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    Clinical Trial Results:
    A multicenter, randomized, double-blind, placebo-controlled 12-week, parallel-group study with a 6 week follow up period to demonstrate efficacy and safety of subcutaneous Omalizumab in patients with urticaria factitia refractory to standard treatment

    Summary
    EudraCT number
    		 2011-005615-87
    Trial protocol
    		 DE  
    Global end of trial date
    25 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Sep 2021
    First version publication date
    16 Sep 2021
    Other versions
    Summary report(s)
    		 Symptomatic dermographism patients
    Symptomatic dermographism patients
    Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    CIGE025EDE17T
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Hesna Gözlükaya, Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin, 49 30450518296, hesna.goezluekaya@charite.de
    Scientific contact
    Hesna Gözlükaya, Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin, 49 30450518296, hesna.goezluekaya@charite.de
    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
    01 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effects of 150 and 300 mg omalizumab on wheal development in patients with urticaria factitia
    Protection of trial subjects
    Omalizumab (Xolair®) is a recombinant humanized monoclonal antibody that binds to IgE at its binding site to FcεRI. Omalizumab is currently indicated in patients with moderate to severe allergic asthma, 12 years and older. Up to now, more than 100,000 patients have been treated with omalizumab worldwide. Free IgE levels fall between 89-98% over 16 to 24 weeks of therapy. Associated with the fall in free IgE levels is a down-regulation in the expression of FcεRI receptors on basophils and mast cells. This mechanism of action is postulated to account for the reduction of exacerbations and symptoms of allergic asthma. In the EU, omalizumab is licensed for severe allergic asthma, while there is an expanded indication to moderate allergic asthma in the USA. Safety parameters were documented at each study visit and reported accordingly. Safety parameters included adverse events, laboratory values, clinical monitoring, and prescribed clinic visits. There were no significant differences in the frequency of occurrence of adverse events or other unexpected events between the omalizumab groups and the placebo group.
    Background therapy
    		 No backround therapy
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jul 2012
    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
    Germany: 61
    Worldwide total number of subjects
    61
    EEA total number of subjects
    61
    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)
    50
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 3 study centers in Germany, between December 2012 (first patient first visit) and December 2014 (last patient last visit).

    Pre-assignment
    Screening details
    		 60 patients with chronic urticaria factitia were planned, 61 were randomized, all 61 were analyzed regarding safety and 55 regarding efficacy. A total of 61 subjects entered the screening period (up to 2 weeks). All 61 subjects were randomized and received at least (two) dose of study drug.

    Pre-assignment period milestones
    Number of subjects started
    		 61
    Number of subjects completed
    		 61

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Omalizumab 150mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omalizumab 150mg
    Investigational medicinal product code
    Other name
    Xolair
    Pharmaceutical forms
    Suspension for emulsion for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Drug: Omalizumab 150mg, s.c., every 4 weeks

    Arm title
    		 Omalizumab 300mg
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    Other name
    Xolair
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Omalizumab 150mg, s.c., every 4 weeks

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Drug: Placebo Placebo, s.c., every 4 weeks

    Number of subjects in period 1
    		Omalizumab 150mg Omalizumab 300mg Placebo
    Started
    19
    21
    21
    Completed
    19
    21
    21

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Omalizumab 150mg
    Reporting group description
    		 -

    Reporting group title
    Omalizumab 300mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Omalizumab 150mg Omalizumab 300mg Placebo Total
    Number of subjects
    		 19 21 21 61
    Age categorical
    as described in the manuscript
    Units: Subjects
        Age 26-46 years
    		 0 0 21 21
        Age 34-52 years
    		 19 0 0 19
        Age 31-51 years
    		 0 21 0 21
    Gender categorical
    as described in the manuscript
    Units: Subjects
        Female
    		 13 9 12 34
        Male
    		 6 12 9 27

    End points

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    End points reporting groups
    Reporting group title
    Omalizumab 150mg
    Reporting group description
    		 -

    Reporting group title
    Omalizumab 300mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo

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    End point title
    		 Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo [1]
    End point description
    every 4 weeks
    End point type
    Primary
    End point timeframe
    70 days
    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: See manuskript
    End point values
    		 Omalizumab 150mg Omalizumab 300mg Placebo
    Number of subjects analysed
    19
    21
    21
    Units: wheal development up to four pins
        geometric mean (standard deviation)
    -1.8 ± 1.7
    -2.0 ± 1.8
    -0.6 ± 1.4
    No statistical analyses for this end point

    Secondary: To assess the effects of omalizumab in urticaria factitia patients on quality of life

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    End point title
    		 To assess the effects of omalizumab in urticaria factitia patients on quality of life
    End point description
    every 4 weeks
    End point type
    Secondary
    End point timeframe
    70 days
    End point values
    		 Omalizumab 150mg Omalizumab 300mg Placebo
    Number of subjects analysed
    19
    21
    21
    Units: Dermatology quality of life score
        geometric mean (standard error)
    -6.611 ± 1.234
    -5.579 ± 1.478
    -2.316 ± 0.949
    No statistical analyses for this end point

    Secondary: To assess the effects of omalizumab in UF patients on physician global assessment of disease severity

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    End point title
    		 To assess the effects of omalizumab in UF patients on physician global assessment of disease severity
    End point description
    every 4 weeks
    End point type
    Secondary
    End point timeframe
    70 days
    End point values
    		 Omalizumab 150mg Omalizumab 300mg Placebo
    Number of subjects analysed
    18
    19
    20 [2]
    Units: units on a sclae
        geometric mean (standard error)
    21.8 ± 3.63
    28.33 ± 6.23
    40.32 ± 6.162
    Notes
    [2] - Data were not collected
    No statistical analyses for this end point

    Secondary: To assess long-term effects of omalizumab in UF patients, change in friction thresholds from day 70 (week 10) to day 112 (week 16) will be assessed

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    End point title
    		 To assess long-term effects of omalizumab in UF patients, change in friction thresholds from day 70 (week 10) to day 112 (week 16) will be assessed
    End point description
    every 4 weeks
    End point type
    Secondary
    End point timeframe
    112 days
    End point values
    		 Omalizumab 150mg Omalizumab 300mg Placebo
    Number of subjects analysed
    19
    21
    21
    Units: Fric Test grades
        geometric mean (standard deviation)
    -1.0556 ± 1.39209
    -0.8421 ± 1.77210
    -0.8333 ± 1.50489
    No statistical analyses for this end point

    Secondary: Number of Participants with Serious Adverse Events and Adverse Events

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    End point title
    		 Number of Participants with Serious Adverse Events and Adverse Events
    End point description
    every 4 weeks
    End point type
    Secondary
    End point timeframe
    112
    End point values
    		 Omalizumab 150mg Omalizumab 300mg Placebo
    Number of subjects analysed
    19
    21
    21
    Units: participants
        number (not applicable)
    1
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the whole trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 no dictionary used
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Omalizumab 150mg
    Reporting group description
    		 -

    Reporting group title
    Omalizumab 300mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Omalizumab 150mg Omalizumab 300mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 21 (4.76%)
    1 / 21 (4.76%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Surgical and medical procedures
    Inguinal hernia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Unspecified renal colic
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute Cystitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Omalizumab 150mg Omalizumab 300mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 19 (94.74%)
    15 / 21 (71.43%)
    18 / 21 (85.71%)
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    6 / 19 (31.58%)
    9 / 21 (42.86%)
    10 / 21 (47.62%)
         occurrences all number
    6
    9
    10
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 19 (63.16%)
    6 / 21 (28.57%)
    8 / 21 (38.10%)
         occurrences all number
    12
    6
    8

    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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    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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