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    Clinical Trial Results:
    A multicenter, randomized, double-blind, placebo-controlled phase 2b dose-finding study to investigate the efficacy and safety of ligelizumab (QGE031) in adolescent patients with Chronic Spontaneous Urticaria (CSU)

    Summary
    EudraCT number
    		 2017-004207-52
    Trial protocol
    		 DE   ES   BE   HU   EE  
    Global end of trial date
    03 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Aug 2021
    First version publication date
    13 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CQGE031C2202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03437278
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, 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
    03 Feb 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Change in the Urticaria Activity Score (UAS7) between baseline and Week 24
    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
    01 Aug 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 6
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    India: 5
    Country: Number of subjects enrolled
    Russian Federation: 5
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    Turkey: 7
    Worldwide total number of subjects
    49
    EEA total number of subjects
    19
    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)
    49
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from 20 sites: Argentina (3), Belgium (1), Canada (2), Germany (2), Hungary (1), India (3), Russia (3), Spain (2), Taiwan (1) and Turkey (2).

    Pre-assignment
    Screening details
    		 Participants underwent a Screening period of up to 4 weeks.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ligelizumab 24 mg
    Arm description
    		 Participants received a dose of ligelizumab 24 mg (low dose) which consisted of one injection of 0.2 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ligelizumab
    Investigational medicinal product code
    QGE031
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ligelizumab comes in 120 mg per 1 ml liquid vials. Participants received one injection every 4 weeks at a dose of 24 mg, low dose.

    Arm title
    		 Ligelizumab 120 mg
    Arm description
    		 Participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ligelizumab
    Investigational medicinal product code
    QGE031
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ligelizumab comes in 120 mg per 1 ml liquid vials. Participants received one injection every 4 weeks at a dose of 120 mg, high dose.

    Arm title
    		 Placebo + Ligelizumab 120 mg
    Arm description
    		 Participants received Placebo which consisted of one injection of 1 ml placebo every 4 weeks from Day 1 to Week 8 (inclusive). From week 12 to week 20 (inclusive), participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo 0 mg per 1 ml liquid injection once every 4 weeks.

    Investigational medicinal product name
    Ligelizumab
    Investigational medicinal product code
    QGE031
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ligelizumab comes in 120 mg per 1 ml liquid vials. Participants received one injection every 4 weeks at a dose of 120 mg, high dose.

    Number of subjects in period 1
    		Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
    Started
    24
    13
    12
    Completed
    22
    13
    10
    Not completed
    2
    0
    2
         Physician decision
    1
    -
    1
         Adverse event, non-fatal
    -
    -
    1
         Progressive disease
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ligelizumab 24 mg
    Reporting group description
    		 Participants received a dose of ligelizumab 24 mg (low dose) which consisted of one injection of 0.2 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).

    Reporting group title
    Ligelizumab 120 mg
    Reporting group description
    		 Participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).

    Reporting group title
    Placebo + Ligelizumab 120 mg
    Reporting group description
    		 Participants received Placebo which consisted of one injection of 1 ml placebo every 4 weeks from Day 1 to Week 8 (inclusive). From week 12 to week 20 (inclusive), participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial.

    Reporting group values
    		 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg Total
    Number of subjects
    		 24 13 12 49
    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 0 0 0
        Adolescents (12-17 years)
    		 24 13 12 49
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 14.9 ± 1.94 15.2 ± 1.41 14.4 ± 1.51 -
    Sex: Female, Male
    Units: Participants
        Female
    		 10 9 9 28
        Male
    		 14 4 3 21
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 7 1 2 10
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 1 0 0 1
        White
    		 16 12 10 38
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Ligelizumab 24 mg
    Reporting group description
    		 Participants received a dose of ligelizumab 24 mg (low dose) which consisted of one injection of 0.2 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).

    Reporting group title
    Ligelizumab 120 mg
    Reporting group description
    		 Participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).

    Reporting group title
    Placebo + Ligelizumab 120 mg
    Reporting group description
    		 Participants received Placebo which consisted of one injection of 1 ml placebo every 4 weeks from Day 1 to Week 8 (inclusive). From week 12 to week 20 (inclusive), participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial.

    Subject analysis set title
    All participants with PK data
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in the study (low dose, high dose and placebo+high dose) with available pharmacokinetic data

    Primary: Change from baseline of weekly Urticaria Activity Score (UAS7) at week 24

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    End point title
    		 Change from baseline of weekly Urticaria Activity Score (UAS7) at week 24 [1]
    End point description
    UAS7 is a self-reported scoring system to evaluate urticaria signs and symptoms. UAS7 is the sum of daily urticaria activity scores (UAS) over a seven-day period. The possible range of UAS7 score is 0 to 42 (0 to 6 for daily UAS x 7 days). A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week. No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    Baseline, week 24
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis were not planned for this primary endpoint
    End point values
    		 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
    Number of subjects analysed
    23
    13
    11
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -20.36 ± 12.963
    -22.50 ± 13.503
    -21.26 ± 14.480
    No statistical analyses for this end point

    Secondary: Change from baseline of weekly Urticaria Activity Score (UAS7) at weeks 12 and 40

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    End point title
    		 Change from baseline of weekly Urticaria Activity Score (UAS7) at weeks 12 and 40
    End point description
    UAS7 is a self-reported scoring system to evaluate urticaria signs and symptoms. UAS7 is the sum of daily urticaria activity scores (UAS) over a seven-day period. The possible range of UAS7 score is 0 to 42 (0 to 6 for daily UAS x 7 days). A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week.
    End point type
    Secondary
    End point timeframe
    Baseline, weeks 12 and 40
    End point values
    		 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
    Number of subjects analysed
    24
    13
    12
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=23, 13, 12)
    -15.70 ± 10.867
    -18.38 ± 12.268
    -12.96 ± 13.043
        Week 40 (n=22, 12, 10)
    -17.50 ± 12.619
    -15.65 ± 11.096
    -19.43 ± 17.667
    No statistical analyses for this end point

    Secondary: Percentage of participants with complete response in weekly Urticaria Activity Score (UAS7)

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    End point title
    		 Percentage of participants with complete response in weekly Urticaria Activity Score (UAS7)
    End point description
    UAS7 is a self-reported scoring system to evaluate urticaria signs and symptoms. UAS7 is the sum of daily urticaria activity scores (UAS) over a seven-day period. The possible range of UAS7 score is 0 to 42 (0 to 6 for daily UAS x 7 days). A higher urticaria activity score indicates more severe symptoms. A complete UAS7 response is defined as UAS7=0, no wheals neither pruritus. Participants with post-baseline missing data were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24 and 40
    End point values
    		 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
    Number of subjects analysed
    24
    13
    12
    Units: Participants
        Week 12
    4
    5
    2
        Week 24
    8
    8
    4
        Week 40
    3
    2
    4
    No statistical analyses for this end point

    Secondary: Change from baseline of weekly Itch Severity Score (ISS7)

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    End point title
    		 Change from baseline of weekly Itch Severity Score (ISS7)
    End point description
    ISS7 is the sum of daily Itch Severity Score (ISS) over a seven-day period. The possible range of ISS7 score is 0-21 (0-3 for daily ISS x 7 days), where 0 is defined as complete ISS7 response (no itching) and 21 is the worst score. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week.
    End point type
    Secondary
    End point timeframe
    Baseline, weeks 12, 24 and 40
    End point values
    		 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
    Number of subjects analysed
    24
    13
    12
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=23, 13, 12)
    -7.66 ± 5.824
    -7.81 ± 6.047
    -6.34 ± 6.936
        Week 24 (n=23, 13, 12)
    -9.71 ± 7.049
    -9.85 ± 6.488
    -10.28 ± 7.811
        Week 40 (n=22, 12, 10)
    -8.73 ± 6.656
    -6.86 ± 5.848
    -9.88 ± 8.687
    No statistical analyses for this end point

    Secondary: Percentage of participants with complete response in weekly Itch Severity Score (ISS7)

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    End point title
    		 Percentage of participants with complete response in weekly Itch Severity Score (ISS7)
    End point description
    ISS7 is the sum of daily Itch Severity Score (ISS) over a seven-day period. The possible range of ISS7 score is 0-21 (0-3 for daily ISS x 7 days), where 0 is defined as complete ISS7 response (no itching) and 21 is the worst score. Participants with post-baseline missing data were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24 and 40
    End point values
    		 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
    Number of subjects analysed
    24
    13
    12
    Units: Participants
        Week 12
    4
    5
    2
        Week 24
    9
    8
    4
        Week 40
    4
    2
    4
    No statistical analyses for this end point

    Secondary: Change from baseline of weekly Hives Severity Score (HSS7)

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    End point title
    		 Change from baseline of weekly Hives Severity Score (HSS7)
    End point description
    HSS7 is the sum of daily Hives Severity Score (HSS) over a seven-day period. The possible range of HSS7 score is 0-21 (0-3 for daily HSS x 7 days), where 0 is defined as complete HSS7 response (no wheals) and 21 is the worst score. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week.
    End point type
    Secondary
    End point timeframe
    Baseline, weeks 12, 24 and 40
    End point values
    		 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
    Number of subjects analysed
    24
    13
    12
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=23, 13, 12)
    -8.03 ± 6.307
    -10.58 ± 7.225
    -6.62 ± 6.385
        Week 24 (n=23, 13, 11)
    -10.65 ± 6.673
    -12.65 ± 7.785
    -10.98 ± 6.842
        Week 40 (n=22, 12, 10)
    -8.77 ± 6.770
    -8.78 ± 6.084
    -9.55 ± 9.197
    No statistical analyses for this end point

    Secondary: Percentage of participants with complete response in weekly Hives Severity Score (HSS7)

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    End point title
    		 Percentage of participants with complete response in weekly Hives Severity Score (HSS7)
    End point description
    HSS7 is the sum of daily Hives Severity Score (HSS) over a seven-day period. The possible range of HSS7 score is 0-21 (0-3 for daily HSS x 7 days), where 0 is defined as complete HSS7 response (no wheals) and 21 is the worst score. Participants with post-baseline missing data were considered as non-responders.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24 and 40
    End point values
    		 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
    Number of subjects analysed
    24
    13
    12
    Units: Participants
        Week 12
    6
    6
    2
        Week 24
    10
    9
    4
        Week 40
    5
    2
    5
    No statistical analyses for this end point

    Secondary: Change from baseline of the Children Dermatology Life Quality Index (CDLQI)

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    End point title
    		 Change from baseline of the Children Dermatology Life Quality Index (CDLQI)
    End point description
    The children dermatology life quality index questionnaire is a 10-item dermatology- specific health-related quality of life measure designed for use in children. Participants rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. The CDLQI total score is a sum of all 10 item responses, each individual response ranging from 0 (not at all) to 3 (very much). Total score ranges from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change score from baseline indicates improvement. Baseline was defined as the last non-missing value prior to or on the first treatment date. To handle the missing data, if a participant had only one item missing score per visit, then it was imputed to 0 and total score was calculated accordingly. If there were 2 or more item missing scores per visit, then the total score for the visit was considered as missing.
    End point type
    Secondary
    End point timeframe
    Baseline, weeks 12, 24 and 40
    End point values
    		 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
    Number of subjects analysed
    24
    13
    12
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=19, 13, 11)
    -10.1 ± 4.88
    -6.6 ± 8.05
    -5.0 ± 6.23
        Week 24 (n=21, 10, 11)
    -11.5 ± 6.85
    -8.8 ± 10.43
    -10.1 ± 6.74
        Week 40 (n=19, 11, 11)
    -10.3 ± 6.86
    -5.5 ± 9.04
    -8.6 ± 8.54
    No statistical analyses for this end point

    Secondary: Change from baseline in total human immunoglobulin E (IgE)

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    End point title
    		 Change from baseline in total human immunoglobulin E (IgE)
    End point description
    Change from baseline in IgE (free IgE plus IgE bound to ligelizumab) at weeks 12, 24 and 40 as a pharmacodynamic measurement.
    End point type
    Secondary
    End point timeframe
    Baseline, weeks 12, 24 and 40
    End point values
    		 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
    Number of subjects analysed
    24
    13
    12
    Units: International units / millilitre
    arithmetic mean (standard deviation)
        Week 12 (n=17, 11, 9)
    186 ± 160
    245 ± 291
    -43.1 ± 56.2
        Week 24 (n=19, 12, 9)
    169 ± 126
    328 ± 504
    325 ± 411
        Week 40 (n=19, 13, 9)
    30.4 ± 105
    -15.6 ± 118
    -22.0 ± 93.0
    No statistical analyses for this end point

    Secondary: Apparent Clearance (CL/F) of Ligelizumab estimated with PopPK model

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    End point title
    		 Apparent Clearance (CL/F) of Ligelizumab estimated with PopPK model
    End point description
    Model-based estimate of apparent clearance (CL/F) was derived using compartmental pharmacokinetic population (PopPK) modelling using non-linear mixed effects model for ligelizumab. Apparent clearance population estimate was derived through fitting individual drug administration history and collected ligelizumab concentrations at the specified data points (listed in Time Frame).
    End point type
    Secondary
    End point timeframe
    Weeks 0 (baseline), 4, 8, 12, 16, 20 (all pre-dose) and weeks 24, 32 and 40
    End point values
    		 All participants with PK data
    Number of subjects analysed
    47
    Units: Liters / day
        median (inter-quartile range (Q1-Q3))
    0.66 (0.44 to 1.03)
    No statistical analyses for this end point

    Secondary: Apparent volume of distribution of Ligelizumab estimated with a PopPK model

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    End point title
    		 Apparent volume of distribution of Ligelizumab estimated with a PopPK model
    End point description
    Model-based estimate of apparent volume of distribution was derived using compartmental pharmacokinetic population (PopPK) modelling using non-linear mixed effects model for ligelizumab. Apparent volume of distribution population estimate was derived through fitting individual drug administration history and collected ligelizumab concentrations at the specified data points (listed in Time Frame).
    End point type
    Secondary
    End point timeframe
    Weeks 0 (baseline), 4, 8, 12, 16, 20 (all pre-dose) and weeks 24, 32 and 40
    End point values
    		 All participants with PK data
    Number of subjects analysed
    47
    Units: Liters
        median (inter-quartile range (Q1-Q3))
    14.5 (11.02 to 16.65)
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

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    End point title
    		 Number of participants with adverse events (AEs) and serious adverse events (SAEs)
    End point description
    Number of participants with AEs and SAEs, including significant changes from baseline in vital signs (blood pressure, pulse rate), electrocardiograms and laboratory values qualifying and reported as AEs. The number of participants in each category is reported in the table.
    End point type
    Secondary
    End point timeframe
    From the start of treatment to 20 weeks after end of treatment, assessed up to maximum duration of 40 weeks
    End point values
    		 Ligelizumab 24 mg Ligelizumab 120 mg Placebo + Ligelizumab 120 mg
    Number of subjects analysed
    24
    13
    12
    Units: Participants
        AEs
    18
    11
    9
        Treatment related AEs
    6
    5
    2
        SAEs
    1
    0
    1
        SAEs leading to treatment discontinuation
    0
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the start of treatment until 20 weeks after end of treatment, assessed up to maximum duration of 40 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Ligelizumab 24 mg q4w
    Reporting group description
    		 Ligelizumab 24 mg q4w

    Reporting group title
    Ligelizumab 120 mg q4w
    Reporting group description
    		 Ligelizumab 120 mg q4w

    Reporting group title
    Placebo - Ligelizumab 120 mg q4w
    Reporting group description
    		 Placebo - Ligelizumab 120 mg q4w

    Reporting group title
    Total
    Reporting group description
    		 Total

    Serious adverse events
    		 Ligelizumab 24 mg q4w Ligelizumab 120 mg q4w Placebo - Ligelizumab 120 mg q4w Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    2 / 49 (4.08%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Cardiac disorders
    Pulmonary valve incompetence
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ligelizumab 24 mg q4w Ligelizumab 120 mg q4w Placebo - Ligelizumab 120 mg q4w Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 24 (75.00%)
    11 / 13 (84.62%)
    9 / 12 (75.00%)
    38 / 49 (77.55%)
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    1
    Arthropod bite
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    2 / 49 (4.08%)
         occurrences all number
    0
    1
    1
    2
    Face injury
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    3 / 49 (6.12%)
         occurrences all number
    2
    0
    1
    3
    Headache
         subjects affected / exposed
    5 / 24 (20.83%)
    1 / 13 (7.69%)
    4 / 12 (33.33%)
    10 / 49 (20.41%)
         occurrences all number
    7
    2
    11
    20
    Intercostal neuralgia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    1
    Migraine
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    6
    0
    6
    General disorders and administration site conditions
    Administration site erythema
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    2
    0
    2
    Injection site erythema
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    1
    Injection site pain
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    3 / 49 (6.12%)
         occurrences all number
    1
    1
    1
    3
    Injection site reaction
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    1
    Pyrexia
         subjects affected / exposed
    2 / 24 (8.33%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    4 / 49 (8.16%)
         occurrences all number
    2
    2
    0
    4
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 24 (12.50%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    4 / 49 (8.16%)
         occurrences all number
    9
    0
    1
    10
    Abdominal pain upper
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
    4 / 49 (8.16%)
         occurrences all number
    2
    0
    5
    7
    Gastritis
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    2
    0
    0
    2
    Nausea
         subjects affected / exposed
    1 / 24 (4.17%)
    3 / 13 (23.08%)
    1 / 12 (8.33%)
    5 / 49 (10.20%)
         occurrences all number
    1
    3
    1
    5
    Odynophagia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    0
    1
    Toothache
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    1
    Vomiting
         subjects affected / exposed
    1 / 24 (4.17%)
    3 / 13 (23.08%)
    0 / 12 (0.00%)
    4 / 49 (8.16%)
         occurrences all number
    1
    3
    0
    4
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    2 / 49 (4.08%)
         occurrences all number
    0
    1
    2
    3
    Menstruation irregular
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    0
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    2 / 49 (4.08%)
         occurrences all number
    3
    0
    1
    4
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    3 / 49 (6.12%)
         occurrences all number
    5
    0
    1
    6
    Chronic spontaneous urticaria
         subjects affected / exposed
    5 / 24 (20.83%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    5 / 49 (10.20%)
         occurrences all number
    10
    0
    0
    10
    Dry skin
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    0
    1
    Onycholysis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    5
    0
    0
    5
    Back pain
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    4
    0
    0
    4
    Fibromyalgia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    0
    1
    Medial tibial stress syndrome
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    1
    1
    Muscle spasms
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 49 (2.04%)
         occurrences all number
    0
    0
    2
    2
    Infections and infestations
    Gastrointestinal infection
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    2 / 49 (4.08%)
         occurrences all number
    0
    1
    1
    2
    Influenza
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 13 (7.69%)
    2 / 12 (16.67%)
    5 / 49 (10.20%)
         occurrences all number
    4
    1
    2
    7
    Nasopharyngitis
         subjects affected / exposed
    7 / 24 (29.17%)
    4 / 13 (30.77%)
    4 / 12 (33.33%)
    15 / 49 (30.61%)
         occurrences all number
    14
    9
    6
    29
    Pharyngitis
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    1
    1
    0
    2
    Post procedural infection
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    0
    1
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    2 / 49 (4.08%)
         occurrences all number
    0
    2
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 24 (12.50%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    5 / 49 (10.20%)
         occurrences all number
    5
    3
    0
    8
    Urinary tract infection
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 13 (15.38%)
    1 / 12 (8.33%)
    4 / 49 (8.16%)
         occurrences all number
    1
    5
    1
    7
    Viral infection
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    0
    1

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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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