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    Clinical Trial Results:
    A multi-center, randomized, double-blind, placebo controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Inducible Urticaria (CINDU) in adolescents and adults inadequately controlled with H1-antihistamines

    Summary
    EudraCT number
    		 2020-003018-11
    Trial protocol
    		 HU   SK   ES   SI   NL   FR   DE   GR   IT   BG   AT  
    Global end of trial date
    09 Aug 2022

    Results information
    Results version number
    		 v1
    This version publication date
    25 Feb 2023
    First version publication date
    25 Feb 2023
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CQGE031E12301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05024058
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma, AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Study Director, Novartis Pharma, AG, +41 6133241111, novartis.email@novartis.com
    Scientific contact
    Study Director, Novartis Pharma, AG, +41 6133241111, 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?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Aug 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Aug 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrate superiority of ligelizumab versus placebo with regards to the change from baseline in response to a standardized provocation test for each CINDU subtype.
    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
    16 Nov 2021
    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
    Greece: 1
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    Russian Federation: 12
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Slovakia: 2
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    Turkey: 4
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    39
    EEA total number of subjects
    13
    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)
    5
    Adults (18-64 years)
    34
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 39 participants were randomized. None completed study.

    Pre-assignment
    Screening details
    		 Study terminated by sponsor.

    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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 72 mg ligelizumab, symptomatic dermographism
    Arm description
    		 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ligelizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    72 mg per 0.6 mL

    Arm title
    		 120 mg ligelizumab, symptomatic dermographism
    Arm description
    		 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ligelizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    120 mg per 1 mL

    Arm title
    		 Placebo - 72 mg ligelizumab, symptomatic dermographism
    Arm description
    		 Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism
    Arm type
    		 Placebo

    Investigational medicinal product name
    Ligelizumab placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0 mg per 1 mL

    Arm title
    		 Placebo - 120 mg ligelizumab, symptomatic dermographism
    Arm description
    		 Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism
    Arm type
    		 Placebo

    Investigational medicinal product name
    Ligelizumab placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0 mg per 1 mL

    Arm title
    		 72 mg ligelizumab cold urticaria
    Arm description
    		 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ligelizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    72 mg per 0.6 mL

    Arm title
    		 120 mg ligelizumab, cold urticaria
    Arm description
    		 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ligelizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    120 mg per 1 mL

    Arm title
    		 Placebo - 72 mg ligelizumab, cold urticaria
    Arm description
    		 Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria
    Arm type
    		 Placebo

    Investigational medicinal product name
    Ligelizumab placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0 mg per 1 mL

    Arm title
    		 Placebo - 120 mg ligelizumab, cold urticaria
    Arm description
    		 Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cold urticaria
    Arm type
    		 Placebo

    Investigational medicinal product name
    Ligelizumab placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0 mg per 1 mL

    Arm title
    		 120 mg Ligelizumab, cholinergic urticaria
    Arm description
    		 120 mg ligelizumab subcutaneous injection every 4 weeks in participants with cholinergic urticaria
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ligelizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    120 mg per 1 mL

    Arm title
    		 Placebo - 120 mg ligelizumab, cholinergic urticaria
    Arm description
    		 Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria
    Arm type
    		 Placebo

    Investigational medicinal product name
    Ligelizumab placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0 mg per 1 mL

    Number of subjects in period 1
    		72 mg ligelizumab, symptomatic dermographism 120 mg ligelizumab, symptomatic dermographism Placebo - 72 mg ligelizumab, symptomatic dermographism Placebo - 120 mg ligelizumab, symptomatic dermographism 72 mg ligelizumab cold urticaria 120 mg ligelizumab, cold urticaria Placebo - 72 mg ligelizumab, cold urticaria Placebo - 120 mg ligelizumab, cold urticaria 120 mg Ligelizumab, cholinergic urticaria Placebo - 120 mg ligelizumab, cholinergic urticaria
    Started
    5
    6
    4
    2
    3
    3
    1
    3
    6
    6
    Completed Treatment
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Started Follow-up
    2
    5
    4
    0
    3
    2
    0
    2
    5
    6
    Completed Follow-up
    1
    5
    3
    0
    3
    2
    0
    1
    5
    5
    Completed
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Not completed
    5
    6
    4
    2
    3
    3
    1
    3
    6
    6
         Study Terminated by Sponsor
    5
    6
    4
    2
    3
    3
    1
    3
    6
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    72 mg ligelizumab, symptomatic dermographism
    Reporting group description
    		 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism

    Reporting group title
    120 mg ligelizumab, symptomatic dermographism
    Reporting group description
    		 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism

    Reporting group title
    Placebo - 72 mg ligelizumab, symptomatic dermographism
    Reporting group description
    		 Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism

    Reporting group title
    Placebo - 120 mg ligelizumab, symptomatic dermographism
    Reporting group description
    		 Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism

    Reporting group title
    72 mg ligelizumab cold urticaria
    Reporting group description
    		 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria

    Reporting group title
    120 mg ligelizumab, cold urticaria
    Reporting group description
    		 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria

    Reporting group title
    Placebo - 72 mg ligelizumab, cold urticaria
    Reporting group description
    		 Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria

    Reporting group title
    Placebo - 120 mg ligelizumab, cold urticaria
    Reporting group description
    		 Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cold urticaria

    Reporting group title
    120 mg Ligelizumab, cholinergic urticaria
    Reporting group description
    		 120 mg ligelizumab subcutaneous injection every 4 weeks in participants with cholinergic urticaria

    Reporting group title
    Placebo - 120 mg ligelizumab, cholinergic urticaria
    Reporting group description
    		 Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria

    Reporting group values
    		 72 mg ligelizumab, symptomatic dermographism 120 mg ligelizumab, symptomatic dermographism Placebo - 72 mg ligelizumab, symptomatic dermographism Placebo - 120 mg ligelizumab, symptomatic dermographism 72 mg ligelizumab cold urticaria 120 mg ligelizumab, cold urticaria Placebo - 72 mg ligelizumab, cold urticaria Placebo - 120 mg ligelizumab, cold urticaria 120 mg Ligelizumab, cholinergic urticaria Placebo - 120 mg ligelizumab, cholinergic urticaria Total
    Number of subjects
    		 5 6 4 2 3 3 1 3 6 6 39
    Age Categorical
    Units:
        <=18 years
    		 1 1 1 0 0 1 0 1 0 0 5
        Between 18 and 65 years
    		 4 5 3 2 3 2 1 2 6 6 34
        >=65 years
    		 0 0 0 0 0 0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 30.4 ( 9.81 ) 28.3 ( 12.74 ) 40.8 ( 18.86 ) 36.5 ( 12.02 ) 35.3 ( 12.50 ) 31.7 ( 16.17 ) 60.0 ( 9.99 ) 32.3 ( 26.58 ) 28.8 ( 9.62 ) 25.2 ( 5.56 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 3 3 2 2 3 2 1 1 2 0 19
        Male
    		 2 3 2 0 0 1 0 2 4 6 20
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 4 6 4 2 3 3 1 3 5 5 36
        Black or African American
    		 1 0 0 0 0 0 0 0 0 1 2
        Asian
    		 0 0 0 0 0 0 0 0 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    72 mg ligelizumab, symptomatic dermographism
    Reporting group description
    		 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism

    Reporting group title
    120 mg ligelizumab, symptomatic dermographism
    Reporting group description
    		 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism

    Reporting group title
    Placebo - 72 mg ligelizumab, symptomatic dermographism
    Reporting group description
    		 Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism

    Reporting group title
    Placebo - 120 mg ligelizumab, symptomatic dermographism
    Reporting group description
    		 Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism

    Reporting group title
    72 mg ligelizumab cold urticaria
    Reporting group description
    		 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria

    Reporting group title
    120 mg ligelizumab, cold urticaria
    Reporting group description
    		 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria

    Reporting group title
    Placebo - 72 mg ligelizumab, cold urticaria
    Reporting group description
    		 Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria

    Reporting group title
    Placebo - 120 mg ligelizumab, cold urticaria
    Reporting group description
    		 Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cold urticaria

    Reporting group title
    120 mg Ligelizumab, cholinergic urticaria
    Reporting group description
    		 120 mg ligelizumab subcutaneous injection every 4 weeks in participants with cholinergic urticaria

    Reporting group title
    Placebo - 120 mg ligelizumab, cholinergic urticaria
    Reporting group description
    		 Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria

    Primary: Change from baseline in Total Fric Score in participants with symptomatic dermographism

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    End point title
    		 Change from baseline in Total Fric Score in participants with symptomatic dermographism [1] [2]
    End point description
    Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width)
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    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: Study was terminated early with too few patients meeting the primary endpoint analysis timepoint to perform proper hypothesis testing.
    [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: Study was terminated early with too few patients meeting the primary endpoint analysis timepoint to perform proper hypothesis testing.
    End point values
    		 72 mg ligelizumab, symptomatic dermographism 120 mg ligelizumab, symptomatic dermographism Placebo - 72 mg ligelizumab, symptomatic dermographism Placebo - 120 mg ligelizumab, symptomatic dermographism
    Number of subjects analysed
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    Units: Scores on a scale
    Notes
    [3] - No subjects were analyzed since the study was prematurely terminated.
    [4] - No subjects were analyzed since the study was prematurely terminated.
    [5] - No subjects were analyzed since the study was prematurely terminated.
    [6] - No subjects were analyzed since the study was prematurely terminated.
    No statistical analyses for this end point

    Primary: Change from baseline in critical temperature threshold in participants with cold urticaria

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    End point title
    		 Change from baseline in critical temperature threshold in participants with cold urticaria [7] [8]
    End point description
    The TempTest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    Notes
    [7] - 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: Study was terminated early with too few patients meeting the primary endpoint analysis timepoint to perform proper hypothesis testing.
    [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: Study was terminated early with too few patients meeting the primary endpoint analysis timepoint to perform proper hypothesis testing.
    End point values
    		 72 mg ligelizumab cold urticaria 120 mg ligelizumab, cold urticaria Placebo - 72 mg ligelizumab, cold urticaria Placebo - 120 mg ligelizumab, cold urticaria
    Number of subjects analysed
    0 [9]
    0 [10]
    0 [11]
    0 [12]
    Units: Temperature
    Notes
    [9] - No subjects were analyzed since the study was prematurely terminated
    [10] - No subjects were analyzed since the study was prematurely terminated
    [11] - No subjects were analyzed since the study was prematurely terminated
    [12] - No subjects were analyzed since the study was prematurely terminated
    No statistical analyses for this end point

    Primary: Change from baseline in itch numerical rating scale in participants with cholinergic urticaria

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    End point title
    		 Change from baseline in itch numerical rating scale in participants with cholinergic urticaria [13] [14]
    End point description
    Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 (“no itch”) to 10 (“worst possible itch”)
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    Notes
    [13] - 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: Study was terminated early with too few patients meeting the primary endpoint analysis timepoint to perform proper hypothesis testing.
    [14] - 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: Study was terminated early with too few patients meeting the primary endpoint analysis timepoint to perform proper hypothesis testing.
    End point values
    		 120 mg Ligelizumab, cholinergic urticaria Placebo - 120 mg ligelizumab, cholinergic urticaria
    Number of subjects analysed
    0 [15]
    0 [16]
    Units: Scores on a scale
    Notes
    [15] - No subjects were analyzed since the study was prematurely terminated.
    [16] - No subjects were analyzed since the study was prematurely terminated.
    No statistical analyses for this end point

    Secondary: Proportion of participants with symptomatic dermographism with Total Fric score = 0

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    End point title
    		 Proportion of participants with symptomatic dermographism with Total Fric score = 0 [17]
    End point description
    Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width)
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [17] - 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: Study was terminated early with too few patients meeting the primary endpoint analysis timepoint to perform proper hypothesis testing.
    End point values
    		 72 mg ligelizumab, symptomatic dermographism 120 mg ligelizumab, symptomatic dermographism Placebo - 72 mg ligelizumab, symptomatic dermographism Placebo - 120 mg ligelizumab, symptomatic dermographism
    Number of subjects analysed
    0 [18]
    0 [19]
    0 [20]
    0 [21]
    Units: Proportion of participants
    Notes
    [18] - No subjects were analyzed since the study was prematurely terminated.
    [19] - No subjects were analyzed since the study was prematurely terminated.
    [20] - No subjects were analyzed since the study was prematurely terminated.
    [21] - No subjects were analyzed since the study was prematurely terminated.
    No statistical analyses for this end point

    Secondary: Change from baseline in itch numerical rating scale in participants with symptomatic dermographism

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    End point title
    		 Change from baseline in itch numerical rating scale in participants with symptomatic dermographism [22]
    End point description
    Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 (“no itch”) to 10 (“worst possible itch”)
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    Notes
    [22] - 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: Study was terminated early with too few patients meeting the primary endpoint analysis timepoint to perform proper hypothesis testing.
    End point values
    		 72 mg ligelizumab, symptomatic dermographism 120 mg ligelizumab, symptomatic dermographism Placebo - 72 mg ligelizumab, symptomatic dermographism Placebo - 120 mg ligelizumab, symptomatic dermographism
    Number of subjects analysed
    0 [23]
    0 [24]
    0 [25]
    0 [26]
    Units: Scores on a scale
    Notes
    [23] - No subjects were analyzed since the study was prematurely terminated.
    [24] - No subjects were analyzed since the study was prematurely terminated.
    [25] - No subjects were analyzed since the study was prematurely terminated.
    [26] - No subjects were analyzed since the study was prematurely terminated.
    No statistical analyses for this end point

    Secondary: Proportion of participants with cold urticaria with complete response (no itch or hives) to the TempTest

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    End point title
    		 Proportion of participants with cold urticaria with complete response (no itch or hives) to the TempTest [27]
    End point description
    The TempTest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [27] - 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: Study was terminated early with too few patients meeting the primary endpoint analysis timepoint to perform proper hypothesis testing.
    End point values
    		 72 mg ligelizumab cold urticaria 120 mg ligelizumab, cold urticaria Placebo - 72 mg ligelizumab, cold urticaria Placebo - 120 mg ligelizumab, cold urticaria
    Number of subjects analysed
    0 [28]
    0 [29]
    0 [30]
    0 [31]
    Units: Proportion of participants
    Notes
    [28] - No subjects were analyzed since the study was prematurely terminated.
    [29] - No subjects were analyzed since the study was prematurely terminated.
    [30] - No subjects were analyzed since the study was prematurely terminated.
    [31] - No subjects were analyzed since the study was prematurely terminated.
    No statistical analyses for this end point

    Secondary: Change from baseline in itch numerical rating scale in participants with cold urticaria

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    End point title
    		 Change from baseline in itch numerical rating scale in participants with cold urticaria [32]
    End point description
    Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 (“no itch”) to 10 (“worst possible itch”)
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    Notes
    [32] - 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: Study was terminated early with too few patients meeting the primary endpoint analysis timepoint to perform proper hypothesis testing.
    End point values
    		 72 mg ligelizumab cold urticaria 120 mg ligelizumab, cold urticaria Placebo - 72 mg ligelizumab, cold urticaria Placebo - 120 mg ligelizumab, cold urticaria
    Number of subjects analysed
    0 [33]
    0 [34]
    0 [35]
    0 [36]
    Units: Scores on a scale
    Notes
    [33] - No subjects were analyzed since the study was prematurely terminated.
    [34] - No subjects were analyzed since the study was prematurely terminated.
    [35] - No subjects were analyzed since the study was prematurely terminated.
    [36] - No subjects were analyzed since the study was prematurely terminated.
    No statistical analyses for this end point

    Secondary: Proportion of participants with cholinergic urticaria with itch numerical rating scale =0

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    End point title
    		 Proportion of participants with cholinergic urticaria with itch numerical rating scale =0 [37]
    End point description
    Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 (“no itch”) to 10 (“worst possible itch”)
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [37] - 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: Study was terminated early with too few patients meeting the primary endpoint analysis timepoint to perform proper hypothesis testing.
    End point values
    		 120 mg Ligelizumab, cholinergic urticaria Placebo - 120 mg ligelizumab, cholinergic urticaria
    Number of subjects analysed
    0 [38]
    0 [39]
    Units: Proportion of participants
    Notes
    [38] - No subjects were analyzed since the study was prematurely terminated.
    [39] - No subjects were analyzed since the study was prematurely terminated.
    No statistical analyses for this end point

    Secondary: Proportion of participants with cholinergic urticaria with physician global assessment of severity of hives (PGA - hive score) =0

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    End point title
    		 Proportion of participants with cholinergic urticaria with physician global assessment of severity of hives (PGA - hive score) =0 [40]
    End point description
    Physician global assessment of severity of hives PGA is an assessment of all lesions scored on a scale from 0-5 (with 0= No hives and 5=Very severe hives)
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [40] - 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: Study was terminated early with too few patients meeting the primary endpoint analysis timepoint to perform proper hypothesis testing.
    End point values
    		 120 mg Ligelizumab, cholinergic urticaria Placebo - 120 mg ligelizumab, cholinergic urticaria
    Number of subjects analysed
    0 [41]
    0 [42]
    Units: Proportion of participants
    Notes
    [41] - No subjects were analyzed since the study was prematurely terminated.
    [42] - No subjects were analyzed since the study was prematurely terminated.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected after signature of the informed consent (ICF) form until after 16 weeks from last dose (12 wks from end of treatment). Treatment period was 24 wks. SAEs were collected after signature of the ICF until after 16 wks from last dose.
    Adverse event reporting additional description
    AE: Untoward medical occurrence, unfavorable/unintended sign, symptom, disease or injury, temporally assoc. with use of a marketed/investigational medicinal product, gene therapy, theragnostic product or medical device in patients, clinical-trial subjs, device users or other persons, whether or not considered to be related to or due to the product.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    QGE031 72mg
    Reporting group description
    		 QGE031 72mg

    Reporting group title
    QGE031 120mg
    Reporting group description
    		 QGE031 120mg

    Reporting group title
    Total
    Reporting group description
    		 Total

    Reporting group title
    Placebo - QGE031 120mg
    Reporting group description
    		 Placebo - QGE031 120mg

    Reporting group title
    Placebo - QGE031 72mg
    Reporting group description
    		 Placebo - QGE031 72mg

    Serious adverse events
    		 QGE031 72mg QGE031 120mg Total Placebo - QGE031 120mg Placebo - QGE031 72mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    0 / 39 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 QGE031 72mg QGE031 120mg Total Placebo - QGE031 120mg Placebo - QGE031 72mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 8 (37.50%)
    6 / 15 (40.00%)
    13 / 39 (33.33%)
    1 / 11 (9.09%)
    3 / 5 (60.00%)
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    0
    1
    Nervous system disorders
    Tension headache
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Migraine
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    1 / 39 (2.56%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Headache
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    3
    0
    3
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 15 (0.00%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Vertigo
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Nausea
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 15 (0.00%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 15 (0.00%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Endocrine disorders
    Hypopituitarism
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Groin pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 15 (0.00%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Arthralgia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Muscle spasms
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 15 (0.00%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Infections and infestations
    Peritonsillar abscess
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 15 (0.00%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    0
    1
    COVID-19
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Herpes simplex
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 15 (0.00%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Influenza
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 15 (13.33%)
    2 / 39 (5.13%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 15 (0.00%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 15 (6.67%)
    1 / 39 (2.56%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0

    More information

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

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Study was terminated early with too few patients meeting the primary endpoint analysis timepoint to perform proper hypothesis testing.
    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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