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    Clinical Trial Results:
    A phase IV, multicenter, single-arm and open-label study with omalizumab (Xolair®) in chronic spontaneous urticaria (CSU) patients who remain symptomatic despite antihistamine (H1) treatment

    Summary
    EudraCT number
    2014-005424-97
    Trial protocol
    FR  
    Global end of trial date
    11 Jan 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Jan 2017
    First version publication date
    27 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CIGE025EFR02
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02550106
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the proportion of patients with a urticaria control test (UCT) score ≥ 12 (indicating a well-controlled urticaria) at Week 12 in adult patients with chronic spontaneous urticaria (CSU) with inadequate response to H1 antihistamine treatment and treated by omalizumab 300 mg S.C. every 4 weeks.
    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
    22 Apr 2015
    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
    France: 136
    Worldwide total number of subjects
    136
    EEA total number of subjects
    136
    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)
    126
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Full Analysis Set

    Pre-assignment
    Screening details
    The study consisted of a screening period (Day -7 to Day -1), a treatment period of 12 weeks (Day 1 to Day 85) and an extension period up to commercial availability of omalizumab in France. Omalizumab was launched on the French market on 03-Nov-2015.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    This was an open-label, non-blinded study.

    Arms
    Arm title
    OMALIZUMAB
    Arm description
    sub cutaneous injections of 300 mg every 4 weeks until Week 8
    Arm type
    Experimental

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intravesical solution/solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg S.C. every 4 weeks

    Number of subjects in period 1
    OMALIZUMAB
    Started
    136
    Completed
    124
    Not completed
    12
         Protocol deviation
    6
         Lack of efficacy
    3
         Adverse event, non-fatal
    1
         Consent withdrawn by subject
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OMALIZUMAB
    Reporting group description
    sub cutaneous injections of 300 mg every 4 weeks until Week 8

    Reporting group values
    OMALIZUMAB Total
    Number of subjects
    136 136
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    126 126
        From 65-84 years
    10 10
        85 years and over
    0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    44.4 ± 12.67 -
    Gender, Male/Female
    Units: Subjects
        Female
    106 106
        Male
    30 30

    End points

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    End points reporting groups
    Reporting group title
    OMALIZUMAB
    Reporting group description
    sub cutaneous injections of 300 mg every 4 weeks until Week 8

    Subject analysis set title
    OMALIZUMAB with ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until W8

    Subject analysis set title
    OMALIZUMAB without angioedema
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneaous injections of 300 mg every 4 weeks until Week 8

    Subject analysis set title
    OMALIZUMAB with ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until Week 8

    Subject analysis set title
    OMALIZUMAB without ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until W8

    Subject analysis set title
    OMALIZUMAB with ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until EOS

    Subject analysis set title
    OMALIZUMAB without ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until W8

    Subject analysis set title
    OMALIZUMAB with ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until EOS

    Subject analysis set title
    OMALIZUMAB without ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until End Of Study (EOS)

    Subject analysis set title
    OMALIZUMAB with ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until EOS

    Subject analysis set title
    OMALIZUMAB without ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until EOS

    Subject analysis set title
    OMALIZUMAB with ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until EOS

    Subject analysis set title
    OMALIZUMAB without ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until EOS

    Subject analysis set title
    OMALIZUMAB with ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until EOS

    Subject analysis set title
    OMALIZUMAB without ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until EOS

    Subject analysis set title
    OMALIZUMAB with ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until Week 8

    Subject analysis set title
    OMALIZUMAB without ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until W8

    Subject analysis set title
    OMALIZUMAB with ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until W8

    Subject analysis set title
    OMALIZUMAB without ANGIOEDEMA
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneous injections of 300 mg every 4 weeks until W8

    Subject analysis set title
    OMALIZUMAB Without angioedema
    Subject analysis set type
    Full analysis
    Subject analysis set description
    sub cutaneaous injections of 300 mg every 4 weeks until Week 8

    Primary: Percent of participants with an urticaria control test [UCT] score of greater than or equal to 12

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    End point title
    Percent of participants with an urticaria control test [UCT] score of greater than or equal to 12 [1]
    End point description
    UCT number and percentage of patients with disease control, UCT score at least 12 at Week 12 No statistical analysis was planned for this primary outcome in this single-arm study
    End point type
    Primary
    End point timeframe
    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: This is a single-arm study
    End point values
    OMALIZUMAB
    Number of subjects analysed
    136
    Units: percent of participants
        number (confidence interval 95%)
    75 (66.9 to 82)
    No statistical analyses for this end point

    Secondary: Proportion of participants with UAS7≤6 (patients achieving disease control), in adult patients with CSU, with or without the presence of angioedema

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    End point title
    Proportion of participants with UAS7≤6 (patients achieving disease control), in adult patients with CSU, with or without the presence of angioedema
    End point description
    End point type
    Secondary
    End point timeframe
    WEEK 12
    End point values
    OMALIZUMAB with ANGIOEDEMA OMALIZUMAB without angioedema
    Number of subjects analysed
    83
    51
    Units: percent of participants
        number (confidence interval 95%)
    69.6 (58.2 to 79.5)
    63.8 (48.5 to 77.3)
    No statistical analyses for this end point

    Secondary: CSU disease activity using the urticaria activity score (UAS7), with or without the presence of angioedema

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    End point title
    CSU disease activity using the urticaria activity score (UAS7), with or without the presence of angioedema
    End point description
    End point type
    Secondary
    End point timeframe
    WEEK 12
    End point values
    OMALIZUMAB with ANGIOEDEMA OMALIZUMAB without ANGIOEDEMA
    Number of subjects analysed
    79
    47
    Units: absolute value
    arithmetic mean (standard deviation)
        baseline
    29.7 ± 7.32
    29.2 ± 6.72
        at week 12
    6.6 ± 10.08
    6.5 ± 9.11
    No statistical analyses for this end point

    Secondary: control of the CSU using the UCT score, with or without the presence of angioedema

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    End point title
    control of the CSU using the UCT score, with or without the presence of angioedema
    End point description
    End point type
    Secondary
    End point timeframe
    WEEK 12
    End point values
    OMALIZUMAB with ANGIOEDEMA OMALIZUMAB without ANGIOEDEMA
    Number of subjects analysed
    82
    50
    Units: absolute value
    arithmetic mean (standard deviation)
        baseline
    3 ± 2.06
    3.6 ± 2.55
        at week 12
    13.1 ± 3.95
    12.9 ± 3.97
    No statistical analyses for this end point

    Secondary: control of the CSU using the UCT score for patients in extension treatment period phase at week 16, with or without the presence of angioedema

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    End point title
    control of the CSU using the UCT score for patients in extension treatment period phase at week 16, with or without the presence of angioedema
    End point description
    End point type
    Secondary
    End point timeframe
    week 16
    End point values
    OMALIZUMAB with ANGIOEDEMA OMALIZUMAB without ANGIOEDEMA
    Number of subjects analysed
    70
    42
    Units: absolute value
        arithmetic mean (standard deviation)
    14.2 ± 2.96
    13.4 ± 3.4
    No statistical analyses for this end point

    Secondary: control of the CSU using the UCT score for patients in extension treatment period phase at week 20, with or without the presence of angioedema

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    End point title
    control of the CSU using the UCT score for patients in extension treatment period phase at week 20, with or without the presence of angioedema
    End point description
    End point type
    Secondary
    End point timeframe
    week 20
    End point values
    OMALIZUMAB with ANGIOEDEMA OMALIZUMAB without ANGIOEDEMA
    Number of subjects analysed
    48
    34
    Units: absolute value
        arithmetic mean (standard deviation)
    14.4 ± 2.4
    13.3 ± 4.11
    No statistical analyses for this end point

    Secondary: control of the CSU using the UCT score for patients in extension treatment period phase at week 24, with or without the presence of angioedema

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    End point title
    control of the CSU using the UCT score for patients in extension treatment period phase at week 24, with or without the presence of angioedema
    End point description
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    OMALIZUMAB with ANGIOEDEMA OMALIZUMAB without ANGIOEDEMA
    Number of subjects analysed
    14
    12
    Units: absolute value
        arithmetic mean (standard deviation)
    14.5 ± 2.14
    13.4 ± 3.75
    No statistical analyses for this end point

    Secondary: control of the CSU using the UCT score for patients in extension treatment period phase at week 28, with or without the presence of angioedema

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    End point title
    control of the CSU using the UCT score for patients in extension treatment period phase at week 28, with or without the presence of angioedema
    End point description
    End point type
    Secondary
    End point timeframe
    week 28
    End point values
    OMALIZUMAB with ANGIOEDEMA OMALIZUMAB without ANGIOEDEMA
    Number of subjects analysed
    2
    2
    Units: absolute value
        arithmetic mean (standard deviation)
    13.5 ± 3.54
    12 ± 5.66
    No statistical analyses for this end point

    Secondary: The quality of life using the chronic urticaria quality of life (CU-QoL) questionnaire

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    End point title
    The quality of life using the chronic urticaria quality of life (CU-QoL) questionnaire
    End point description
    End point type
    Secondary
    End point timeframe
    WEEK 12
    End point values
    OMALIZUMAB with ANGIOEDEMA OMALIZUMAB without ANGIOEDEMA
    Number of subjects analysed
    80
    49
    Units: absolute value
    arithmetic mean (standard deviation)
        baseline
    68.9 ± 15.64
    62.4 ± 17.76
        at 12 weeks
    32.5 ± 13.33
    33.3 ± 13.32
    No statistical analyses for this end point

    Secondary: The angioedema quality of life (AE-QoL)

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    End point title
    The angioedema quality of life (AE-QoL)
    End point description
    End point type
    Secondary
    End point timeframe
    WEEK 12
    End point values
    OMALIZUMAB with ANGIOEDEMA
    Number of subjects analysed
    78
    Units: absolute value
    arithmetic mean (standard deviation)
        baseline
    57.88 ± 22.474
        at week 12
    16.4 ± 20.074
    No statistical analyses for this end point

    Secondary: The dermatology life quality index (DLQI)

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    End point title
    The dermatology life quality index (DLQI)
    End point description
    End point type
    Secondary
    End point timeframe
    WEEK 12
    End point values
    OMALIZUMAB without ANGIOEDEMA OMALIZUMAB Without angioedema
    Number of subjects analysed
    79
    49
    Units: absolute value
    arithmetic mean (standard deviation)
        baseline
    14.2 ± 5.39
    13.2 ± 6.67
        at week 12
    2.4 ± 3.95
    2.7 ± 5.12
    No statistical analyses for this end point

    Secondary: angioedema activity using the angioedema activity score (AAS)

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    End point title
    angioedema activity using the angioedema activity score (AAS)
    End point description
    End point type
    Secondary
    End point timeframe
    WEEK 12
    End point values
    OMALIZUMAB with ANGIOEDEMA
    Number of subjects analysed
    78
    Units: absolute value
    arithmetic mean (standard deviation)
        baseline
    32.7 ± 27.21
        at week 12
    3.7 ± 10.4
    No statistical analyses for this end point

    Adverse events

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

    Serious adverse events
    Omalizumab 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 136 (6.62%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    CERVICAL VERTEBRAL FRACTURE
         subjects affected / exposed
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    FRACTURED SACRUM
         subjects affected / exposed
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    LIGAMENT SPRAIN
         subjects affected / exposed
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    PHARYNGEAL OEDEMA
         subjects affected / exposed
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    BLADDER DILATATION
         subjects affected / exposed
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    URINARY INCONTINENCE
         subjects affected / exposed
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    FOOT DEFORMITY
         subjects affected / exposed
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INTERVERTEBRAL DISC PROTRUSION
         subjects affected / exposed
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SACROILIITIS
         subjects affected / exposed
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    OBESITY
         subjects affected / exposed
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    PNEUMONIA
         subjects affected / exposed
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Omalizumab 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 136 (32.35%)
    Investigations
    WEIGHT INCREASED
         subjects affected / exposed
    7 / 136 (5.15%)
         occurrences all number
    7
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    22 / 136 (16.18%)
         occurrences all number
    33
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    23 / 136 (16.91%)
         occurrences all number
    33
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    12 / 136 (8.82%)
         occurrences all number
    14

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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