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    Clinical Trial Results:
    Open-Label Extension Study of Omalizumab in Patients with Chronic Rhinosinusitis with Nasal Polyps

    Summary
    EudraCT number
    		 2017-003450-16
    Trial protocol
    		 GB   PT   FI   CZ   BE   DE   HU   ES   PL  
    Global end of trial date
    16 Mar 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    05 May 2021
    First version publication date
    25 Mar 2021
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    WA40169
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03478930
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche, Ltd.
    Sponsor organisation address
    Grenzacherstrasse 124., Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche, Ltd., F. Hoffmann-La Roche, Ltd., 41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche, Ltd., F. Hoffmann-La Roche, Ltd., 41 616878333, 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
    16 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To evaluate adverse events associated with usage of omalizumab in subjects with CRSwNP - To evaluate efficacy of continued treatment with omalizumab after an initial 24 week treatment period - To evaluate the durability of response following treatment discontinuation
    Protection of trial subjects
    This study was conducted in full conformance with the ICH E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research was conducted, whichever afforded the greater protection to the individual. All study subjects were required to read and sign and informed consent form.
    Background therapy
    		 Mometasone furoate monohydrate nasal spray was used as background therapy.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 May 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Canada: 6
    Country: Number of subjects enrolled
    Czechia: 4
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Spain: 23
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    Mexico: 5
    Country: Number of subjects enrolled
    Poland: 54
    Country: Number of subjects enrolled
    Portugal: 21
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    Ukraine: 61
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 49
    Worldwide total number of subjects
    249
    EEA total number of subjects
    120
    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)
    211
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who completed the treatment period of Study GA39688/GA39855 and fulfilled the eligibility criteria for the open-label extension (OLE) study were enrolled.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Received placebo in GA39688 or GA39855
    Arm description
    		 After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible subjects were enrolled into WA60169. All subjects in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
    Arm type
    		 Experimental

    Investigational medicinal product name
    omalizumab
    Investigational medicinal product code
    Other name
    Xolair IGE025 RO5489789
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W). Omalizumab dose was determined based on serum total IgE levels and body weight from the screening data from the parent studies.

    Arm title
    		 Received omalizumab in GA39688 or GA39855
    Arm description
    		 After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible subjects were enrolled into WA60169. All subjects in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
    Arm type
    		 Experimental

    Investigational medicinal product name
    omalizumab
    Investigational medicinal product code
    Other name
    Xolair IGE025 RO5489789
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W). Omalizumab dose was determined based on serum total IgE levels and body weight from the screening data from the parent studies.

    Number of subjects in period 1
    		Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Started
    126
    123
    Completed
    117
    114
    Not completed
    9
    9
         Consent withdrawn by subject
    6
    5
         Adverse event, non-fatal
    -
    1
         Lack of efficacy
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Received placebo in GA39688 or GA39855
    Reporting group description
    		 After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible subjects were enrolled into WA60169. All subjects in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.

    Reporting group title
    Received omalizumab in GA39688 or GA39855
    Reporting group description
    		 After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible subjects were enrolled into WA60169. All subjects in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.

    Reporting group values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855 Total
    Number of subjects
    		 126 123 249
    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)
    		 105 106 211
        From 65-84 years
    		 21 17 38
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.6 ± 11.9 49.9 ± 13.1 -
    Sex: Female, Male
    Units: participants
        Female
    		 44 45 89
        Male
    		 82 78 160
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 2 2
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 2 2
        White
    		 126 117 243
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 2 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 8 11 19
        Not Hispanic or Latino
    		 117 110 227
        Unknown or Not Reported
    		 1 2 3

    End points

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    End points reporting groups
    Reporting group title
    Received placebo in GA39688 or GA39855
    Reporting group description
    		 After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible subjects were enrolled into WA60169. All subjects in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.

    Reporting group title
    Received omalizumab in GA39688 or GA39855
    Reporting group description
    		 After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible subjects were enrolled into WA60169. All subjects in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.

    Subject analysis set title
    Full Analysis Set of the open label extension (FAS-OLE)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects enrolled into the OLE, grouped according to the treatment assigned (omalizumab or placebo) at randomization of the previous studies. Subjects who were not enrolled in the OLE study, their parent study data were not included in the analyses. All subjects in the FAS received at least one dose of study drug.

    Subject analysis set title
    Safety Analysis Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All safety analyses were based on the subset of the FAS-OLE, who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One subject randomized to the placebo arm in a parent study accidently received omalizumab.

    Subject analysis set title
    Pharmacokinetic Evaluable Analysis Set (PKAS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The PKAS consisted of subjects who received study drug in the form of their per-protocol dose according to baseline total IgE and body weight in the dosing table. Subjects receiving the wrong dose or frequency of the treatment assigned (placebo or omalizumab) or the wrong treatment assigned were excluded from this population.

    Primary: Change From Baseline in Nasal Polyp Score (NPS)

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    End point title
    		 Change From Baseline in Nasal Polyp Score (NPS) [1]
    End point description
    Total NPS ranges from 0 to 8 (sum of 0-4 for left and right nasal passage scores per the following criteria), with a lower score indicating smaller-sized nasal polyps: 0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate; 2 = Polyps reaching below the lower border of the middle turbinate (modified to accommodate those with a middle turbinectomy, such that polyp must have reached the top of the inferior turbinate.); 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate; and 4 = Large polyps causing complete obstruction of the inferior nasal cavity. Two blinded primary independent expert readers reviewed every post-screening recorded video endoscopy for a given subject to determine total NPS. A third reader chose one of the two scores to be used for analysis in cases where there was any discrepancy in total NPS assigned between the two primary readers.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics was planned to be reported in the endpoint.
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    126
    123
    Units: Sore on a scale
    arithmetic mean (confidence interval 95%)
        Week 4
    -0.17 (-0.38 to 0.05)
    -0.85 (-1.07 to -0.63)
        Week 8
    -0.26 (-0.49 to -0.02)
    -1.06 (-1.30 to -0.82)
        Week 16
    -0.17 (-0.38 to 0.05)
    -1.09 (-1.31 to -0.87)
        Week 24
    -0.19 (-0.42 to 0.03)
    -1.01 (-1.24 to -0.78)
        Week 36
    -0.83 (-1.07 to -0.59)
    -1.09 (-1.32 to -0.85)
        Week 52
    -0.97 (-1.25 to -0.69)
    -1.31 (-1.60 to -1.03)
        Week 64
    -0.40 (-0.66 to -0.13)
    -0.85 (-1.12 to -0.58)
        Week 76
    -0.48 (-0.76 to -0.20)
    -0.54 (-0.83 to -0.25)
    No statistical analyses for this end point

    Primary: Change From Baseline in Average Daily Nasal Congestion Score (NCS)

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    End point title
    		 Change From Baseline in Average Daily Nasal Congestion Score (NCS) [2]
    End point description
    The Nasal Congestion Score (NCS) was assessed daily by the participant via an electronic diary as the response to the following question: Is your nose blocked? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0 = Not at all; 1 = Mild; 2 = Moderate; and 3 = Severe. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the subject on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics was planned to be reported in the endpoint.
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    126
    123
    Units: Score on a scale
    arithmetic mean (confidence interval 95%)
        Week 4
    -0.17 (-0.27 to -0.07)
    -0.39 (-0.50 to -0.29)
        Week 8
    -0.25 (-0.38 to -0.13)
    -0.73 (-0.85 to -0.60)
        Week 12
    -0.31 (-0.44 to -0.18)
    -0.81 (-0.94 to -0.68)
        Week 16
    -0.32 (-0.46 to -0.19)
    -0.88 (-1.02 to -0.74)
        Week 20
    -0.34 (-0.48 to -0.20)
    -0.85 (-1.00 to -0.71)
        Week 24
    -0.31 (-0.46 to -0.16)
    -0.85 (-1.00 to -0.70)
        Week 28
    -0.61 (-0.76 to -0.47)
    -0.88 (-1.03 to -0.73)
        Week 32
    -0.72 (-0.87 to -0.57)
    -0.90 (-1.05 to -0.75)
        Week 36
    -0.74 (-0.89 to -0.59)
    -0.98 (-1.13 to -0.82)
        Week 40
    -0.73 (-0.88 to -0.59)
    -1.02 (-1.17 to -0.87)
        Week 44
    -0.89 (-1.05 to -0.73)
    -1.04 (-1.20 to -0.88)
        Week 48
    -0.94 (-1.10 to -0.79)
    -1.04 (-1.20 to -0.88)
        Week 52
    -0.99 (-1.14 to -0.83)
    -1.12 (-1.28 to -0.96)
        Week 56
    -0.80 (-0.97 to -0.64)
    -0.98 (-1.14 to -0.81)
        Week 60
    -0.71 (-0.87 to -0.54)
    -0.88 (-1.05 to -0.71)
        Week 64
    -0.63 (-0.80 to -0.46)
    -0.88 (-1.05 to -0.71)
        Week 68
    -0.64 (-0.80 to -0.47)
    -0.78 (-0.95 to -0.62)
        Week 72
    -0.56 (-0.73 to -0.40)
    -0.71 (-0.87 to -0.54)
        Week 76
    -0.58 (-0.76 to -0.41)
    -0.65 (-0.83 to -0.48)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Adverse Events (AE) and Serious Adverse Events (SAE)

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    End point title
    		 Percentage of Subjects with Adverse Events (AE) and Serious Adverse Events (SAE) [3]
    End point description
    A serious adverse event was defined as any adverse event that met any of the following criteria: was fatal; was life-threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study drug; or, was a significant medical event in the investigator's judgment. Multiple occurrences of the same serious adverse event in one individual were counted once.
    End point type
    Primary
    End point timeframe
    From Start to End (Weeks 24 to 52) of OLE Study
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics was planned to be reported in the endpoint.
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    126 [4]
    123 [5]
    Units: Percentage of Subjects
    number (not applicable)
        With at least one AE
    49.6
    43.5
        With at least one SAE
    4.8
    2.4
    Notes
    [4] - n=125; One subject randomized to the placebo arm in a parent study accidently received omalizumab.
    [5] - n=124; One subject randomized to the placebo arm in a parent study accidently received omalizumab.
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Adverse Events Leading to Discontinuation of Omalizumab

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    End point title
    		 Percentage of Subjects with Adverse Events Leading to Discontinuation of Omalizumab [6]
    End point description
    A serious adverse event was defined as any adverse event that met any of the following criteria: was fatal; was life-threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study drug; or, was a significant medical event in the investigator's judgment. Multiple occurrences of the same serious adverse event in one individual were counted once.
    End point type
    Primary
    End point timeframe
    From Start to End (Weeks 24 to 76) of OLE Study
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics was planned to be reported in the endpoint.
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    126 [7]
    123 [8]
    Units: Percentage of Subjects
        number (not applicable)
    0.8
    0.0
    Notes
    [7] - n=125; One subject randomized to the placebo arm in a parent study accidently received omalizumab.
    [8] - n=124; One subject randomized to the placebo arm in a parent study accidently received omalizumab.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS)

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    End point title
    		 Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS)
    End point description
    The Total Nasal Symptom Score (TNSS) was defined as the sum of the four individual scores for Nasal Congestion Score, Anterior Rhinorrhea Score, Posterior Rhinorrhea Score, and Sense of Smell Score, ranging from 0 (no symptoms) to 12 (most severe symptoms), assessed daily by the subject via an electronic diary. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the subject on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    126
    123
    Units: Score on a Scale
    arithmetic mean (confidence interval 95%)
        Week 4
    -0.50 (-0.80 to -0.19)
    -1.44 (-1.75 to -1.13)
        Week 8
    -0.72 (-1.09 to -0.34)
    -2.44 (-2.82 to -2.06)
        Week 12
    -0.82 (-1.22 to -0.41)
    -2.73 (-3.14 to -2.32)
        Week 16
    -0.87 (-1.30 to -0.43)
    -2.84 (-3.29 to -2.40)
        Week 20
    -0.93 (-1.36 to -0.49)
    -2.84 (-3.27 to -2.40)
        Week 24
    -0.92 (-1.37 to -0.47)
    -2.82 (-3.27 to -2.36)
        Week 28
    -1.80 (-2.25 to -1.34)
    -2.94 (-3.40 to -2.48)
        Week 32
    -2.19 (-2.64 to -1.74)
    -3.14 (-3.60 to -2.68)
        Week 36
    -2.22 (-2.69 to -1.76)
    -3.24 (-3.71 to -2.77)
        Week 40
    -2.32 (-2.77 to -1.86)
    -3.40 (-3.87 to -2.94)
        Week 44
    -2.72 (-3.21 to -2.24)
    -3.52 (-4.02 to -3.03)
        Week 48
    -2.84 (-3.32 to -2.36)
    -3.49 (-3.98 to -3.00)
        Week 52
    -3.01 (-3.49 to -2.53)
    -3.83 (-4.31 to -3.34)
        Week 56
    -2.54 (-3.04 to -2.04)
    -3.23 (-3.74 to -2.72)
        Week 60
    -2.27 (-2.78 to -1.76)
    -2.90 (-3.42 to -2.38)
        Week 64
    -1.94 (-2.44 to -1.43)
    -2.97 (-3.49 to -2.46)
        Week 68
    -1.83 (-2.33 to -1.33)
    -2.59 (-3.09 to -2.08)
        Week 72
    -1.59 (-2.10 to -1.08)
    -2.37 (-2.88 to -1.85)
        Week 76
    -1.63 (-2.19 to -1.08)
    -2.18 (-2.74 to -1.62)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Loss of Sense of Smell Score

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    End point title
    		 Change From Baseline in Loss of Sense of Smell Score
    End point description
    The Sense of Smell Score was assessed daily by the subject via an electronic diary as the response to the following question: Is your sense of smell reduced? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0 = Not at all; 1 = Mild; 2 = Moderate; and 3 = Severe. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the subject on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    126
    123
    Units: Score on a Scale
    arithmetic mean (confidence interval 95%)
        Week 4
    -0.07 (-0.16 to 0.02)
    -0.22 (-0.31 to -0.13)
        Week 8
    -0.14 (-0.25 to -0.03)
    -0.43 (-0.55 to -0.32)
        Week 12
    -0.14 (-0.27 to -0.02)
    -0.57 (-0.70 to -0.45)
        Week 16
    -0.19 (-0.33 to -0.06)
    -0.58 (-0.72 to -0.44)
        Week 20
    -0.21 (-0.35 to -0.08)
    -0.58 (-0.72 to -0.45)
        Week 24
    -0.23 (-0.36 to -0.09)
    -0.56 (-0.70 to -0.43)
        Week 28
    -0.26 (-0.40 to -0.12)
    -0.58 (-0.72 to -0.44)
        Week 32
    -0.39 (-0.54 to -0.24)
    -0.65 (-0.80 to -0.50)
        Week 36
    -0.39 (-0.54 to -0.25)
    -0.63 (-0.77 to -0.48)
        Week 40
    -0.42 (-0.57 to -0.27)
    -0.66 (-0.81 to -0.51)
        Week 44
    -0.51 (-0.67 to -0.36)
    -0.70 (-0.85 to -0.54)
        Week 48
    -0.54 (-0.70 to -0.38)
    -0.70 (-0.86 to -0.54)
        Week 52
    -0.60 (-0.76 to -0.43)
    -0.76 (-0.92 to -0.59)
        Week 56
    -0.54 (-0.69 to -0.38)
    -0.62 (-0.78 to -0.46)
        Week 60
    -0.50 (-0.65 to -0.34)
    -0.56 (-0.71 to -0.40)
        Week 64
    -0.41 (-0.57 to -0.26)
    -0.53 (-0.68 to -0.37)
        Week 68
    -0.39 (-0.53 to -0.24)
    -0.44 (-0.59 to -0.30)
        Week 72
    -0.35 (-0.49 to -0.21)
    -0.42 (-0.56 to -0.28)
        Week 76
    -0.35 (-0.50 to -0.20)
    -0.39 (-0.54 to -0.24)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Average Daily Posterior Rhinorrhea Score

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    End point title
    		 Change From Baseline in Average Daily Posterior Rhinorrhea Score
    End point description
    The Posterior Rhinorrhea Score was assessed daily by the subject via an electronic diary as the response to the following question: Do you feel dripping at the back of the nose? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0=Not at all; 1=Mild; 2=Moderate; and 3=Severe. For each study day, a score was calculated using an average of the prior 7 days among available days within a pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the subject on at least 4 of the prior 7 days, otherwise the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    126
    123
    Units: Score on a Scale
    arithmetic mean (confidence interval 95%)
        Week 4
    -0.13 (-0.23 to -0.03)
    -0.35 (-0.44 to -0.25)
        Week 8
    -0.13 (-0.24 to -0.02)
    -0.58 (-0.70 to -0.47)
        Week 12
    -0.14 (-0.25 to -0.02)
    -0.60 (-0.72 to -0.48)
        Week 16
    -0.11 (-0.24 to 0.02)
    -0.63 (-0.76 to -0.50)
        Week 20
    -0.14 (-0.27 to -0.02)
    -0.64 (-0.77 to -0.51)
        Week 24
    -0.15 (-0.29 to -0.02)
    -0.66 (-0.79 to -0.52)
        Week 28
    -0.36 (-0.49 to -0.22)
    -0.67 (-0.81 to -0.53)
        Week 32
    -0.46 (-0.60 to -0.32)
    -0.72 (-0.86 to -0.58)
        Week 36
    -0.46 (-0.60 to -0.32)
    -0.76 (-0.90 to -0.62)
        Week 40
    -0.49 (-0.62 to -0.36)
    -0.77 (-0.91 to -0.64)
        Week 44
    -0.58 (-0.72 to -0.44)
    -0.80 (-0.94 to -0.65)
        Week 48
    -0.60 (-0.74 to -0.46)
    -0.77 (-0.91 to -0.62)
        Week 52
    -0.62 (-0.75 to -0.48)
    -0.87 (-1.00 to -0.73)
        Week 56
    -0.52 (-0.66 to -0.38)
    -0.74 (-0.88 to -0.59)
        Week 60
    -0.47 (-0.62 to -0.33)
    -0.70 (-0.85 to -0.55)
        Week 64
    -0.38 (-0.52 to -0.23)
    -0.78 (-0.93 to -0.63)
        Week 68
    -0.37 (-0.52 to -0.21)
    -0.66 (-0.81 to -0.50)
        Week 72
    -0.27 (-0.42 to -0.11)
    -0.61 (-0.76 to -0.45)
        Week 76
    -0.28 (-0.44 to -0.12)
    -0.53 (-0.70 to -0.37)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Average Daily Anterior Rhinorrhea Score

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    End point title
    		 Change From Baseline in Average Daily Anterior Rhinorrhea Score
    End point description
    The Anterior Rhinorrhea Score was assessed daily by the subject via an electronic diary as the response to the following question: Do you have a runny nose? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0=Not at all; 1=Mild; 2=Moderate; and 3=Severe. For each study day, a score was calculated using an average of the prior 7 days among available days within a pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the subject on at least 4 of the prior 7 days, otherwise the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    126
    123
    Units: Score on a Scale
    arithmetic mean (confidence interval 95%)
        Week 4
    -0.13 (-0.23 to -0.03)
    -0.47 (-0.57 to -0.37)
        Week 8
    -0.21 (-0.32 to -0.09)
    -0.68 (-0.80 to -0.57)
        Week 12
    -0.24 (-0.36 to -0.13)
    -0.73 (-0.85 to -0.61)
        Week 16
    -0.26 (-0.38 to -0.13)
    -0.74 (-0.87 to -0.61)
        Week 20
    -0.24 (-0.37 to -0.11)
    -0.74 (-0.87 to -0.61)
        Week 24
    -0.24 (-0.38 to -0.11)
    -0.73 (-0.87 to -0.59)
        Week 28
    -0.58 (-0.71 to -0.45)
    -0.80 (-0.93 to -0.66)
        Week 32
    -0.65 (-0.77 to -0.52)
    -0.84 (-0.97 to -0.71)
        Week 36
    -0.66 (-0.79 to -0.52)
    -0.85 (-0.99 to -0.71)
        Week 40
    -0.71 (-0.85 to -0.57)
    -0.93 (-1.07 to -0.79)
        Week 44
    -0.77 (-0.91 to -0.63)
    -0.96 (-1.10 to -0.82)
        Week 48
    -0.80 (-0.95 to -0.66)
    -0.94 (-1.09 to -0.80)
        Week 52
    -0.85 (-0.98 to -0.71)
    -1.06 (-1.19 to -0.92)
        Week 56
    -0.71 (-0.85 to -0.56)
    -0.89 (-1.03 to -0.74)
        Week 60
    -0.61 (-0.76 to -0.46)
    -0.75 (-0.90 to -0.60)
        Week 64
    -0.54 (-0.69 to -0.39)
    -0.77 (-0.92 to -0.61)
        Week 68
    -0.47 (-0.62 to -0.32)
    -0.69 (-0.84 to -0.54)
        Week 72
    -0.43 (-0.59 to -0.28)
    -0.62 (-0.77 to -0.46)
        Week 76
    -0.45 (-0.62 to -0.29)
    -0.57 (-0.74 to -0.40)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score

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    End point title
    		 Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score
    End point description
    The SNOT-22 Questionnaire, a disease specific HRQoL measure, comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every subject was asked to rate how severe each problem had been for them over the past 2 weeks on a scale from 0 (no problem at all) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating less disease and better HRQoL. A negative score indicates a decrease (or improvement) from the baseline score.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    126
    123
    Units: Score on a Scale
    arithmetic mean (confidence interval 95%)
        Week 4
    -8.43 (-10.82 to -6.04)
    -17.86 (-20.28 to -15.44)
        Week 8
    -8.85 (-11.56 to -6.15)
    -21.74 (-24.47 to -19.01)
        Week 16
    -8.52 (-11.32 to -5.72)
    -24.56 (-27.40 to -21.73)
        Week 24
    -7.76 (-10.73 to -4.80)
    -23.56 (-26.55 to -20.57)
        Week 36
    -17.87 (-20.91 to -14.83)
    -25.42 (-28.51 to -22.34)
        Week 52
    -22.39 (-25.39 to -19.40)
    -28.47 (-31.52 to -25.42)
        Week 64
    -17.02 (-20.31 to -13.72)
    -22.66 (-26.01 to -19.31)
        Week 76
    -15.37 (-18.79 to -11.95)
    -19.44 (-22.89 to -15.99)
    No statistical analyses for this end point

    Secondary: Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score

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    End point title
    		 Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score
    End point description
    The EQ-5D-5L contains a visual analog score (VAS), providing a global assessment of health. The EQ-VAS questionnaire is a self-reported questionnaire that measures health state. The VAS is a 100 mm scale from worst (0 mm) to best (100 mm) health the subject can imagine.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 16, 24, 36, 52, 64, and 76
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    126
    123
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Week 16
    -0.6 ± 20.8
    6.4 ± 16.7
        Week 24
    2.3 ± 19.6
    7.9 ± 16.9
        Week 36
    7.4 ± 20.0
    9.3 ± 16.1
        Week 52
    8.5 ± 22.2
    10.8 ± 17.9
        Week 64
    5.3 ± 21.4
    5.3 ± 18.4
        Week 76
    2.8 ± 20.4
    4.4 ± 20.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains

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    End point title
    		 Percentage of Subjects Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains
    End point description
    The EQ-5D-5L contains five domains: Mobility, Self-Care, Usual activity, Pain/Discomfort, and Anxiety/Depression, providing a global assessment of health. Each item is rated by the subject on a five-point scale indicating the followings: Level 1 - no problem; Level 2 - slight problems; Level 3 - moderate problems; Level 4 - severe problems; Level 5 - extreme problems.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 16, 24, 36, 52, 64 and 76
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    126
    123
    Units: Percentage of Subjects
    number (not applicable)
        Baseline Usual activities
    57.9
    59.5
        Baseline Mobility
    67.5
    68.6
        Baseline Self-care
    83.3
    90.9
        Baseline Pain/Discomfort
    27.0
    27.3
        Baseline Anxiety/Depression
    49.2
    47.9
        Week 16 Usual activities
    54.0
    75.6
        Week 16 Mobility
    60.5
    79.7
        Week 16 Self-care
    84.7
    91.1
        Week 16 Pain/Discomfort
    32.2
    48.0
        Week 16 Anxiety/Depression
    48.4
    57.7
        Week 24 Usual activities
    60.8
    69.9
        Week 24 Mobility
    66.4
    74.0
        Week 24 Self-care
    87.2
    89.4
        Week 24 Pain/Discomfort
    29.6
    51.2
        Week 24 Anxiety/Depression
    47.2
    60.2
        Week 36 Usual activities
    60.3
    74.8
        Week 36 Mobility
    69.4
    75.6
        Week 36 Self-care
    83.5
    90.8
        Week 36 Pain/Discomfort
    40.5
    48.7
        Week 36 Anxiety/Depression
    55.4
    68.9
        Week 52 Usual activities
    65.5
    74.6
        Week 52 Mobility
    72.3
    71.9
        Week 52 Self-care
    87.4
    91.2
        Week 52 Pain/Discomfort
    40.3
    56.1
        Week 52 Anxiety/Depression
    62.2
    70.2
        Week 64 Usual activities
    62.9
    72.1
        Week 64 Mobility
    62.1
    70.3
        Week 64 Self-care
    84.5
    90.1
        Week 64 Pain/Discomfort
    32.8
    47.7
        Week 64 Anxiety/Depression
    50.9
    61.3
        Week 76 Usual activities
    64.6
    71.4
        Week 76 Mobility
    66.4
    76.8
        Week 76 Self-care
    85.0
    89.3
        Week 76 Pain/Discomfort
    34.5
    48.2
        Week 76 Anxiety/Depression
    51.3
    58.0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score (in subjects with comorbid asthma only)

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    End point title
    		 Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score (in subjects with comorbid asthma only)
    End point description
    The AQLQ is a 32-item participant-reported measure of asthma-related quality of life (QoL) with a total score (the mean of all 32 responses) ranging from 1 (severely impaired) to 7 (not impaired at all); a higher score indicates a better QoL. An increase of at least 0.5 points in the AQLQ score was considered the minimal important difference for improvement in QoL.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 16, 24, 36, 52, 64, and 76
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    69
    73
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Week 16
    0.05 ± 1.14
    0.77 ± 1.15
        Week 24
    -0.01 ± 0.94
    0.84 ± 1.25
        Week 36
    0.50 ± 1.05
    0.84 ± 1.27
        Week 52
    0.52 ± 1.10
    0.95 ± 1.23
        Week 64
    0.34 ± 1.12
    0.66 ± 1.35
        Week 76
    0.27 ± 1.15
    0.42 ± 1.57
    No statistical analyses for this end point

    Secondary: Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) Score

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    End point title
    		 Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) Score
    End point description
    The UPSIT is a 40-question instrument that measures an individual’s ability to detect odors and ranges from 0 to 40, with a higher score indicating a better sense of smell. It is a self-administered "scratch-and-sniff" test provided in booklets that have 40 microencapsulated odorants, each with a multiple-choice option for the response. The number of correct responses is summed to provide a total score.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 8, 16, 24, 36, 52, 64, and 76
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    126
    123
    Units: Score on a Scale
    arithmetic mean (confidence interval 95%)
        Week 8
    0.49 (-0.69 to 1.67)
    5.04 (3.85 to 6.23)
        Week 16
    0.83 (-0.33 to 1.99)
    4.31 (3.14 to 5.48)
        Week 24
    0.46 (-0.71 to 1.64)
    4.24 (3.04 to 5.43)
        Week 36
    3.47 (2.10 to 4.84)
    4.27 (2.90 to 5.65)
        Week 52
    3.88 (2.57 to 5.20)
    4.13 (2.78 to 5.47)
        Week 64
    1.81 (0.56 to 3.06)
    2.77 (1.49 to 4.05)
        Week 76
    0.62 (-0.47 to 1.71)
    1.42 (0.32 to 2.52)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With a Clinically Significant Change From Baseline in Laboratory Values

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    End point title
    		 Percentage of Subjects With a Clinically Significant Change From Baseline in Laboratory Values
    End point description
    Investigators will assess the subjects' clinical laboratory values (e.g., serum chemistry, hematology evaluations including complete blood count [CBC] with differential and platelet counts, and urinalysis values) at timepoints throughout this OLE study relative to the subjects' values at baseline from studies GA39688/GA39855 and parameters with clinically significant changes from baseline will be reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 36, 52, 64, and 76
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    126
    123
    Units: Percentage of Subjects
    number (not applicable)
        Baseline OLE (Week 24)
    0.0
    0.0
        Week 36
    0.0
    0.0
        Week 52
    0.0
    0.0
        Week 64
    0.0
    0.0
        Week 76
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Minimum Serum Concentrations (Ctrough) of Omalizumab at Specified Timepoints

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    End point title
    		 Minimum Serum Concentrations (Ctrough) of Omalizumab at Specified Timepoints
    End point description
    Serum concentrations of omalizumab were quantified using an enzyme-linked immunoabsorbent assay (ELISA) with a lower limit of quantification (LLOQ) of 28.0 nanograms per millilitre (ng/mL). According to the analysis plan, values below the lower limit of quantification (BLQ) were set to 14 ng/mL (i.e. half of LLOQ value). We confirm that all 121 and 123 participants contributed data to the PK outcome measure. The reason why the numbers of participants analyzed are different from the overall number of participants is mainly because some PK concentrations at those time points are below LLOQ. Other reasons include: (1) Five participants received accidental dose of Omalizumab at the OLE Week52 thus are excluded for PK sample results for OLE Week64 and OLE Week76, and (2) One participant received omalizumab as concomitant medication in the follow-up period and is excluded from PK sample results for OLE Week76.
    End point type
    Secondary
    End point timeframe
    Predose at Weeks 36, 52, 64, and 76
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    121
    123
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Week 36
    33100 ± 83.8
    34500 ± 95.7
        Week 52
    29700 ± 133.4
    27700 ± 158.5
        Week 64
    1650 ± 199.8
    1780 ± 214.2
        Week 76
    93.3 ± 352.7
    109 ± 246.4
    No statistical analyses for this end point

    Secondary: Serum Concentration of Total Immunoglobulin E (IgE)

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    End point title
    		 Serum Concentration of Total Immunoglobulin E (IgE)
    End point description
    Serum concentrations of total immunoglobulin E (IgE) were measured throughout the study, as target engagement biomarkers of omalizumab, using validated quantitative immunoassays with lower limits of quantification of 2 International Units per millilitre (IU/mL), and upper limits of quantification (ULQ) of 5000 IU/mL.
    End point type
    Secondary
    End point timeframe
    Predose at Weeks 36, 52, 64, and 76
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    126
    123
    Units: IU/mL
    arithmetic mean (standard deviation)
        Week 36
    665 ± 530
    522 ± 367
        Week 52
    635 ± 463
    532 ± 424
        Week 64
    390 ± 366
    335 ± 342
        Week 76
    231 ± 226
    196 ± 191
    No statistical analyses for this end point

    Secondary: Serum Concentration of Free IgE

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    End point title
    		 Serum Concentration of Free IgE
    End point description
    Serum concentrations of free IgE were measured throughout the study, as target engagement biomarkers of omalizumab, using validated quantitative immunoassays with LLOQ of 0.83 IU/mL, and ULQ of 62.5 IU/mL. The free IgE assay had limited range to measure circulating levels of free IgE in the presence of complexes of omalizumab-IgE. Results above ULQ were set to 62.5 IU/mL. If results for 1/3 or fewer of the participants were greater than the ULQ, then summary statistics were reported. If the results for more than 1/3 of participants were greater than the ULQ, then only the median, interquartile range and minimum were calculated, and the mean, standard deviation, and maximum were non-reportable; 9999=non-reportable. The following are available for median and interquartile ranges (IQR; IQ1-IQ3): Placebo: OLE Week 64 median 55.4 (IQR 33.3 - 62.5), OLE Week 76 median 62.5 (IQR 31.1 - 62.5). Omalizumab: OLE Week 64 median 55.8 (IQR 37.5 - 62.5), OLE Week 76 median 62.5 (IQR 47.9 - 62.5)
    End point type
    Secondary
    End point timeframe
    Predose at Weeks 36, 52, 64, and 76
    End point values
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Number of subjects analysed
    126
    123
    Units: IU/mL
    arithmetic mean (standard deviation)
        Week 36
    8.08 ± 4.73
    7.73 ± 6.37
        Week 52
    9.09 ± 8.81
    9.52 ± 10.8
        Week 64
    9999 ± 9999
    9999 ± 9999
        Week 76
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Start to End (Weeks 24 to 76) of OLE Study
    Adverse event reporting additional description
    One subject randomized to the placebo arm in a parent study accidently received omalizumab.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    .22.1
    Reporting groups
    Reporting group title
    Received placebo in GA39688 or GA39855
    Reporting group description
    		 After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible subjects were enrolled into WA60169. All subjects in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.

    Reporting group title
    Received omalizumab in GA39688 or GA39855
    Reporting group description
    		 After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible subjects were enrolled into WA60169. All subjects in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.

    Serious adverse events
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 125 (9.60%)
    8 / 124 (6.45%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 125 (1.60%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal polyps
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 125 (1.60%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 125 (0.80%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular abscess
         subjects affected / exposed
    0 / 125 (0.00%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Received placebo in GA39688 or GA39855 Received omalizumab in GA39688 or GA39855
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 125 (22.40%)
    19 / 124 (15.32%)
    Respiratory, thoracic and mediastinal disorders
    Nasal polyps
         subjects affected / exposed
    13 / 125 (10.40%)
    4 / 124 (3.23%)
         occurrences all number
    16
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 125 (10.40%)
    19 / 124 (15.32%)
         occurrences all number
    34
    33
    Sinusitis
         subjects affected / exposed
    13 / 125 (10.40%)
    9 / 124 (7.26%)
         occurrences all number
    16
    16

    More information

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

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

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