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    Clinical Trial Results:
    A multi-center, randomized, double-blind, placebo and active controlled phase 2b dose-finding study of QGE031 as add-on therapy to investigate the efficacy and safety in patients with chronic spontaneous urticaria (CSU)

    Summary
    EudraCT number
    		 2014-005559-16
    Trial protocol
    		 DE   ES   GB   GR  
    Global end of trial date
    12 Jun 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    30 Nov 2018
    First version publication date
    22 Jun 2018
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    CQGE031C2201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02477332
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharmaceuticals, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharmaceuticals, 41 613241111, Novartis.email@novartis.com
    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@novarts.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jun 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to establish the dose-response relationship of ligelizumab with respect to achievement of complete hives response at Week 12 in patients with chronic spontaneous urticaria (CSU) when added to H1-antihistamines (H1-AH) alone or in combination with H2- antihistamines (H2-AH) and/or a leukotriene receptor antagonist (LTRA). Note: Complete hives response is defined as a Hive Severity Score (HSS7) of 0. Analogously, complete itch response and complete urticaria response are defined as an itch severity score (ISS7) and an urticaria activity score (UAS7) of 0, respectively.
    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
    		 H1-AH at approved or increased doses alone or in combination with H2-AH and/or a leukotriene receptor anagonist. (LTRA).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jul 2015
    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
    Australia: 33
    Country: Number of subjects enrolled
    Canada: 28
    Country: Number of subjects enrolled
    Germany: 56
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Greece: 8
    Country: Number of subjects enrolled
    Japan: 36
    Country: Number of subjects enrolled
    Russian Federation: 38
    Country: Number of subjects enrolled
    Spain: 61
    Country: Number of subjects enrolled
    Taiwan: 35
    Country: Number of subjects enrolled
    United States: 83
    Worldwide total number of subjects
    382
    EEA total number of subjects
    129
    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)
    360
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 574 subjects screened; 382 subjects randomized; 338 (88.5%) subjects completed treatment epoch; 349 (91.4%) subjects entered follow-up phase and 320 (83.8%) completed the follow-up epoch

    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, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 QGE031 24 mg s.c. q4w
    Arm description
    		 ligelizumab 24 mg injection subcutaneous every 4 weeks
    Arm type
    		 Experimental

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

    Arm title
    		 QGE031 72 mg s.c. q4w
    Arm description
    		 ligelizumab 72 mg injection subcutaneous every 4 weeks
    Arm type
    		 Experimental

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

    Arm title
    		 QGE031 240 mg s.c. q4w
    Arm description
    		 ligelizumab 240 mg injection subcutaneous every 4 weeks
    Arm type
    		 Experimental

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

    Arm title
    		 Omalizumab 300 mg s.c. q4w
    Arm description
    		 omalizumab 300 mg injection subcutaneous every 4 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    omalizumab 300 mg injection subcutaneous every 4 weeks

    Arm title
    		 Placebo s.c. q4w
    Arm description
    		 placebo injection subcutaneous every 4 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    placebo injection subcutaneous every 4 weeks

    Arm title
    		 QGE031 120 mg s.c. s.d.
    Arm description
    		 ligelizumab 120 mg injection subcutaneous single dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ligelizumab
    Investigational medicinal product code
    QGE031
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Ligelizumab 120 mg injection subcutaneous every 4 weeks.

    Number of subjects in period 1
    		QGE031 24 mg s.c. q4w QGE031 72 mg s.c. q4w QGE031 240 mg s.c. q4w Omalizumab 300 mg s.c. q4w Placebo s.c. q4w QGE031 120 mg s.c. s.d.
    Started
    43
    84
    85
    85
    43
    42
    Completed
    40
    77
    73
    72
    39
    37
    Not completed
    3
    7
    12
    13
    4
    5
         Consent withdrawn by subject
    -
    3
    1
    2
    1
    -
         Physician decision
    -
    -
    1
    3
    -
    1
         Adverse event, non-fatal
    -
    1
    1
    2
    1
    2
         Technical problems
    -
    -
    1
    -
    -
    -
         Non-compliance with study treatment
    -
    1
    2
    -
    -
    -
         Pregnancy
    -
    -
    -
    1
    -
    -
         Lost to follow-up
    -
    -
    2
    -
    -
    -
         Lack of efficacy
    1
    2
    1
    2
    1
    1
         Protocol deviation
    2
    -
    3
    3
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    QGE031 24 mg s.c. q4w
    Reporting group description
    		 ligelizumab 24 mg injection subcutaneous every 4 weeks

    Reporting group title
    QGE031 72 mg s.c. q4w
    Reporting group description
    		 ligelizumab 72 mg injection subcutaneous every 4 weeks

    Reporting group title
    QGE031 240 mg s.c. q4w
    Reporting group description
    		 ligelizumab 240 mg injection subcutaneous every 4 weeks

    Reporting group title
    Omalizumab 300 mg s.c. q4w
    Reporting group description
    		 omalizumab 300 mg injection subcutaneous every 4 weeks

    Reporting group title
    Placebo s.c. q4w
    Reporting group description
    		 placebo injection subcutaneous every 4 weeks

    Reporting group title
    QGE031 120 mg s.c. s.d.
    Reporting group description
    		 ligelizumab 120 mg injection subcutaneous single dose

    Reporting group values
    		 QGE031 24 mg s.c. q4w QGE031 72 mg s.c. q4w QGE031 240 mg s.c. q4w Omalizumab 300 mg s.c. q4w Placebo s.c. q4w QGE031 120 mg s.c. s.d. Total
    Number of subjects
    		 43 84 85 85 43 42 382
    Age Categorical
    Units: Subjects
        <=18 years
    		 0 0 0 0 0 0 0
        Between 18 and 65 years
    		 39 77 85 81 41 37 360
        >=65 years
    		 4 7 0 4 2 5 22
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.1 ( 14.36 ) 44.3 ( 12.38 ) 42.9 ( 10.51 ) 41.8 ( 13.06 ) 45.4 ( 11.22 ) 42.4 ( 14.54 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 31 61 67 66 31 30 286
        Male
    		 12 23 18 19 12 12 96

    End points

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    End points reporting groups
    Reporting group title
    QGE031 24 mg s.c. q4w
    Reporting group description
    		 ligelizumab 24 mg injection subcutaneous every 4 weeks

    Reporting group title
    QGE031 72 mg s.c. q4w
    Reporting group description
    		 ligelizumab 72 mg injection subcutaneous every 4 weeks

    Reporting group title
    QGE031 240 mg s.c. q4w
    Reporting group description
    		 ligelizumab 240 mg injection subcutaneous every 4 weeks

    Reporting group title
    Omalizumab 300 mg s.c. q4w
    Reporting group description
    		 omalizumab 300 mg injection subcutaneous every 4 weeks

    Reporting group title
    Placebo s.c. q4w
    Reporting group description
    		 placebo injection subcutaneous every 4 weeks

    Reporting group title
    QGE031 120 mg s.c. s.d.
    Reporting group description
    		 ligelizumab 120 mg injection subcutaneous single dose

    Primary: Percentage of Participants with Complete Hives Response (HSS7=0)

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    End point title
    		 Percentage of Participants with Complete Hives Response (HSS7=0)
    End point description
    The primary objective was to establish the dose-response relationship of ligelizumab (24, 72 and 240 mg every 4 weeks) with respect to achievement of complete hives response (HSS7=0) at Week 12 and select an appropriate dose (or range of doses) which is likely to be superior to omalizumab at the highest approved dose (300 mg every 4 weeks). Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days, with a possible range of 0 - 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (>12 hives/12 hours) To confirm an overall dose-response signal based on MCP-Mod, and to estimate the minimal ligelizumab dose that shows a relevant superior effect over omalizumab, based on the selected dose response model, the lowest ligelizumab dose that provides a response rate 15% higher than the response of omalizumab 300 mg.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 QGE031 24 mg s.c. q4w QGE031 72 mg s.c. q4w QGE031 240 mg s.c. q4w Omalizumab 300 mg s.c. q4w Placebo s.c. q4w QGE031 120 mg s.c. s.d.
    Number of subjects analysed
    43
    84
    85
    85
    43
    42
    Units: Percentage of participants
        number (confidence interval 95%)
    30.2 (17.2 to 46.1)
    51.2 (40.0 to 62.3)
    42.4 (31.7 to 53.6)
    25.9 (17.0 to 36.5)
    0 (0.0 to 8.2)
    19.0 (8.6 to 34.1)
    Statistical analysis title
    		 Dose response analysis
    Statistical analysis description
    Dose response relationship with respect to achievement of complete hives response. (HSS7=0)
    Comparison groups
    QGE031 24 mg s.c. q4w v QGE031 72 mg s.c. q4w v QGE031 240 mg s.c. q4w v Omalizumab 300 mg s.c. q4w
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Estimated target dose
    Point estimate
    32.5
    Confidence interval
         level
    		 60%
         sides
    2-sided
         lower limit
    		 27.5
         upper limit
    		 42.5

    Secondary: Complete hives response (HSS7=0) rate at Week 12 measured over 7 days

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    End point title
    		 Complete hives response (HSS7=0) rate at Week 12 measured over 7 days [1]
    End point description
    Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Complete hives response defined as HSS7 = 0. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (>12 hives/12 hours)
    End point type
    Secondary
    End point timeframe
    Week 12
    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: Data from the ligelizumab 120 mg single dose treatment arm were not included in this analysis.
    End point values
    		 QGE031 24 mg s.c. q4w QGE031 72 mg s.c. q4w QGE031 240 mg s.c. q4w Omalizumab 300 mg s.c. q4w Placebo s.c. q4w
    Number of subjects analysed
    43
    84
    85
    85
    43
    Units: Participants
    13
    43
    36
    22
    0
    No statistical analyses for this end point

    Secondary: Change from baseline in Hives Severity Score (HSS7) at Week 12 measured over 7 days

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    End point title
    		 Change from baseline in Hives Severity Score (HSS7) at Week 12 measured over 7 days [2]
    End point description
    Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (>12 hives/12 hours)
    End point type
    Secondary
    End point timeframe
    Week 12
    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: Data from the ligelizumab 120 mg single dose treatment arm were not included in this analysis.
    End point values
    		 QGE031 24 mg s.c. q4w QGE031 72 mg s.c. q4w QGE031 240 mg s.c. q4w Omalizumab 300 mg s.c. q4w Placebo s.c. q4w
    Number of subjects analysed
    40
    81
    78
    77
    41
    Units: Score on a scale
        median (confidence interval 95%)
    -9.75 (-15.75 to -2.50)
    -15.50 (-20.00 to -6.00)
    -13.50 (-19.00 to -9.00)
    -11.00 (-16.50 to -4.50)
    -6.50 (-13.00 to -2.33)
    No statistical analyses for this end point

    Secondary: HSS7=0 response: at Week 20 measured over 7 days

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    End point title
    		 HSS7=0 response: at Week 20 measured over 7 days [3]
    End point description
    Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Complete hives response defined as HSS7 = 0. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (>12 hives/12 hours)
    End point type
    Secondary
    End point timeframe
    Week 20
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data from the ligelizumab 120 mg single dose treatment arm were not included in this analysis.
    End point values
    		 QGE031 24 mg s.c. q4w QGE031 72 mg s.c. q4w QGE031 240 mg s.c. q4w Omalizumab 300 mg s.c. q4w Placebo s.c. q4w
    Number of subjects analysed
    43
    84
    85
    85
    43
    Units: Participants
    11
    43
    38
    29
    4
    No statistical analyses for this end point

    Secondary: Change from baseline in Hives Severity Score (HSS7) at Week 20 measured over 7 days

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    End point title
    		 Change from baseline in Hives Severity Score (HSS7) at Week 20 measured over 7 days [4]
    End point description
    Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1 - Mild (1-6 hives/12 hours) 2 - Moderate (7-12 hives/12 hours) 3 - Severe (>12 hives/12 hours)
    End point type
    Secondary
    End point timeframe
    Week 20
    Notes
    [4] - 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: Data from the ligelizumab 120 mg single dose treatment arm were not included in this analysis.
    End point values
    		 QGE031 24 mg s.c. q4w QGE031 72 mg s.c. q4w QGE031 240 mg s.c. q4w Omalizumab 300 mg s.c. q4w Placebo s.c. q4w
    Number of subjects analysed
    39
    78
    74
    73
    40
    Units: Score on a scale
        median (confidence interval 95%)
    -9.00 (-12.50 to -3.50)
    -16.50 (-20.50 to -6.83)
    -14.00 (-19.50 to -9.00)
    -11.00 (-16.00 to -4.25)
    -7.50 (-13.50 to -2.25)
    No statistical analyses for this end point

    Secondary: Change from baseline in Itch Severity Score (ISS7) at Week 12 measured over 7 days

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    End point title
    		 Change from baseline in Itch Severity Score (ISS7) at Week 12 measured over 7 days [5]
    End point description
    Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate)
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [5] - 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: Data from the ligelizumab 120 mg single dose treatment arm were not included in this analysis.
    End point values
    		 QGE031 24 mg s.c. q4w QGE031 72 mg s.c. q4w QGE031 240 mg s.c. q4w Omalizumab 300 mg s.c. q4w Placebo s.c. q4w
    Number of subjects analysed
    40
    81
    78
    77
    41
    Units: Score on a scale
        median (confidence interval 95%)
    -7.50 (-12.75 to -3.50)
    -9.50 (-14.50 to -6.00)
    -9.00 (-14.00 to -4.50)
    -8.00 (-11.50 to -4.50)
    -5.50 (-8.50 to -2.50)
    No statistical analyses for this end point

    Secondary: Change from baseline in Itch Severity Score (ISS7) at Week 20 measured over 7 days

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    End point title
    		 Change from baseline in Itch Severity Score (ISS7) at Week 20 measured over 7 days [6]
    End point description
    Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate)
    End point type
    Secondary
    End point timeframe
    Week 20
    Notes
    [6] - 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: Data from the ligelizumab 120 mg single dose treatment arm were not included in this analysis.
    End point values
    		 QGE031 24 mg s.c. q4w QGE031 72 mg s.c. q4w QGE031 240 mg s.c. q4w Omalizumab 300 mg s.c. q4w Placebo s.c. q4w
    Number of subjects analysed
    39
    78
    74
    73
    40
    Units: Score on a scale
        median (confidence interval 95%)
    -7.00 (-11.00 to -2.00)
    -10.25 (-14.00 to -6.50)
    -10.00 (-14.00 to -5.50)
    -8.83 (-11.50 to -3.50)
    -5.00 (-9.50 to -2.25)
    No statistical analyses for this end point

    Secondary: Change from baseline in Urticaria Activity Score (UAS7) at Week 12 measured over 7 days

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    End point title
    		 Change from baseline in Urticaria Activity Score (UAS7) at Week 12 measured over 7 days [7]
    End point description
    UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [7] - 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: Data from the ligelizumab 120 mg single dose treatment arm were not included in this analysis.
    End point values
    		 QGE031 24 mg s.c. q4w QGE031 72 mg s.c. q4w QGE031 240 mg s.c. q4w Omalizumab 300 mg s.c. q4w Placebo s.c. q4w
    Number of subjects analysed
    40
    81
    78
    77
    41
    Units: Score on a scale
        median (confidence interval 95%)
    -19.50 (-26.75 to -6.25)
    -26.50 (-33.00 to -12.00)
    -21.75 (-32.50 to -14.00)
    -19.00 (-29.00 to -8.50)
    -12.00 (-21.00 to -6.00)
    No statistical analyses for this end point

    Secondary: Change from baseline in Urticaria Activity Score (UAS7) at Week 20 measured over 7 days

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    End point title
    		 Change from baseline in Urticaria Activity Score (UAS7) at Week 20 measured over 7 days [8]
    End point description
    UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.
    End point type
    Secondary
    End point timeframe
    Week 20
    Notes
    [8] - 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: Data from the ligelizumab 120 mg single dose treatment arm were not included in this analysis.
    End point values
    		 QGE031 24 mg s.c. q4w QGE031 72 mg s.c. q4w QGE031 240 mg s.c. q4w Omalizumab 300 mg s.c. q4w Placebo s.c. q4w
    Number of subjects analysed
    39
    78
    74
    73
    40
    Units: Score on a scale
        median (confidence interval 95%)
    -16.00 (-23.00 to -7.00)
    -27.00 (-33.00 to -15.00)
    -22.92 (-32.50 to -13.50)
    -18.50 (-28.50 to -11.00)
    -13.00 (-21.00 to -5.50)
    No statistical analyses for this end point

    Secondary: Complete Urticaria Activity Score Response (UAS7=0) rate at Week 12 measured over 7 days

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    End point title
    		 Complete Urticaria Activity Score Response (UAS7=0) rate at Week 12 measured over 7 days [9]
    End point description
    UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. Complete urticaria activity response is defined as UAS7 = 0.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [9] - 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: Data from the ligelizumab 120 mg single dose treatment arm were not included in this analysis.
    End point values
    		 QGE031 24 mg s.c. q4w QGE031 72 mg s.c. q4w QGE031 240 mg s.c. q4w Omalizumab 300 mg s.c. q4w Placebo s.c. q4w
    Number of subjects analysed
    43
    84
    85
    85
    43
    Units: Participants
    13
    37
    34
    22
    0
    No statistical analyses for this end point

    Secondary: UAS7=0 response: at Week 20 measured over 7 days

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    End point title
    		 UAS7=0 response: at Week 20 measured over 7 days [10]
    End point description
    UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. Complete urticaria activity response is defined as UAS7 = 0.
    End point type
    Secondary
    End point timeframe
    Week 20
    Notes
    [10] - 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: Data from the ligelizumab 120 mg single dose treatment arm were not included in this analysis.
    End point values
    		 QGE031 24 mg s.c. q4w QGE031 72 mg s.c. q4w QGE031 240 mg s.c. q4w Omalizumab 300 mg s.c. q4w Placebo s.c. q4w
    Number of subjects analysed
    43
    84
    85
    85
    43
    Units: participants
    8
    33
    34
    26
    2
    No statistical analyses for this end point

    Secondary: Complete Itch Response (ISS7=0) rate at Week 12 measured over 7 days

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    End point title
    		 Complete Itch Response (ISS7=0) rate at Week 12 measured over 7 days [11]
    End point description
    Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Complete itch response defined as ISS7 = 0. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate)
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [11] - 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: Data from the ligelizumab 120 mg single dose treatment arm were not included in this analysis.
    End point values
    		 QGE031 24 mg s.c. q4w QGE031 72 mg s.c. q4w QGE031 240 mg s.c. q4w Omalizumab 300 mg s.c. q4w Placebo s.c. q4w
    Number of subjects analysed
    43
    84
    85
    85
    43
    Units: participants
    17
    40
    36
    25
    2
    No statistical analyses for this end point

    Secondary: ISS7=0 response: at Week 20 measured over 7 days

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    End point title
    		 ISS7=0 response: at Week 20 measured over 7 days [12]
    End point description
    Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Complete itch response defined as ISS7 = 0. Itch Severity Score scale: 0 - None 1 - Mild (minimal awareness, easily tolerated) 2 - Moderate (definite awareness, bothersome but tolerable) 3 - Severe (difficult to tolerate)
    End point type
    Secondary
    End point timeframe
    Week 20
    Notes
    [12] - 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: Data from the ligelizumab 120 mg single dose treatment arm were not included in this analysis.
    End point values
    		 QGE031 24 mg s.c. q4w QGE031 72 mg s.c. q4w QGE031 240 mg s.c. q4w Omalizumab 300 mg s.c. q4w Placebo s.c. q4w
    Number of subjects analysed
    43
    84
    85
    85
    43
    Units: participants
    8
    35
    36
    28
    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 are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    QGE031 24 mg q4w
    Reporting group description
    		 QGE031 24 mg q4w

    Reporting group title
    QGE031 72 mg q4w
    Reporting group description
    		 QGE031 72 mg q4w

    Reporting group title
    QGE031 240 mg q4w
    Reporting group description
    		 QGE031 240 mg q4w

    Reporting group title
    Omalizumab 300 mg q4w
    Reporting group description
    		 Omalizumab 300 mg q4w

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    QGE031 120 mg s.d.
    Reporting group description
    		 QGE031 120 mg s.d.

    Serious adverse events
    		 QGE031 24 mg q4w QGE031 72 mg q4w QGE031 240 mg q4w Omalizumab 300 mg q4w Placebo QGE031 120 mg s.d.
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 43 (6.98%)
    2 / 84 (2.38%)
    2 / 85 (2.35%)
    3 / 85 (3.53%)
    4 / 43 (9.30%)
    4 / 42 (9.52%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign lung neoplasm
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast neoplasm
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 84 (1.19%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemangioma of liver
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    1 / 43 (2.33%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    1 / 43 (2.33%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fractured coccyx
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 84 (1.19%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    1 / 85 (1.18%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    1 / 43 (2.33%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    1 / 43 (2.33%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    1 / 43 (2.33%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    1 / 43 (2.33%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon dysplasia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    1 / 85 (1.18%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    1 / 43 (2.33%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cyst
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    1 / 43 (2.33%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prurigo
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    1 / 85 (1.18%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    1 / 43 (2.33%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sjogren's syndrome
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    1 / 85 (1.18%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 QGE031 24 mg q4w QGE031 72 mg q4w QGE031 240 mg q4w Omalizumab 300 mg q4w Placebo QGE031 120 mg s.d.
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 43 (55.81%)
    45 / 84 (53.57%)
    46 / 85 (54.12%)
    44 / 85 (51.76%)
    30 / 43 (69.77%)
    28 / 42 (66.67%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 84 (3.57%)
    3 / 85 (3.53%)
    2 / 85 (2.35%)
    4 / 43 (9.30%)
    1 / 42 (2.38%)
         occurrences all number
    1
    3
    3
    3
    5
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 43 (2.33%)
    5 / 84 (5.95%)
    2 / 85 (2.35%)
    2 / 85 (2.35%)
    3 / 43 (6.98%)
    3 / 42 (7.14%)
         occurrences all number
    1
    5
    3
    2
    4
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 43 (4.65%)
    5 / 84 (5.95%)
    2 / 85 (2.35%)
    2 / 85 (2.35%)
    4 / 43 (9.30%)
    0 / 42 (0.00%)
         occurrences all number
    2
    6
    2
    4
    5
    0
    Headache
         subjects affected / exposed
    7 / 43 (16.28%)
    9 / 84 (10.71%)
    7 / 85 (8.24%)
    12 / 85 (14.12%)
    7 / 43 (16.28%)
    1 / 42 (2.38%)
         occurrences all number
    12
    11
    10
    14
    20
    1
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 84 (2.38%)
    5 / 85 (5.88%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    2
    7
    0
    0
    1
    Injection site reaction
         subjects affected / exposed
    0 / 43 (0.00%)
    3 / 84 (3.57%)
    6 / 85 (7.06%)
    0 / 85 (0.00%)
    1 / 43 (2.33%)
    0 / 42 (0.00%)
         occurrences all number
    0
    4
    9
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 43 (4.65%)
    4 / 84 (4.76%)
    5 / 85 (5.88%)
    6 / 85 (7.06%)
    2 / 43 (4.65%)
    2 / 42 (4.76%)
         occurrences all number
    2
    4
    5
    6
    3
    2
    Gastritis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 84 (0.00%)
    0 / 85 (0.00%)
    0 / 85 (0.00%)
    0 / 43 (0.00%)
    3 / 42 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    Nausea
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 84 (1.19%)
    2 / 85 (2.35%)
    5 / 85 (5.88%)
    2 / 43 (4.65%)
    1 / 42 (2.38%)
         occurrences all number
    1
    1
    2
    5
    2
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 43 (2.33%)
    5 / 84 (5.95%)
    4 / 85 (4.71%)
    2 / 85 (2.35%)
    1 / 43 (2.33%)
    3 / 42 (7.14%)
         occurrences all number
    1
    6
    4
    2
    1
    4
    Urticaria
         subjects affected / exposed
    1 / 43 (2.33%)
    9 / 84 (10.71%)
    3 / 85 (3.53%)
    4 / 85 (4.71%)
    5 / 43 (11.63%)
    7 / 42 (16.67%)
         occurrences all number
    2
    10
    4
    4
    19
    10
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 43 (2.33%)
    6 / 84 (7.14%)
    1 / 85 (1.18%)
    2 / 85 (2.35%)
    1 / 43 (2.33%)
    1 / 42 (2.38%)
         occurrences all number
    1
    6
    3
    2
    1
    1
    Back pain
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 84 (1.19%)
    0 / 85 (0.00%)
    1 / 85 (1.18%)
    1 / 43 (2.33%)
    3 / 42 (7.14%)
         occurrences all number
    0
    1
    0
    1
    1
    4
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 84 (1.19%)
    0 / 85 (0.00%)
    5 / 85 (5.88%)
    1 / 43 (2.33%)
    0 / 42 (0.00%)
         occurrences all number
    1
    1
    0
    5
    1
    0
    Influenza
         subjects affected / exposed
    1 / 43 (2.33%)
    4 / 84 (4.76%)
    4 / 85 (4.71%)
    5 / 85 (5.88%)
    1 / 43 (2.33%)
    1 / 42 (2.38%)
         occurrences all number
    1
    4
    4
    5
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 43 (16.28%)
    7 / 84 (8.33%)
    10 / 85 (11.76%)
    10 / 85 (11.76%)
    6 / 43 (13.95%)
    9 / 42 (21.43%)
         occurrences all number
    8
    8
    12
    13
    9
    13
    Urinary tract infection
         subjects affected / exposed
    0 / 43 (0.00%)
    5 / 84 (5.95%)
    4 / 85 (4.71%)
    5 / 85 (5.88%)
    0 / 43 (0.00%)
    2 / 42 (4.76%)
         occurrences all number
    0
    6
    4
    5
    0
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    7 / 43 (16.28%)
    13 / 84 (15.48%)
    17 / 85 (20.00%)
    17 / 85 (20.00%)
    13 / 43 (30.23%)
    10 / 42 (23.81%)
         occurrences all number
    12
    19
    20
    24
    18
    15

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Mar 2015
    This amendment was generated to correct a typographical error of the EUDRACT number on the cover page of the protocol.
    24 Mar 2015
    This amendment was generated to update barrier methods of contraception in the exclusion criteria to reflect the latest recommendations related to acceptable forms of contraception in the study.
    09 Feb 2016
    This amendment: a. introduced a futility analysis prior to Week 12 analysis, b. clarified the dosing scheme for H1- antihistamine, receptor blockers in accordance to local health authority guidance, c. included updated generic SAE reporting language per clinical trial protocol template change, d. also included removal of multiple biomarkers assays and other editorial changes.

    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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    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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