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    Clinical Trial Results:
    A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Dosing Regimens of MEMP1972A in Adults with Allergic Asthma who are Inadequately Controlled on Inhaled Corticosteroids and a Second Controller (COSTA)

    Summary
    EudraCT number
    2011-003997-10
    Trial protocol
    BE   DE   HU   BG  
    Global end of trial date
    17 Nov 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Apr 2016
    First version publication date
    17 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GB27980
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01582503
    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
    23 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Nov 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to evaluate the efficacy and safety of quilizumab in adult participants with allergic asthma inadequately controlled despite high-dose inhaled corticosteroid (ICS) (greater than or equal to [>=] 400 microgram per day [mcg/day] total daily dose of fluticasone propionate or equivalent) and a second controller after 36 weeks of treatment.
    Protection of trial subjects
    The study was conducted in accordance with the United States Food and Drug Administration (FDA) regulations, the International Conference on Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP), and applicable local, state, and federal laws, as well as other applicable country laws.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Apr 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    11 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 42
    Country: Number of subjects enrolled
    Canada: 10
    Country: Number of subjects enrolled
    Mexico: 7
    Country: Number of subjects enrolled
    New Zealand: 11
    Country: Number of subjects enrolled
    Peru: 55
    Country: Number of subjects enrolled
    Romania: 38
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    Ukraine: 35
    Country: Number of subjects enrolled
    United States: 127
    Country: Number of subjects enrolled
    Poland: 93
    Country: Number of subjects enrolled
    Belgium: 15
    Country: Number of subjects enrolled
    Bulgaria: 104
    Country: Number of subjects enrolled
    Germany: 21
    Country: Number of subjects enrolled
    Hungary: 13
    Worldwide total number of subjects
    578
    EEA total number of subjects
    284
    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)
    527
    From 65 to 84 years
    51
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 1212 participants were screened, out of which 578 participants were randomized to the study treatment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo matched to quilizumab subcutaneously on Weeks 0, 4, 8, 12, 16, 20, 24, 28, and 32.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo matched to quilizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo matched to quilizumab subcutaneously on Weeks 0, 4, 8, 12, 16, 20, 24, 28, and 32.

    Arm title
    Quilizumab 150 mg
    Arm description
    Participants received quilizumab at the dose of 150 milligram (mg) subcutaneously on Weeks 0, 4, 12, and 24.
    Arm type
    Experimental

    Investigational medicinal product name
    Quilizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received quilizumab subcutaneously at specified dose and time.

    Arm title
    Quilizumab 450 mg
    Arm description
    Participants received quilizumab at the dose of 450 mg subcutaneously on Weeks 0, 4, 12, and 24.
    Arm type
    Experimental

    Investigational medicinal product name
    Quilizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received quilizumab subcutaneously at specified dose and time.

    Arm title
    Quilizumab 300 mg
    Arm description
    Participants received quilizumab at the dose of 300 mg subcutaneously on Weeks 0, 4, 8, 12, 16, 20, 24, 28, and 32.
    Arm type
    Experimental

    Investigational medicinal product name
    Quilizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received quilizumab subcutaneously at specified dose and time.

    Number of subjects in period 1
    Placebo Quilizumab 150 mg Quilizumab 450 mg Quilizumab 300 mg
    Started
    145
    145
    145
    143
    Completed
    44
    44
    41
    41
    Not completed
    101
    101
    104
    102
         Consent withdrawn by subject
    17
    18
    16
    11
         Physician decision
    -
    2
    2
    -
         Study terminated by sponsor
    82
    76
    77
    83
         Adverse event
    -
    2
    1
    -
         Non-compliance
    -
    3
    1
    1
         Lost to follow-up
    1
    -
    5
    4
         unspecified
    1
    -
    2
    2
         Lack of efficacy
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo matched to quilizumab subcutaneously on Weeks 0, 4, 8, 12, 16, 20, 24, 28, and 32.

    Reporting group title
    Quilizumab 150 mg
    Reporting group description
    Participants received quilizumab at the dose of 150 milligram (mg) subcutaneously on Weeks 0, 4, 12, and 24.

    Reporting group title
    Quilizumab 450 mg
    Reporting group description
    Participants received quilizumab at the dose of 450 mg subcutaneously on Weeks 0, 4, 12, and 24.

    Reporting group title
    Quilizumab 300 mg
    Reporting group description
    Participants received quilizumab at the dose of 300 mg subcutaneously on Weeks 0, 4, 8, 12, 16, 20, 24, 28, and 32.

    Reporting group values
    Placebo Quilizumab 150 mg Quilizumab 450 mg Quilizumab 300 mg Total
    Number of subjects
    145 145 145 143 578
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    47.9 ± 13 46.7 ± 13.4 47 ± 13.6 44.8 ± 12.2 -
    Gender categorical
    Units: Subjects
        Female
    84 89 98 86 357
        Male
    61 56 47 57 221

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo matched to quilizumab subcutaneously on Weeks 0, 4, 8, 12, 16, 20, 24, 28, and 32.

    Reporting group title
    Quilizumab 150 mg
    Reporting group description
    Participants received quilizumab at the dose of 150 milligram (mg) subcutaneously on Weeks 0, 4, 12, and 24.

    Reporting group title
    Quilizumab 450 mg
    Reporting group description
    Participants received quilizumab at the dose of 450 mg subcutaneously on Weeks 0, 4, 12, and 24.

    Reporting group title
    Quilizumab 300 mg
    Reporting group description
    Participants received quilizumab at the dose of 300 mg subcutaneously on Weeks 0, 4, 8, 12, 16, 20, 24, 28, and 32.

    Primary: Annualized Rate of Asthma Exacerbations

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    End point title
    Annualized Rate of Asthma Exacerbations
    End point description
    An asthma exacerbation is defined as new or increased asthma symptoms (including wheeze, cough, dyspnea, chest tightness, or nocturnal awakenings due to these symptoms) that lead to hospitalization or treatment with systemic corticosteroids defined as: a) Treatment with oral, intravenous, or intramuscular corticosteroids for at least 3 days, or b) Emergency department visit with at least one dose of intravenous or intramuscular corticosteroids. Adjusted exacerbation rates of protocol-defined asthma exacerbations per 52 weeks were reported. Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 36
    End point values
    Placebo Quilizumab 150 mg Quilizumab 450 mg Quilizumab 300 mg
    Number of subjects analysed
    145
    145
    145
    143
    Units: exacerbations per year
        number (not applicable)
    0.62
    0.66
    0.69
    0.5
    Statistical analysis title
    Quilizumab 150 mg vs. Placebo
    Statistical analysis description
    Annualized Rate of Asthma Exacerbations: Quilizumab 150 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 150 mg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.812
    Method
    Poisson regression
    Parameter type
    Exacerbation rate reduction
    Point estimate
    -5.7
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -54.65
         upper limit
    27.81
    Notes
    [1] - Missing values were imputed using last observation carried forward (LOCF). Model was adjusted for periostin status (less than [<] 50, greater than or equal to [>=] 50), number of prior exacerbations (1, greater than [>] 1), Immunoglobulin E (IgE) level (<200 international units per milliliter [IU/mL], >=200 IU/mL).
    Statistical analysis title
    Quilizumab 450 mg vs. Placebo
    Statistical analysis description
    Annualized Rate of Asthma Exacerbations: Quilizumab 450 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 450 mg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    = 0.6474
    Method
    Poisson regression
    Parameter type
    Exacerbation rate reduction
    Point estimate
    -11.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -62.7
         upper limit
    24.04
    Notes
    [2] - Missing values were imputed using LOCF. Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1), IgE level (<200 IU/mL, >=200 IU/mL).
    Statistical analysis title
    Quilizumab 300 mg vs. Placebo
    Statistical analysis description
    Annualized Rate of Asthma Exacerbations: Quilizumab 300 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 300 mg
    Number of subjects included in analysis
    288
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    = 0.3821
    Method
    Poisson regression
    Parameter type
    Exacerbation rate reduction
    Point estimate
    19.6
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -21.27
         upper limit
    46.75
    Notes
    [3] - Missing values were imputed using LOCF. Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1), IgE level (<200 IU/mL, >=200 IU/mL).

    Secondary: Percent Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 12 and 36

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    End point title
    Percent Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 12 and 36
    End point description
    The percent change from baseline in FEV1 (liters) was calculated at Week 12 and 36 using the formula: (FEV1 at Week 12 or 36 [respectively] minus (-) FEV1 at baseline) / FEV1 at baseline multiplied by (*) 100 for each treatment group. ITT population included all participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, and Week 36
    End point values
    Placebo Quilizumab 150 mg Quilizumab 450 mg Quilizumab 300 mg
    Number of subjects analysed
    145
    145
    145
    143
    Units: percent change
    arithmetic mean (standard deviation)
        Percent change at Week 12
    6.91 ± 23.866
    11.25 ± 30.998
    9.41 ± 23.5
    7.56 ± 25.692
        Percent change at Week 36
    7.62 ± 23.674
    13.5 ± 30.473
    7.85 ± 25.549
    7.15 ± 24.773
    Statistical analysis title
    Week 12: Quilizumab 150 mg vs. Placebo
    Statistical analysis description
    Percent change from baseline in FEV1 at Week 12: Quilizumab 150 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 150 mg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    superiority [4]
    P-value
    = 0.2064
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    3.843
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.162
         upper limit
    8.848
    Notes
    [4] - Missing values were imputed using LOCF. Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1), IgE level (<200 IU/mL, >=200 IU/mL) and baseline FEV1 (L).
    Statistical analysis title
    Week 12: Quilizumab 450 mg vs. Placebo
    Statistical analysis description
    Percent change from baseline in FEV1 at Week 12: Quilizumab 450 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 450 mg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    superiority [5]
    P-value
    = 0.4752
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    2.169
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -2.832
         upper limit
    7.171
    Notes
    [5] - Missing values were imputed using LOCF. Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1), IgE level (<200 IU/mL, >=200 IU/mL) and baseline FEV1 (L).
    Statistical analysis title
    Week 12: Quilizumab 300 mg vs. Placebo
    Statistical analysis description
    Percent change from baseline in FEV1 at Week 12: Quilizumab 300 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 300 mg
    Number of subjects included in analysis
    288
    Analysis specification
    Pre-specified
    Analysis type
    superiority [6]
    P-value
    = 0.721
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    1.092
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -3.941
         upper limit
    6.124
    Notes
    [6] - Missing values were imputed using LOCF. Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1), IgE level (<200 IU/mL, >=200 IU/mL) and baseline FEV1 (L).
    Statistical analysis title
    Week 36: Quilizumab 150 mg vs. Placebo
    Statistical analysis description
    Percent change from baseline in FEV1 at Week 36: Quilizumab 150 mg vs. Placebo
    Comparison groups
    Quilizumab 150 mg v Placebo
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    superiority [7]
    P-value
    = 0.0679
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    5.593
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.556
         upper limit
    10.63
    Notes
    [7] - Missing values were imputed using LOCF. Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1), IgE level (<200 IU/mL, >=200 IU/mL) and baseline FEV1 (L).
    Statistical analysis title
    Week 36: Quilizumab 450 mg vs. Placebo
    Statistical analysis description
    Percent change from baseline in FEV1 at Week 36: Quilizumab 450 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 450 mg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    superiority [8]
    P-value
    = 0.9833
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.064
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.969
         upper limit
    5.097
    Notes
    [8] - Missing values were imputed using LOCF. Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1), IgE level (<200 IU/mL, >=200 IU/mL) and baseline FEV1 (L).
    Statistical analysis title
    Week 36: Quilizumab 300 mg vs. Placebo
    Statistical analysis description
    Percent change from baseline in FEV1 at Week 36: Quilizumab 300 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 300 mg
    Number of subjects included in analysis
    288
    Analysis specification
    Pre-specified
    Analysis type
    superiority [9]
    P-value
    = 0.9631
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.142
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.922
         upper limit
    5.207
    Notes
    [9] - Missing values were imputed using LOCF. Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1), IgE level (<200 IU/mL, >=200 IU/mL) and baseline FEV1 (L).

    Secondary: Change from Baseline in Daytime Asthma Symptoms Score at Weeks 12 and 36

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    End point title
    Change from Baseline in Daytime Asthma Symptoms Score at Weeks 12 and 36
    End point description
    Daytime asthma symptoms were calculated from assessments recorded on participant diaries. The daytime asthma symptoms score ranges from 0 to 4, with higher scores indicating more severe symptoms. Daily scores were averaged over the previous 1 week (7 days) prior to the timepoint of interest, with the exception of the baseline value which was derived based on the last 14 days prior to randomization. ITT population included all participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, and Week 36
    End point values
    Placebo Quilizumab 150 mg Quilizumab 450 mg Quilizumab 300 mg
    Number of subjects analysed
    145
    145
    145
    143
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change at Week 12
    -0.54 ± 0.746
    -0.51 ± 0.66
    -0.48 ± 0.793
    -0.51 ± 0.712
        Change at Week 36
    -0.68 ± 0.863
    -0.64 ± 0.783
    -0.64 ± 0.898
    -0.7 ± 0.809
    Statistical analysis title
    Week 12: Quilizumab 150 mg vs. Placebo
    Statistical analysis description
    Change from baseline in Daytime Asthma Symptoms Score at Week 12: Quilizumab 150 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 150 mg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    superiority [10]
    P-value
    = 0.6506
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.037
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.097
         upper limit
    0.171
    Notes
    [10] - Missing values were imputed using LOCF. Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1), IgE level (<200 IU/mL, >=200 IU/mL) and baseline daytime asthma symptom score.
    Statistical analysis title
    Week 12: Quilizumab 450 mg vs. Placebo
    Statistical analysis description
    Change from baseline in Daytime Asthma Symptoms Score at Week 12: Quilizumab 450 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 450 mg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    superiority [11]
    P-value
    = 0.5042
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.054
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.08
         upper limit
    0.188
    Notes
    [11] - Missing values were imputed using LOCF. Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1), IgE level (<200 IU/mL, >=200 IU/mL) and baseline daytime asthma symptom score.
    Statistical analysis title
    Week 12: Quilizumab 300 mg vs. Placebo
    Statistical analysis description
    Change from baseline in Daytime Asthma Symptoms Score at Week 12: Quilizumab 300 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 300 mg
    Number of subjects included in analysis
    288
    Analysis specification
    Pre-specified
    Analysis type
    superiority [12]
    P-value
    = 0.8466
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.016
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.119
         upper limit
    0.15
    Notes
    [12] - Missing values were imputed using LOCF. Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1), IgE level (<200 IU/mL, >=200 IU/mL) and baseline daytime asthma symptom score.
    Statistical analysis title
    Week 36: Quilizumab 150 mg vs. Placebo
    Statistical analysis description
    Change from baseline in Daytime Asthma Symptoms Score at Week 36: Quilizumab 150 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 150 mg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    superiority [13]
    P-value
    = 0.5522
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.053
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.094
         upper limit
    0.201
    Notes
    [13] - Missing values were imputed using LOCF. Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1), IgE level (<200 IU/mL, >=200 IU/mL) and baseline daytime asthma symptom score.
    Statistical analysis title
    Week 36: Quilizumab 450 mg vs. Placebo
    Statistical analysis description
    Change from baseline in Daytime Asthma Symptoms Score at Week 36: Quilizumab 450 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 450 mg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    superiority [14]
    P-value
    = 0.6961
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    0.035
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.112
         upper limit
    0.182
    Notes
    [14] - Missing values were imputed using LOCF. Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1), IgE level (<200 IU/mL, >=200 IU/mL) and baseline daytime asthma symptom score.
    Statistical analysis title
    Week 36: Quilizumab 300 mg vs. Placebo
    Statistical analysis description
    Change from baseline in Daytime Asthma Symptoms Score at Week 36: Quilizumab 300 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 300 mg
    Number of subjects included in analysis
    288
    Analysis specification
    Pre-specified
    Analysis type
    superiority [15]
    P-value
    = 0.6895
    Method
    ANCOVA
    Parameter type
    Least squares mean difference
    Point estimate
    -0.036
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.184
         upper limit
    0.112
    Notes
    [15] - Missing values were imputed using LOCF. Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1), IgE level (<200 IU/mL, >=200 IU/mL) and baseline daytime asthma symptom score.

    Secondary: Proportion of Well-controlled Weeks

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    End point title
    Proportion of Well-controlled Weeks
    End point description
    “Well-controlled” week was defined by documentation in the daily diary, as the participant having had no night-time awakenings due to asthma symptoms and less than or equal to (<=) 2 days of short-acting beta agonist (SABA) use per week. ITT population included all participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 24 up to Week 36
    End point values
    Placebo Quilizumab 150 mg Quilizumab 450 mg Quilizumab 300 mg
    Number of subjects analysed
    145
    145
    145
    143
    Units: ratio
        arithmetic mean (standard deviation)
    0.329 ± 0.394
    0.306 ± 0.383
    0.362 ± 0.413
    0.34 ± 0.395
    Statistical analysis title
    Quilizumab 150 mg vs. Placebo
    Statistical analysis description
    Proportion of Well-Controlled Weeks from Week 24 to Week 36: Quilizumab 150 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 150 mg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    superiority [16]
    P-value
    = 0.5819
    Method
    Wilcoxon rank sum test
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.023
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.098
         upper limit
    0.053
    Notes
    [16] - Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1) and IgE level (<200 IU/mL, >=200 IU/mL).
    Statistical analysis title
    Quilizumab 450 mg vs. Placebo
    Statistical analysis description
    Proportion of Well-Controlled Weeks from Week 24 to Week 36: Quilizumab 450 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 450 mg
    Number of subjects included in analysis
    290
    Analysis specification
    Pre-specified
    Analysis type
    superiority [17]
    P-value
    = 0.4941
    Method
    Wilcoxon rank sum test
    Parameter type
    Mean difference (final values)
    Point estimate
    0.033
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.045
         upper limit
    0.111
    Notes
    [17] - Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1) and IgE level (<200 IU/mL, >=200 IU/mL).
    Statistical analysis title
    Quilizumab 300 mg vs. Placebo
    Statistical analysis description
    Proportion of Well-Controlled Weeks from Week 24 to Week 36: Quilizumab 300 mg vs. Placebo
    Comparison groups
    Placebo v Quilizumab 300 mg
    Number of subjects included in analysis
    288
    Analysis specification
    Pre-specified
    Analysis type
    superiority [18]
    P-value
    = 0.9591
    Method
    Wilcoxon rank sum test
    Parameter type
    Mean difference (final values)
    Point estimate
    0.011
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.066
         upper limit
    0.088
    Notes
    [18] - Model was adjusted for periostin status (<50, >=50), number of prior exacerbations (1, >1) and IgE level (<200 IU/mL, >=200 IU/mL).

    Secondary: Number of Participants with Treatment−induced Anti-therapeutic Antibodies (ATAs) and Treatment−enhanced ATAs to Quilizumab

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    End point title
    Number of Participants with Treatment−induced Anti-therapeutic Antibodies (ATAs) and Treatment−enhanced ATAs to Quilizumab
    End point description
    Treatment-induced ATA = a negative or missing baseline ATA result(s) and at least 1 positive postbaseline ATA result. Treatment-enhanced ATA = a positive ATA result at baseline with one or more postbaseline titer results that are at least 0.60 transducing units (t.u.) greater than the baseline titer result. ITT population included all participants who received at least 1 dose of study drug. N (number of subjects analyzed) = number of participants who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 36
    End point values
    Placebo Quilizumab 150 mg Quilizumab 450 mg Quilizumab 300 mg
    Number of subjects analysed
    143
    142
    144
    141
    Units: participants
    number (not applicable)
        Treatment-induced ATAs
    7
    2
    2
    2
        Treatment-enhanced ATAs
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Serum Quilizumab Concentrations at Weeks 4, 12, 24, and 36

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    End point title
    Serum Quilizumab Concentrations at Weeks 4, 12, 24, and 36 [19]
    End point description
    Pharmacokinetics (PK)-evaluable population included all participants who received any amount of quilizumab. Only participants who received quilizumab were to be analyzed for this outcome measure. N (number of subjects analyzed) = number of participants who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 2 hours post-dose on Weeks 4, 12, 24, and 36
    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: Only participants who received quilizumab were to be analyzed for this outcome measure.
    End point values
    Quilizumab 150 mg Quilizumab 450 mg Quilizumab 300 mg
    Number of subjects analysed
    140
    143
    141
    Units: microgram per milliliter
    arithmetic mean (standard deviation)
        Week 4
    5.68 ± 2.34
    17.1 ± 7.04
    11.6 ± 4.54
        Week 12
    2.55 ± 1.99
    7.2 ± 3.8
    16.7 ± 6.67
        Week 24
    1.31 ± 4.57
    2.25 ± 2.21
    16.8 ± 7.71
        Week 36
    0.743 ± 1.75
    2.23 ± 3.4
    18.2 ± 8.65
    No statistical analyses for this end point

    Secondary: Maximum Observed Serum Quilizumab Concentration after Doses at Week 4 (Cmax, Week 5) and Week 24 (Cmax, Week 25)

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    End point title
    Maximum Observed Serum Quilizumab Concentration after Doses at Week 4 (Cmax, Week 5) and Week 24 (Cmax, Week 25) [20]
    End point description
    PK-evaluable population included all participants who received any amount of quilizumab. Only participants who received quilizumab were to be analyzed for this outcome measure. N (number of subjects analyzed) = number of participants who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    2 hours post-dose on Week 4, pre-dose on Week 5, 2 hours post-dose on Week 24, and pre-dose on Week 25
    Notes
    [20] - 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: Only participants who received quilizumab were to be analyzed for this outcome measure.
    End point values
    Quilizumab 150 mg Quilizumab 450 mg Quilizumab 300 mg
    Number of subjects analysed
    140
    143
    141
    Units: microgram per milliliter
    arithmetic mean (standard deviation)
        Cmax, Week 5
    18 ± 7.78
    51.6 ± 19.5
    34 ± 12.6
        Cmax, Week 25
    14.3 ± 5.49
    38.3 ± 15.4
    36.8 ± 15.4
    No statistical analyses for this end point

    Secondary: Time to Reach Maximum Observed Serum Quilizumab Concentration after Doses at Week 4 (tmax, Week 5) and Week 24 (tmax, Week 25)

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    End point title
    Time to Reach Maximum Observed Serum Quilizumab Concentration after Doses at Week 4 (tmax, Week 5) and Week 24 (tmax, Week 25) [21]
    End point description
    PK-evaluable population included all participants who received any amount of quilizumab. Only participants who received quilizumab were to be analyzed for this outcome measure. N (number of subjects analyzed) = number of participants who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    2 hours post-dose on Week 4, pre-dose on Week 5, 2 hours post-dose on Week 24, and pre-dose on Week 25
    Notes
    [21] - 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: Only participants who received quilizumab were to be analyzed for this outcome measure.
    End point values
    Quilizumab 150 mg Quilizumab 450 mg Quilizumab 300 mg
    Number of subjects analysed
    140
    143
    141
    Units: days
    arithmetic mean (standard deviation)
        tmax, Week 5
    36.4 ± 4.25
    36.2 ± 2.99
    36.2 ± 3.51
        tmax, Week 25
    176 ± 6.5
    177 ± 5.47
    176 ± 5.08
    No statistical analyses for this end point

    Secondary: Elimination Half-Life of Quilizumab

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    End point title
    Elimination Half-Life of Quilizumab [22]
    End point description
    PK-evaluable population included all participants who received any amount of quilizumab. Only participants who received quilizumab were to be analyzed for this outcome measure. N (number of subjects analyzed) = number of participants who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 2 hours post-dose on Baseline (Week 0), Weeks 4, 5, 12, 24, 25, 32, 36, 42, 48, 60, 84
    Notes
    [22] - 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: Only participants who received quilizumab were to be analyzed for this outcome measure.
    End point values
    Quilizumab 150 mg Quilizumab 450 mg Quilizumab 300 mg
    Number of subjects analysed
    140
    143
    141
    Units: days
        arithmetic mean (standard deviation)
    18.7 ± 2.45
    17.6 ± 2.89
    16.4 ± 2.42
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 84
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo matched to quilizumab subcutaneously on Weeks 0, 4, 8, 12, 16, 20, 24, 28, and 32.

    Reporting group title
    Quilizumab 150 mg
    Reporting group description
    Participants received quilizumab at the dose of 150 milligram (mg) subcutaneously on Weeks 0, 4, 12, and 24.

    Reporting group title
    Quilizumab 450 mg
    Reporting group description
    Participants received quilizumab at the dose of 450 mg subcutaneously on Weeks 0, 4, 12, and 24.

    Reporting group title
    Quilizumab 300 mg
    Reporting group description
    Participants received quilizumab at the dose of 300 mg subcutaneously on Weeks 0, 4, 8, 12, 16, 20, 24, 28, and 32.

    Serious adverse events
    Placebo Quilizumab 150 mg Quilizumab 450 mg Quilizumab 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 145 (8.28%)
    11 / 145 (7.59%)
    10 / 145 (6.90%)
    16 / 143 (11.19%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    1 / 145 (0.69%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    0 / 143 (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
    Uterine leiomyoma
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hysterectomy
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    1 / 145 (0.69%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Convalescent
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    5 / 145 (3.45%)
    2 / 145 (1.38%)
    6 / 145 (4.14%)
    6 / 143 (4.20%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Major depression
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    0 / 143 (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
    Post−traumatic neck syndrome
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative hernia
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    0 / 143 (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
    Mitral valve prolapse
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Gallbladder enlargement
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankylosing spondylitis
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    1 / 145 (0.69%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastitis
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth infection
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervicitis
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parametritis
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 145 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    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 Quilizumab 150 mg Quilizumab 450 mg Quilizumab 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    90 / 145 (62.07%)
    96 / 145 (66.21%)
    86 / 145 (59.31%)
    81 / 143 (56.64%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 145 (6.21%)
    10 / 145 (6.90%)
    8 / 145 (5.52%)
    7 / 143 (4.90%)
         occurrences all number
    10
    28
    12
    9
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    6 / 145 (4.14%)
    9 / 145 (6.21%)
    11 / 145 (7.59%)
    6 / 143 (4.20%)
         occurrences all number
    26
    37
    33
    45
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    59 / 145 (40.69%)
    61 / 145 (42.07%)
    52 / 145 (35.86%)
    51 / 143 (35.66%)
         occurrences all number
    126
    135
    125
    104
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    26 / 145 (17.93%)
    20 / 145 (13.79%)
    27 / 145 (18.62%)
    22 / 143 (15.38%)
         occurrences all number
    41
    36
    42
    35
    Upper respiratory tract infection
         subjects affected / exposed
    16 / 145 (11.03%)
    15 / 145 (10.34%)
    17 / 145 (11.72%)
    12 / 143 (8.39%)
         occurrences all number
    22
    25
    22
    15
    Bronchitis
         subjects affected / exposed
    18 / 145 (12.41%)
    9 / 145 (6.21%)
    11 / 145 (7.59%)
    15 / 143 (10.49%)
         occurrences all number
    22
    12
    16
    20
    Sinusitis
         subjects affected / exposed
    14 / 145 (9.66%)
    10 / 145 (6.90%)
    9 / 145 (6.21%)
    8 / 143 (5.59%)
         occurrences all number
    23
    18
    13
    13
    Pharyngitis
         subjects affected / exposed
    6 / 145 (4.14%)
    7 / 145 (4.83%)
    8 / 145 (5.52%)
    9 / 143 (6.29%)
         occurrences all number
    9
    7
    12
    10
    Respiratory tract infection
         subjects affected / exposed
    4 / 145 (2.76%)
    5 / 145 (3.45%)
    4 / 145 (2.76%)
    8 / 143 (5.59%)
         occurrences all number
    4
    8
    6
    19
    Rhinitis
         subjects affected / exposed
    2 / 145 (1.38%)
    4 / 145 (2.76%)
    2 / 145 (1.38%)
    9 / 143 (6.29%)
         occurrences all number
    2
    5
    3
    14

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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