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    Clinical Trial Results:
    A phase II, multi-centre, randomized, double blind, placebo-controlled study to determine the mode of action of omalizumab in patients with chronic idiopathic urticaria (CIU) who remain symptomatic with antihistamine treatment (H1)

    Summary
    EudraCT number
    		 2011-004216-31
    Trial protocol
    		 DE  
    Global end of trial date
    10 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Apr 2018
    First version publication date
    26 Apr 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CIGE025E2201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01599637
    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
    10 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to determine whether treatment with omalizumab in patients with CIU results in a reduction of the high affinity IgE receptor (FcεRI) and/or IgE positive skin cells following 12 weeks of treatment (Day 85).
    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. The use of loratadine as rescue medication was reduced by treatment with omalizumab 300 mg both in terms of the number of days per week and the number of tablets per week.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Apr 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A planned number of approximately 30 patients with CIU were randomized 2:1 to receive either 300 mg omalizumab or matching placebo s.c.. Study treatment was administered on 3 separate occasions i.e. at Day 1, Day 29 and Day 57.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IGE025
    Arm description
    		 IGE025 administered subcutaneously every 4 weeks at the study center
    Arm type
    		 Experimental

    Investigational medicinal product name
    omalizumab
    Investigational medicinal product code
    IGE025
    Other name
    omalizumab
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    omalizumab 300 mg s.c. on Day 1, Day 29 and Day 57

    Arm title
    		 Placebo to IGE025
    Arm description
    		 Placebo administered subcutaneously every 4 weeks at the study center
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo to IGE025
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo to IGE025 s.c. on Day 1, Day 29 and Day 57

    Number of subjects in period 1
    		IGE025 Placebo to IGE025
    Started
    20
    10
    Completed
    19
    8
    Not completed
    1
    2
         Adverse event, non-fatal
    1
    -
         administrative problems
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IGE025
    Reporting group description
    		 IGE025 administered subcutaneously every 4 weeks at the study center

    Reporting group title
    Placebo to IGE025
    Reporting group description
    		 Placebo administered subcutaneously every 4 weeks at the study center

    Reporting group values
    		 IGE025 Placebo to IGE025 Total
    Number of subjects
    		 20 10 30
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 20 10 30
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 37.5 ( 11.02 ) 41.1 ( 7.96 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 18 8 26
        Male
    		 2 2 4
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic or Latino
    		 20 10 30
        Unknown or Not Reported
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    Urticaria Patients
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients for study at baseline

    Subject analysis set title
    Healthy Subjects
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Baseline Value, healthy volunteers, no treatment applied

    Subject analysis sets values
    		 Urticaria Patients Healthy Subjects
    Number of subjects
    30
    10
    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)
    30
    10
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender, Male/Female
    Units: Participants
        Female
        Male
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
        Not Hispanic or Latino
        Unknown or Not Reported

    End points

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    End points reporting groups
    Reporting group title
    IGE025
    Reporting group description
    		 IGE025 administered subcutaneously every 4 weeks at the study center

    Reporting group title
    Placebo to IGE025
    Reporting group description
    		 Placebo administered subcutaneously every 4 weeks at the study center

    Subject analysis set title
    Urticaria Patients
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients for study at baseline

    Subject analysis set title
    Healthy Subjects
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Baseline Value, healthy volunteers, no treatment applied

    Primary: Observed values and absolute change from baseline in FceRI positive skin cells: Dermis, lesional and non lesional skin

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    End point title
    		 Observed values and absolute change from baseline in FceRI positive skin cells: Dermis, lesional and non lesional skin
    End point description
    Observed values and absolute change in FcεRI positive skin cells: dermis non-lesional and lesional. The primary variable for this study was the relative change from baseline in the high affinity IgE receptor (FcεRI) positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment.The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2 No Statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    Baseline through Day 85 post-treatment
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    20
    10
    Units: FcεRI positive skin cells
    arithmetic mean (standard deviation)
        FcεRI +ve skin cells: dermis lesional D1 (n=19,8)
    18.14 ( 7.08 )
    15.17 ( 3.11 )
        FcεRI +ve skin cells: dermis lesional d85 (n=10,7)
    13.4 ( 5.88 )
    20.19 ( 8.76 )
        FcεRI +ve skin cells:dermis lesional Chge(n=10,6)
    -5.42 ( 7.42 )
    3.69 ( 10.58 )
        FcεRI +ve skincells:dermis nonlesional D1(n=19,10)
    18.91 ( 9.42 )
    20.48 ( 5.54 )
        FcεRI +ve skincells:dermis nonlesional D85(n=18,8)
    14.72 ( 7.56 )
    20.81 ( 7.3 )
        FcεRI +ve skincells:dermis nonlesional Chg(n=17,8)
    -5.4 ( 9.06 )
    -0.07 ( 9.33 )
    Statistical analysis title
    		 Primary D1-D85
    Comparison groups
    IGE025 v Placebo to IGE025
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.82
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Observed values and absolute change from baseline in IgE positive skin cells: Dermis, lesional and non lesional skin

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    End point title
    		 Observed values and absolute change from baseline in IgE positive skin cells: Dermis, lesional and non lesional skin
    End point description
    Observed values and absolute change in IgE positive skin cells: dermis non-lesional and lesional The primary variable for this study was the relative change from baseline in IgE positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2. No Statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    Baseline through Day 85 post-treatment
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    20
    10
    Units: IgE positive skin cells
    arithmetic mean (standard deviation)
        IgE positive cells, lesional D1 (n=19,8)
    12.93 ( 8.61 )
    15.23 ( 15.71 )
        IgE positive cells, lesional D85 (n=10,7)
    6.73 ( 7.9 )
    12.47 ( 6.54 )
        IgE positive cells, lesional chg(n=10.6)
    -5.69 ( 10.96 )
    -3.95 ( 20.76 )
        IgE positive cells,non-lesional D1 (n=19,10)
    13.82 ( 10.21 )
    16.59 ( 9.35 )
        IgE positive cells,non-lesional D85 (n=18,8)
    9.8 ( 11.66 )
    18.3 ( 7.51 )
        IgE positive cells,non-lesional Chng (n=17,8)
    -4.87 ( 9.83 )
    -0.84 ( 6.18 )
    Statistical analysis title
    		 Stats Primary
    Comparison groups
    IGE025 v Placebo to IGE025
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.82
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Correlation of change from baseline in IgE receptor FceRI with change from baseline in UAS7 at week 12 by treatment, skin layer and lesion status

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    End point title
    		 Correlation of change from baseline in IgE receptor FceRI with change from baseline in UAS7 at week 12 by treatment, skin layer and lesion status
    End point description
    Correlation of primary endpoint with The UAS7 which is a composite eDiary−recorded score with numeric severity intensity ratings on a scale of 0−3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.
    End point type
    Secondary
    End point timeframe
    Baseline through Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    20
    10
    Units: correlation coefficient
    number (not applicable)
        Dermis, lesional
    0.3305
    -0.1889
        Dermis, non-lesional
    0.2785
    0.5057
        Epidermis, lesional
    0.0021
    0.0101
        Epidermis, non-lesional
    0.0644
    0.1563
    No statistical analyses for this end point

    Secondary: Correlation of change from baseline in IgE on positive skin cells with change from baseline in UAS7 at week 12 by treatment, skin layer and lesion status

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    End point title
    		 Correlation of change from baseline in IgE on positive skin cells with change from baseline in UAS7 at week 12 by treatment, skin layer and lesion status
    End point description
    Correlation of primary endpoint with The UAS7 which is a composite eDiary−recorded score with numeric severity intensity ratings on a scale of 0−3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.
    End point type
    Secondary
    End point timeframe
    Baseline through Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    20
    10
    Units: correlation coefficient
    number (not applicable)
        Dermis, lesional
    0.4841
    -0.0952
        Dermis, non-lesional
    0.2759
    0.4947
        Epidermis, lesional
    0.219
    -0.1142
        Epidermis, non-lesional
    0.1574
    -0.231
    No statistical analyses for this end point

    Secondary: observed values and absolute change from baseline in skin cell subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by parameter, skin layer, lesion status, treatment and visit

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    End point title
    		 observed values and absolute change from baseline in skin cell subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by parameter, skin layer, lesion status, treatment and visit
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    20
    10
    Units: # positive cells
    arithmetic mean (standard deviation)
        CD11c Epidermis Non lesional Baseline (n= 19,10)
    1.06 ( 1.077 )
    1.25 ( 0.584 )
        CD11c Epidermis Non lesional Day 8 (n=19,10)
    1.41 ( 1.313 )
    0.95 ( 0.92 )
        CD11c Epidermis Non lesional D 8(n=18,10) Chge
    0.39 ( 1.351 )
    -0.3 ( 1.255 )
        CD11c Epidermis Non lesional D 29(n=4,0)
    1 ( 0 )
    0 ( 0 )
        CD11c Epidermis Non lesional D 29(n=4,0) Chg
    0.7 ( 0.383 )
    0 ( 0 )
        CD11c Epidermis Non lesional D 85(n=18,8)
    1.19 ( 0.806 )
    0.53 ( 0.544 )
        CD11c Epidermis Non lesional D 85(n=17,8) Chge
    0.04 ( 1.216 )
    -0.84 ( 0.524 )
        CD11c Epidermis Non lesional D 140(n=17,7)
    1.25 ( 1.63 )
    0.58 ( 0.942 )
        CD11c Epidermis Non lesional D 140(n=17,7) Chge
    0.04 ( 1.216 )
    -0.75 ( 0.939 )
        CD11c Epidermis lesional baseline (n=19,8)
    1.17 ( 1.363 )
    3.79 ( 8.028 )
        CD11c Epidermis lesional D8 (n=11,10)
    1.63 ( 1.425 )
    1.19 ( 1.329 )
        CD11c Epidermis lesional D8 (n=11,8) Change
    0.39 ( 1.153 )
    -2.74 ( 8.466 )
        CD11c Epidermis lesional D29 (n=5,0)
    1.56 ( 1.609 )
    0 ( 0 )
        CD11c Epidermis lesional D29 (n=5,0) Change
    0.88 ( 1.677 )
    0 ( 0 )
        CD11c Epidermis lesional D85 (n=10,7)
    1.18 ( 0.577 )
    0.46 ( 0.378 )
        CD11c Epidermis lesional D85 (n=10,6) Change
    -0.06 ( 1.234 )
    -4.06 ( 9.384 )
        CD11c Epidermis lesional D140 (n=6,5)
    0.53 ( 0.555 )
    0.18 ( 0.171 )
        CD11c Epidermis lesional D140 (n=6,5) Change
    0.12 ( 0.599 )
    -6.37 ( 11.503 )
        CD11c Dermis non lesional baseline (n=19,10)
    17.86 ( 7.322 )
    22.97 ( 12.248 )
        CD11c Dermis non lesional D8 (n=19,10)
    18.33 ( 8.971 )
    20.22 ( 10.861 )
        CD11c Dermis non lesional D8 (n=19,10) Change
    0.42 ( 7.613 )
    -2.75 ( 6.149 )
        CD11c Dermis non lesional D29 (n=4,0)
    15.63 ( 10.636 )
    0 ( 0 )
        CD11c Dermis non lesional D29 (n=4,0) Change
    0.93 ( 15.472 )
    0 ( 0 )
        CD11c Dermis non lesional D85 (n=18,8)
    17.05 ( 5.656 )
    23.73 ( 19.031 )
        CD11c Dermis non lesional D85 (n=17,8) Change
    -1.52 ( 7.562 )
    -1.23 ( 15.514 )
        CD11c Dermis non lesional D140 (n=17,7)
    22.85 ( 11.189 )
    15.58 ( 9.691 )
        CD11c Dermis non lesional D140 (n=16,7) Change
    3.51 ( 11.162 )
    -11.51 ( 15.849 )
        CD11c Dermis lesional baseline(n=19,8)
    27.14 ( 12.552 )
    22.46 ( 9.7 )
        CD11c Dermis lesional D8(n=11,10)
    28.85 ( 22.24 )
    22.12 ( 8.669 )
        CD11c Dermis lesional D8(n=11,8) Change
    3.56 ( 16.705 )
    0.99 ( 8.677 )
        CD11c Dermis lesional D29 (n=5,0)
    27.04 ( 11.509 )
    0 ( 0 )
        CD11c Dermis lesional D29 (n=5,0) Change
    -0.28 ( 5.403 )
    0 ( 0 )
        CD11c Dermis lesional D85 (n=10,7)
    24.82 ( 13.724 )
    22.59 ( 16.719 )
        CD11c Dermis lesional D85 (n=10,6) Change
    -0.09 ( 15 )
    4.07 ( 22.288 )
        CD11c Dermis lesional D140 (n=6,5)
    37.33 ( 21.229 )
    22.59 ( 16.719 )
        CD11c Dermis lesional D140 (n=6,4) Change
    11.3 ( 23.485 )
    12.43 ( 9.21 )
        CD3 Epidermis non lesional Baseline (n=19,10)
    0.37 ( 0.593 )
    0.68 ( 1.151 )
        CD3 Epidermis non lesional Day 8 (n=19,10)
    0.49 ( 0.754 )
    0.34 ( 0.422 )
        CD3 Epidermis non lesional Day 8 (n=18,10) Change
    0.14 ( 0.636 )
    -0.34 ( 1.091 )
        CD3 Epidermis non lesional Day 29 (n=4,0)
    0.32 ( 0.367 )
    0 ( 0 )
        CD3 Epidermis non lesional Day 29 (n=4,0) Change
    0.07 ( 0.094 )
    0 ( 0 )
        CD3 Epidermis non lesional Day 85 (n=18,8)
    0.47 ( 0.66 )
    0.3 ( 0.283 )
        CD3 Epidermis non lesional Day 85 (n=17,8) Change
    0.14 ( 0.438 )
    -0.46 ( 1.249 )
        CD3 Epidermis non lesional Day 140 (n=17,7)
    0.36 ( 0.47 )
    0.75 ( 1.245 )
        CD3 Epidermis non lesional Day 140 (n=16,7) Change
    -0.08 ( 0.554 )
    -0.09 ( 2.092 )
        CD3 Epidermis lesional Baseline (n=19,8)
    0.42 ( 0.459 )
    0.49 ( 0.892 )
        CD3 Epidermis lesional Day 8(n=11,10)
    0.55 ( 0.561 )
    0.84 ( 0.913 )
        CD3 Epidermis lesional Day 8(n=11,10) Change
    0.14 ( 0.604 )
    0.11 ( 1.058 )
        CD3 Epidermis lesional Day 29(n=5,0)
    0.28 ( 0.438 )
    0 ( 0 )
        CD3 Epidermis lesional Day 29(n=5,0) Change
    -0.33 ( 0.574 )
    0 ( 0 )
        CD3 Epidermis lesional Day 85(n=10,7)
    0.46 ( 0.558 )
    0.47 ( 0.499 )
        CD3 Epidermis lesional Day 85(n=10,6) Change
    0.07 ( 0.672 )
    -0.09 ( 0.873 )
        CD3 Epidermis lesional Day 140(n=7,5)
    0.84 ( 0.983 )
    0.94 ( 0.969 )
        CD3 Epidermis lesional Day 140(n=7,4) Change
    0.27 ( 0.843 )
    0.98 ( 0.642 )
        CD3 Dermis non lesional Baseline(n=19,10)
    9.97 ( 4.924 )
    12.46 ( 7.954 )
        CD3 Dermis non lesional Day 8(n=19,10)
    10.81 ( 5.359 )
    8.66 ( 4.495 )
        CD3 Dermis non lesional Day 8(n=18,10) Change
    0.72 ( 6.503 )
    -3.8 ( 5.984 )
        CD3 Dermis non lesional Day 29(n=4,0)
    6.87 ( 1.427 )
    0 ( 0 )
        CD3 Dermis non lesional Day 29(n=4,0) Change
    -1.78 ( 3.096 )
    0 ( 0 )
        CD3 Dermis non lesional Day 85(n=18,8)
    12.71 ( 9.845 )
    11.46 ( 7.9 )
        CD3 Dermis non lesional Day 85(n=18,8) Change
    2.61 ( 8.287 )
    -2.09 ( 5.865 )
        CD3 Dermis non lesional Day 140(n=17,7)
    11.8 ( 6.96 )
    7.22 ( 5.823 )
        CD3 Dermis non lesional Day 140(n=16,7) Change
    1.03 ( 5.717 )
    -6.15 ( 10.618 )
        CD3 Dermis lesional Baseline(n=19,8)
    12.75 ( 6.934 )
    11.94 ( 6.245 )
        CD3 Dermis lesional Day 8 (n=11,10)
    14.93 ( 8.543 )
    12.56 ( 8.894 )
        CD3 Dermis lesional Day 8 (n=11,10) Change
    2.07 ( 6.576 )
    1.58 ( 7.177 )
        CD3 Dermis lesional Day 29 (n=5,0)
    13.08 ( 7.275 )
    0 ( 0 )
        CD3 Dermis lesional day 29 (n=5,0) Change
    0.78 ( 10.054 )
    0 ( 0 )
        CD3 Dermis lesional Day 85 (n=10,7)
    11.01 ( 3.615 )
    14.44 ( 13.122 )
        CD3 Dermis lesional Day 85 (n=10,6) Change
    0.46 ( 5.775 )
    2.24 ( 13.351 )
        CD3 Dermis lesional Day 140 (n=7,5)
    12.42 ( 7.6 )
    14.58 ( 19.403 )
        CD3 Dermis lesional Day 140(n=7,4) Change
    0.93 ( 10.179 )
    6.33 ( 20.884 )
        CD4 Epidermis non lesional Baseline (n=19,10)
    0.99 ( 1.4 )
    1.07 ( 1.018 )
        CD4 Epidermis non lesional Day 8 (n=19,10)
    1.2 ( 1.428 )
    1.46 ( 1.639 )
        CD4 Epidermis non lesional Day 8 (n=18,10) Change
    0.33 ( 1.287 )
    0.39 ( 1.826 )
        CD4 Epidermis non lesional Day 29 (n=4,0)
    1.43 ( 1.144 )
    0 ( 0 )
        CD4 Epidermis non lesional Day 29 (n=4,0) change
    -0.13 ( 0.922 )
    0 ( 0 )
        CD4 Epidermis non lesional Day 85(n=18,8)
    0.69 ( 1.528 )
    0.44 ( 0.36 )
        CD4 Epdiermis non lesional Day 85(n=18,8) Change
    -0.31 ( 2.239 )
    -0.49 ( 0.797 )
        CD4 Epidermis non lesional Day 140(n=17,7)
    0.81 ( 0.742 )
    0.76 ( 1.355 )
        CD4 Epidermis non lesional Day 140(n=16,7) Change
    -0.07 ( 1.283 )
    -0.04 ( 1.802 )
        CD4 Epidermis lesional Baseline(n=19,8)
    0.95 ( 1.066 )
    0.91 ( 1.204 )
        CD4 Epidermis lesional Day 8(n=11,10)
    0.63 ( 0.725 )
    0.9 ( 0.92 )
        CD4 Epidermis lesional Day 8(n=11,8) Change
    -0.46 ( 1.193 )
    -0.04 ( 0.68 )
        CD4 Epidermis lesional Day 29(n=5,0)
    1.52 ( 1.927 )
    0 ( 0 )
        CD4 Epdiermis lesional Day 29(n=5,0) Change
    0.12 ( 1.726 )
    0 ( 0 )
        CD4 Epidermis lesional Day 85(n=10,7)
    0.68 ( 0.691 )
    0.47 ( 0.432 )
        CD4 Epidermis lesional Day 85(n=10,6) Change
    -0.2 ( 0.847 )
    -0.78 ( 1.3489 )
        CD4 Epidermis lesional Day 140(n=6,5)
    0.03 ( 0.082 )
    0.84 ( 0.518 )
        CD4 Epidermis lesional Day 140(n=6,4) Change
    -0.61 ( 1.281 )
    -0.73 ( 1.473 )
        CD4 Dermis non lesional Baseline(n=19,10)
    16.81 ( 6.868 )
    19.39 ( 13.966 )
        CD4 Dermis non lesional Day 8(n=19,10)
    17.8 ( 8.144 )
    16.04 ( 10.59 )
        CD4 Dermis non lesional Day 8(n=18,10) Change
    1.21 ( 9.816 )
    -3.35 ( 10.063 )
        CD4 Dermis non lesional Day 29(n=4,0)
    15.58 ( 5.07 )
    0 ( 0 )
        CD4 Dermis non lesional Day 29(n=4,0) Change
    -0.88 ( 1.928 )
    0 ( 0 )
        CD4 Dermis non lesional Day 85(n=18,8) Change
    19.33 ( 7.741 )
    19.21 ( 10.316 )
        CD4 Dermis non lesional Day 85(n=17,8) Change
    1.94 ( 10.126 )
    -2.32 ( 9.451 )
        CD4 Dermis non lesional Day 140(n=17,7)
    21.14 ( 11.3 )
    16.9 ( 10.151 )
        CD4 Dermis non lesional Day 140(n=16,7) Change
    3.36 ( 11.994 )
    -2.01 ( 13.6 )
        CD4 Dermis lesional baseline(n=19,8)
    14.28 ( 5.351 )
    18.98 ( 9.361 )
        CD4 Dermis lesional Day 8(n=11,10)
    17.84 ( 10.403 )
    17.74 ( 9.23 )
        CD4 Dermis lesional Day 8(n=11,8) Change
    2.86 ( 7.576 )
    0.1 ( 10.085 )
        CD4 Dermis lesional Day 29(n=5,0)
    17.12 ( 8.146 )
    0 ( 0 )
        CD4 Dermis lesional Day 29(n=5,0) Change
    3.2 ( 4.25 )
    0 ( 0 )
        CD4 Dermis lesional Day 85(n=10,7)
    17.2 ( 6.815 )
    19.8 ( 12.617 )
        CD4 Dermis lesional Day 85(n=10,6) Change
    3.41 ( 7.859 )
    0.98 ( 10.706 )
        CD4 Dermis lesional Day 140(n=6,5)
    12.81 ( 10.305 )
    19.8 ( 12.617 )
        CD4 Dermis lesional Day 140(n=6,4) Change
    2.58 ( 11.073 )
    -0.15 ( 11.3 )
        CD8 Epidermis non lesional Baseline(n=19,10)
    0.2 ( 0.306 )
    0.24 ( 0.42 )
        CD8 Epidermis non lesional Day 8(n=19,10)
    0.4 ( 0.593 )
    0.2 ( 0.34 )
        CD8 Epidermis non lesional Day 8(n=18,10) Change
    0.24 ( 0.55 )
    -0.04 ( 0.532 )
        CD8 Epidermis non lesional Day 29(n=4,0)
    0.39 ( 0.347 )
    0 ( 0 )
        CD8 Epidermis non lesional Day 29(n=4,0) Change
    -0.21 ( 0.448 )
    0 ( 0 )
        CD8 Epidermis non lesional Day 85(n=18,8)
    0.22 ( 0.361 )
    0.15 ( 0.207 )
        CD8 Epidermis non lesional Day 85(n=17,8) Change
    0 ( 0.473 )
    -0.13 ( 0.354 )
        CD8 Epidermis non lesional Day 140(n=17,7)
    0.16 ( 0.215 )
    0.28 ( 0.351 )
        CD8 Epidermis non lesional Day 140(n=16,7) Change
    -0.04 ( 0.344 )
    -0.01 ( 0.566 )
        CD8 Epidermis lesional Baseline(n=19,8)
    0.34 ( 0.644 )
    0.14 ( 0.207 )
        CD8 Epidermis lesional Day 8(n=11,10)
    0.43 ( 0.568 )
    0.08 ( 0.14 )
        CD8 Epidermis lesional Day 8(n=11,8) Change
    0.3 ( 0.534 )
    -0.11 ( 0.236 )
        CD8 Epidermis lesional Day 29(n=5,0)
    0.2 ( 0.346 )
    0 ( 0 )
        CD8 Epidermis lesional Day 29(n=5,0) Change
    0.08 ( 0.363 )
    0 ( 0 )
        CD8 Epidermis lesional Day 85(n=10,7)
    0.14 ( 0.313 )
    0.03 ( 0.076 )
        CD8 Epidermis lesional Day 85(n=10,6) Change
    -0.01 ( 0.356 )
    -0.15 ( 0.235 )
        CD8 Epidermis lesional Day 140(n=6,5)
    0.03 ( 0.082 )
    0.33 ( 0.239 )
        CD8 Epidermis lesional Day 140(n=6,4) Change
    -0.53 ( 1.129 )
    0.18 ( 0.304 )
        CD8 Dermis non lesional Baseline(n=19,10)
    5.74 ( 3.278 )
    6.59 ( 3.826 )
        CD8 Dermis non lesional Day 8(n=19,10)
    7.1 ( 5.02 )
    5.5 ( 3.779 )
        CD8 Dermis non lesional Day 8 (n=18,10) Change
    1.19 ( 4.798 )
    -1.09 ( 1.374 )
        CD8 Dermis non lesional Day 29(n=4,0)
    8.45 ( 5.369 )
    0 ( 0 )
        CD8 Dermis non lesional Day 29(n=4,0) Change
    1.8 ( 1.849 )
    0 ( 0 )
        CD8 Dermis non lesional Day 85 (n=18,8) Change
    5.51 ( 3.725 )
    7.62 ( 4.288 )
        CD8 Dermis non lesional Day 85 (n=17,8) Change
    -0.46 ( 2.757 )
    0.35 ( 3.067 )
        CD8 Dermis non lesional Day 140(n=17,7) Change
    4.3 ( 2.357 )
    5.09 ( 3.523 )
        CD8 Dermis non lesional Day 140(n=16,7) Change
    -1.74 ( 2.726 )
    -2.65 ( 1.686 )
        CD8 Dermis lesional Baseline(n=19,8)
    5.67 ( 2.983 )
    4.63 ( 2.448 )
        CD8 Dermis non lesional Day 8(n=11,10)
    7.55 ( 4.953 )
    6.12 ( 3.847 )
        CD8 Dermis non lesional Day 8(n=11,8) Change
    1.02 ( 5.174 )
    0.88 ( 2.679 )
        CD8 Dermis non lesional Day 29(n=5,0)
    10.14 ( 6.133 )
    0 ( 0 )
        CD8 Dermis non lesional Day 29(n=5,0) Change
    2.48 ( 5.639 )
    0 ( 0 )
        CD8 Dermis non lesional Day 85(n=10,7)
    7.19 ( 3.022 )
    6.7 ( 6.69 )
        CD8 Dermis non lesional Day 85(n=10,6) Change
    0.98 ( 3.556 )
    1.48 ( 6.628 )
        CD8 Dermis non lesional Day 140(n=6,5)
    7.73 ( 6.774 )
    6.37 ( 10.549 )
        CD8 Dermis non lesional Day 140(n=6,4)
    1.87 ( 7.44 )
    3.57 ( 10.671 )
        CD117 Epidermis non lesional Baseline (n=19,10)
    9.47 ( 5.07 )
    10.99 ( 4.498 )
        CD117 Epidermis non lesional Day 8 (n=19,10)
    10.29 ( 4.555 )
    9.68 ( 3.057 )
        CD117 Epidermis non lesional Day 8 (n=18,10) Chge
    0.99 ( 5.511 )
    -1.31 ( 2.493 )
        CD117 Epidermis non lesional Day 29 (n=4,0)
    12 ( 4.578 )
    0 ( 0 )
        CD117 Epidermis non lesional Day 29 (n=4,0) Chge
    1.05 ( 2.996 )
    0 ( 0 )
        CD117 Epidermis non lesional Day 85 (n=18,8)
    8.75 ( 4.492 )
    9.17 ( 2.55 )
        CD117 Epidermis non lesional Day 85 (n=17,8) Chge
    -1.62 ( 5.338 )
    -1.02 ( 4.166 )
        CD117 Epidermis non lesional Day 140 (n=17,7)
    9.89 ( 3.427 )
    8.01 ( 2.744 )
        CD117 Epidermis non lesional Day 140 (n=16,7) Chge
    0.023 ( 3.866 )
    -2.43 ( 2.234 )
        CD117 Epidermis lesional baseline(n=19,8)
    7.64 ( 3.71 )
    10.18 ( 3.804 )
        CD117 Epidermis lesional Day 8(n=11,10)
    11.25 ( 5.742 )
    10.84 ( 3.865 )
        CD117 Epidermis lesional Day 8(n=11,8) Change
    2.58 ( 4.315 )
    1.42 ( 5.978 )
        CD117 Epidermis lesional Day 29(n=5,0)
    14.06 ( 4.272 )
    0 ( 0 )
        CD117 Epidermis lesional Day 29(n=5,0) Change
    3.74 ( 4.844 )
    0 ( 0 )
        CD117 Epidermis lesional Day 85(n=10,7)
    10.68 ( 6.16 )
    8.77 ( 2.606 )
        CD117 Epidermis lesional Day 85(n=10,6) Change
    2.1 ( 5.703 )
    -0.97 ( 3.885 )
        CD117 Epidermis lesional Day 140(n=6,5)
    9.88 ( 4.399 )
    8.66 ( 2.136 )
        CD117 Epidermis lesional Day 140(n=6,4) Change
    2.41 ( 3.792 )
    -0.98 ( 3.444 )
        CD117 Dermis non lesional Baseline (n=19,10)
    10.59 ( 6.616 )
    10.11 ( 2.91 )
        CD117 Dermis non lesional Day 8 (n=19,10)
    12 ( 6.37 )
    9.2 ( 3.319 )
        CD117 Dermis non lesional Day 8 (n=18,10) Change
    1.49 ( 5.924 )
    -0.91 ( 3.078 )
        CD117 Dermis non lesional Day 29 (n=4,0)
    10.08 ( 2.062 )
    0 ( 0 )
        CD117 Dermis non lesional Day 29 (n=4,0) Change
    -0.47 ( 2.968 )
    0 ( 0 )
        CD117 Dermis non lesional Day 85 (n=18,8)
    10.93 ( 6.046 )
    11.18 ( 4.568 )
        CD117 Dermis non lesional Day 85 (n=17,8) Change
    -0.01 ( 5.75 )
    0.52 ( 3.239 )
        CD117 Dermis non lesional Day 140(n=17,7)
    12.05 ( 4.212 )
    7.22 ( 2.1 )
        CD117 Dermis non lesional Day 140 (n=16,7) Change
    0.69 ( 5.439 )
    -3.79 ( 2.284 )
        CD117 Dermis lesional Baseline(n=19,8)
    9 ( 4.57 )
    7.31 ( 2.468 )
        CD117 Dermis lesional Day 8(n=11,10)
    10.15 ( 6.629 )
    8.08 ( 2.743 )
        CD117 Dermis lesional Day 8(n=11,8) Change
    0.6 ( 4.374 )
    1.26 ( 2.89 )
        CD117 Dermis lesional Day 29(n=5,0)
    12.42 ( 5.175 )
    0 ( 0 )
        CD117 Dermis lesional Day 29(n=5,0) Change
    5.39 ( 5.412 )
    0 ( 0 )
        CD117 Dermis lesional Day 85(n=10,7)
    11.07 ( 6.023 )
    9.51 ( 2.891 )
        CD117 Dermis lesional Day 85(n=10,6) Change
    2.11 ( 5.917 )
    3.03 ( 2.659 )
        CD117 Dermis lesional Day 140(n=6,5)
    10.92 ( 6.704 )
    8.87 ( 4.017 )
        CD117 Dermis lesional Day 140(n=6,4) Change
    5.12 ( 6.41 )
    2.88 ( 4.907 )
        Giemsa Epidermis non lesional Baseline (n=19,10)
    0 ( 0 )
    0 ( 0 )
        Giemsa Epidermis non lesional Day 8 (n=19,10)
    0 ( 0 )
    0 ( 0 )
        Giemsa Epidermis non lesional Day 8 (n=18,10) Chge
    0 ( 0 )
    0 ( 0 )
        Giemsa Epidermis non lesional Day 29 (n=4,0)
    0 ( 0 )
    0 ( 0 )
        Giemsa Epidermis non lesional Day 29 (n=4,0) Chge
    0 ( 0 )
    0 ( 0 )
        Giemsa Epidermis non lesional Day 85 (n=18,8)
    0 ( 0 )
    0 ( 0 )
        Giemsa Epidermis non lesional Day 85 (n=17,8)
    0 ( 0 )
    0 ( 0 )
        Giemsa Epidermis non lesional Day 140(n=18,8)
    0 ( 0 )
    0 ( 0 )
        Giemsa Epidermis non lesional Day 140(n=17,8) Chge
    0 ( 0 )
    0 ( 0 )
        Giemsa Epidermis lesional Baseline (n=19,8)
    0 ( 0 )
    0.03 ( 0.071 )
        Giemsa Epidermis lesional Day 8 (n=11,10)
    0 ( 0 )
    0 ( 0 )
        Giemsa Epidermis lesional Day 8 (n=11,8) Chge
    0 ( 0 )
    -0.03 ( 0.071 )
        Giemsa Epidermis lesional Day 29(n=5,0 )
    0 ( 0 )
    0 ( 0 )
        Giemsa Epidermis lesional Day 29(n=5,0 ) Chge
    0 ( 0 )
    0 ( 0 )
        Giemsa Epidermis lesional Day 85 (n=10,6)
    0 ( 0 )
    0 ( 0 )
        Giemsa Epidermis lesional Day 85 (n=10,5) Chge
    0 ( 0 )
    -0.04 ( 0.089 )
        Giemsa Epidermis lesional Day 140(n=6,5 )
    0 ( 0 )
    1 ( 2.236 )
        Giemsa Epidermis lesional Day 140(n=6,4 ) Chge
    0 ( 0 )
    1.25 ( 2.5 )
        Giemsa Dermis non lesional Baseline (n=19,10 )
    6.91 ( 4.751 )
    6.8 ( 8.61 )
        Giemsa Dermis non lesional Day 8 (n=19,10 )
    5.51 ( 4.142 )
    4.47 ( 4.529 )
        Giemsa Dermis non lesional Day 8 (n=18,10 ) Chge
    -1.33 ( 5.141 )
    -2.33 ( 4.75 )
        Giemsa Dermis non lesional Day 29 (n=4,0 )
    3.88 ( 1.876 )
    0 ( 0 )
        Giemsa Dermis non lesional Day 29 (n=4,0 ) Chge
    -1.62 ( 1.811 )
    0 ( 0 )
        Giemsa Dermis non lesional Day 85 (n=18,8 )
    4.75 ( 3.397 )
    5.28 ( 4.906 )
        Giemsa Dermis non lesional Day 85 (n=17,8 ) Chge
    -2.34 ( 3.618 )
    -2.16 ( 6.705 )
        Giemsa Dermis non lesional Day 140 (n=18,10 )
    6.69 ( 5.409 )
    3.12 ( 3.12 )
        Giemsa Dermis non lesional Day 140 (n=18,10 ) Chge
    -1.35 ( 5.078 )
    -4.86 ( 7.348 )
        Giemsa Dermis lesional Baseline(n=19,8 )
    8.29 ( 5.189 )
    4.79 ( 5.931 )
        Giemsa Dermis lesional Day 8(n=11,10 )
    6.71 ( 4.309 )
    4.8 ( 4.512 )
        Giemsa Dermis lesional Day 8(n=11,8 ) Chge
    -1.75 ( 6.143 )
    0.18 ( 3.394 )
        Giemsa Dermis lesional Day 29(n=5,0 )
    8.09 ( 11.851 )
    0 ( 0 )
        Giemsa Dermis lesional Day 29(n=5,0 ) Chge
    2.57 ( 12.812 )
    0 ( 0 )
        Giemsa Dermis lesional Day 85(n=10,6 )
    5.96 ( 2.589 )
    10.3 ( 15.647 )
        Giemsa Dermis lesional Day 85 (n=10,5 ) Chge
    -1.56 ( 7.155 )
    6.36 ( 9.563 )
        Giemsa Dermis lesional Day 140(n=6,5 )
    7.57 ( 2.589 )
    9.44 ( 10.468 )
        Giemsa Dermis lesional Day 140 (n=6,4 ) Chge
    -1.2 ( 7.929 )
    4.5 ( 5.073 )
        H&E Epidermis non lesional Baseline(n=19,10 )
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis non lesional day 8(n=19,10 )
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis non lesional Day 8(n=18,10 ) Chge
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis non lesional Day 29(n=4,0 )
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis non lesional Day 29(n=4,0 ) Chge
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis non lesional Day 85(n=17,8 )
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis non lesional Day 85(n=16,8 ) Chge
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis non lesional Day 140 (n=17,7 )
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis non lesional Day 140 (n=16,7 ) Chge
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis lesional Baseline(n=19,8 )
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis lesional Day 8(n=11,10 )
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis lesional Day 8(n=11,8 ) Chge
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis lesional Day 29(n=5,0 )
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis lesional Day 29(n=5,0 ) Chge
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis lesional Day 85(n=10,6 )
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis lesional Day 85(n=10,5 ) Chge
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis lesional Day 140(n=6,5 )
    0 ( 0 )
    0 ( 0 )
        H&E Epidermis lesional Day 140(n=6,4 ) Chge
    0 ( 0 )
    0 ( 0 )
        H&E Dermis non lesional Baseline(n=19,10 )
    0 ( 0 )
    0 ( 0 )
        H&E Dermis non lesional Day 8(n=19,10 )
    0.01 ( 0.046 )
    0.02 ( 0.063 )
        H&E Dermis non lesional Day 8(n=18,10 ) Chge
    0.01 ( 0.047 )
    0.02 ( 0.063 )
        H&E Dermis non lesional Day 29(n=4,0 )
    0 ( 0 )
    0 ( 0 )
        H&E Dermis non lesional Day 29(n=4,0 ) Chge
    0 ( 0 )
    0 ( 0 )
        H&E Dermis non lesional Day 85(n=17,8)
    0 ( 0 )
    0 ( 0 )
        H&E Dermis non lesional Day 85(n=16,8 ) Chge
    0 ( 0 )
    0 ( 0 )
        H&E Dermis non lesional Day 140(n=17,7 )
    0 ( 0 )
    0.03 ( 0.076 )
        H&E Dermis non lesional Day 140(n=16,7 ) Chge
    0 ( 0 )
    0.03 ( 0.076 )
        H&E Dermis lesional Baseline(n=19,8 )
    0.02 ( 0.071 )
    0.03 ( 0.071 )
        H&E Dermis lesional Day 8(n=11,10 )
    0.05 ( 0.129 )
    0 ( 0 )
        H&E Dermis lesional Day 8(n=11,8 ) Chge
    0.03 ( 0.159 )
    -0.03 ( 0.071 )
        H&E Dermis lesional Day 29(n=5,0 )
    0 ( 0 )
    0 ( 0 )
        H&E Dermis lesional Day 29(n=5,0 ) Chge
    0 ( 0 )
    0 ( 0 )
        H&E Dermis lesional Day 85(n=10,6 )
    0 ( 0 )
    0.03 ( 0.082 )
        H&E Dermis lesional Day 85(n=10,5 ) Chge
    0 ( 0 )
    0.04 ( 0.089 )
        H&E Dermis lesional Day 140(n=6,5 )
    0 ( 0 )
    0 ( 0 )
        H&E Dermis lesional Day 140(n=6,4 ) Chge
    0 ( 0 )
    0 ( 0 )
        Tryptase Epidermis non lesional Baseline (n=19,10)
    0 ( 0 )
    0 ( 0 )
        Tryptase Epidermis non lesional Day 8 (n=19,10)
    0.02 ( 0.092 )
    0 ( 0 )
        Tryptase Epidermis non lesional Day 8(n=18,10) Chg
    0.02 ( 0.094 )
    0 ( 0 )
        Tryptase Epidermis non lesional Day 29 (n=4,0)
    0 ( 0 )
    0 ( 0 )
        Tryptase Epidermis non lesional Day 29 (n=4,0) Chg
    0 ( 0 )
    0 ( 0 )
        Tryptase Epidermis non lesional Day 85 (n=18,8)
    0.03 ( 0.103 )
    0 ( 0 )
        Tryptase Epidermis non lesional Day 85(n=17,8) Chg
    0.04 ( 0.1 )
    0 ( 0 )
        Tryptase Epidermis non lesional Day 140 (n=17,7)
    0.02 ( 0.097 )
    0 ( 0 )
        Tryptase Epidermis non lesional Day140(n=16,7) Chg
    0.03 ( 0.1 )
    0 ( 0 )
        Tryptase Epidermis lesional Baseline (n=19,8)
    0.01 ( 0.046 )
    0.08 ( 0.149 )
        Tryptase Epidermis lesional day 8 (n=11,10)
    0.33 ( 1.085 )
    0.1 ( 0.316 )
        Tryptase Epidermis lesional Day 8 (n=11,8) Chg
    0.31 ( 1.093 )
    0.05 ( 0.334 )
        Tryptase Epidermis lesional Day 29 (n=5,0)
    0.12 ( 0.268 )
    0 ( 0 )
        Tryptase Epidermis lesional Day 29 (n=5,0) Chg
    0.08 ( 0.179 )
    0 ( 0 )
        Tryptase Epidermis lesional Day 85(n=10,7)
    0 ( 0 )
    0 ( 0 )
        Tryptase Epidermis lesional Day 85(n=10,6) Chg
    -0.02 ( 0.063 )
    -0.1 ( 0.167 )
        Tryptase Epidermis lesional Day 140 (n=7,5)
    0 ( 0 )
    0 ( 0 )
        Tryptase Epidermis lesional Day 140 (n=7,4) Chg
    -0.03 ( 0.076 )
    -0.1 ( 0.2 )
        Tryptase Dermis non lesional Baseline (n=19,10)
    6.55 ( 3.988 )
    7.2 ( 3.045 )
        Tryptase Dermis non lesional Day 8 (n=19,10)
    7.14 ( 4.479 )
    8.37 ( 2.305 )
        Tryptase Dermis non lesional Day 8 (n=18,10) Chg
    1.14 ( 2.989 )
    1.17 ( 3.03 )
        Tryptase Dermis non lesional Day 29 (n=4,0)
    8.22 ( 4.981 )
    0 ( 0 )
        Tryptase Dermis non lesional Day 29 (n=4,0) Chg
    0.67 ( 4.816 )
    0 ( 0 )
        Tryptase Dermis non lesional Day 85 (n=18,8)
    7.66 ( 4.076 )
    8.33 ( 3.547 )
        Tryptase Dermis non lesional Day 85 (n=17,8) Chg
    0.54 ( 3.753 )
    1.35 ( 3.839 )
        Tryptase Dermis non lesional Day 140 (n=17,7)
    7.77 ( 4.296 )
    6.95 ( 1.812 )
        Tryptase Dermis non lesional Day 140 (n=16,7) Chg
    1.27 ( 3.599 )
    -0.62 ( 3.002 )
        Tryptase Dermis lesional Baseline (n=19,8)
    6.08 ( 3.764 )
    6.41 ( 2.658 )
        Tryptase Dermis lesional Day 8 (n=11,10)
    7.19 ( 3.618 )
    6.99 ( 3.451 )
        Tryptase Dermis lesional Day 8 (n=11,8) Chg
    0.71 ( 2.809 )
    0.88 ( 2.998 )
        Tryptase Dermis lesional Day 29(n=5,0)
    10.2 ( 4.658 )
    0 ( 0 )
        Tryptase Dermis lesional Day 29(n=5,0) Chg
    3.8 ( 3.023 )
    0 ( 0 )
        Tryptase Dermis lesional Day 85(n=10,7)
    6.76 ( 3.082 )
    6.93 ( 3.135 )
        Tryptase Dermis lesional Day 85(n=10,6) Chg
    0.39 ( 4.141 )
    1.67 ( 2.047 )
        Tryptase Dermis lesional Day 140(n=7,5)
    6.59 ( 6.335 )
    6.79 ( 1.635 )
        Tryptase Dermis lesional Day 140(n=7,4) Chg
    2.68 ( 6.641 )
    1.97 ( 2.049 )
    No statistical analyses for this end point

    Secondary: Observed values from baseline through end of study of serum chemkines or histamine in peripheral blood cells by parameter, treatment and visit

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    End point title
    		 Observed values from baseline through end of study of serum chemkines or histamine in peripheral blood cells by parameter, treatment and visit
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline through Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    20
    10
    Units: ug/mL
    arithmetic mean (standard deviation)
        Chemokine CCR3 Baseline (n=19,10)
    2.9669 ( 2.31825 )
    3.0394 ( 2.38102 )
        Chemokine CCR3 Day 2 (n=20, 10)
    2.819 ( 2.94786 )
    3.3035 ( 3.52023 )
        Chemokine CCR3 Day 8 (n=20,10)
    2.5597 ( 2.22009 )
    2.2742 ( 1.58648 )
        Chemokine CCR3 Day 15 (n=19,8)
    2.2711 ( 1.98781 )
    2.0216 ( 1.46346 )
        Chemokine CCR3 Day 29 (n=20,9)
    2.5869 ( 2.31661 )
    2.2826 ( 1.56237 )
        Chemokine CCR3 Day 85 (n=17,8)
    2.5178 ( 1.93931 )
    1.8724 ( 1.16171 )
        Chemokine CCR3 Day 140 (n=18,10)
    2.022 ( 2.44218 )
    2.406 ( 1.85351 )
        Chemokine CXCR3/IP-10 Baseline (n=19,10)
    0.102 ( 0.07807 )
    0.0638 ( 0.07208 )
        Chemokine CXCR3/IP-10 Day 2 (n=20,9)
    0.0836 ( 0.0663 )
    0.0621 ( 0.06496 )
        Chemokine CXCR3/IP-10 Day 8 (n=19,8)
    0.091 ( 0.07704 )
    0.0772 ( 0.0599 )
        Chemokine CXCR3/IP-10 Day 15 (n=19,7)
    0.0883 ( 0.06303 )
    0.0546 ( 0.0255 )
        Chemokine CXCR3/IP-10 Day 29 (n=20,9)
    0.0881 ( 0.07624 )
    0.0601 ( 0.04219 )
        Chemokine CXCR3/IP-10 Day 85 (n=17,8)
    0.0714 ( 0.03079 )
    0.043 ( 0.0291 )
        Chemokine CXCR3/IP-10 Day 140 (n=18,9)
    0.0864 ( 0.07319 )
    0.0859 ( 0.07489 )
        Histamine Baseline (n=19,10)
    5.0526 ( 2.06757 )
    5.2 ( 1.13529 )
        Histamine Day 2 (n=20,10)
    4.15 ( 1.6111 )
    5 ( 1.76383 )
        Histamine Day 8 (n=20,10)
    4.5 ( 2.01311 )
    5.4 ( 2.01108 )
        Histamine Day 15 (n=19,8)
    4.5789 ( 1.6437 )
    4.75 ( 1.83225 )
        Histamine Day 29 (n=20,9)
    5.15 ( 2.20705 )
    4.7778 ( 3.38296 )
        Histamine Day 85 (n=17,8)
    5.8235 ( 1.50977 )
    5 ( 1.30931 )
        Histamine Day 140 (n=18,10)
    4.8333 ( 2.64019 )
    5.7 ( 1.76698 )
        Chemokine ICAM-1 Baseline (n=19,10)
    0.4858 ( 0.09955 )
    0.5191 ( 0.14846 )
        Chemokine ICAM-1 Day 2 (n=20,10)
    0.4468 ( 0.07872 )
    0.4975 ( 0.14406 )
        Chemokine ICAM-1 Day 8 (n=20,10)
    0.4967 ( 0.12551 )
    0.4728 ( 0.15713 )
        Chemokine ICAM-1 Day 15 (n=19,8)
    0.4788 ( 0.12577 )
    0.4709 ( 0.11789 )
        Chemokine ICAM-1 Day 29 (n=20,9)
    0.4633 ( 0.10172 )
    0.4704 ( 0.11356 )
        Chemokine ICAM-1 Day 85 ( n= 17,8)
    0.4314 ( 0.10424 )
    0.4037 ( 0.05599 )
        Chemokine ICAM-1 Day 140 ( n=15,10)
    0.4314 ( 0.10921 )
    0.4918 ( 0.1525 )
    No statistical analyses for this end point

    Secondary: Observed values and change from baseline in peripheral blood cell subsets (FACS parameters) at Week 12 (Day 85) by treatment (PD analysis set) measured as % out of leukocytes.

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    End point title
    		 Observed values and change from baseline in peripheral blood cell subsets (FACS parameters) at Week 12 (Day 85) by treatment (PD analysis set) measured as % out of leukocytes.
    End point description
    Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.
    End point type
    Secondary
    End point timeframe
    Baseline through Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    20
    10
    Units: % out of leukocytes
    arithmetic mean (standard deviation)
        Basophils D1 (n=19,10) Units
    0.23 ( 0.132 )
    0.36 ( 0.482 )
        Basophils D85 (n=7,5) Units
    0.47 ( 0.215 )
    0.4 ( 0.451 )
        Basophils chge (n=7,5) Units
    0.22 ( 0.268 )
    -0.06 ( 0.176 )
        CD19+ B cells bound IgE D1 (n=8,8)
    4.53 ( 5.001 )
    15.19 ( 22.609 )
        CD19+ B cells bound IgE D85(n=5,7)
    7.32 ( 7.579 )
    25.66 ( 26.485 )
        CD19+ B cells bound IgE chge (n=5,7
    1.46 ( 3.545 )
    12.53 ( 21.725 )
        CD19+ B cells D1 (n=10,9)
    3.57 ( 2.298 )
    2.5 ( 1.247 )
        CD19+ B cells D85 (n=7,7)
    3.84 ( 1.595 )
    3.25 ( 2.007 )
        CD19+ B cells Chge (n=7,7)
    0.31 ( 1.377 )
    0.73 ( 0.805 )
        Dendritic cells D1 (n=10,7)
    0.37 ( 0.196 )
    0.24 ( 0.14 )
        Dendritic cells D85 (n=8,5)
    0.37 ( 0.231 )
    0.27 ( 0.21 )
        Dendritic cells Chge (n=7,5)
    0.02 ( 0.272 )
    -0.02 ( 0.182 )
    No statistical analyses for this end point

    Secondary: Observed values and change from baseline in peripheral blood cell subsets (FACS parameters) at Week 12 (Day 85) by treatment (PD analysis set) measured in fluorescence units.

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    End point title
    		 Observed values and change from baseline in peripheral blood cell subsets (FACS parameters) at Week 12 (Day 85) by treatment (PD analysis set) measured in fluorescence units.
    End point description
    Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.
    End point type
    Secondary
    End point timeframe
    Baseline through Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    20
    10
    Units: Flourescence units
    arithmetic mean (standard deviation)
        Basophils with FcεR1 exp D1 (n=11,8)
    292391 ( 135848 )
    312038 ( 147037 )
        Basophils with FcεR1 exp D85 (n=7,5)
    79457 ( 29333 )
    291000 ( 108028 )
        Basophils with FcεR1 expression Chge (n=6,5)
    -243700 ( 118883 )
    -38260 ( 60085 )
        Basophils with bound IgE D 1 (n=11,7)
    149656 ( 112936 )
    236071 ( 89043 )
        Basophils with bound IgE D85 (n=7,5)
    9554 ( 6214 )
    212620 ( 109645 )
        Basophils with bound IgE Chge (n=6,5)
    -178487 ( 103456 )
    -12680 ( 59998 )
        CD19+ B cells with FcεR2 exp D1 (n=10,9)
    59040 ( 42446 )
    59700 ( 27171 )
        CD19+ B cells with FcεR2 exp D85 (n=7,7)
    59429 ( 55980 )
    49243 ( 33460 )
        CD19+ B cells with FcεR2 exp chge (n=7,7)
    12814 ( 32631 )
    3986 ( 16779 )
        Dendritic cells with FcεR1 expr D1 (n=10,7)
    40880 ( 17191 )
    43029 ( 12363 )
        Dendritic cells with FcεR1 expr D85 (n=6,5)
    38283 ( 5768 )
    36962 ( 18562 )
        Dendritic cells with FcεR1 expr Chge (n=5,5)
    -10100 ( 16887 )
    -516 ( 5925 )
    No statistical analyses for this end point

    Secondary: Comparison of baseline PD parameters between healthy volunteers and urticaria patients by skin layer Pharmacodynamic analysis set

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    End point title
    		 Comparison of baseline PD parameters between healthy volunteers and urticaria patients by skin layer Pharmacodynamic analysis set
    End point description
    The # positive cell values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Healthy Subjects Urticaria Patients
    Number of subjects analysed
    10
    30
    Units: # positive cells
    arithmetic mean (standard deviation)
        CD11c Epidermis ( n= 10,29)
    1.16 ( 1.13058 )
    1.1241 ( 0.92944 )
        CD11c Dermis (n=10,29)
    14.64 ( 9.31083 )
    19.6207 ( 9.4226 )
        CD11c All skin layers (n=20,58)
    7.9 ( 9.45983 )
    10.3724 ( 11.44855 )
        CD 3 Epidermis (n=10,29)
    0.16 ( 0.26331 )
    0.4759 ( 0.82046 )
        Cd 3 Dermis (n=10,29)
    10.16 ( 9.00311 )
    10.8276 ( 6.11385 )
        CD 3 All Skin Layers (n=20,58)
    5.16 ( 8.04634 )
    5.6517 ( 6.77879 )
        CD 4 Epidermis (n=10,29)
    1.025 ( 1.75804 )
    1.0207 ( 1.26297 )
        CD 4 Dermis (n=10,29)
    15.775 ( 10.06565 )
    17.7 ( 9.72481 )
        CD 4 All Skin Layers (n=20,58)
    8.4 ( 10.33004 )
    9.3603 ( 10.86324 )
        CD 8 Epidermis (n=10,29)
    0.06 ( 0.13499 )
    0.2138 ( 0.34197 )
        CD 8 Dermis (n=10,29)
    5.9083 ( 4.07998 )
    6.0322 ( 3.43255 )
        CD 8 All Skin Layers (n=20,58)
    2.9842 ( 4.11029 )
    3.123 ( 3.80226 )
        CD 117 Epidermis (n=10,29)
    10.16 ( 3.80386 )
    9.9931 ( 4.85502 )
        CD 117 Dermis (n=10,29)
    8.22 ( 2.44849 )
    10.4241 ( 5.56025 )
        CD 117 All Skin Layers (n=20,58)
    9.19 ( 3.26865 )
    10.2086 ( 5.17814 )
        Fc epsilon receptor I Epidermis (n=10,29)
    4.98 ( 2.02309 )
    6.0776 ( 3.12906 )
        Fc epsilon receptor I Dermis (n=10,29)
    14.2 ( 6.76133 )
    19.45 ( 8.21582 )
        Fc epsilon receptor I All Skin Layers (n=20,58)
    9.59 ( 6.77968 )
    12.7638 ( 9.13548 )
        Giemsa Epidermis (n=10,29)
    0 ( 0 )
    0 ( 0 )
        Giemsa Dermis (n=10,29)
    4.8 ( 5.62929 )
    6.869 ( 6.19228 )
        Giemsa All Skin Layers (n=20,58)
    2.4 ( 4.59061 )
    3.4345 ( 5.55324 )
        Haematoxylin + Eosin Epidermis (n=10,29)
    0 ( 0 )
    0 ( 0 )
        Haematoxylin + Eosin Dermis (n=10,29)
    0 ( 0 )
    0 ( 0 )
        Haematoxylin + Eosin All Skin Layers (n=20,58)
    0 ( 0 )
    0 ( 0 )
        IgE Epidermis (n=10,29)
    0.08 ( 0.13984 )
    1.0603 ( 2.30385 )
        IgE Dermis (n=10,29)
    8.76 ( 5.92231 )
    14.7776 ( 9.84503 )
        IgE All Skin layers (n=20,58)
    4.42 ( 6.03739 )
    7.919 ( 9.9038 )
        IgE + CD 11c Epidermis (n=10,28)
    0 ( 0 )
    0.0357 ( 0.12237 )
        IgE + CD 11c Dermis (n=10,29)
    0.915 ( 1.29401 )
    1.0115 ( 1.0529 )
        IgE+CD 11c All Layers (n=20,57)
    0.4575 ( 1.00672 )
    0.5322 ( 0.89651 )
        IgE + Tryptase Epidermis (n=10,28)
    0 ( 0 )
    0 ( 0 )
        IgE + Tryptase Dermis (n=10,29)
    1.3 ( 1.01215 )
    0.8713 ( 0.79919 )
        IgE + Tryptase All Skin Layers (n=20,57)
    0.65 ( 0.96437 )
    0.4433 ( 0.71586 )
        Tryptase Epidermis (n=10,29)
    0 ( 0 )
    0 ( 0 )
        Tryptase Dermis (n=10,29)
    6.64 ( 3.53371 )
    6.7741 ( 3.64713 )
        Tryptase All Skin Layers (n=20,58)
    3.32 ( 4.18539 )
    3.3871 ( 4.26704 )
    No statistical analyses for this end point

    Secondary: Serum levels of omalizumab

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    End point title
    		 Serum levels of omalizumab
    End point description
    Serum concentrations (ng/mL) of omalizumab by visit after the administration of omalizumab 300 mg every 4 weeks
    End point type
    Secondary
    End point timeframe
    Baseline through Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    20
    0 [1]
    Units: ng/mL
    arithmetic mean (standard deviation)
        Day 1
    0 ( 0 )
    ( )
        Day 2
    13400 ( 4690 )
    ( )
        Day 8
    30100 ( 7800 )
    ( )
        Day 29
    17000 ( 5500 )
    ( )
        Day 57
    25000 ( 8640 )
    ( )
        Day 85
    28800 ( 11400 )
    ( )
    Notes
    [1] - There was not a serum level in placebo arm
    No statistical analyses for this end point

    Secondary: Mean (SD) serum total IgE concentration from baseline by visit

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    End point title
    		 Mean (SD) serum total IgE concentration from baseline by visit
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline through Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    20
    10
    Units: ng/mL
    arithmetic mean (standard deviation)
        Day 1 Mean (n=20,10)
    1037 ( 2474 )
    442 ( 580.7 )
        Day 2 Mean (20,10)
    1152 ( 2539 )
    447 ( 587.5 )
        Day 8 Mean (n=20,10)
    1970 ( 2992 )
    449 ( 593.1 )
        Day 29 Mean (n=20,9)
    2160 ( 2688 )
    462 ( 628.7 )
        Day 57 Mean (n=19,8)
    2430 ( 3343 )
    490 ( 648 )
        Day 85 Mean (n=17,8)
    2222 ( 2931 )
    475 ( 616.8 )
    No statistical analyses for this end point

    Secondary: Mean (SD) serum total IgE % change from baseline by visit

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    End point title
    		 Mean (SD) serum total IgE % change from baseline by visit
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline through Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    20
    10
    Units: Percent
    arithmetic mean (standard deviation)
        Day 2 % Change (n=19,10)
    27.1 ( 20.08 )
    0.2 ( 5.13 )
        Day 8 % Change (n=19,10)
    174.7 ( 84.93 )
    -1.5 ( 9.13 )
        Day 29 % Change (n=19,9)
    247.2 ( 121.81 )
    -4 ( 12.17 )
        Day 57 % Change (n=18,8)
    247.8 ( 134.1 )
    -4.4 ( 18.59 )
        Day 85 % Change (n=16,8)
    244.8 ( 138.28 )
    -6.9 ( 24.1 )
    No statistical analyses for this end point

    Secondary: Mean (SD) serum free IgE concentration from baseline by visit

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    End point title
    		 Mean (SD) serum free IgE concentration from baseline by visit
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline through Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    20
    10
    Units: ng/mL
    arithmetic mean (standard deviation)
        Day 1 Mean (n=20,10)
    1037 ( 2474 )
    442 ( 580.69 )
        Day 2 Mean (n= 20,9)
    26.8 ( 34.27 )
    111.5 ( 60.75 )
        Day 8 Mean (n=20,10)
    24.306 ( 29.7698 )
    112.169 ( 58.6525 )
        Day 29 Mean (n=20,9)
    41.506 ( 40.5322 )
    107.881 ( 60.1708 )
        Day 57 Mean (n=19,8)
    38.502 ( 39.5567 )
    122.318 ( 51.1087 )
        Day 85 Mean (n=17,8)
    35.776 ( 41.5426 )
    120.978 ( 50.6692 )
    No statistical analyses for this end point

    Secondary: Mean (SD) serum free IgE % change from baseline by visit

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    End point title
    		 Mean (SD) serum free IgE % change from baseline by visit
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline through Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    20
    10
    Units: % change
    arithmetic mean (standard deviation)
        Day 2 % Change (n=19,9)
    -96.166 ( 2.9216 )
    -60.475 ( 17.933 )
        Day 8 % Change (n=20,10)
    -96.446 ( 2.0162 )
    -60.804 ( 15.8379 )
        Day 29 % Change (n=19,9)
    -93.363 ( 3.5975 )
    -61.456 ( 17.234 )
        Day 57 % Change (n=18,8)
    -94.46 ( 3.0681 )
    -61.27 ( 18.6447 )
        Day 85 % Change (n=16,8)
    -94.75 ( 3.42 )
    -61.906 ( 17.7819 )
    No statistical analyses for this end point

    Secondary: Summary statistics of observed values and absolute change from baseline in specific IgE against allergens and bacterial antigens by parameter, treatment and visit

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    End point title
    		 Summary statistics of observed values and absolute change from baseline in specific IgE against allergens and bacterial antigens by parameter, treatment and visit
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline through Day 140
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    20
    10
    Units: IU/mL
    arithmetic mean (standard deviation)
        Alternaria alternara Baseline (n= 0, 1)
    0 ( 0 )
    0.136 ( 0 )
        Alternaria alternara Day 140 (n= 0,1)
    0 ( 0 )
    0.114 ( 0 )
        Artemisia vulgaris (Mugwort) Baseline (n=1,1)
    0.273 ( 0 )
    1.48 ( 0 )
        Artemisia vulgaris (Mugwort) Day 140( n=0,1)
    0 ( 0 )
    1.91 ( 0 )
        Cat dander Basseline (n=3,1)
    17.9677 ( 22.73833 )
    0.698 ( 0 )
        Cat dander Day 140 (n=2,1)
    21.01 ( 26.14881 )
    0.898 ( 0 )
        Common silver Birch Baseline (n=6,3)
    12.364 ( 19.48667 )
    12.3767 ( 11.22609 )
        Common silver Birch Day 140 (n=4,3)
    4.489 ( 6.15938 )
    14.86 ( 16.58164 )
        Dog dander Baseline (n=2,1)
    26.772 ( 37.09199 )
    0.512 ( 0 )
        Dog dander Day 140 (n=1,1)
    50.1 ( 0 )
    0.669 ( 0 )
        Dermatophagoides farinae Baseline (n=3,1)
    3.3333 ( 3.39883 )
    0.434 ( 0 )
        Dermatophagoides farinae Day 140 (n=2,1)
    5.32 ( 0.89095 )
    0.497 ( 0 )
        Dermatophagoides pteronyssinus Baseline (n=5,1)
    2.125 ( 1.46791 )
    0.455 ( 0 )
        Dermatophagoides pteronyssinus Day 140(n=4,1)
    5.2463 ( 3.72052 )
    0.517 ( 0 )
        Grey Alder (t2) Baseline (n=4,3)
    15.765 ( 20.03961 )
    10.9533 ( 10.92027 )
        Grey Alder (t2) Day 140(n=3,3)
    4.49 ( 5.16654 )
    13.0533 ( 15.24029 )
        German Cockroach Baseline (n=4,2)
    0.8605 ( 0.93609 )
    0.4425 ( 0.62579 )
        German Cockroach Day 140 (n=4,2)
    3.0263 ( 2.8719 )
    0.4705 ( 0.66539 )
        Hazelnut Baseline (n=3,3)
    8.9627 ( 14.49722 )
    7.3267 ( 8.2816 )
        Hazelnut Day 140 (n=2,3)
    1.445 ( 1.50977 )
    8.9927 ( 10.59244 )
        Olive (black, fresh) Baseline (n=4,1)
    0.089 ( 0.178 )
    0 ( 0 )
        Olive (black, fresh) Day 140 (n=3,1)
    0.1037 ( 0.17956 )
    0 ( 0 )
        Platanus acerifolia Baseline (n=1,1)
    0.121 ( 0 )
    3.71 ( 0 )
        Platanus acerifolia Day 140 (n=0,1)
    0 ( 0 )
    4.83 ( 0 )
        Parietaria judaica Baseline(n=0,1)
    0 ( 0 )
    1.49 ( 0 )
        Parietaria judaica Day 140 (n=0,1)
    0 ( 0 )
    2 ( 0 )
        Staphylococcal enterotoxin A Baseline (n=20,10)
    0.7264 ( 3.07821 )
    0.0741 ( 0.1358 )
        Staphylococcal enterotoxin A Day 140 (n=18,10)
    1.6161 ( 4.39936 )
    0.1077 ( 0.15294 )
        Staphylococcal enterotoxin C Baseline (n=20,10)
    0.8976 ( 3.02621 )
    0.1626 ( 0.27226 )
        Staphylococcal enterotoxin C Day 140 (n=18,10)
    2.1089 ( 4.19834 )
    0.1922 ( 0.28071 )
        Staphylococcal enterotoxin TSST Baseline (n=20,10)
    0.539 ( 1.02581 )
    0.1537 ( 0.23902 )
        Staphylococcal enterotoxin TSST Day 140 (n=18,10)
    0.8402 ( 1.05356 )
    0.1468 ( 0.22155 )
        Alternaria alternara Absolute Change (n = 0,1)
    0 ( 0 )
    -0.022 ( 0 )
        Artemisia vulgaris Absolute Change (n = 0,1)
    0 ( 0 )
    0.43 ( 0 )
        Cat dander Absolute Change (n = 2,1)
    -1.1315 ( 4.33951 )
    0.2 ( 0 )
        Common Silver Birch Absolute Change (n = 4,3)
    -10.2145 ( 26.47094 )
    2.4833 ( 5.63479 )
        Dog dander Absolute Change (n = 1,1)
    -2.9 ( 0 )
    0.157 ( 0 )
        Dermatophagoides farinae Absolute Change(n=2,1)
    3.935 ( 1.46371 )
    0.063 ( 0 )
        Dermatophagoides pteronyssinus Abs Chge (n=4,1)
    3.68 ( 3.05938 )
    0.062 ( 0 )
        Grey Alder Absolute Change(n=3,3)
    -12.63 ( 27.47614 )
    2.1 ( 4.509 )
        German Cockroach Absolute Change(n=4,2)
    2.1658 ( 2.03436 )
    0.028 ( 0.0396 )
        Hazelnut Absolute Change(n=2,3)
    -11.83 ( 18.1585 )
    1.666 ( 2.47183 )
        Olive (black, fresh) Absolute Change(n=3,1)
    -0.015 ( 0.02598 )
    0 ( 0 )
        Platanus acerifolia Absolute Change(n=0,1)
    0 ( 0 )
    1.12 ( 0 )
        Parietaria judaica Absolute Change(n=0,1)
    0 ( 0 )
    0.51 ( 0 )
        Staphylococcal enterotoxin A Abs chge (n=18,10)
    0.809 ( 2.63582 )
    0.0336 ( 0.09116 )
        Staphylococcal enterotoxin C Abs chge (n=18,10)
    1.1116 ( 2.26524 )
    0.0296 ( 0.06545 )
        Staphylococcal enterotoxin TSST Abs chge(n=18,10)
    0.2608 ( 0.72963 )
    -0.0069 ( 0.15669 )
    No statistical analyses for this end point

    Secondary: Change from baseline in Urticaria activity score (UAS7)

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    End point title
    		 Change from baseline in Urticaria activity score (UAS7)
    End point description
    Efficacy was assessed by the urticaria activity score (UAS). UAS was completed each morning and evening on a daily basis to record patient symptoms of itch and hives via an electronic diary. The UAS is a composite eDiary−recorded score with numeric severity intensity ratings on a scale of 0−3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease. A negative change score (Week 12 score minus Baseline score) indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    17
    8
    Units: units on a scale
        arithmetic mean (standard deviation)
    -23.1 ( 12.94 )
    -8.1 ( 14.45 )
    No statistical analyses for this end point

    Secondary: Likert scale-Physician’s and Patients in-clinic global assessment by treatment

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    End point title
    		 Likert scale-Physician’s and Patients in-clinic global assessment by treatment
    End point description
    The investigator or the person he or she designated and the patient provided scoring of the patient’s global assessment of symptoms (urticaria lesions (hives) and pruritus) reflective of the patient’s condition over the 12 hours prior to the visit (0 = no symptoms, 1 = mild, 2 = moderate 3 = severe
    End point type
    Secondary
    End point timeframe
    Baseline, Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    17
    8
    Units: score
    arithmetic mean (standard deviation)
        Physicians Baseline (n=17,9)
    2 ( 0.87 )
    2.2 ( 0.83 )
        Physicians Week 12, (day 85) (n=17,8)
    0.8 ( 1.01 )
    2 ( 1.31 )
        Patients Baseline (n=17,9)
    2.4 ( 0.87 )
    2.4 ( 0.53 )
        Patients Week 12, (day 85) (n=17,8)
    0.9 ( 1.05 )
    1.9 ( 0.99 )
    No statistical analyses for this end point

    Secondary: Percentage of angioedema-free days weeks 4 through 12 by treatment

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    End point title
    		 Percentage of angioedema-free days weeks 4 through 12 by treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Day 29 to Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    17
    8
    Units: Percentage of days
        arithmetic mean (standard deviation)
    90.9 ( 22.83 )
    70.5 ( 28.5 )
    No statistical analyses for this end point

    Secondary: Change from baseline in Dermatology Life Quality Index (DLQI) by treatment

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    End point title
    		 Change from baseline in Dermatology Life Quality Index (DLQI) by treatment
    End point description
    The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. An overall score was calculated as well as for the following domains: Symptoms and Feelings, Daily Activities, Leisure, Work and School, Personal Relationships, Treatment.Negative score shows positive efficacy. Meaning of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
    End point type
    Secondary
    End point timeframe
    Baseline through Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    16
    8
    Units: Score
        arithmetic mean (standard deviation)
    -10.19 ( 8.159 )
    -3.13 ( 7.18 )
    No statistical analyses for this end point

    Secondary: Skindex-29 by treatment

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    End point title
    		 Skindex-29 by treatment
    End point description
    The Skindex-29 is a validated 29-item instrument to measure the effects of skin disease on patients’ quality of life.Results are reported as 3 scale scores (functioning, emotions and symptoms) and a composite score (average scale score). The domain scores and the overall score are expressed on a 100-point scale, with higher scores indicating a lower level of quality of life. The cuttoff values for each category are noted below. Symtoms; 39 mild, 42 moderate,52 severe. Emotions; 24 mild, 35 moderate, 39 severe. Functioning: 21 mild, 32 moderate, 37 severe. Overal Score: 25 mild, 32 moderate, 44 severe.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    16
    8
    Units: Score
    arithmetic mean (standard deviation)
        Baseline (n= 16,9)
    17.98 ( 7.807 )
    21.67 ( 9.068 )
        Day 85 (n=16,8)
    6.17 ( 7.119 )
    22.63 ( 10.276 )
    No statistical analyses for this end point

    Secondary: Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by treatment

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    End point title
    		 Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by treatment
    End point description
    The Cu-Q2OL is a 23-item CIU-specific health-related quality of life questionnaire. Patients rated their CIU symptoms and the impact of their CIU on various aspects of their lives. An overall score was calculated as well for the following domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Zero is the minmum score and 100 the maximum score. The higher score correlates to more disease activity.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 85
    End point values
    		 IGE025 Placebo to IGE025
    Number of subjects analysed
    17
    9
    Units: score
    arithmetic mean (standard deviation)
        Baseline (n=16,8)
    53.71 ( 19.881 )
    59.24 ( 15.35 )
        Day 85 (n=17,8)
    14.51 ( 22.319 )
    53.53 ( 29.817 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV).  All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    IGE025 300mg
    Reporting group description
    		 IGE025 300mg

    Serious adverse events
    		 Placebo IGE025 300mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo IGE025 300mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 10 (70.00%)
    17 / 20 (85.00%)
    Investigations
    Fungal test positive
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Fractured coccyx
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Syncope
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Injection site pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Tongue pruritus
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Pleurisy
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 10 (10.00%)
    3 / 20 (15.00%)
         occurrences all number
    1
    3
    Alopecia areata
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Tenosynovitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Arthralgia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 10 (40.00%)
    7 / 20 (35.00%)
         occurrences all number
    5
    9
    Influenza
         subjects affected / exposed
    2 / 10 (20.00%)
    3 / 20 (15.00%)
         occurrences all number
    2
    5
    Bronchitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Periodontitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Tooth abscess
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jan 2012
    Amendment 1: This amendment was created to address comments raised by the reviewing Ethics Committee and recommendations by the Health Authority. Changes requested that impacted the protocol included: adding additional risk/benefit text concerning the sampling procedure and local anesthesia risks for the biopsies performed during the trial, including text in the statistical analysis section concerning the healthy volunteer control subjects and removing text related to assenting procedures. The lower weight limit for entry into the study was increased, and sample processing details were also updated based on the requirements of the analyzing laboratories.
    06 Nov 2012
    Amendment 2: This amendment was primarily initiated to align Inclusion criteria #2 (assessment of UAS7 score for the determination of patient eligibility) with the intended patient population. Additional changes being made to the protocol were largely administrative and provided greater clarity on study procedures and address earlier inconsistencies in wording.

    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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