subjects affected / exposed
    0 / 73 (0.00%)
    2 / 71 (2.82%)
    0 / 74 (0.00%)
         occurrences all number
    0
    2
    0
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    0 / 73 (0.00%)
    2 / 71 (2.82%)
    0 / 74 (0.00%)
         occurrences all number
    0
    2
    0
    Skin and subcutaneous tissue disorders
    ACNE
         subjects affected / exposed
    2 / 73 (2.74%)
    0 / 71 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    2
    0
    0
    CHRONIC SPONTANEOUS URTICARIA
         subjects affected / exposed
    3 / 73 (4.11%)
    1 / 71 (1.41%)
    1 / 74 (1.35%)
         occurrences all number
    3
    1
    1
    DERMATITIS CONTACT
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    3 / 74 (4.05%)
         occurrences all number
    1
    0
    4
    ECZEMA
         subjects affected / exposed
    5 / 73 (6.85%)
    3 / 71 (4.23%)
    2 / 74 (2.70%)
         occurrences all number
    5
    3
    3
    MILIARIA
         subjects affected / exposed
    2 / 73 (2.74%)
    1 / 71 (1.41%)
    1 / 74 (1.35%)
         occurrences all number
    2
    1
    1
    URTICARIA
         subjects affected / exposed
    2 / 73 (2.74%)
    4 / 71 (5.63%)
    2 / 74 (2.70%)
         occurrences all number
    2
    5
    2
    Psychiatric disorders
    INSOMNIA
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    2 / 74 (2.70%)
         occurrences all number
    0
    0
    2
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    2 / 73 (2.74%)
    0 / 71 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    2
    0
    0
    Infections and infestations
    BRONCHITIS
         subjects affected / exposed
    2 / 73 (2.74%)
    0 / 71 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    2
    0
    0
    CONJUNCTIVITIS
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    2 / 74 (2.70%)
         occurrences all number
    0
    1
    2
    CYSTITIS
         subjects affected / exposed
    0 / 73 (0.00%)
    2 / 71 (2.82%)
    0 / 74 (0.00%)
         occurrences all number
    0
    2
    0
    FOLLICULITIS
         subjects affected / exposed
    1 / 73 (1.37%)
    2 / 71 (2.82%)
    0 / 74 (0.00%)
         occurrences all number
    1
    2
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    9 / 73 (12.33%)
    7 / 71 (9.86%)
    12 / 74 (16.22%)
         occurrences all number
    10
    10
    14
    OTITIS EXTERNA
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    2 / 74 (2.70%)
         occurrences all number
    0
    0
    2
    PHARYNGITIS
         subjects affected / exposed
    3 / 73 (4.11%)
    3 / 71 (4.23%)
    0 / 74 (0.00%)
         occurrences all number
    3
    3
    0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 73 (0.00%)
    3 / 71 (4.23%)
    0 / 74 (0.00%)
         occurrences all number
    0
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Oct 2014
    Amendment 1 (10-Oct-2014), issued before any patients had been enrolled, introduced the following changes to incorporate updated information elicited by dedicated study feasibility assessments and feedback from contracted vendors: Changed basophil high-affinity IgE receptor density assessment from mandatory to optional. Updated treatment assignment and randomization procedures. Updated logistics of dispensing the investigational treatment. Updated the list of permitted and prohibited concomitant medications. Updated site monitoring procedures as the central analysis was no longer applied in this study. Updated the blood log according to the vendor’s instructions. Clearly defined UAS7 and weekly itch severity score in Glossary of terms.

    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.
    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.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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