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    Clinical Trial Results:
    A Phase II, Multicenter, Randomized, Double-Blind, Placebo- Controlled Dose-Ranging Study of Xolair (Omalizumab) in Patients with Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic with Antihistamine Treatment (H1)

    Summary
    EudraCT number
    		 2009-009498-87
    Trial protocol
    		 DE  
    Global end of trial date
    07 Jan 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Q4577g
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00866788
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Jan 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jan 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy of single doses of omalizumab compared with placebo in participants with refractory chronic idiopathic urticaria (CIU) receiving concomitant H1 antihistamine therapy. The secondary objectives were to evaluate the safety and efficacy of different dose levels of omalizumab in participants with refractory CIU, to evaluate the efficacy of omalizumab in participants with refractory CIU on the participant-reported, quality-of-life-related outcome measures and to evaluate the pharmacokinetics and pharmacodynamics of omalizumab in participants with refractory CIU.
    Protection of trial subjects
    This study was conducted in accordance with the United States Food and Drug Administration (U.S. FDA) regulations, the International Conference on Harmonisation E6 Guideline for Good Clinical Practice, and applicable local, state, and federal laws, as well as other applicable country laws.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Mar 2009
    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: 13
    Country: Number of subjects enrolled
    United States: 77
    Worldwide total number of subjects
    90
    EEA total number of subjects
    13
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    5
    Adults (18-64 years)
    80
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were screened from Week -2 to Week -1.

    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
    		 Investigator, Data analyst, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their preallocation a chronic idiopathic urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a single subcutaneous placebo injection on Day 0 of the study.

    Arm title
    		 Omalizumab 75 milligrams (mg)
    Arm description
    		 Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their preallocation CIU H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    Other name
    Xolair®
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    75 mg of omalizumab (Xolair) was administered subcutaneously on Day 0 of the study.

    Arm title
    		 Omalizumab 300 mg
    Arm description
    		 Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their preallocation CIU H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    Other name
    Xolair®
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg of omalizumab (Xolair) was administered subcutaneously on Day 0 of the study.

    Arm title
    		 Omalizumab 600 mg
    Arm description
    		 Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their preallocation CIU H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    Other name
    Xolair®
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    600 mg of omalizumab (Xolair) was administered subcutaneously on Day 0 of the study.

    Number of subjects in period 1
    		Placebo Omalizumab 75 milligrams (mg) Omalizumab 300 mg Omalizumab 600 mg
    Started
    21
    23
    25
    21
    Completed Week 4
    20
    18
    23
    20
    Completed
    15
    17
    23
    16
    Not completed
    6
    6
    2
    5
         Consent withdrawn by subject
    2
    1
    -
    1
         Physician decision
    -
    -
    1
    1
         Disease progression
    3
    1
    1
    -
         Pregnancy
    -
    1
    -
    -
         Adverse event
    -
    2
    -
    1
         Lost to follow-up
    1
    1
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their preallocation a chronic idiopathic urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.

    Reporting group title
    Omalizumab 75 milligrams (mg)
    Reporting group description
    		 Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their preallocation CIU H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.

    Reporting group title
    Omalizumab 300 mg
    Reporting group description
    		 Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their preallocation CIU H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.

    Reporting group title
    Omalizumab 600 mg
    Reporting group description
    		 Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their preallocation CIU H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.

    Reporting group values
    		 Placebo Omalizumab 75 milligrams (mg) Omalizumab 300 mg Omalizumab 600 mg Total
    Number of subjects
    		 21 23 25 21 90
    Age categorical
    Units: Subjects
        12-<18 years
    		 2 2 1 0 5
        18-<40 years
    		 7 10 12 11 40
        >=40 years
    		 12 11 12 10 45
    Gender categorical
    Units: Subjects
        Female
    		 17 15 17 12 61
        Male
    		 4 8 8 9 29

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their preallocation a chronic idiopathic urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.

    Reporting group title
    Omalizumab 75 milligrams (mg)
    Reporting group description
    		 Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their preallocation CIU H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.

    Reporting group title
    Omalizumab 300 mg
    Reporting group description
    		 Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their preallocation CIU H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.

    Reporting group title
    Omalizumab 600 mg
    Reporting group description
    		 Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their preallocation CIU H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.

    Primary: Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4

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    End point title
    		 Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4
    End point description
    The UAS is a composite diary-recorded score, which is the sum of the numeric severity intensity ratings (0 = none to 3 = intense) for 1) the number of wheals (hives) and 2) the intensity of the pruritus (itch). The UAS7 is the sum of the daily average UAS (morning and evening values) for 7 days. The maximum UAS7 score is 42. Intent-to-Treat population (all randomized participants). The last observation carried forward value was used if a participant's Week 4 diary data were completely missing. One participant from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the primary analysis.
    End point type
    Primary
    End point timeframe
    Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
    End point values
    		 Placebo Omalizumab 75 milligrams (mg) Omalizumab 300 mg Omalizumab 600 mg
    Number of subjects analysed
    21
    23
    25
    20
    Units:  scores on a scale
        arithmetic mean (standard deviation)
    -6.91 ( 9.84 )
    -9.79 ( 11.75 )
    -19.93 ( 12.38 )
    -14.56 ( 10.17 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Omalizumab 75 milligrams (mg)
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1601 [1]
    Method
    		 van Elteren test
    Confidence interval
    Notes
    [1] - The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v Omalizumab 300 mg
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003 [2]
    Method
    		 van Elteren test
    Confidence interval
    Notes
    [2] - The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v Omalizumab 600 mg
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0473 [3]
    Method
    		 van Elteren test
    Confidence interval
    Notes
    [3] - The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).

    Secondary: Change in the Weekly Pruritus Score From Baseline to Week 4

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    End point title
    		 Change in the Weekly Pruritus Score From Baseline to Week 4
    End point description
    The pruritus (itch) score was recorded by participants twice daily (morning and evening) based on the severity of itch over the last 12 hours, using a scale from 0 (none) to 3 (severe). The weekly pruritus score was the sum of average daily pruritus scores over the previous 7 days. The range of the weekly score is 0-21. Intent-to-Treat population (all randomized participants). The last observation carried forward value was used if a participant's Week 4 diary data were completely missing. One participant from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
    End point values
    		 Placebo Omalizumab 75 milligrams (mg) Omalizumab 300 mg Omalizumab 600 mg
    Number of subjects analysed
    21
    23
    25
    20
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -3.45 ( 5.22 )
    -4.5 ( 5.84 )
    -9.22 ( 5.98 )
    -6.46 ( 5.63 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Omalizumab 75 milligrams (mg)
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.164 [4]
    Method
    		 van Elteren test
    Confidence interval
    Notes
    [4] - The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v Omalizumab 300 mg
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0005 [5]
    Method
    		 van Elteren test
    Confidence interval
    Notes
    [5] - The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v Omalizumab 600 mg
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0558 [6]
    Method
    		 van Elteren test
    Confidence interval
    Notes
    [6] - The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).

    Secondary: Change in the Weekly Score for Number of Hives From Baseline to Week 4

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    End point title
    		 Change in the Weekly Score for Number of Hives From Baseline to Week 4
    End point description
    The number of hives was recorded by participants twice daily (morning and evening) using a scale from 0 (no hives) to 3 (more than 12 hives). The weekly score of number of hives was the sum of the average daily scores over the previous 7 days, and ranged from 0 to 21. Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
    End point values
    		 Placebo Omalizumab 75 milligrams (mg) Omalizumab 300 mg Omalizumab 600 mg
    Number of subjects analysed
    21
    23
    25
    20
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -3.46 ( 5.17 )
    -5.28 ( 6.91 )
    -10.71 ( 6.75 )
    -8.1 ( 6 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Omalizumab 75 milligrams (mg) v Placebo
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1411 [7]
    Method
    		 van Elteren test
    Confidence interval
    Notes
    [7] - The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v Omalizumab 300 mg
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003 [8]
    Method
    		 van Elteren test
    Confidence interval
    Notes
    [8] - The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v Omalizumab 600 mg
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0248 [9]
    Method
    		 van Elteren test
    Confidence interval
    Notes
    [9] - The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).

    Secondary: Change in the Weekly Score for Sleep Interference From Baseline to Week 4

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    End point title
    		 Change in the Weekly Score for Sleep Interference From Baseline to Week 4
    End point description
    The extent to which hives or itch interfered with participants’ sleep was recorded once daily in the patient diary using a scale from 0 (no interference) to 3 (substantial interference, waking often). The weekly score of sleep interference was the sum of the daily scores over the previous 7 days, and ranged from 0 to 21. Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
    End point values
    		 Placebo Omalizumab 75 milligrams (mg) Omalizumab 300 mg Omalizumab 600 mg
    Number of subjects analysed
    21
    23
    25
    20
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -3.23 ( 5.93 )
    -3.9 ( 5.03 )
    -5.81 ( 5.36 )
    -6.85 ( 6.23 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Omalizumab 75 milligrams (mg)
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5507 [10]
    Method
    		 van Elteren test
    Confidence interval
    Notes
    [10] - The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v Omalizumab 300 mg
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1525 [11]
    Method
    		 van Elteren test
    Confidence interval
    Notes
    [11] - The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v Omalizumab 600 mg
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0449 [12]
    Method
    		 van Elteren test
    Confidence interval
    Notes
    [12] - The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).

    Secondary: Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4

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    End point title
    		 Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4
    End point description
    Diphenhydramine 25mg was provided and used on an as-needed basis (maximum 3 times/day) as rescue medication. The weekly score for the amount of rescue medication is the sum of the daily scores for the amount of rescue medication used at each day in the week, and ranged from 0 to 21. Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)
    End point values
    		 Placebo Omalizumab 75 milligrams (mg) Omalizumab 300 mg Omalizumab 600 mg
    Number of subjects analysed
    21
    23
    25
    20
    Units: pills
        arithmetic mean (standard deviation)
    -1.38 ( 4.39 )
    -1.74 ( 4.48 )
    -2.64 ( 5.17 )
    -1.69 ( 3.56 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Omalizumab 75 milligrams (mg)
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7261 [13]
    Method
    		 van Elteren test
    Confidence interval
    Notes
    [13] - The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v Omalizumab 300 mg
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.162 [14]
    Method
    		 van Elteren test
    Confidence interval
    Notes
    [14] - The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v Omalizumab 600 mg
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6504 [15]
    Method
    		 van Elteren test
    Confidence interval
    Notes
    [15] - The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).

    Secondary: Number of Patients With Adverse Events by Severity

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    End point title
    		 Number of Patients With Adverse Events by Severity
    End point description
    The severity (i.e. intensity) of each Adverse Event (AE) was graded according to the following scale: Mild: Symptoms causing no or minimal interference with usual social and functional activities. Moderate: Symptoms causing greater than minimal interference with usual social and functional activities. Severe: Symptoms causing inability to perform usual social and functional activities. Additional AE data is provided in the AE section below. The terms “severe” and “serious” are not synonymous. Severity refers to the intensity of an AE. A “Serious” AE is defined below. Safety-Evaluable Population, which included all randomized participants who received any study drug. number (n) equals (=) number of participants analyzed in the specified category.
    End point type
    Secondary
    End point timeframe
    16 weeks overall (data reported separately for "up to 4 weeks" and "Weeks 5 to 16")
    End point values
    		 Placebo Omalizumab 75 milligrams (mg) Omalizumab 300 mg Omalizumab 600 mg
    Number of subjects analysed
    21
    23
    25
    21
    Units: participants
    number (not applicable)
        4 Weeks - Any Adverse Event (n=21,23,25,21)
    10
    8
    12
    10
        4 Weeks - Mild (n=21,23,25,21)
    8
    4
    6
    7
        4 Weeks - Moderate (n=21,23,25,21)
    2
    3
    5
    2
        4 Weeks - Severe (n=21,23,25,21)
    0
    1
    1
    1
        Follow-up period-Any adverse event (n=20,18,23,20)
    7
    9
    12
    5
        Follow-up period-Mild (n=20,18,23,20)
    4
    5
    4
    3
        Follow-up period-Moderate (n=20,18,23,20)
    2
    2
    6
    1
        Follow-up period-Severe (n=20,18,23,20)
    1
    2
    2
    1
    No statistical analyses for this end point

    Secondary: Number of Participants With Immunogenicity

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    End point title
    		 Number of Participants With Immunogenicity
    End point description
    Immunogenicity was measured by detection of anti-therapeutic antibodies (anti-omalizumab antibodies) using a fragment enzyme-linked immunosorbent assay (ELISA). Analysis was performed on safety-evaluable population.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Placebo Omalizumab 75 milligrams (mg) Omalizumab 300 mg Omalizumab 600 mg
    Number of subjects analysed
    21
    23
    25
    21
    Units: participants
        number (not applicable)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Maximum Observed Concentration (Cmax) of Omalizumab

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    End point title
    		 Maximum Observed Concentration (Cmax) of Omalizumab [16]
    End point description
    Cmax is the maximum (or peak) concentration of omalizumab in serum. The analysis was performed on Pharmacokinetic-Evaluable Population which included all randomized participants who received omalizumab and had pharmacokinetic data available. Here, number of participants analyzed = participants with available data for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo group did not receive any omalizumab, therefore Cmax is not applicable.
    End point values
    		 Omalizumab 75 milligrams (mg) Omalizumab 300 mg Omalizumab 600 mg
    Number of subjects analysed
    22
    23
    20
    Units: micrograms per milliliter (µg/mL)
        arithmetic mean (standard deviation)
    11.4 ( 16.4 )
    33.1 ( 10.4 )
    67 ( 26.9 )
    No statistical analyses for this end point

    Secondary: Time to Maximum Concentration (Tmax) of Omalizumab

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    End point title
    		 Time to Maximum Concentration (Tmax) of Omalizumab [17]
    End point description
    Tmax is the time to maximum concentration of omalizumab. Here, number of participants analyzed = participants with available data for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo group did not receive any omalizumab, therefore Tmax is not applicable.
    End point values
    		 Omalizumab 75 milligrams (mg) Omalizumab 300 mg Omalizumab 600 mg
    Number of subjects analysed
    22
    23
    20
    Units: days
        arithmetic mean (standard deviation)
    7.37 ( 3.72 )
    8.01 ( 5.54 )
    6.24 ( 3.51 )
    No statistical analyses for this end point

    Secondary: Area Under the Concentration-time Curve from Time of Dosing Extrapolated to Infinity (AUC-Inf)

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    End point title
    		 Area Under the Concentration-time Curve from Time of Dosing Extrapolated to Infinity (AUC-Inf) [18]
    End point description
    AUCinf is the area under the concentration-time curve from time of dosing extrapolated to infinity. AUCinf was measured in microgram times day per milliliter (µg*day/mL). The analysis was performed on Pharmacokinetic-Evaluable Population. Here, number of participants analyzed = participants with available data for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo group did not receive any omalizumab, therefore AUC-Inf is not applicable.
    End point values
    		 Omalizumab 75 milligrams (mg) Omalizumab 300 mg Omalizumab 600 mg
    Number of subjects analysed
    18
    22
    19
    Units: µg*day/mL
        arithmetic mean (standard deviation)
    317 ( 99.6 )
    1260 ( 580 )
    2800 ( 1140 )
    No statistical analyses for this end point

    Secondary: Terminal Half-Life (t1/2) of Omalizumab

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    End point title
    		 Terminal Half-Life (t1/2) of Omalizumab [19]
    End point description
    Terminal Half-Life (t1/2) is the time required for the serum concentration of omalizumab to decrease by half in the final stage of its elimination. The analysis was performed on Pharmacokinetic−Evaluable Population. Here, number of participants analyzed = participants with available data for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo group did not receive any omalizumab, therefore t1/2 is not applicable.
    End point values
    		 Omalizumab 75 milligrams (mg) Omalizumab 300 mg Omalizumab 600 mg
    Number of subjects analysed
    18
    22
    19
    Units: days
        arithmetic mean (standard deviation)
    18.2 ( 4.76 )
    17.1 ( 4.41 )
    22.5 ( 5.9 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were recorded from Day -7 until end of study at 16 weeks
    Adverse event reporting additional description
    A Serious AE is any AE that is either: fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study treatment or considered a significant medical event by the investigator.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their preallocation a CIU H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.

    Reporting group title
    Omalizumab 75 mg
    Reporting group description
    		 Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their preallocation CIU H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.

    Reporting group title
    Omalizumab 300 mg
    Reporting group description
    		 Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their preallocation CIU H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.

    Reporting group title
    Omalizumab 600 mg
    Reporting group description
    		 Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their preallocation CIU H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.

    Serious adverse events
    		 Placebo Omalizumab 75 mg Omalizumab 300 mg Omalizumab 600 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 25 (4.00%)
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 25 (4.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Omalizumab 75 mg Omalizumab 300 mg Omalizumab 600 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 21 (23.81%)
    9 / 23 (39.13%)
    11 / 25 (44.00%)
    8 / 21 (38.10%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    2 / 25 (8.00%)
    3 / 21 (14.29%)
         occurrences all number
    1
    0
    4
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    2 / 25 (8.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Idiopathic urticaria
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    1 / 25 (4.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    1
    1
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 23 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 21 (4.76%)
    4 / 23 (17.39%)
    3 / 25 (12.00%)
    1 / 21 (4.76%)
         occurrences all number
    4
    5
    3
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    3 / 25 (12.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    2
    3
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jul 2009
    Study Q4577g was amended to consolidate the two CIU protocols for Germany and the United States into one single protocol covering both countries, per recommendation by Genentech’s Product Development Regulatory.

    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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