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    Clinical Trial Results:
    A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Benralizumab in Patients with Eosinophilic Chronic Rhinosinusitis with Nasal Polyps (ORCHID)

    Summary
    EudraCT number
    		 2021-000267-72
    Trial protocol
    		 BE   HU   FR   PL   IT   BG  
    Global end of trial date
    07 Apr 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Feb 2026
    First version publication date
    18 Feb 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D3252C00002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    151 85, Sodertalje, Sweden,
    Public contact
    Global Clinical Head, AstraZeneca, +1 18772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Head, AstraZeneca, +1 18772409479, 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
    11 Jun 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Aug 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Apr 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of benralizumab on nasal polyp burden and patient-reported nasal blockage (NB).
    Protection of trial subjects
    The investigator or his/her representative explained the nature of the study to the participant or his/her legally authorised representative and answered all questions regarding the study. Participants were informed that their participation was voluntary and they were free to refuse to participate and may withdraw their consent at any time and for any reason during the study. Participants or their legally authorised representative were required to sign a statement of informed consent that meets the requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance Portability and Accountability Act (HIPAA) requirements, where applicable, and the IRB/IEC or study centre. The medical record included a statement that written informed consent was obtained before the participant was enrolled in the study and the date the written consent was obtained. The authorised person obtaining the informed consent also signed the ICF. Participants must be re-consented to the most current version of the ICF(s) during their participation in the study. A copy of the ICF(s) must be provided to the participant or the participant’s legally authorised representative. Participants who were rescreened were required to sign a new ICF. The ICF contained a separate section that addresses and documents the collection and use of any mandatory and/or optional human biological samples. The investigator or authorized designee explained to each participant the objectives of the analysis to be done on the samples and any potential future use. Participants were told that they were free to refuse to participate in any optional samples or the future use and may withdraw their consent at any time and for any reason during the retention period.
    Background therapy
    		 -
    Evidence for comparator
    		 After enrolment, and prior to entering a screening/run in period, eligible participants had their current daily INCS therapy standardized to Mometasone Furoate (MFNS), total daily dose of 400 mcg or equivalent (highest local approved dose for CRSwNP), which was maintained throughout the study until the last DB visit (V11).
    Actual start date of recruitment
    25 Nov 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 15
    Country: Number of subjects enrolled
    Australia: 16
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Bulgaria: 12
    Country: Number of subjects enrolled
    Chile: 17
    Country: Number of subjects enrolled
    China: 83
    Country: Number of subjects enrolled
    Hungary: 20
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Japan: 25
    Country: Number of subjects enrolled
    Poland: 28
    Country: Number of subjects enrolled
    Russian Federation: 6
    Country: Number of subjects enrolled
    Taiwan: 6
    Country: Number of subjects enrolled
    Thailand: 16
    Country: Number of subjects enrolled
    Türkiye: 9
    Country: Number of subjects enrolled
    United States: 13
    Country: Number of subjects enrolled
    Viet Nam: 2
    Worldwide total number of subjects
    287
    EEA total number of subjects
    79
    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)
    254
    From 65 to 84 years
    33
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 15NOV2019 and 01JUN2023, a total of 295 participants were randomized to either the treatment (n=147) or placebo (n=148) arms of the double-blind treatment period. Eight participants were excluded due to Japan GCP breach. Therefore, 144 participants started in the treatment arm and 143 in the placebo arm, for a total of 287 participants.

    Pre-assignment
    Screening details
    		 All patients completed a 6-week run-in period during which inclusion/exclusion criteria was assessed, medical history and surgical history were documented, Nasal endoscopy performed, and patient reported outcomes (PROs), clinical laboratories, and diet questionnaires were administered.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Benralizumab DB
    Arm description
    		 All participants who received Benralizumab in the double-blind (DB) period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30 mg SC

    Arm title
    		 Placebo DB
    Arm description
    		 All participants who received Placebo in the DB period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo SC

    Number of subjects in period 1
    		Benralizumab DB Placebo DB
    Started
    144
    143
    Completed
    129
    130
    Not completed
    15
    13
         Consent withdrawn by subject
    9
    6
         Physician decision
    1
    2
         Adverse event, non-fatal
    1
    1
         Pregnancy
    1
    -
         IP discontinuation
    1
    1
         Lost to follow-up
    -
    2
         Patient did not meet randomization criteria
    -
    1
         Site closure
    2
    -
    Period 2
    Period 2 title
    Open-Label Extension Period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Benralizumab OLE
    Arm description
    		 All participants who received Benralizumab in the double-blind (DB) period and continued to receive Benralizumab in the open-label extension (OLE) period
    Arm type
    		 Experimental

    Investigational medicinal product name
    30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 56, 60, 64) and Q8W thereafter (Weeks 72, 80, 88, 96 and 104).
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30 mg SC

    Arm title
    		 Placebo switched to Benralizumab OLE
    Arm description
    		 All participants who initially received Placebo in the DB period, then switched to receive Benralizumab in the open-label extension (OLE) period
    Arm type
    		 Experimental

    Investigational medicinal product name
    30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 56, 60, 64) and Q8W thereafter (Weeks 72, 80, 88, 96 and 104).
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30 mg SC

    Number of subjects in period 2 [1]
    		Benralizumab OLE Placebo switched to Benralizumab OLE
    Started
    122
    125
    Completed
    80
    86
    Not completed
    42
    39
         Consent withdrawn by subject
    18
    6
         Physician decision
    3
    2
         Adverse event, non-fatal
    1
    3
         patient withdrew due to failure of treatment
    1
    2
         Study terminated by sponsor
    19
    26
    Notes
    [1] - 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: All patients who completed the 56-week double-blind treatment period were eligible to continue into one year OLE, during which all patients received 8 doses of benralizumab 30 mg. Patients who did not enter OLE, had their last study visit at Week 56 (EoDB) for follow-up and without administration of IP.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Benralizumab DB
    Reporting group description
    		 All participants who received Benralizumab in the double-blind (DB) period.

    Reporting group title
    Placebo DB
    Reporting group description
    		 All participants who received Placebo in the DB period.

    Reporting group values
    		 Benralizumab DB Placebo DB Total
    Number of subjects
    		 144 143 287
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 128 126 254
        >=65 years
    		 16 17 33
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 49.5 ( 12.7 ) 49.8 ( 12.7 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 61 54 115
        Male
    		 83 89 172
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 77 73 150
        Black or African American
    		 0 2 2
        Asian
    		 66 66 132
        American Indian or Alaska Native
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Other
    		 1 2 3

    End points

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    End points reporting groups
    Reporting group title
    Benralizumab DB
    Reporting group description
    		 All participants who received Benralizumab in the double-blind (DB) period.

    Reporting group title
    Placebo DB
    Reporting group description
    		 All participants who received Placebo in the DB period.
    Reporting group title
    Benralizumab OLE
    Reporting group description
    		 All participants who received Benralizumab in the double-blind (DB) period and continued to receive Benralizumab in the open-label extension (OLE) period

    Reporting group title
    Placebo switched to Benralizumab OLE
    Reporting group description
    		 All participants who initially received Placebo in the DB period, then switched to receive Benralizumab in the open-label extension (OLE) period

    Primary: Change from baseline in endoscopic total nasal polyp score (NPS).

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    End point title
    		 Change from baseline in endoscopic total nasal polyp score (NPS).
    End point description
    The total NPS is the sum (maximum 8) of the right and left nostril scores, as evaluated by nasal endoscopy and the left and right score are based on central read with scale from 0 to 4. The total NPS and the changes from baseline to each post-baseline value was calculated.
    End point type
    Primary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Benralizumab DB Placebo DB
    Number of subjects analysed
    127
    121
    Units: Score
        arithmetic mean (standard deviation)
    -0.3 ( 1.6 )
    -0.1 ( 1.3 )
    Statistical analysis title
    		 Repeated measures model
    Statistical analysis description
    Null Hypothesis: Difference in mean change from baseline in NPS at 56 weeks (Benralizumab minus placebo) = 0
    Comparison groups
    Benralizumab DB v Placebo DB
    Number of subjects included in analysis
    248
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.1707
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.247
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.599
         upper limit
    		 0.106
    Notes
    [1] - WP (worst possible value) for subjects rescued by surgery for CRSwNP and WOCF (worst-observation carried forward) for subjects rescued by SCS use for CRSwNP. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.

    Primary: Change from baseline in mean nasal blockage score (NBS).

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    End point title
    		 Change from baseline in mean nasal blockage score (NBS).
    End point description
    The NBS is an item in the NPSD. Patients were asked to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0 – none; 1 – mild; 2 – moderate; 3 – severe. The NBS and the changes from baseline were summarised every two weeks (bi-weekly). Baseline was the average of daily responses from Day ‒13 to Day 1. Bi-weekly mean were calculated if at least 8 days in each 14-day period had evaluable data; otherwise, the biweekly mean was set to missing.
    End point type
    Primary
    End point timeframe
    Baseline to week 56
    End point values
    		 Benralizumab DB Placebo DB
    Number of subjects analysed
    114
    118
    Units: Score
        arithmetic mean (standard deviation)
    -0.64 ( 0.98 )
    -0.45 ( 0.90 )
    Statistical analysis title
    		 Repeated measures model
    Statistical analysis description
    Null Hypothesis: Difference in mean change from baseline in bi-weekly mean NBS at 56 weeks (Benralizumab minus placebo) = 0
    Comparison groups
    Benralizumab DB v Placebo DB
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    P-value
    		 = 0.1831
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.155
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.383
         upper limit
    		 0.073
    Notes
    [2] - WP (worst possible value) for subjects rescued by surgery for CRSwNP and WOCF (worst-observation carried forward) for subjects rescued by SCS use for CRSwNP. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.

    Secondary: Change from baseline in difficulty with sense of smell (DSS) score

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    End point title
    		 Change from baseline in difficulty with sense of smell (DSS) score
    End point description
    The DSS is an item in the NPSD. Patients were asked to rate the severity of their worst difficulty with sense of smell over the past 24 hours using the following response options: 0–none; 1–mild; 2–moderate; 3–severe. The DSS and the changes from baseline were summarised every two weeks (bi-weekly). Baseline was the average of daily responses from Day ‒13 to Day 1. Bi-weekly mean of DSS was calculated if at least 8 days in each 14-day period have evaluable data; otherwise the bi-weekly mean was set to missing.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Benralizumab DB Placebo DB
    Number of subjects analysed
    114
    118
    Units: Score
        arithmetic mean (standard deviation)
    -0.26 ( 0.78 )
    -0.05 ( 0.56 )
    Statistical analysis title
    		 Repeated measures model
    Statistical analysis description
    Null Hypothesis: Difference in mean change from baseline in bi-weekly mean DSS at 56 weeks (Benralizumab minus placebo) = 0
    Comparison groups
    Benralizumab DB v Placebo DB
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    P-value
    		 = 0.0196 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.191
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.351
         upper limit
    		 -0.031
    Notes
    [3] - WP (worst possible value) for subjects rescued by surgery for CRSwNP and WOCF (worst-observation carried forward) for subjects rescued by SCS use for CRSwNP. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.
    [4] - The p-value is unadjusted.

    Secondary: Sinus Opacification by CT Scan

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    End point title
    		 Sinus Opacification by CT Scan
    End point description
    Change from baseline in Lund- Mackay score (LMS). The Lund-Mackay score scoring system is used to provide a quantitative assessment of nasal sinuses on sinus CT scans. Based on the sinus CT images, the five sinuses (maxillary, anterior ethmoid, posterior ethmoid, sphenoid and frontal) on each site are score by central radiologist as follows: (0-Normal; 1-Partial Opacification; 2-Total Opacification). The osteomeatal complex is scored for right and left sides (0 - Not occluded; 2- Occluded). The total score ranges from 0 to 24 (higher scores indicate poorer outcomes).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Benralizumab DB Placebo DB
    Number of subjects analysed
    114
    104
    Units: Score
        arithmetic mean (standard deviation)
    -1.3 ( 3.4 )
    -0.7 ( 3.5 )
    Statistical analysis title
    		 Repeated measures model
    Statistical analysis description
    Null Hypothesis: Difference in mean change from baseline in LMS at 56 weeks (Benralizumab minus placebo) = 0
    Comparison groups
    Benralizumab DB v Placebo DB
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    P-value
    		 = 0.1456
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.663
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.559
         upper limit
    		 0.232
    Notes
    [5] - WP (worst possible value) for subjects rescued by surgery for CRSwNP. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.

    Secondary: Disease specific health-related quality of life (HRQoL)

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    End point title
    		 Disease specific health-related quality of life (HRQoL)
    End point description
    Change from baseline in SinoNasal Outcome Test (SNOT-22) score. SinoNasal Outcome Test 22 scores are participant-reported and assess physical problems, functional limitations and emotional consequences of SinoNasal conditions. Patient-reported symptom severity and symptom impact over the past 2 weeks are captured via a 6-point scale (0-No Problem to 5-Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110 (higher scores indicate poorer outcomes).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Benralizumab DB Placebo DB
    Number of subjects analysed
    127
    122
    Units: Score
        arithmetic mean (standard error)
    -18.0 ( 29.6 )
    -15.2 ( 26.6 )
    Statistical analysis title
    		 Repeated measures model
    Statistical analysis description
    Null Hypothesis: Difference in mean change from baseline in SNOT-22 at 56 weeks (Benralizumab minus placebo) = 0
    Comparison groups
    Benralizumab DB v Placebo DB
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    P-value
    		 = 0.5844
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -1.783
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.171
         upper limit
    		 4.606
    Notes
    [6] - WP (worst possible value) for subjects rescued by surgery for CRSwNP and WOCF (worst-observation carried forward) for subjects rescued by SCS use for CRSwNP. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.

    Secondary: Time to first nasal polyp surgery

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    End point title
    		 Time to first nasal polyp surgery
    End point description
    Time to the first surgery for CRSwNP= Start date of the first surgery for CRSwNP ‒ date of randomisation + 1
    End point type
    Secondary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Benralizumab DB Placebo DB
    Number of subjects analysed
    139
    135
    Units: Months
        median (full range (min-max))
    6.31 (3.3 to 10.5)
    7.79 (4.4 to 12.4)
    Statistical analysis title
    		 Proportional hazards regression model
    Statistical analysis description
    Null Hypothesis: Hazard ratio of time to first surgery for CRSwNP (Benralizumab/placebo) = 1
    Comparison groups
    Benralizumab DB v Placebo DB
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6776 [7]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.31
         upper limit
    		 2.09
    Notes
    [7] - This endpoint was not a part of the pre-specified testing strategy and was not multiplicity protected. The p-value was considered nominal.

    Secondary: Time to first SCS course for CRSwNP

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    End point title
    		 Time to first SCS course for CRSwNP
    End point description
    Time to the first SCS use for CRSwNP = Start date of the first SCS use for CRSwNP ‒ date of randomisation + 1
    End point type
    Secondary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Benralizumab DB Placebo DB
    Number of subjects analysed
    139
    135
    Units: Months
        median (full range (min-max))
    5.62 (0.1 to 13.0)
    6.37 (0.1 to 11.4)
    Statistical analysis title
    		 Proportional hazards regression model
    Statistical analysis description
    Null Hypothesis: Hazard ratio of time to first SCS use for CRSwNP (Benralizumab/placebo) = 1
    Comparison groups
    Benralizumab DB v Placebo DB
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.8033 [8]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 1.69
    Notes
    [8] - This endpoint was not a part of the pre-specified testing strategy and was not multiplicity protected. The p-value was considered nominal.

    Secondary: Time to first NP surgery and/or SCS use for CRSwNP

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    End point title
    		 Time to first NP surgery and/or SCS use for CRSwNP
    End point description
    Time to first surgery and/or SCS use for CRSwNP = earlier date of (start date of first surgery for CRSwNP, start date of first SCS use for CRSwNP) – date of randomisation + 1
    End point type
    Secondary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Benralizumab DB Placebo DB
    Number of subjects analysed
    139
    135
    Units: Months
        median (full range (min-max))
    5.70 (0.1 to 13.0)
    6.37 (0.1 to 12.4)
    Statistical analysis title
    		 Proportional hazards regression model
    Statistical analysis description
    Null Hypothesis: Hazard ratio of time to first surgery and/or SCS use for CRSwNP (Benralizumab/placebo) = 1
    Comparison groups
    Benralizumab DB v Placebo DB
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5226 [9]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.43
    Notes
    [9] - This endpoint was not a part of the pre-specified testing strategy and was not multiplicity protected. The p-value was considered nominal.

    Secondary: Change from baseline in bi-weekly mean nasal polyps symptom diary total symptom score

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    End point title
    		 Change from baseline in bi-weekly mean nasal polyps symptom diary total symptom score
    End point description
    Patients were asked to consider their experience with NP over the past 24 hours when responding to each question and report the severity of each symptom at its worst using a 4-point rating scale (0–none; 1–mild; 2–moderate; 3–severe). Questions to capture patient-reported difficulty with sleep and daily activities due to nasal symptoms use the same rating scale. A TSS (total symptom score) was calculated by taking the sum of the first 8 items in the NPSD (Nasal polyps symptom diary). Bi-weekly mean of each item in the NPSD was calculated if at least 8 days in each 14-day period have evaluable data; otherwise the biweekly mean was set to missing.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Benralizumab DB Placebo DB
    Number of subjects analysed
    114
    118
    Units: Score
        arithmetic mean (standard deviation)
    -3.19 ( 5.78 )
    -2.32 ( 5.83 )
    Statistical analysis title
    		 Repeated measures model
    Statistical analysis description
    Null Hypothesis: Difference in mean change from baseline in NPSD TSS at 56 weeks (Benralizumab minus placebo) = 0
    Comparison groups
    Benralizumab DB v Placebo DB
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 [10]
    P-value
    		 = 0.2201 [11]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.235
         upper limit
    		 0.515
    Notes
    [10] - WP (worst possible value) for subjects rescued by surgery for CRSwNP and WOCF (worst-observation carried forward) for subjects rescued by SCS use for CRSwNP. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.
    [11] - This endpoint was not a part of the pre-specified testing strategy and was not multiplicity protected. The p-value was considered nominal.

    Secondary: Proportion of patients with surgery and/or use SCS for CRSwNP

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    End point title
    		 Proportion of patients with surgery and/or use SCS for CRSwNP
    End point description
    The number of courses of SCS for CRSwNP: noted an SCS course can be considered as a new course if the start date is preceded by at least 7 days after the end date of the last SCS course for CRSwNP (i.e. start date of the new course - end date of the last course > 7)
    End point type
    Secondary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Benralizumab DB Placebo DB
    Number of subjects analysed
    139
    135
    Units: Participants
    26
    30
    Statistical analysis title
    		 Cochran–Mantel–Haenszel (CMH) test
    Statistical analysis description
    Cochran–Mantel–Haenszel (CMH) test stratified by region, and baseline BMI status.
    Comparison groups
    Benralizumab DB v Placebo DB
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.513 [12]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 1.48
    Notes
    [12] - This endpoint was not a part of the pre-specified testing strategy and was not multiplicity protected. The p-value was considered nominal.

    Secondary: Proportion of patients with surgery for CRSwNP

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    End point title
    		 Proportion of patients with surgery for CRSwNP
    End point description
    Proportion of patients with surgery for CRSwNP
    End point type
    Secondary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Benralizumab DB Placebo DB
    Number of subjects analysed
    139
    135
    Units: Participants
    8
    10
    Statistical analysis title
    		 Cochran–Mantel–Haenszel (CMH) test
    Statistical analysis description
    Cochran–Mantel–Haenszel (CMH) test stratified by region, and baseline BMI status.
    Comparison groups
    Benralizumab DB v Placebo DB
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5662 [13]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.28
         upper limit
    		 1.99
    Notes
    [13] - This endpoint was not a part of the pre-specified testing strategy and was not multiplicity protected. The p-value was considered nominal.

    Secondary: Proportion of patients with SCS use for CRSwNP

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    End point title
    		 Proportion of patients with SCS use for CRSwNP
    End point description
    The number of courses of SCS for CRSwNP: noted an SCS course can be considered as a new course if the start date is preceded by at least 7 days after the end date of the last SCS course for CRSwNP (i.e. start date of the new course - end date of the last course > 7)
    End point type
    Secondary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Benralizumab DB Placebo DB
    Number of subjects analysed
    139
    135
    Units: Participants
    21
    22
    Statistical analysis title
    		 Cochran–Mantel–Haenszel (CMH) test
    Statistical analysis description
    Cochran–Mantel–Haenszel (CMH) test stratified by region, and baseline BMI status.
    Comparison groups
    Benralizumab DB v Placebo DB
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8454 [14]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.81
    Notes
    [14] - This endpoint was not a part of the pre-specified testing strategy and was not multiplicity protected. The p-value was considered nominal.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On study AEs were collected from the first dose to the last date in study, up to 112 weeks.
    Adverse event reporting additional description
    AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Benralizumab DB
    Reporting group description
    		 All participants who received Benralizumab in the double-blind (DB) period.

    Reporting group title
    Placebo switched to Benralizumab OLE‌
    Reporting group description
    		 All participants who initially received Placebo in the DB period, then switched to receive Benralizumab in the open-label extension (OLE) period‌

    Reporting group title
    Benralizumab OLE‌
    Reporting group description
    		 All participants who received Benralizumab in the double-blind (DB) period and continued to receive Benralizumab in the open-label extension (OLE) period‌

    Reporting group title
    Placebo DB
    Reporting group description
    		 All participants who received Placebo in the DB period.

    Serious adverse events
    		 Benralizumab DB Placebo switched to Benralizumab OLE‌ Benralizumab OLE‌ Placebo DB
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 144 (8.33%)
    9 / 125 (7.20%)
    6 / 122 (4.92%)
    12 / 143 (8.39%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colorectal adenoma
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fibula fracture
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Guillain-Barre syndrome
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Reflux gastritis
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    1 / 144 (0.69%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vulval leukoplakia
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthmatic crisis
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic rhinosinusitis with nasal polyps
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 125 (0.80%)
    1 / 122 (0.82%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 125 (0.80%)
    2 / 122 (1.64%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 144 (0.69%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
    2 / 143 (1.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 125 (0.80%)
    1 / 122 (0.82%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of asthma
         subjects affected / exposed
    0 / 144 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Benralizumab DB Placebo switched to Benralizumab OLE‌ Benralizumab OLE‌ Placebo DB
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    78 / 144 (54.17%)
    33 / 125 (26.40%)
    37 / 122 (30.33%)
    59 / 143 (41.26%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 144 (7.64%)
    4 / 125 (3.20%)
    1 / 122 (0.82%)
    7 / 143 (4.90%)
         occurrences all number
    15
    9
    1
    10
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    7 / 144 (4.86%)
    0 / 125 (0.00%)
    2 / 122 (1.64%)
    4 / 143 (2.80%)
         occurrences all number
    8
    0
    2
    6
    Pyrexia
         subjects affected / exposed
    7 / 144 (4.86%)
    4 / 125 (3.20%)
    1 / 122 (0.82%)
    3 / 143 (2.10%)
         occurrences all number
    7
    5
    1
    3
    Gastrointestinal disorders
    Chronic gastritis
         subjects affected / exposed
    6 / 144 (4.17%)
    2 / 125 (1.60%)
    0 / 122 (0.00%)
    1 / 143 (0.70%)
         occurrences all number
    7
    2
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    16 / 144 (11.11%)
    8 / 125 (6.40%)
    7 / 122 (5.74%)
    22 / 143 (15.38%)
         occurrences all number
    20
    10
    8
    31
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 144 (1.39%)
    3 / 125 (2.40%)
    2 / 122 (1.64%)
    6 / 143 (4.20%)
         occurrences all number
    2
    3
    2
    6
    Back pain
         subjects affected / exposed
    7 / 144 (4.86%)
    2 / 125 (1.60%)
    1 / 122 (0.82%)
    1 / 143 (0.70%)
         occurrences all number
    7
    2
    1
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    22 / 144 (15.28%)
    7 / 125 (5.60%)
    9 / 122 (7.38%)
    16 / 143 (11.19%)
         occurrences all number
    23
    7
    9
    16
    Influenza
         subjects affected / exposed
    1 / 144 (0.69%)
    1 / 125 (0.80%)
    4 / 122 (3.28%)
    3 / 143 (2.10%)
         occurrences all number
    1
    1
    4
    3
    Nasopharyngitis
         subjects affected / exposed
    11 / 144 (7.64%)
    8 / 125 (6.40%)
    9 / 122 (7.38%)
    9 / 143 (6.29%)
         occurrences all number
    12
    9
    10
    10
    Pneumonia
         subjects affected / exposed
    3 / 144 (2.08%)
    4 / 125 (3.20%)
    1 / 122 (0.82%)
    1 / 143 (0.70%)
         occurrences all number
    3
    4
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    13 / 144 (9.03%)
    4 / 125 (3.20%)
    9 / 122 (7.38%)
    14 / 143 (9.79%)
         occurrences all number
    16
    5
    10
    18

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Sep 2020
    Added study mitigation language which provided sites with measures that may be implemented if a participant was not able to visit a study site to ensure that the clinical trial can continue whilst minimizing risk to the participant, maintaining compliance with GCP, and minimizing risks to the study integrity.
    12 Feb 2021
    Augmenting the eligibility criteria to enroll a population who will be benefit from Benralizumab; providing the eligible patients with additional around one-year treatment with open-label benralizumab; adding intranasal corticosteroid spray (INCS) as background treatment which is align with global standard of care for nasal polyps; increasing the sample size since western cohort has been included. The list of key secondary endpoints was updated.

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

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