Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Non-Cystic Fibrosis Bronchiectasis (MAHALE)

    Summary
    EudraCT number
    		 2020-004068-24
    Trial protocol
    		 DK   DE   PL   IT  
    Global end of trial date
    16 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 May 2025
    First version publication date
    02 May 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D325BC00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05006573
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    151 85, Sodertalje, Sweden,
    Public contact
    AstraZeneca Information Center, AstraZeneca, +1 8002369933, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Head, AstraZeneca, +1 8772409479, 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
    17 Jun 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect of benralizumab 30 mg Q4W on bronchiectasis exacerbations
    Protection of trial subjects
    This study is conducted in accordance with the protocol and with the following: Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines; Applicable International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) Guidelines; Applicable laws and regulations. The protocol, protocol amendments, Informed Consent Form (ICF), Investigator Brochure, and other relevant documents (e.g. advertisements) must be submitted to an Institutional Review Board/Independent Ethics Committee (IRB/IEC) by the Investigator and reviewed and approved by the IRB/IEC before the study is initiated. Any amendments to the protocol will require IRB/IEC approval before implementation of changes made to the study design, except for changes necessary to eliminate an immediate hazard to study patients. Where applicable as per relevant laws and regulations, amendments will also be submitted to, reviewed and approved by regulatory authorities/national competent authorities.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jul 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 8 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 6
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    China: 6
    Country: Number of subjects enrolled
    India: 5
    Country: Number of subjects enrolled
    Philippines: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 11
    Country: Number of subjects enrolled
    Viet Nam: 19
    Country: Number of subjects enrolled
    Argentina: 12
    Country: Number of subjects enrolled
    Australia: 16
    Country: Number of subjects enrolled
    Denmark: 15
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Russian Federation: 13
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    United Kingdom: 1
    Worldwide total number of subjects
    139
    EEA total number of subjects
    42
    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)
    77
    From 65 to 84 years
    62
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 100 participants were randomized to receive treatment in study D325BC00001 (MAHALE) with benralizumab 30 mg or placebo. Of the 100 patients randomized, 99 (99%) received treatment with study drug. 54 (54%) patients received benralizumab 30 mg and 45 (45%) patients received placebo.

    Pre-assignment
    Screening details
    		 All patients completed a screening period of 2 to 6 weeks during which inclusion/exclusion criteria was assessed, disease activity, lung function and patient reported outcomes (PROs) were recorded, medical history and clinical laboratory were taken.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Benralizumab 30 mg
    Arm description
    		 Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benralizumab
    Investigational medicinal product code
    Other name
    Fasenra
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Benralizumab 30 mg administered subcutaneously every 4 weeks

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo injection delivered subcutaneously every 4 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching placebo administrated subcutaneously every 4 weeks

    Number of subjects in period 1 [1]
    		Benralizumab 30 mg Placebo
    Started
    54
    45
    Completed
    42
    42
    Not completed
    12
    3
         Physician decision
    2
    -
         Consent withdrawn by subject
    7
    2
         other reasons
    -
    1
         Study terminated by sponsor
    1
    -
         Protocol deviation
    2
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Not every enrolled participant got dosed. Some participants enrolled (signed consent) but failed screening so they did not start double-blind treatment period.
    Period 2
    Period 2 title
    Open-label extension period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Benralizumab 30 mg
    Arm description
    		 Benralizumab 30 mg injection delivered subcutaneously every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benralizumab
    Investigational medicinal product code
    Other name
    Fasenra
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Benralizumab 30 mg administered subcutaneously every 4 weeks

    Arm title
    		 Placebo switched to Benralizumab 30 mg
    Arm description
    		 Subjects who received placebo in the double-blind period switched to Benralizumab 30 mg injection delivered subcutaneously every 4 weeks in open-label extension period
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benralizumab
    Investigational medicinal product code
    Other name
    Fasenra
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Benralizumab 30 mg administrated subcutaneously every 4 weeks

    Number of subjects in period 2 [2]
    		Benralizumab 30 mg Placebo switched to Benralizumab 30 mg
    Started
    38
    40
    Completed
    38
    39
    Not completed
    0
    1
         other reason
    -
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all participants enrolled in the open-label extension period.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Benralizumab 30 mg
    Reporting group description
    		 Benralizumab 30 mg injection delivered subcutaneously every 4 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo injection delivered subcutaneously every 4 weeks

    Reporting group values
    		 Benralizumab 30 mg Placebo Total
    Number of subjects
    		 54 45 99
    Age Categorical
    Units: participants
        >= 18 to <= 65 years
    		 34 21 55
        > 65 years
    		 20 24 44
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.2 ( 13.14 ) 59.2 ( 15.49 ) -
    Sex: Female, Male
    Units:
        Female
    		 37 35 72
        Male
    		 17 10 27
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 17 14 31
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 36 31 67
        More than one race
    		 1 0 1
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 4 7 11
        Not Hispanic or Latino
    		 50 38 88
        Unknown or Not Reported
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who were randomized and received any Investigational Product.

    Subject analysis sets values
    		 Full Analysis Set
    Number of subjects
    99
    Age Categorical
    Units: participants
        >= 18 to <= 65 years
    55
        > 65 years
    44
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    59.2 ( 14.18 )
    Sex: Female, Male
    Units:
        Female
    72
        Male
    27
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
        Asian
    31
        Native Hawaiian or Other Pacific Islander
    0
        Black or African American
    0
        White
    67
        More than one race
    1
        Unknown or Not Reported
    0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    11
        Not Hispanic or Latino
    88
        Unknown or Not Reported
    0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Benralizumab 30 mg
    Reporting group description
    		 Benralizumab 30 mg injection delivered subcutaneously every 4 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo injection delivered subcutaneously every 4 weeks
    Reporting group title
    Benralizumab 30 mg
    Reporting group description
    		 Benralizumab 30 mg injection delivered subcutaneously every 4 weeks

    Reporting group title
    Placebo switched to Benralizumab 30 mg
    Reporting group description
    		 Subjects who received placebo in the double-blind period switched to Benralizumab 30 mg injection delivered subcutaneously every 4 weeks in open-label extension period

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who were randomized and received any Investigational Product.

    Primary: Annualized bronchiectasis exacerbations rate in the double-blind period

    		 Close Top of page
    End point title
    		 Annualized bronchiectasis exacerbations rate in the double-blind period
    End point description
    Annualized Non-Cystic Fibrosis Bronchiectasis (NCFB) exacerbations rate through end of double-blind treatment period.
    End point type
    Primary
    End point timeframe
    Double-blind period
    End point values
    		 Benralizumab 30 mg Placebo
    Number of subjects analysed
    54
    45
    Units: exacerbations per year
        least squares mean (confidence interval 95%)
    1.44 (1.05 to 1.97)
    1.27 (0.89 to 1.80)
    Statistical analysis title
    		 negative binomial model
    Statistical analysis description
    The rate ratio (Benralizumab/Placebo) and its 95% CI are estimated using a negative binomial model. The covariates include treatment arm, baseline blood eosinophil category, and number of exacerbations from previous year.
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.5911
    Method
    		 negative binomial model
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.82
    Notes
    [1] - marginal standardization method is used.

    Secondary: Time to first exacerbation in the double-blind treatment period

    		 Close Top of page
    End point title
    		 Time to first exacerbation in the double-blind treatment period
    End point description
    Time to first NCFB exacerbation in the double-blind treatment period
    End point type
    Secondary
    End point timeframe
    Double-blind period
    End point values
    		 Benralizumab 30 mg Placebo
    Number of subjects analysed
    54
    45
    Units: participants
    32
    26
    Statistical analysis title
    		 Cox proportional hazards model
    Statistical analysis description
    The analysis is performed using cox proportional hazards model with covariates of treatment group, number of exacerbations in previous year and baseline eosinophil category.
    Comparison groups
    Benralizumab 30 mg v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6677
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.91

    Secondary: Change from baseline in QoL-B-RSS over the double-blind period

    		 Close Top of page
    End point title
    		 Change from baseline in QoL-B-RSS over the double-blind period
    End point description
    Change from baseline in Quality of Life-Bronchiectasis-Respiratory Symptoms Scale over the double-blind treatment period. QoL-B-RSS scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
    End point type
    Secondary
    End point timeframe
    Double-blind period
    End point values
    		 Benralizumab 30 mg Placebo
    Number of subjects analysed
    54
    45
    Units: score
    arithmetic mean (standard deviation)
        Week 2
    6.6 ( 12.57 )
    3.1 ( 11.65 )
        Week 4
    5.8 ( 12.53 )
    -1.5 ( 12.49 )
        Week 6
    6.8 ( 14.39 )
    0.7 ( 10.94 )
        Week 8
    6.6 ( 14.17 )
    2.1 ( 16.29 )
        Week 10
    5.3 ( 13.02 )
    -1.0 ( 14.46 )
        Week 12
    7.2 ( 11.47 )
    0.9 ( 15.44 )
        Week 14
    8.0 ( 12.28 )
    3.7 ( 14.63 )
        Week 16
    6.2 ( 14.51 )
    1.3 ( 15.79 )
        Week 18
    8.6 ( 14.41 )
    2.6 ( 18.60 )
        Week 20
    8.6 ( 15.41 )
    1.4 ( 18.58 )
        Week 22
    8.4 ( 13.30 )
    3.9 ( 20.33 )
        Week 24
    9.3 ( 17.31 )
    4.4 ( 17.70 )
        Week 26
    7.4 ( 15.07 )
    3.8 ( 18.40 )
        Week 28
    6.5 ( 15.92 )
    2.7 ( 21.33 )
        Week 30
    7.5 ( 14.26 )
    1.2 ( 17.32 )
        Week 32
    12.1 ( 14.37 )
    2.4 ( 19.09 )
        Week 34
    7.6 ( 12.58 )
    2.8 ( 18.90 )
        Week 36
    9.6 ( 17.44 )
    3.6 ( 19.31 )
        Week 38
    8.1 ( 14.96 )
    1.3 ( 17.68 )
        Week 40
    9.6 ( 17.32 )
    -1.1 ( 18.50 )
        Week 42
    7.1 ( 14.93 )
    3.3 ( 16.25 )
        Week 44
    7.5 ( 15.00 )
    0.8 ( 20.76 )
        Week 46
    8.6 ( 17.76 )
    3.4 ( 18.89 )
        Week 48
    8.1 ( 16.75 )
    3.2 ( 20.52 )
        Week 50
    9.8 ( 14.63 )
    0.1 ( 15.42 )
        Week 52
    7.3 ( 17.91 )
    0.2 ( 18.12 )
    No statistical analyses for this end point

    Secondary: Change from baseline in pre-dose pre-BD FEV1 over the double-blind treatment period

    		 Close Top of page
    End point title
    		 Change from baseline in pre-dose pre-BD FEV1 over the double-blind treatment period
    End point description
    Change from baseline in pre-dose pre-bronchodilator (BD) forced expiratory volume in one second (FEV1) over the double-blind treatment period
    End point type
    Secondary
    End point timeframe
    Double-blind period
    End point values
    		 Benralizumab 30 mg Placebo
    Number of subjects analysed
    54
    45
    Units: liter
    arithmetic mean (standard deviation)
        Week 4
    0.0139 ( 0.14327 )
    -0.0477 ( 0.10758 )
        Week 8
    0.0048 ( 0.15392 )
    -0.0465 ( 0.15263 )
        Week 16
    -0.0191 ( 0.15964 )
    -0.0282 ( 0.11452 )
        Week 24
    -0.0378 ( 0.17290 )
    -0.0595 ( 0.16409 )
        Week 32
    -0.0248 ( 0.16782 )
    -0.0921 ( 0.17543 )
        Week 40
    -0.0597 ( 0.18924 )
    -0.1037 ( 0.16808 )
        Week 48
    -0.1236 ( 0.16353 )
    -0.0849 ( 0.13783 )
        Week 52
    -0.1093 ( 0.13130 )
    -0.1186 ( 0.14969 )
    No statistical analyses for this end point

    Secondary: Change from baseline in LCQ total score over the double-blind period

    		 Close Top of page
    End point title
    		 Change from baseline in LCQ total score over the double-blind period
    End point description
    Change from baseline in Leicester Cough Questionnaire (LCQ) total score over the double-blind treatment period. LCQ total scores range from 3 to 21. Higher scores indicate better quality of life.
    End point type
    Secondary
    End point timeframe
    Double-blind period
    End point values
    		 Benralizumab 30 mg Placebo
    Number of subjects analysed
    54
    45
    Units: score
    arithmetic mean (standard deviation)
        Week 2
    0.5 ( 2.22 )
    0.5 ( 2.13 )
        Week 4
    0.7 ( 2.35 )
    0.0 ( 2.15 )
        Week 6
    0.8 ( 2.76 )
    0.6 ( 2.56 )
        Week 8
    0.8 ( 3.37 )
    0.3 ( 2.85 )
        Week 10
    1.0 ( 2.77 )
    0.1 ( 2.76 )
        Week 12
    1.0 ( 2.51 )
    0.4 ( 3.03 )
        Week 14
    1.4 ( 2.78 )
    0.8 ( 3.16 )
        Week 16
    0.9 ( 2.61 )
    0.5 ( 3.10 )
        Week 18
    1.0 ( 3.42 )
    1.1 ( 3.55 )
        Week 20
    1.4 ( 3.28 )
    0.8 ( 3.39 )
        Week 22
    0.9 ( 3.32 )
    0.8 ( 4.03 )
        Week 24
    1.0 ( 3.43 )
    1.2 ( 3.48 )
        Week 26
    0.9 ( 3.58 )
    1.0 ( 3.54 )
        Week 28
    0.5 ( 4.31 )
    0.9 ( 4.08 )
        Week 30
    0.7 ( 3.33 )
    0.8 ( 4.06 )
        Week 32
    1.8 ( 3.45 )
    0.7 ( 4.14 )
        Week 34
    0.8 ( 2.43 )
    0.8 ( 3.92 )
        Week 36
    1.2 ( 3.48 )
    0.8 ( 3.95 )
        Week 38
    1.0 ( 3.61 )
    0.6 ( 4.24 )
        Week 40
    1.2 ( 3.93 )
    0.2 ( 3.86 )
        Week 42
    0.6 ( 3.42 )
    0.3 ( 4.19 )
        Week 44
    0.5 ( 3.23 )
    0.3 ( 4.02 )
        Week 46
    0.7 ( 3.68 )
    0.6 ( 4.22 )
        Week 48
    0.3 ( 3.78 )
    0.5 ( 4.20 )
        Week 50
    0.7 ( 3.29 )
    -0.2 ( 3.41 )
        Week 52
    0.2 ( 3.94 )
    -0.1 ( 2.86 )
    No statistical analyses for this end point

    Secondary: Change from baseline in QoL-B scales (excluding QoL-B-RSS) over the double-blind period: Physical Functioning Scale

    		 Close Top of page
    End point title
    		 Change from baseline in QoL-B scales (excluding QoL-B-RSS) over the double-blind period: Physical Functioning Scale
    End point description
    change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Physical Functioning Scale. QoL-B Physical Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
    End point type
    Secondary
    End point timeframe
    Double-blind period
    End point values
    		 Benralizumab 30 mg Placebo
    Number of subjects analysed
    54
    45
    Units: score
    arithmetic mean (standard deviation)
        Week 2
    0.5 ( 12.23 )
    -0.0 ( 16.50 )
        Week 4
    1.5 ( 17.68 )
    0.8 ( 19.39 )
        Week 6
    4.1 ( 20.81 )
    0.2 ( 17.97 )
        Week 8
    3.3 ( 15.07 )
    0.3 ( 20.81 )
        Week 10
    1.5 ( 19.22 )
    1.0 ( 22.06 )
        Week 12
    3.1 ( 19.54 )
    0.5 ( 21.89 )
        Week 14
    4.4 ( 15.48 )
    4.2 ( 22.15 )
        Week 16
    3.5 ( 18.06 )
    3.3 ( 25.17 )
        Week 18
    4.8 ( 19.15 )
    2.2 ( 23.01 )
        Week 20
    4.5 ( 18.45 )
    4.7 ( 25.18 )
        Week 22
    3.1 ( 19.62 )
    2.2 ( 22.96 )
        Week 24
    5.2 ( 18.21 )
    4.7 ( 23.03 )
        Week 26
    3.6 ( 20.68 )
    3.6 ( 24.40 )
        Week 28
    3.8 ( 24.77 )
    4.8 ( 24.39 )
        Week 30
    2.5 ( 21.33 )
    4.8 ( 25.50 )
        Week 32
    6.7 ( 18.80 )
    5.9 ( 24.73 )
        Week 34
    2.7 ( 19.14 )
    3.5 ( 24.90 )
        Week 36
    0.6 ( 22.76 )
    4.7 ( 24.78 )
        Week 38
    1.9 ( 16.40 )
    3.5 ( 23.5 )
        Week 40
    2.1 ( 23.55 )
    4.1 ( 25.01 )
        Week 42
    1.3 ( 21.13 )
    5.5 ( 28.92 )
        Week 44
    0.6 ( 23.62 )
    4.2 ( 24.03 )
        Week 46
    2.0 ( 22.89 )
    7.9 ( 23.42 )
        Week 48
    0.0 ( 27.89 )
    7.6 ( 22.98 )
        Week 50
    5.3 ( 23.46 )
    1.3 ( 21.08 )
        Week 52
    5.1 ( 23.90 )
    2.1 ( 19.25 )
    No statistical analyses for this end point

    Secondary: Change from baseline in QoL-B scales (excluding QoL-B-RSS) over the double-blind period: Role Functioning Scale

    		 Close Top of page
    End point title
    		 Change from baseline in QoL-B scales (excluding QoL-B-RSS) over the double-blind period: Role Functioning Scale
    End point description
    Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Role Functioning Scale. QoL-B Role Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
    End point type
    Secondary
    End point timeframe
    Double-blind period
    End point values
    		 Benralizumab 30 mg Placebo
    Number of subjects analysed
    54
    45
    Units: score
    arithmetic mean (standard deviation)
        Week 2
    1.1 ( 13.64 )
    -1.2 ( 11.11 )
        Week 4
    2.8 ( 13.00 )
    -0.3 ( 14.53 )
        Week 6
    2.7 ( 14.80 )
    2.5 ( 12.05 )
        Week 8
    0.5 ( 16.27 )
    0.2 ( 15.02 )
        Week 10
    1.2 ( 14.09 )
    2.7 ( 16.32 )
        Week 12
    1.7 ( 16.36 )
    2.3 ( 16.96 )
        Week 14
    3.0 ( 16.10 )
    2.1 ( 16.70 )
        Week 16
    0.1 ( 17.77 )
    -0.3 ( 16.60 )
        Week 18
    2.4 ( 16.93 )
    -0.0 ( 17.67 )
        Week 20
    0.9 ( 16.01 )
    0.5 ( 18.25 )
        Week 22
    2.8 ( 21.11 )
    4.0 ( 20.47 )
        Week 24
    1.9 ( 22.60 )
    0.6 ( 19.67 )
        Week 26
    -0.1 ( 21.44 )
    1.2 ( 18.36 )
        Week 28
    -1.9 ( 21.02 )
    2.7 ( 17.79 )
        Week 30
    1.1 ( 20.83 )
    -0.3 ( 19.04 )
        Week 32
    4.4 ( 15.08 )
    0.2 ( 18.17 )
        Week 34
    1.4 ( 18.01 )
    1.7 ( 17.97 )
        Week 36
    -0.6 ( 19.18 )
    0.5 ( 16.69 )
        Week 38
    1.4 ( 18.15 )
    -2.2 ( 19.65 )
        Week 40
    1.7 ( 22.20 )
    0.2 ( 21.80 )
        Week 42
    -1.3 ( 21.48 )
    1.8 ( 20.19 )
        Week 44
    0.6 ( 25.33 )
    -1.4 ( 17.46 )
        Week 46
    0.4 ( 23.89 )
    4.0 ( 19.00 )
        Week 48
    -1.2 ( 25.03 )
    0.2 ( 18.16 )
        Week 50
    0.7 ( 21.26 )
    -1.9 ( 12.55 )
        Week 52
    -0.8 ( 23.28 )
    1.1 ( 17.81 )
    No statistical analyses for this end point

    Secondary: Change from baseline in QoL-B scales (excluding QoL-B-RSS) over the double-blind period: Emotional Functioning Scale

    		 Close Top of page
    End point title
    		 Change from baseline in QoL-B scales (excluding QoL-B-RSS) over the double-blind period: Emotional Functioning Scale
    End point description
    Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Emotional Functioning Scale. QoL-B Emotional Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
    End point type
    Secondary
    End point timeframe
    Double-blind period
    End point values
    		 Benralizumab 30 mg Placebo
    Number of subjects analysed
    54
    45
    Units: score
    arithmetic mean (standard deviation)
        Week 2
    0.2 ( 13.63 )
    2.0 ( 17.43 )
        Week 4
    -0.7 ( 14.07 )
    1.4 ( 14.42 )
        Week 6
    3.5 ( 17.99 )
    4.2 ( 14.98 )
        Week 8
    -1.2 ( 16.84 )
    1.4 ( 17.77 )
        Week 10
    0.2 ( 16.43 )
    -1.0 ( 16.58 )
        Week 12
    2.8 ( 17.30 )
    1.6 ( 21.38 )
        Week 14
    4.7 ( 14.31 )
    1.8 ( 20.79 )
        Week 16
    2.2 ( 16.56 )
    1.2 ( 22.48 )
        Week 18
    3.2 ( 15.57 )
    3.8 ( 21.68 )
        Week 20
    3.9 ( 15.82 )
    1.4 ( 22.27 )
        Week 22
    2.8 ( 18.46 )
    2.1 ( 23.09 )
        Week 24
    2.4 ( 17.80 )
    2.9 ( 19.32 )
        Week 26
    3.0 ( 17.15 )
    4.3 ( 22.00 )
        Week 28
    0.4 ( 25.82 )
    1.6 ( 24.43 )
        Week 30
    2.7 ( 22.55 )
    1.5 ( 23.79 )
        Week 32
    4.0 ( 15.82 )
    3.0 ( 22.42 )
        Week 34
    1.4 ( 19.64 )
    1.9 ( 23.23 )
        Week 36
    1.9 ( 17.89 )
    4.5 ( 22.75 )
        Week 38
    2.6 ( 20.79 )
    1.9 ( 22.64 )
        Week 40
    1.7 ( 23.35 )
    2.3 ( 22.28 )
        Week 42
    1.1 ( 21.97 )
    3.4 ( 22.67 )
        Week 44
    1.9 ( 25.89 )
    1.8 ( 18.95 )
        Week 46
    3.9 ( 22.02 )
    6.8 ( 22.77 )
        Week 48
    5.8 ( 22.10 )
    5.4 ( 22.83 )
        Week 50
    5.5 ( 20.69 )
    3.0 ( 18.14 )
        Week 52
    6.0 ( 26.30 )
    0.9 ( 24.98 )
    No statistical analyses for this end point

    Secondary: Change from baseline in QoL-B scales (excluding QoL-B-RSS) over the double-blind period: Social Functioning Scale

    		 Close Top of page
    End point title
    		 Change from baseline in QoL-B scales (excluding QoL-B-RSS) over the double-blind period: Social Functioning Scale
    End point description
    Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Social Functioning Scale. QoL-B Social Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
    End point type
    Secondary
    End point timeframe
    Double-blind period
    End point values
    		 Benralizumab 30 mg Placebo
    Number of subjects analysed
    54
    45
    Units: score
    arithmetic mean (standard deviation)
        Week 2
    6.4 ( 17.60 )
    4.5 ( 17.35 )
        Week 4
    4.4 ( 18.62 )
    6.3 ( 22.69 )
        Week 6
    8.4 ( 21.60 )
    5.8 ( 20.05 )
        Week 8
    9.7 ( 23.10 )
    9.2 ( 20.53 )
        Week 10
    9.4 ( 19.64 )
    6.0 ( 20.31 )
        Week 12
    10.6 ( 23.32 )
    5.8 ( 21.42 )
        Week 14
    10.9 ( 23.03 )
    7.7 ( 20.52 )
        Week 16
    9.1 ( 20.73 )
    6.0 ( 23.53 )
        Week 18
    11.6 ( 21.61 )
    10.3 ( 22.43 )
        Week 20
    11.8 ( 22.59 )
    8.9 ( 21.43 )
        Week 22
    7.2 ( 20.42 )
    9.5 ( 24.09 )
        Week 24
    10.1 ( 24.90 )
    10.7 ( 24.14 )
        Week 26
    10.1 ( 22.86 )
    9.9 ( 22.46 )
        Week 28
    8.8 ( 24.67 )
    8.7 ( 24.83 )
        Week 30
    10.2 ( 26.57 )
    7.7 ( 24.82 )
        Week 32
    12.8 ( 23.84 )
    8.6 ( 24.48 )
        Week 34
    9.6 ( 27.93 )
    9.3 ( 24.95 )
        Week 36
    12.0 ( 27.06 )
    8.1 ( 25.53 )
        Week 38
    10.2 ( 27.83 )
    6.5 ( 25.41 )
        Week 40
    13.9 ( 32.35 )
    8.3 ( 27.77 )
        Week 42
    10.2 ( 29.40 )
    8.6 ( 28.16 )
        Week 44
    9.9 ( 28.68 )
    1.8 ( 24.50 )
        Week 46
    9.1 ( 27.40 )
    6.6 ( 29.11 )
        Week 48
    12.1 ( 27.11 )
    3.9 ( 30.74 )
        Week 50
    10.2 ( 23.60 )
    -1.7 ( 26.85 )
        Week 52
    11.6 ( 27.91 )
    2.3 ( 25.29 )
    No statistical analyses for this end point

    Secondary: Change from baseline in QoL-B scales (excluding QoL-B-RSS) over the double-blind period: Vitality Scale

    		 Close Top of page
    End point title
    		 Change from baseline in QoL-B scales (excluding QoL-B-RSS) over the double-blind period: Vitality Scale
    End point description
    Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Vitality Scale. QoL-B Vitality Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
    End point type
    Secondary
    End point timeframe
    Double-blind period
    End point values
    		 Benralizumab 30 mg Placebo
    Number of subjects analysed
    54
    45
    Units: score
    arithmetic mean (standard deviation)
        Week 2
    3.0 ( 18.77 )
    -2.4 ( 13.54 )
        Week 4
    3.1 ( 17.82 )
    0.3 ( 15.21 )
        Week 6
    4.0 ( 18.83 )
    -2.0 ( 13.88 )
        Week 8
    4.9 ( 17.84 )
    -1.1 ( 16.26 )
        Week 10
    6.4 ( 16.32 )
    -3.1 ( 18.83 )
        Week 12
    5.8 ( 18.48 )
    -3.9 ( 16.24 )
        Week 14
    8.8 ( 20.69 )
    -2.7 ( 18.22 )
        Week 16
    5.2 ( 19.66 )
    -0.5 ( 19.71 )
        Week 18
    5.0 ( 19.78 )
    -1.4 ( 18.69 )
        Week 20
    7.1 ( 19.99 )
    -1.3 ( 19.28 )
        Week 22
    5.7 ( 21.66 )
    -0.6 ( 21.04 )
        Week 24
    4.1 ( 20.87 )
    1.0 ( 19.67 )
        Week 26
    6.2 ( 20.18 )
    -1.6 ( 20.66 )
        Week 28
    3.9 ( 21.75 )
    -2.1 ( 21.57 )
        Week 30
    4.4 ( 21.84 )
    -4.3 ( 22.74 )
        Week 32
    6.1 ( 19.97 )
    0.0 ( 20.49 )
        Week 34
    1.1 ( 18.98 )
    -0.8 ( 20.96 )
        Week 36
    1.0 ( 18.59 )
    -2.7 ( 18.72 )
        Week 38
    4.1 ( 18.88 )
    -0.0 ( 19.52 )
        Week 40
    2.6 ( 23.01 )
    -2.7 ( 21.97 )
        Week 42
    3.0 ( 21.54 )
    -1.0 ( 24.37 )
        Week 44
    2.9 ( 21.11 )
    -3.4 ( 21.24 )
        Week 46
    5.2 ( 24.65 )
    1.0 ( 20.10 )
        Week 48
    2.0 ( 23.48 )
    -1.3 ( 20.97 )
        Week 50
    7.7 ( 20.81 )
    0.0 ( 18.14 )
        Week 52
    5.3 ( 18.74 )
    -5.3 ( 23.53 )
    No statistical analyses for this end point

    Secondary: Change from baseline in QoL-B scales (excluding QoL-B-RSS) over the double-blind period: Health Perceptions Scale

    		 Close Top of page
    End point title
    		 Change from baseline in QoL-B scales (excluding QoL-B-RSS) over the double-blind period: Health Perceptions Scale
    End point description
    Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Health Perceptions Scale. QoL-B Health Perceptions Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
    End point type
    Secondary
    End point timeframe
    Double-blind period
    End point values
    		 Benralizumab 30 mg Placebo
    Number of subjects analysed
    54
    45
    Units: score
    arithmetic mean (standard deviation)
        Week 2
    1.3 ( 12.95 )
    3.3 ( 14.12 )
        Week 4
    1.2 ( 14.87 )
    -0.2 ( 16.72 )
        Week 6
    3.5 ( 16.90 )
    3.7 ( 16.06 )
        Week 8
    5.3 ( 17.23 )
    4.3 ( 18.46 )
        Week 10
    5.6 ( 16.57 )
    2.1 ( 18.47 )
        Week 12
    7.5 ( 16.69 )
    3.3 ( 17.74 )
        Week 14
    7.4 ( 16.78 )
    1.4 ( 18.99 )
        Week 16
    1.9 ( 16.25 )
    2.4 ( 20.35 )
        Week 18
    5.8 ( 16.68 )
    1.7 ( 20.69 )
        Week 20
    4.6 ( 18.21 )
    3.9 ( 21.70 )
        Week 22
    5.0 ( 16.70 )
    6.3 ( 21.99 )
        Week 24
    7.2 ( 17.18 )
    5.0 ( 19.85 )
        Week 26
    2.8 ( 16.76 )
    5.0 ( 20.26 )
        Week 28
    3.4 ( 18.81 )
    2.4 ( 20.68 )
        Week 30
    4.5 ( 18.03 )
    4.3 ( 21.87 )
        Week 32
    7.0 ( 16.37 )
    2.4 ( 20.09 )
        Week 34
    4.2 ( 17.68 )
    2.9 ( 22.29 )
        Week 36
    3.5 ( 17.84 )
    2.0 ( 20.56 )
        Week 38
    4.2 ( 16.30 )
    3.0 ( 22.90 )
        Week 40
    5.1 ( 16.95 )
    1.4 ( 22.35 )
        Week 42
    4.7 ( 18.38 )
    4.4 ( 23.77 )
        Week 44
    4.8 ( 21.03 )
    1.5 ( 20.78 )
        Week 46
    6.6 ( 22.45 )
    1.8 ( 19.07 )
        Week 48
    7.3 ( 21.32 )
    3.9 ( 23.68 )
        Week 50
    6.9 ( 20.42 )
    4.7 ( 18.65 )
        Week 52
    4.0 ( 21.53 )
    0.4 ( 24.13 )
    No statistical analyses for this end point

    Secondary: Change from baseline in QoL-B scales (excluding QoL-B-RSS) over the double-blind period: Treatment Burden Scale

    		 Close Top of page
    End point title
    		 Change from baseline in QoL-B scales (excluding QoL-B-RSS) over the double-blind period: Treatment Burden Scale
    End point description
    Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Treatment Burden Scale. QoL-B Treatment Burden Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
    End point type
    Secondary
    End point timeframe
    Double-blind period
    End point values
    		 Benralizumab 30 mg Placebo
    Number of subjects analysed
    54
    45
    Units: score
    arithmetic mean (standard deviation)
        Week 2
    3.6 ( 22.56 )
    -2.2 ( 16.75 )
        Week 4
    3.7 ( 18.62 )
    -2.1 ( 13.34 )
        Week 6
    6.0 ( 23.20 )
    -2.1 ( 15.72 )
        Week 8
    4.8 ( 18.35 )
    -1.9 ( 14.87 )
        Week 10
    4.0 ( 17.31 )
    1.1 ( 17.83 )
        Week 12
    0.3 ( 17.27 )
    -0.4 ( 12.54 )
        Week 14
    0.6 ( 20.74 )
    -4.1 ( 14.73 )
        Week 16
    4.4 ( 20.10 )
    -1.1 ( 16.34 )
        Week 18
    -1.9 ( 16.28 )
    -1.2 ( 14.92 )
        Week 20
    4.1 ( 16.01 )
    0.3 ( 15.84 )
        Week 22
    -1.3 ( 14.37 )
    -0.8 ( 16.82 )
        Week 24
    -1.0 ( 18.58 )
    -1.1 ( 14.45 )
        Week 26
    1.9 ( 17.32 )
    2.5 ( 15.37 )
        Week 28
    -5.1 ( 24.00 )
    1.4 ( 15.11 )
        Week 30
    -2.0 ( 19.14 )
    -1.1 ( 18.39 )
        Week 32
    -2.1 ( 16.32 )
    -0.8 ( 15.12 )
        Week 34
    -0.4 ( 16.70 )
    -4.0 ( 17.95 )
        Week 36
    -0.7 ( 16.68 )
    -1.5 ( 16.69 )
        Week 38
    -4.2 ( 25.27 )
    -2.9 ( 21.04 )
        Week 40
    -2.0 ( 24.76 )
    -0.4 ( 16.15 )
        Week 42
    -1.5 ( 23.52 )
    1.7 ( 18.78 )
        Week 44
    2.1 ( 17.22 )
    1.4 ( 21.00 )
        Week 46
    -0.0 ( 18.59 )
    4.6 ( 14.62 )
        Week 48
    -0.9 ( 17.25 )
    3.6 ( 19.96 )
        Week 50
    -2.0 ( 22.13 )
    -1.9 ( 18.77 )
        Week 52
    -1.9 ( 25.64 )
    1.7 ( 14.94 )
    No statistical analyses for this end point

    Secondary: Change from baseline in SGRQ total score over the double-blind treatment period

    		 Close Top of page
    End point title
    		 Change from baseline in SGRQ total score over the double-blind treatment period
    End point description
    Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score over the double-blind treatment period. SGRQ total scores range from 0 to 100. 100 represents the worst possible health status and 0 indicates the best possible health status.
    End point type
    Secondary
    End point timeframe
    Double-blind period
    End point values
    		 Benralizumab 30 mg Placebo
    Number of subjects analysed
    54
    45
    Units: score
    arithmetic mean (standard deviation)
        Week 4
    -4.7 ( 14.92 )
    0.6 ( 14.89 )
        Week 8
    -4.3 ( 15.99 )
    -2.4 ( 15.33 )
        Week 16
    -4.4 ( 15.03 )
    -0.1 ( 16.06 )
        Week 24
    -6.3 ( 16.21 )
    -3.9 ( 21.08 )
        Week 32
    -5.8 ( 15.73 )
    -1.6 ( 21.46 )
        Week 40
    -5.8 ( 17.63 )
    -1.6 ( 24.51 )
        Week 48
    -4.9 ( 18.58 )
    -0.0 ( 22.45 )
        Week 52
    -4.4 ( 20.37 )
    4.8 ( 23.33 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Double-blind (DB) period and Open-label Extension (OLE) period. DB Period: From first dose of study drug until end of DB period, up to 52 weeks. OLE Period: From the end of the DB period (week 25 to 53) to the end of OLE period, up to 40 weeks.
    Adverse event reporting additional description
    For analysis of Adverse Events, Safety Analysis Set is used. Safety Analysis Set: All participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo injection delivered subcutaneously every 4 weeks

    Reporting group title
    Benralizumab 30 mg
    Reporting group description
    		 Benralizumab 30 mg injection delivered subcutaneously every 4 weeks

    Serious adverse events
    		 Placebo Benralizumab 30 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 45 (15.56%)
    13 / 54 (24.07%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    6 / 45 (13.33%)
    9 / 54 (16.67%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemophilus infection
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pseudomonal
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Benralizumab 30 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 45 (51.11%)
    37 / 54 (68.52%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 45 (6.67%)
    2 / 54 (3.70%)
         occurrences all number
    3
    2
    Headache
         subjects affected / exposed
    7 / 45 (15.56%)
    5 / 54 (9.26%)
         occurrences all number
    9
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 54 (5.56%)
         occurrences all number
    1
    3
    Pyrexia
         subjects affected / exposed
    3 / 45 (6.67%)
    1 / 54 (1.85%)
         occurrences all number
    5
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 54 (5.56%)
         occurrences all number
    1
    4
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    0
    4
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 45 (0.00%)
    4 / 54 (7.41%)
         occurrences all number
    0
    6
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 45 (4.44%)
    4 / 54 (7.41%)
         occurrences all number
    3
    4
    Infections and infestations
    COVID-19
         subjects affected / exposed
    10 / 45 (22.22%)
    21 / 54 (38.89%)
         occurrences all number
    12
    21
    Nasopharyngitis
         subjects affected / exposed
    6 / 45 (13.33%)
    6 / 54 (11.11%)
         occurrences all number
    6
    10
    Sinusitis
         subjects affected / exposed
    2 / 45 (4.44%)
    4 / 54 (7.41%)
         occurrences all number
    3
    4
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 45 (2.22%)
    4 / 54 (7.41%)
         occurrences all number
    2
    5
    Urinary tract infection
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 54 (5.56%)
         occurrences all number
    0
    3

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jan 2023
    The initial protocol plan was to randomise approximately 420 eligible patients to investigational product with stratification for blood eosinophil count category. However, the coronavirus disease 2019 pandemic’s impact on population characteristics that are part of the trial’s inclusion criteria has resulted in recruitment challenges. These challenges, combined with other external uncertainties, have led to the sponsor’s decision to stop further recruitment into the study. This decision was not due to safety or efficacy concerns for benralizumab in the non-cystic fibrosis bronchiectasis (NCFB) population. Therefore, all randomised patients are allowed to continue the treatment. The collected data will be analysed and shared with the scientific community to enhance understanding of NCFB. Due to the sponsor’s decision to stop recruitment early, this clinical study protocol has been modified such that the duration of the double-blind period for each patient is 28 to 52 weeks, after which eligible patients will enter an open-label extension of approximately 32 weeks (approximately 24 weeks of benralizumab administration followed by an 8-week follow-up visit) that will focus on safety assessments. The protocol, including the study duration, sample size, primary study population, evaluated parameters, the timing of endpoint analyses, statistical analyses to be performed, and frequency and timing of activities in the schedule of assessments have been updated to reflect the significant changes in the overall study design and conduct.

    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.
    Due to the decision to stop recruitment early and small sample size in ≥ the threshold of blood eosinophil count stratum, the study is not powered to assess the hypothesis test for the primary efficacy endpoint.
    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.

    European Medicines Agency © 1995-Tue May 06 15:29:16 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA