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    Clinical Trial Results:
    A Phase 2b Multinational, Randomised, Double-blind, Parallel-group, 24-week Placebo-controlled Study with 28-week Extension to Investigate the Use of Benralizumab in Patients with Chronic Spontaneous Urticaria Who are Symptomatic Despite the Use of Antihistamines (ARROYO)

    Summary
    EudraCT number
    2020-000169-17
    Trial protocol
    BG   DE  
    Global end of trial date
    28 Mar 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Nov 2023
    First version publication date
    09 Nov 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D3259C00001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04612725
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Karlebyhusentren, B674 Astraallen, Södertälje, Sweden, SE-151 85
    Public contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.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
    28 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Mar 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the clinical efficacy of benralizumab compared to placebo in participants with chronic spontaneous urticaria (CSU) who are symptomatic despite the use of H1 antihistamine treatment.
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council for Harmonisation/Good Clinical Practice, applicable regulatory requirements, and the AstraZeneca policy on Bioethics.
    Background therapy
    Participants were maintained on a stable and locally-approved second generation H1 antihistamine treatment for CSU throughout the run-in period.
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Oct 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 46
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Japan: 21
    Country: Number of subjects enrolled
    Korea, Republic of: 8
    Country: Number of subjects enrolled
    Poland: 24
    Country: Number of subjects enrolled
    Spain: 14
    Country: Number of subjects enrolled
    United States: 36
    Worldwide total number of subjects
    155
    EEA total number of subjects
    90
    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)
    133
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This Phase 2b, randomized, double-blind study was conducted in participants with CSU who were symptomatic despite the use of antihistamines at 46 study centers. The study was terminated early by the sponsor as primary results did not support the continued development of benralizumab for the indication of CSU.

    Pre-assignment
    Screening details
    The study had a run-in period (10 days to 4 weeks), followed by a double-blind treatment period (24 weeks) and extension period (28 weeks). A total of 155 participants were randomized and treated in this study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Benralizumab 30 mg
    Arm description
    Participants were randomized to receive benralizumab 30 milligram (mg) subcutaneous (SC) injection every 4 weeks (Q4W) until Week 24 in the double-blind treatment period and then 30 mg Q4W or every 8 weeks (Q8W) during the extension period until Week 52.
    Arm type
    Experimental

    Investigational medicinal product name
    Benralizumab
    Investigational medicinal product code
    MEDI-563
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Benralizumab 30 mg SC injection was administered Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.

    Arm title
    Benralizumab 60 mg
    Arm description
    Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.
    Arm type
    Experimental

    Investigational medicinal product name
    Benralizumab
    Investigational medicinal product code
    MEDI-563
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Benralizumab 60 mg SC injection was administered Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.

    Arm title
    Placebo
    Arm description
    Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.
    Arm type
    Placebo

    Investigational medicinal product name
    Benralizumab
    Investigational medicinal product code
    MEDI-563
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Benralizumab 30 mg SC injection was administered Q4W until Week 36 and then 30 mg Q8W until Week 52 in the extension period.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo SC injection was administered Q4W until Week 24 in the double-blind treatment period.

    Number of subjects in period 1
    Benralizumab 30 mg Benralizumab 60 mg Placebo
    Started
    59
    56
    40
    Completed the treatment period
    53
    53
    37
    Entered extension period
    50
    53
    37
    Completed
    37
    43
    24
    Not completed
    22
    13
    16
         Physician decision
    2
    -
    -
         Consent withdrawn by subject
    11
    6
    9
         Adverse event, non-fatal
    4
    1
    1
         Study terminated by sponsor
    4
    6
    5
         Unspecified
    -
    -
    1
         Lost to follow-up
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Benralizumab 30 mg
    Reporting group description
    Participants were randomized to receive benralizumab 30 milligram (mg) subcutaneous (SC) injection every 4 weeks (Q4W) until Week 24 in the double-blind treatment period and then 30 mg Q4W or every 8 weeks (Q8W) during the extension period until Week 52.

    Reporting group title
    Benralizumab 60 mg
    Reporting group description
    Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.

    Reporting group title
    Placebo
    Reporting group description
    Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.

    Reporting group values
    Benralizumab 30 mg Benralizumab 60 mg Placebo Total
    Number of subjects
    59 56 40 155
    Age Categorical
    Units: Subjects
        <35 years
    11 15 8 34
        >=35 to <=55 years
    32 25 22 79
        >55 years
    16 16 10 42
    Gender Categorical
    Units: Subjects
        Female
    44 45 25 114
        Male
    15 11 15 41
    Race
    Units: Subjects
        White
    46 42 30 118
        Asian
    12 12 8 32
        Black or African American
    1 2 0 3
        Not reported
    0 0 2 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    2 4 4 10
        Not Hispanic or Latino
    57 52 36 145

    End points

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    End points reporting groups
    Reporting group title
    Benralizumab 30 mg
    Reporting group description
    Participants were randomized to receive benralizumab 30 milligram (mg) subcutaneous (SC) injection every 4 weeks (Q4W) until Week 24 in the double-blind treatment period and then 30 mg Q4W or every 8 weeks (Q8W) during the extension period until Week 52.

    Reporting group title
    Benralizumab 60 mg
    Reporting group description
    Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.

    Reporting group title
    Placebo
    Reporting group description
    Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.

    Subject analysis set title
    Benralizumab Q4W Total
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants who received benralizumab 30 mg or 60 mg SC injection Q4W during the study.

    Subject analysis set title
    Benralizumab Q8W Total
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants who received benralizumab 30 mg or 60 mg SC injection Q8W during the study.

    Subject analysis set title
    Benralizumab 30 mg Q4W
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants who received benralizumab 30 mg SC injection Q4W during the study.

    Subject analysis set title
    Benralizumab 30 mg Q8W
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants who received benralizumab 30 mg SC injection Q8W during the study.

    Subject analysis set title
    Benralizumab 60 mg Q4W
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants who received benralizumab 60 mg SC injection Q4W during the study.

    Subject analysis set title
    Benralizumab 60 mg Q8W
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants who received benralizumab 60 mg SC injection Q8W during the study.

    Primary: Least Square (LS) Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7) at Week 12

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    End point title
    Least Square (LS) Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7) at Week 12
    End point description
    The urticaria participant daily diary (UPDD) was completed twice daily (morning and evening) to capture key measures of urticaria disease activity including the itch severity score (ISS). The ISS represents severity on a scale ranging from 0 to 3 (where 0= none, 1= mild, 2= moderate and 3= severe). The ISS7 is the sum of ISS for the previous 7 days. The ISS7 represents itch severity on a scale ranging from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of itch. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization. The full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study.
    End point type
    Primary
    End point timeframe
    Baseline (Day -1) and Week 12
    End point values
    Benralizumab 30 mg Benralizumab 60 mg Placebo
    Number of subjects analysed
    55
    52
    37
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -7.50 (-8.94 to -6.05)
    -8.28 (-9.76 to -6.80)
    -6.49 (-8.24 to -4.74)
    Statistical analysis title
    Treatment difference in ISS7 at Week 12
    Statistical analysis description
    Change from baseline in ISS7 at Week 12= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3824
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -1.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.28
         upper limit
    1.26
    Statistical analysis title
    Treatment difference in ISS7 at Week 12
    Statistical analysis description
    Change from baseline in ISS7 at Week 12= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1244
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -1.79
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.09
         upper limit
    0.5

    Secondary: LS Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Weeks 12 and 24

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    End point title
    LS Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Weeks 12 and 24
    End point description
    The UPDD was completed twice daily (morning and evening) to capture key measures of urticaria disease activity including the UAS7. Participants were asked to document the number of hives they experienced on a scale ranging from 0 to 3 (where 0= none, 1= mild [1 – 6 hives/12 hour], 2= moderate [7 – 12 hives/12 hour] and 3= intense [(> 12 hives/12 hour]). The UAS7 is the sum of UAS for the previous 7 days, that is, the sum of ISS7 and HSS7. The UAS7 represents urticaria severity on a scale from 0 (minimum) to 42 (maximum). Higher scores indicate greater severity of urticaria symptoms. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization. The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. Here, 'n' is number of participants analyzed at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Weeks 12 and 24
    End point values
    Benralizumab 30 mg Benralizumab 60 mg Placebo
    Number of subjects analysed
    55
    53
    37
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 12 (n= 55, 52, 37)
    -14.48 (-17.58 to -11.38)
    -16.77 (-19.94 to -13.59)
    -12.41 (-16.17 to -8.65)
        Week 24 (n= 52, 53, 36)
    -17.99 (-21.29 to -14.68)
    -19.17 (-22.51 to -15.83)
    -15.43 (-19.43 to -11.44)
    Statistical analysis title
    Treatment difference in UAS7 at Week 12
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4016 [1]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -2.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.95
         upper limit
    2.8
    Notes
    [1] - Change from baseline in UAS7 at Week 12= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in UAS7 at Week 12
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0819 [2]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -4.36
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.28
         upper limit
    0.56
    Notes
    [2] - Change from baseline in UAS7 at Week 12= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in UAS7 at Week 24
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3314 [3]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -2.56
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.74
         upper limit
    2.63
    Notes
    [3] - Change from baseline in UAS7 at Week 24= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in UAS7 at Week 24
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1582 [4]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -3.74
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.95
         upper limit
    1.47
    Notes
    [4] - Change from baseline in UAS7 at Week 24= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.

    Secondary: LS Mean Change From Baseline in ISS7 at Week 24

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    End point title
    LS Mean Change From Baseline in ISS7 at Week 24
    End point description
    The UPDD was completed twice daily (morning and evening) to capture key measures of urticaria disease activity including the ISS. The ISS represents severity on a scale ranging from 0 to 3 (where 0= none, 1= mild, 2= moderate and 3= severe). The ISS7 is the sum of ISS for the previous 7 days. The ISS7 represents itch severity on a scale ranging from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of itch. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization. The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Week 24
    End point values
    Benralizumab 30 mg Benralizumab 60 mg Placebo
    Number of subjects analysed
    52
    53
    36
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -9.19 (-10.77 to -7.61)
    -9.33 (-10.93 to -7.73)
    -7.57 (-9.48 to -5.66)
    Statistical analysis title
    Treatment difference in ISS7 at Week 24
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1995 [5]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -1.62
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.1
         upper limit
    0.86
    Notes
    [5] - Change from baseline in ISS7 at Week 24= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in ISS7 at Week 24
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1654 [6]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -1.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.25
         upper limit
    0.73
    Notes
    [6] - Change from baseline in ISS7 at Week 24= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.

    Secondary: Percentage of Responders at Weeks 12 and 24

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    End point title
    Percentage of Responders at Weeks 12 and 24
    End point description
    Responder was defined as a participant whose condition was considered clinically well controlled with UAS7 <=6 at specific time points. The UAS7 is the sum of UAS for the previous 7 days, that is, the sum of ISS7 and HSS7. The UAS7 represents urticaria severity on a scale from 0 (minimum) to 42 (maximum). Higher scores indicate greater severity of urticaria symptoms. The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. Here, 'n' is number of participants analyzed at specific time point and 99999 is no participants were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 12 and 24
    End point values
    Benralizumab 30 mg Benralizumab 60 mg Placebo
    Number of subjects analysed
    59
    56
    40
    Units: percentage of participants
    number (not applicable)
        Week 12 (n= 59, 56, 40)
    22.0
    21.4
    10.0
        Week 24 (n= 59, 56, 40)
    28.8
    37.5
    27.5
    Statistical analysis title
    Treatment difference in Responders at Week 12
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1373 [7]
    Method
    Regression, Logistic
    Parameter type
    percentage difference
    Point estimate
    11.72
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.37
         upper limit
    25.82
    Notes
    [7] - Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.
    Statistical analysis title
    Treatment difference in Responders at Week 12
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1697 [8]
    Method
    Regression, Logistic
    Parameter type
    percentage difference
    Point estimate
    10.73
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.42
         upper limit
    24.88
    Notes
    [8] - Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.
    Statistical analysis title
    Treatment difference in Responders at Week 24
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9105 [9]
    Method
    Regression, Logistic
    Parameter type
    percentage difference
    Point estimate
    1.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -16.9
         upper limit
    18.96
    Notes
    [9] - Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.
    Statistical analysis title
    Treatment difference in Responders at Week 24
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3389 [10]
    Method
    Regression, Logistic
    Parameter type
    percentage difference
    Point estimate
    9.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.37
         upper limit
    27.9
    Notes
    [10] - Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.

    Secondary: LS Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7) at Weeks 12 and 24

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    End point title
    LS Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7) at Weeks 12 and 24
    End point description
    The UPDD was completed twice daily (morning and evening) to capture key measures of urticaria disease activity including the HSS7. Participants were asked to document the number of hives they experienced on a scale ranging from 0 to 3 (where 0= none, 1= mild [1 – 6 hives/12 hour], 2= moderate [7 – 12 hives/12 hour] and 3= intense [(> 12 hives/12 hour]). The HSS7 is the sum of hives severity score for the previous 7 days. The HSS7 represents hives severity on a scale from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of hives. Baseline was defined as the sum of the daily scores for the 7 days prior to the day of randomization. The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. Here, 'n' is number of participants analyzed at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Weeks 12 and 24
    End point values
    Benralizumab 30 mg Benralizumab 60 mg Placebo
    Number of subjects analysed
    55
    53
    37
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 12 (n= 55, 52, 37)
    -7.03 (-8.84 to -5.22)
    -8.47 (-10.32 to -6.62)
    -5.87 (-8.06 to -3.68)
        Week 24 (n= 52, 53, 36)
    -8.88 (-10.76 to -7.00)
    -9.81 (-11.71 to -7.91)
    -7.82 (-10.09 to -5.54)
    Statistical analysis title
    Treatment difference in HSS7 at Week 12
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4203 [11]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -1.16
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4
         upper limit
    1.68
    Notes
    [11] - Change from baseline in HSS7 at Week 12= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in HSS7 at Week 12
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0754 [12]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -2.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.46
         upper limit
    0.27
    Notes
    [12] - Change from baseline in HSS7 at Week 12= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in HSS7 at Week 24
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4772 [13]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -1.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.01
         upper limit
    1.89
    Notes
    [13] - Change from baseline in HSS7 at Week 24= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in HSS7 at Week 24
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1851 [14]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.96
         upper limit
    0.97
    Notes
    [14] - Change from baseline in HSS7 at Week 24= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.

    Secondary: Time to >=5-Point Decrease in ISS7

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    End point title
    Time to >=5-Point Decrease in ISS7
    End point description
    The time to >=5-point decrease (clinically relevant decrease) in ISS7 was reported. The ISS7 is the sum of ISS for the previous 7 days. The ISS7 represents itch severity on a scale ranging from 0 (minimum) to 21 (maximum). Higher scores indicate greater intensity of itch. The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. Only participants with at least 1 >=5-point decrease in ISS7 are analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day -1) up to Week 24
    End point values
    Benralizumab 30 mg Benralizumab 60 mg Placebo
    Number of subjects analysed
    48
    50
    33
    Units: weeks
        median (confidence interval 95%)
    3.0 (2.0 to 5.0)
    2.0 (2.0 to 3.0)
    8.0 (3.0 to 11.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Complete UAS7 Response at Weeks 12 and 24

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    End point title
    Percentage of Participants With Complete UAS7 Response at Weeks 12 and 24
    End point description
    Complete response was defined as participants with UAS7= 0 at specific time points. The UAS7 is the sum of UAS for the previous 7 days, that is, the sum of ISS7 and HSS7. The UAS7 represents urticaria severity on a scale from 0 (minimum) to 42 (maximum). Higher scores indicate greater severity of urticaria symptoms. The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. Here, 'n' is number of participants analyzed at specific time point and 99999 is no participants were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 12 and 24
    End point values
    Benralizumab 30 mg Benralizumab 60 mg Placebo
    Number of subjects analysed
    59
    56
    40
    Units: percentage of participants
    number (not applicable)
        Week 12 (n= 59, 56, 40)
    11.9
    7.1
    10.0
        Week 24 (n= 59, 56, 40)
    16.9
    21.4
    20.0
    Statistical analysis title
    Treatment difference in UAS7 Response at Week 12
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9678 [15]
    Method
    Regression, Logistic
    Confidence interval
    Notes
    [15] - Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.
    Statistical analysis title
    Treatment difference in UAS7 Response at Week 12
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3689 [16]
    Method
    Regression, Logistic
    Confidence interval
    Notes
    [16] - Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.
    Statistical analysis title
    Treatment difference in UAS7 Response at Week 24
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6624 [17]
    Method
    Regression, Logistic
    Parameter type
    percentage difference
    Point estimate
    -3.43
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -18.96
         upper limit
    12.11
    Notes
    [17] - Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.
    Statistical analysis title
    Treatment difference in UAS7 Response at Week 24
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9726 [18]
    Method
    Regression, Logistic
    Parameter type
    percentage difference
    Point estimate
    0.28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -15.84
         upper limit
    16.4
    Notes
    [18] - Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.

    Secondary: Mean Percentage of Angioedema-Free Days Over the Past 7 Days at Weeks 12 and 24

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    End point title
    Mean Percentage of Angioedema-Free Days Over the Past 7 Days at Weeks 12 and 24
    End point description
    The UPDD included a daily yes/no question asking whether the participant experienced angioedema during the past 24 hours. If yes, the participant was asked a follow-up question about how they treated the swelling. The percentage of angioedema-free days was calculated over the past 7 days by (number of angioedema-free days/number of non-missing responses) x 100. The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. Only participants with angioedema at baseline or history of angioedema are analyzed. Here, 'n' is number of participants analyzed at specific time point.
    End point type
    Secondary
    End point timeframe
    Weeks 12 and 24
    End point values
    Benralizumab 30 mg Benralizumab 60 mg Placebo
    Number of subjects analysed
    36
    28
    22
    Units: percentage of days
    arithmetic mean (standard deviation)
        Week 12 (n= 36, 27, 22)
    77.50 ( 35.990 )
    85.63 ( 32.435 )
    81.93 ( 34.548 )
        Week 24 (n= 32, 28, 20)
    78.50 ( 36.992 )
    91.33 ( 27.032 )
    86.79 ( 31.798 )
    No statistical analyses for this end point

    Secondary: LS Mean Change From Baseline in Urticaria Control Test (UCT) at Weeks 12 and 24

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    End point title
    LS Mean Change From Baseline in Urticaria Control Test (UCT) at Weeks 12 and 24
    End point description
    Urticaria disease control was assessed by the UCT using the electronic participant-reported outcome device. The UCT has a retrospective approach using a recall period of 4 weeks and responses on 5-point Likert scales with score ranging from 0 to 4 for each question. Subsequently, the scores for all 4 questions were summed up. The UCT scale range from 0 (minimum) to 16 (maximum). Higher scores indicate better disease control. The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. Here, 'n' is number of participants analyzed at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Weeks 12 and 24
    End point values
    Benralizumab 30 mg Benralizumab 60 mg Placebo
    Number of subjects analysed
    55
    52
    38
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 12 (n= 55, 51, 38)
    4.74 (3.71 to 5.76)
    6.11 (5.05 to 7.17)
    5.02 (3.78 to 6.26)
        Week 24 (n= 51, 52, 37)
    5.24 (4.04 to 6.45)
    6.87 (5.65 to 8.09)
    5.88 (4.44 to 7.32)
    Statistical analysis title
    Treatment difference in UCT at Week 12
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7256 [19]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -0.29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.9
         upper limit
    1.32
    Notes
    [19] - Change from baseline in UCT at Week 12= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in UCT at Week 12
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.189 [20]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    1.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.54
         upper limit
    2.72
    Notes
    [20] - Change from baseline in UCT at Week 12= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in UCT at Week 24
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5048 [21]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -0.63
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.51
         upper limit
    1.24
    Notes
    [21] - Change from baseline in UCT at Week 24= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in UCT at Week 24
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2991 [22]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    0.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.89
         upper limit
    2.88
    Notes
    [22] - Change from baseline in UCT at Week 24= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.

    Secondary: LS Mean Change From Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) at Weeks 12 and 24

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    End point title
    LS Mean Change From Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) at Weeks 12 and 24
    End point description
    The CU-Q2oL is a 23-item assessment of CSU-specific health-related quality of life. Participants were asked to rate their CSU symptoms and the impact of their symptoms over the last 2 weeks on several domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. The questions were scored as 1= not at all, 2= a little, 3= moderately, 4= very much, 5= extremely. The CU-Q2oL scale range from 0 (minimum) to 100 (maximum). Higher scores indicate greater impact of urticaria on health-related quality of life. The FAS included all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. Here, 'n' is number of participants analyzed at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Weeks 12 and 24
    End point values
    Benralizumab 30 mg Benralizumab 60 mg Placebo
    Number of subjects analysed
    55
    52
    38
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 12 (n= 55, 51, 38)
    -16.47 (-20.10 to -12.84)
    -20.34 (-24.09 to -16.60)
    -18.10 (-22.46 to -13.74)
        Week 24 (n= 51, 52, 37)
    -17.60 (-21.81 to -13.40)
    -22.11 (-26.38 to -17.84)
    -19.07 (-24.09 to -14.05)
    Statistical analysis title
    Treatment difference in CU-Q2oL at Week 12
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5704 [23]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    1.63
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.05
         upper limit
    7.32
    Notes
    [23] - Change from baseline in CU-Q2oL at Week 12= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in CU-Q2oL at Week 12
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4416 [24]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -2.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.98
         upper limit
    3.5
    Notes
    [24] - Change from baseline in CU-Q2oL at Week 12= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in CU-Q2oL at Week 24
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6591 [25]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    1.47
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.09
         upper limit
    8.02
    Notes
    [25] - Change from baseline in CU-Q2oL at Week 24= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in CU-Q2oL at Week 24
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3624 [26]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -3.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.62
         upper limit
    3.54
    Notes
    [26] - Change from baseline in CU-Q2oL at Week 24= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.

    Secondary: LS Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 12 and 24

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    End point title
    LS Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 12 and 24
    End point description
    The DLQI is a 10-item assessment of dermatology-specific health-related quality of life. Participants were asked to rate their symptoms and impact of their symptoms over last week on several domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Questions (except question 7) were scored on a 4-point Likert scale: 0= not at all, 1= a little, 2= a lot, 3= very much. Scoring question 7, first part asked: 'Over the last week, has your skin prevented you from working or studying?' Scoring was for response of 0= not relevant and 3= yes. If no, a further question was asked: 'How much has your skin been a problem at work or studying', and scored as: 0= not at all, 1= a little, 2= a lot. The DLQI was calculated by summing score of each question. The DLQI scale range from 0 (minimum) to 30 (maximum). Higher scores indicate greater impact on participant’s life. FAS population. n= number of participants analyzed at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -1) and Weeks 12 and 24
    End point values
    Benralizumab 30 mg Benralizumab 60 mg Placebo
    Number of subjects analysed
    55
    52
    38
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 12 (n= 55, 51, 38)
    -7.58 (-9.18 to -5.98)
    -9.31 (-10.96 to -7.66)
    -8.06 (-9.98 to -6.14)
        Week 24 (n= 51, 52, 37)
    -8.13 (-9.84 to -6.42)
    -10.25 (-11.98 to -8.51)
    -9.37 (-11.41 to -7.33)
    Statistical analysis title
    Treatment difference in DLQI at Week 12
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7037 [27]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    0.48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.02
         upper limit
    2.98
    Notes
    [27] - Change from baseline in DLQI at Week 12= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in DLQI at Week 12
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.332 [28]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -1.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.78
         upper limit
    1.29
    Notes
    [28] - Change from baseline in DLQI at Week 12= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in DLQI at Week 24
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.359 [29]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    1.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.42
         upper limit
    3.9
    Notes
    [29] - Change from baseline in DLQI at Week 24= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.
    Statistical analysis title
    Treatment difference in DLQI at Week 24
    Comparison groups
    Benralizumab 60 mg v Placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5175 [30]
    Method
    Mixed-effect model for repeated measures
    Parameter type
    LS mean difference
    Point estimate
    -0.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.56
         upper limit
    1.8
    Notes
    [30] - Change from baseline in DLQI at Week 24= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.

    Secondary: Serum Concentration of Benralizumab

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    End point title
    Serum Concentration of Benralizumab
    End point description
    Blood samples were collected to determine the serum concentration of benralizumab. The Pharmacokinetic (PK) analysis set included all participants who received study drug and from whom PK blood samples were assumed not to be affected by factors such as protocol violations and who had at least 1 quantifiable serum PK observation post first dose. Here, 'n' is number of participants analyzed at specific time point; 9999= below the lower limit of quantification (LLOQ). The LLOQ is 3.86 nanogram per milliliter (ng/mL) and 99999= no participants were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose on Weeks 4, 12 and 24
    End point values
    Benralizumab 30 mg Benralizumab 60 mg Placebo
    Number of subjects analysed
    55
    54
    34
    Units: ng/mL
    arithmetic mean (standard deviation)
        Week 4 (n=55,54,0)
    990.515 ( 448.6799 )
    2167.606 ( 991.7509 )
    99999 ( 99999 )
        Week 12 (n=53,52,0)
    1321.373 ( 740.5070 )
    3145.352 ( 1577.6726 )
    99999 ( 99999 )
        Week 24 (n=47,49,34)
    1372.806 ( 883.5830 )
    1638.810 ( 946.9466 )
    9999 ( 9999 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Anti-Drug Antibody (ADA) Response to Benralizumab

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    End point title
    Number of Participants With Anti-Drug Antibody (ADA) Response to Benralizumab
    End point description
    Blood samples were measured for presence of ADAs for benralizumab using validated assays. The ADA incidence was defined as ADA negative at baseline and post-baseline ADA positive or ADA positive at baseline and boosted pre-existing titre by > 4-fold during study period. Persistently positive was defined as ADA negative at baseline and positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as ADA negative at baseline, having at least 1 post-baseline ADA positive assessment and not fulfilling conditions of persistently positive. The median of maximum titres was calculated based on maximum titre for each ADA positive participant within each treatment group (including both baseline and post-baseline measurements). The Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'n' is number of participants analyzed for each parameter.
    End point type
    Secondary
    End point timeframe
    Pre-dose on Weeks 12 and 24
    End point values
    Benralizumab 30 mg Benralizumab 60 mg Placebo
    Number of subjects analysed
    59 [31]
    56 [32]
    40 [33]
    Units: participants
        ADA prevalence
    18
    13
    4
        ADA negative
    37
    41
    33
        Only baseline positive
    1
    1
    0
        Baseline and at least 1 post-baseline positive
    3
    4
    0
        ADA incidence
    15
    10
    4
        ADA persistently positive
    10
    4
    4
        ADA transiently positive
    5
    5
    0
        ADA positive:Maximum titre>median maximum titres
    8
    5
    1
        ADA positive:Maximum titre<=median maximum titres
    10
    8
    3
    Notes
    [31] - n= 59, 54, 55, 59, 54, 54, 54, 59, 59.
    [32] - n= 56, 54, 55, 56, 54, 54, 54, 56, 56.
    [33] - n= 40, 37, 39, 40, 37, 37, 37, 40, 40.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are reported from the first dose administration up to 30 days after the last dose of study drug, a maximum of approximately 57 weeks.
    Adverse event reporting additional description
    The Safety analysis set included all participants who received at least 1 dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Benralizumab 30 mg Total
    Reporting group description
    Participants were randomized to receive benralizumab 30 mg SC injection Q4W until Week 24 in the double-blind treatment period and then 30 mg Q4W or Q8W during the extension period until Week 52.

    Reporting group title
    Placebo
    Reporting group description
    Participants were randomized to receive placebo matching with benralizumab Q4W until Week 24 in the double-blind treatment period followed by benralizumab 30 mg SC injection Q4W until Week 36 and then 30 mg Q8W until Week 52.

    Reporting group title
    Benralizumab Q4W Total
    Reporting group description
    Participants who received benralizumab 30 mg or 60 mg SC injection Q4W during the study.

    Reporting group title
    Benralizumab 60 mg Total
    Reporting group description
    Participants were randomized to receive benralizumab 60 mg SC injection Q4W until Week 12 and then 30 mg Q4W until Week 24 in the double-blind treatment period followed by 30 mg Q4W or Q8W during the extension period until Week 52.

    Reporting group title
    Benralizumab Q8W Total
    Reporting group description
    Participants who received benralizumab 30 mg or 60 mg SC injection Q8W during the study.

    Reporting group title
    Benralizumab 30 mg Q8W
    Reporting group description
    Participants who received benralizumab 30 mg SC injection Q8W during the study.

    Reporting group title
    Benralizumab 30 mg Q4W
    Reporting group description
    Participants who received benralizumab 30 mg SC injection Q4W during the study.

    Reporting group title
    Benralizumab 60 mg Q4W
    Reporting group description
    Participants who received benralizumab 60 mg SC injection Q4W during the study.

    Reporting group title
    Benralizumab 60 mg Q8W
    Reporting group description
    Participants who received benralizumab 60 mg SC injection Q8W during the study.

    Serious adverse events
    Benralizumab 30 mg Total Placebo Benralizumab Q4W Total Benralizumab 60 mg Total Benralizumab Q8W Total Benralizumab 30 mg Q8W Benralizumab 30 mg Q4W Benralizumab 60 mg Q4W Benralizumab 60 mg Q8W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 59 (10.17%)
    2 / 40 (5.00%)
    4 / 58 (6.90%)
    2 / 56 (3.57%)
    4 / 57 (7.02%)
    3 / 29 (10.34%)
    3 / 30 (10.00%)
    1 / 28 (3.57%)
    1 / 28 (3.57%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 40 (0.00%)
    0 / 58 (0.00%)
    0 / 56 (0.00%)
    1 / 57 (1.75%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 40 (2.50%)
    0 / 58 (0.00%)
    0 / 56 (0.00%)
    0 / 57 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 40 (0.00%)
    0 / 58 (0.00%)
    0 / 56 (0.00%)
    1 / 57 (1.75%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 40 (0.00%)
    1 / 58 (1.72%)
    0 / 56 (0.00%)
    0 / 57 (0.00%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 40 (0.00%)
    0 / 58 (0.00%)
    0 / 56 (0.00%)
    1 / 57 (1.75%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 40 (0.00%)
    1 / 58 (1.72%)
    0 / 56 (0.00%)
    0 / 57 (0.00%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 40 (2.50%)
    0 / 58 (0.00%)
    0 / 56 (0.00%)
    0 / 57 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 40 (0.00%)
    1 / 58 (1.72%)
    0 / 56 (0.00%)
    0 / 57 (0.00%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 59 (0.00%)
    0 / 40 (0.00%)
    1 / 58 (1.72%)
    1 / 56 (1.79%)
    0 / 57 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Ureterolithiasis
         subjects affected / exposed
    0 / 59 (0.00%)
    0 / 40 (0.00%)
    0 / 58 (0.00%)
    1 / 56 (1.79%)
    1 / 57 (1.75%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Benralizumab 30 mg Total Placebo Benralizumab Q4W Total Benralizumab 60 mg Total Benralizumab Q8W Total Benralizumab 30 mg Q8W Benralizumab 30 mg Q4W Benralizumab 60 mg Q4W Benralizumab 60 mg Q8W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 59 (54.24%)
    22 / 40 (55.00%)
    35 / 58 (60.34%)
    32 / 56 (57.14%)
    29 / 57 (50.88%)
    15 / 29 (51.72%)
    17 / 30 (56.67%)
    18 / 28 (64.29%)
    14 / 28 (50.00%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    3 / 59 (5.08%)
    1 / 40 (2.50%)
    3 / 58 (5.17%)
    1 / 56 (1.79%)
    1 / 57 (1.75%)
    1 / 29 (3.45%)
    2 / 30 (6.67%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    3
    1
    3
    1
    1
    1
    2
    1
    0
    Thermal burn
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 40 (0.00%)
    2 / 58 (3.45%)
    0 / 56 (0.00%)
    0 / 57 (0.00%)
    0 / 29 (0.00%)
    2 / 30 (6.67%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    2
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 40 (2.50%)
    1 / 58 (1.72%)
    4 / 56 (7.14%)
    4 / 57 (7.02%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    1 / 28 (3.57%)
    3 / 28 (10.71%)
         occurrences all number
    1
    1
    1
    4
    4
    1
    0
    1
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 40 (2.50%)
    2 / 58 (3.45%)
    2 / 56 (3.57%)
    0 / 57 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    2 / 28 (7.14%)
    0 / 28 (0.00%)
         occurrences all number
    0
    2
    2
    2
    0
    0
    0
    2
    0
    Headache
         subjects affected / exposed
    4 / 59 (6.78%)
    3 / 40 (7.50%)
    5 / 58 (8.62%)
    5 / 56 (8.93%)
    4 / 57 (7.02%)
    2 / 29 (6.90%)
    2 / 30 (6.67%)
    3 / 28 (10.71%)
    2 / 28 (7.14%)
         occurrences all number
    4
    3
    5
    5
    4
    2
    2
    3
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 59 (5.08%)
    2 / 40 (5.00%)
    4 / 58 (6.90%)
    3 / 56 (5.36%)
    2 / 57 (3.51%)
    2 / 29 (6.90%)
    1 / 30 (3.33%)
    3 / 28 (10.71%)
    0 / 28 (0.00%)
         occurrences all number
    5
    2
    6
    4
    3
    3
    2
    4
    0
    Immune system disorders
    Immunisation reaction
         subjects affected / exposed
    1 / 59 (1.69%)
    2 / 40 (5.00%)
    4 / 58 (6.90%)
    3 / 56 (5.36%)
    0 / 57 (0.00%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    3 / 28 (10.71%)
    0 / 28 (0.00%)
         occurrences all number
    2
    2
    6
    4
    0
    0
    2
    4
    0
    Gastrointestinal disorders
    Dental caries
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 40 (2.50%)
    0 / 58 (0.00%)
    1 / 56 (1.79%)
    3 / 57 (5.26%)
    2 / 29 (6.90%)
    0 / 30 (0.00%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    2
    1
    0
    1
    3
    2
    0
    0
    1
    Nausea
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 40 (0.00%)
    3 / 58 (5.17%)
    3 / 56 (5.36%)
    2 / 57 (3.51%)
    1 / 29 (3.45%)
    1 / 30 (3.33%)
    2 / 28 (7.14%)
    1 / 28 (3.57%)
         occurrences all number
    2
    0
    3
    3
    2
    1
    1
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 59 (0.00%)
    0 / 40 (0.00%)
    2 / 58 (3.45%)
    2 / 56 (3.57%)
    0 / 57 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    2 / 28 (7.14%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    2
    2
    0
    0
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 40 (2.50%)
    3 / 58 (5.17%)
    2 / 56 (3.57%)
    1 / 57 (1.75%)
    1 / 29 (3.45%)
    1 / 30 (3.33%)
    2 / 28 (7.14%)
    0 / 28 (0.00%)
         occurrences all number
    2
    1
    3
    2
    1
    1
    1
    2
    0
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 40 (0.00%)
    2 / 58 (3.45%)
    0 / 56 (0.00%)
    0 / 57 (0.00%)
    0 / 29 (0.00%)
    2 / 30 (6.67%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 59 (3.39%)
    4 / 40 (10.00%)
    1 / 58 (1.72%)
    2 / 56 (3.57%)
    3 / 57 (5.26%)
    1 / 29 (3.45%)
    1 / 30 (3.33%)
    0 / 28 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    2
    9
    1
    2
    3
    1
    1
    0
    2
    Back pain
         subjects affected / exposed
    3 / 59 (5.08%)
    1 / 40 (2.50%)
    2 / 58 (3.45%)
    3 / 56 (5.36%)
    4 / 57 (7.02%)
    2 / 29 (6.90%)
    1 / 30 (3.33%)
    1 / 28 (3.57%)
    2 / 28 (7.14%)
         occurrences all number
    3
    1
    3
    4
    4
    2
    1
    2
    2
    Myalgia
         subjects affected / exposed
    3 / 59 (5.08%)
    1 / 40 (2.50%)
    2 / 58 (3.45%)
    1 / 56 (1.79%)
    2 / 57 (3.51%)
    1 / 29 (3.45%)
    2 / 30 (6.67%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    5
    1
    4
    2
    3
    1
    4
    0
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 59 (5.08%)
    1 / 40 (2.50%)
    3 / 58 (5.17%)
    1 / 56 (1.79%)
    1 / 57 (1.75%)
    1 / 29 (3.45%)
    2 / 30 (6.67%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    3
    1
    4
    2
    1
    1
    2
    2
    0
    COVID-19
         subjects affected / exposed
    8 / 59 (13.56%)
    6 / 40 (15.00%)
    9 / 58 (15.52%)
    10 / 56 (17.86%)
    9 / 57 (15.79%)
    5 / 29 (17.24%)
    3 / 30 (10.00%)
    6 / 28 (21.43%)
    4 / 28 (14.29%)
         occurrences all number
    8
    6
    10
    11
    9
    5
    3
    7
    4
    Nasopharyngitis
         subjects affected / exposed
    5 / 59 (8.47%)
    4 / 40 (10.00%)
    7 / 58 (12.07%)
    6 / 56 (10.71%)
    4 / 57 (7.02%)
    2 / 29 (6.90%)
    3 / 30 (10.00%)
    4 / 28 (14.29%)
    2 / 28 (7.14%)
         occurrences all number
    8
    5
    10
    7
    5
    3
    5
    5
    2
    Onychomycosis
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 40 (0.00%)
    2 / 58 (3.45%)
    0 / 56 (0.00%)
    0 / 57 (0.00%)
    0 / 29 (0.00%)
    2 / 30 (6.67%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    2
    0
    0
    Periodontitis
         subjects affected / exposed
    0 / 59 (0.00%)
    0 / 40 (0.00%)
    2 / 58 (3.45%)
    2 / 56 (3.57%)
    0 / 57 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    2 / 28 (7.14%)
    0 / 28 (0.00%)
         occurrences all number
    0
    0
    2
    2
    0
    0
    0
    2
    0
    Sinusitis
         subjects affected / exposed
    3 / 59 (5.08%)
    4 / 40 (10.00%)
    2 / 58 (3.45%)
    0 / 56 (0.00%)
    1 / 57 (1.75%)
    1 / 29 (3.45%)
    2 / 30 (6.67%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences all number
    3
    5
    2
    0
    1
    1
    2
    0
    0

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jun 2020
    The description of the participants to be enrolled into the study was updated to remove moderate to severe CSU and replace with participants with symptoms not well controlled by standard of care with antihistamines. The primary endpoints have been amended to replace UAS7 with the Itch Severity Score 7 (ISS7) and the secondary endpoints have been amended to replace the ISS7 with the UAS7 and details of the power calculation have been updated to reflect this change. In addition, the reference for the sample size calculation has been updated. New wording was added which would give guidance on how the study could continue in the event of a serious disruption with details of mitigation that could be employed to ensure study continuity.

    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.
    The study was terminated early by the sponsor as the primary analysis results did not support the continued development of benralizumab for the indication of CSU.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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