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    Clinical Trial Results:
    A Randomized, Double-Blind, Head-to-Head Comparison of Dupilumab Versus Omalizumab in Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Comorbid Asthma Patients

    Summary
    EudraCT number
    		 2021-000829-27
    Trial protocol
    		 FR   DE   BE   CZ   FI   HU   SE   ES   DK   PT   PL   IT   RO  
    Global end of trial date
    27 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Dec 2025
    First version publication date
    11 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LPS16747
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04998604
    WHO universal trial number (UTN)
    		 U1111-1255-4713
    Sponsors
    Sponsor organisation name
    Sanofi-Aventis Recherche & Développement
    Sponsor organisation address
    82, Avenue Raspail, Gentilly, France, 94250
    Public contact
    Trial Transparency Team, Sanofi-Aventis Recherche & Développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi-Aventis Recherche & Développement, Contact-US@sanofi.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
    27 Jan 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell.
    Protection of trial subjects
    Participants were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the participant and considering the local culture. During the course of the trial, participants were provided with individual participant cards indicating the nature of the trial the participant is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Sep 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 19
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    Czechia: 49
    Country: Number of subjects enrolled
    Denmark: 9
    Country: Number of subjects enrolled
    Finland: 10
    Country: Number of subjects enrolled
    France: 12
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Hungary: 35
    Country: Number of subjects enrolled
    Italy: 27
    Country: Number of subjects enrolled
    Mexico: 6
    Country: Number of subjects enrolled
    Poland: 64
    Country: Number of subjects enrolled
    Portugal: 30
    Country: Number of subjects enrolled
    Romania: 11
    Country: Number of subjects enrolled
    Spain: 30
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    United States: 26
    Worldwide total number of subjects
    360
    EEA total number of subjects
    309
    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)
    297
    From 65 to 84 years
    63
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 87 active centers in 17 countries. A total of 819 participants were screened between 27 September 2021 and 25 April 2024, of which 459 participants were screen failures. Screen failures were mainly due to not meeting eligibility criteria. EE= Eastern European; ROW= Rest of World.

    Pre-assignment
    Screening details
    		 A total of 360 participants were randomized in a 1:1 ratio to receive either dupilumab or omalizumab in study. Randomization was stratified by prior surgery for nasal polyp, inhaled corticosteroids (ICS) doses (low versus medium/high dose ICS), presence of aspirin-exacerbated respiratory disease (AERD) and region (EE versus ROW).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dupilumab 300 mg Q2W
    Arm description
    		 Participants received dupilumab 300 milligrams (mg) subcutaneous (SC) injection every 2 weeks (Q2W) for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dupilumab
    Investigational medicinal product code
    SAR231893
    Other name
    Dupixent
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dupilumab 300 mg SC injection was administered Q2W for 24 weeks.

    Arm title
    		 Omalizumab 75 to 600 mg Q2W/Q4W
    Arm description
    		 Participants received omalizumab 75 to 600 mg SC injection Q2W/every 4 weeks (Q4W) based on their serum immunoglobulin E (IgE) levels and body weight for 24 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Omalizumab
    Investigational medicinal product code
    Other name
    Xolair
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Omalizumab 75 to 600 mg SC injection was administered Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.

    Number of subjects in period 1
    		Dupilumab 300 mg Q2W Omalizumab 75 to 600 mg Q2W/Q4W
    Started
    181
    179
    Randomized and Treated
    179
    173
    Completed
    174
    165
    Not completed
    7
    14
         Consent withdrawn by subject
    2
    4
         Adverse event, non-fatal
    3
    2
         Not related to coronavirus disease 2019 pandemic
    2
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dupilumab 300 mg Q2W
    Reporting group description
    		 Participants received dupilumab 300 milligrams (mg) subcutaneous (SC) injection every 2 weeks (Q2W) for 24 weeks.

    Reporting group title
    Omalizumab 75 to 600 mg Q2W/Q4W
    Reporting group description
    		 Participants received omalizumab 75 to 600 mg SC injection Q2W/every 4 weeks (Q4W) based on their serum immunoglobulin E (IgE) levels and body weight for 24 weeks.

    Reporting group values
    		 Dupilumab 300 mg Q2W Omalizumab 75 to 600 mg Q2W/Q4W Total
    Number of subjects
    		 181 179 360
    Age Categorical
    Units: participants
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.0 ( 13.33 ) 52.1 ( 12.90 ) -
    Gender Categorical
    Units: participants
        Female
    		 74 88 162
        Male
    		 107 91 198
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 2 2
        Asian
    		 1 1 2
        Black or African American
    		 2 1 3
        White
    		 171 170 341
        Multiple
    		 0 1 1
        Not Reported
    		 6 2 8
        Unknown
    		 1 2 3
    University of Pennsylvania Smell Identification Test (UPSIT)
    UPSIT: a 40-item test to quantitatively assess human olfactory function and it consisted of 4 booklets, each containing 10 odorants with 1 odorant per page. Participant released odorant by rubbing brown-strip (contained odorant microcapsules) with tip of pencil and to indicate which of 4 words best described odor. Thus, each participant received score out of 40 possible correct answers. Total UPSIT score ranged from 0 (loss of smell/anosmia) to 40 (normal sense of smell/normosmia). Higher scores=better olfactory function. Only those participants with data available at baseline are reported.
    Units: score on a scale
        arithmetic mean (standard deviation)
    		 ( ) ( ) -
    Nasal Polyp Score (NPS)
    The NPS was assessed by the independent physician to grade the extent/severity of nasal polyps based on evaluation by nasal endoscopy. The NPS scores for each nostril was graded based on polyp size from 0 (no polyps) to 4 (large polyps causing complete obstruction of the inferior nasal cavity). The total NPS score was calculated as the sum of right and left nostril scores and ranged from 0 (no polyps) to 8 (large polyps). Higher scores indicate more extensive or severe nasal polyps.
    Units: score on a scale
        arithmetic mean (standard deviation)
    		 6.11 ( 1.165 ) 6.15 ( 1.277 ) -
    Subject analysis sets

    Subject analysis set title
    Dupilumab 300 mg Q2W
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.

    Subject analysis set title
    Omalizumab 75 to 600 mg Q2W/Q4W
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.

    Subject analysis sets values
    		 Dupilumab 300 mg Q2W Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects
    180
    175
    Age Categorical
    Units: participants
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender Categorical
    Units: participants
        Female
        Male
    Race
    Units: Subjects
        American Indian or Alaska Native
        Asian
        Black or African American
        White
        Multiple
        Not Reported
        Unknown
    University of Pennsylvania Smell Identification Test (UPSIT)
    UPSIT: a 40-item test to quantitatively assess human olfactory function and it consisted of 4 booklets, each containing 10 odorants with 1 odorant per page. Participant released odorant by rubbing brown-strip (contained odorant microcapsules) with tip of pencil and to indicate which of 4 words best described odor. Thus, each participant received score out of 40 possible correct answers. Total UPSIT score ranged from 0 (loss of smell/anosmia) to 40 (normal sense of smell/normosmia). Higher scores=better olfactory function. Only those participants with data available at baseline are reported.
    Units: score on a scale
        arithmetic mean (standard deviation)
    11.1 ( 5.45 )
    11.0 ( 6.13 )
    Nasal Polyp Score (NPS)
    The NPS was assessed by the independent physician to grade the extent/severity of nasal polyps based on evaluation by nasal endoscopy. The NPS scores for each nostril was graded based on polyp size from 0 (no polyps) to 4 (large polyps causing complete obstruction of the inferior nasal cavity). The total NPS score was calculated as the sum of right and left nostril scores and ranged from 0 (no polyps) to 8 (large polyps). Higher scores indicate more extensive or severe nasal polyps.
    Units: score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    Dupilumab 300 mg Q2W
    Reporting group description
    		 Participants received dupilumab 300 milligrams (mg) subcutaneous (SC) injection every 2 weeks (Q2W) for 24 weeks.

    Reporting group title
    Omalizumab 75 to 600 mg Q2W/Q4W
    Reporting group description
    		 Participants received omalizumab 75 to 600 mg SC injection Q2W/every 4 weeks (Q4W) based on their serum immunoglobulin E (IgE) levels and body weight for 24 weeks.

    Subject analysis set title
    Dupilumab 300 mg Q2W
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.

    Subject analysis set title
    Omalizumab 75 to 600 mg Q2W/Q4W
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.

    Primary: Change From Baseline to Week 24 in Nasal Polyp Score

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    End point title
    		 Change From Baseline to Week 24 in Nasal Polyp Score
    End point description
    The NPS was assessed by the independent physician to grade the extent/severity of nasal polyps based on evaluation by nasal endoscopy. The NPS scores for each nostril was graded based on polyp size from 0 (no polyps) to 4 (large polyps causing complete obstruction of the inferior nasal cavity). The total NPS score was calculated as the sum of right and left nostril scores and ranged from 0 (no polyps) to 8 (large polyps). Higher scores indicated more extensive or severe nasal polyps. Negative change from baseline indicated less severity of nasal polyps. Baseline was defined as the last available valid (non-missing) value up to and including the day of first administration of study treatment. The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and Week 24
    End point values
    		 Dupilumab 300 mg Q2W Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects analysed
    172
    165
    Units: score on a scale
        least squares mean (confidence interval 95%)
    -2.65 (-2.95 to -2.36)
    -1.05 (-1.35 to -0.75)
    Statistical analysis title
    		 Treatment difference in NPS
    Statistical analysis description
    A hierarchical testing procedure was used to control the type-I error and handle multiple secondary endpoint analysis. Testing was performed sequentially in order the endpoints were reported and continued when primary endpoint was statistically significant at 2-sided 0.05.
    Comparison groups
    Dupilumab 300 mg Q2W v Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects included in analysis
    337
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.001 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Least squares (LS) mean difference
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.96
         upper limit
    		 -1.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.182
    Notes
    [1] - At each post-baseline visit, each of the imputed complete data was analyzed by fitting an analysis of covariance (ANCOVA) model with the corresponding baseline value, study treatment (dupilumab, omalizumab), prior surgery (yes, no), ICS doses (low, medium/high), presence of AERD (yes, no), region (EE, ROW) as covariates.
    [2] - The threshold for statistical significance was 0.05 level.

    Primary: Change From Baseline to Week 24 in University of Pennsylvania Smell Identification Test

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    End point title
    		 Change From Baseline to Week 24 in University of Pennsylvania Smell Identification Test
    End point description
    The UPSIT was a 40-item test to quantitatively assess human olfactory function. The UPSIT test consisted of 4 booklets, each containing 10 odorants with 1 odorant per page. The participant was asked to release the odorant by rubbing the brown-strip (contained odorant microcapsules) with the tip of a pencil and to indicate which of 4 words best described the odor. Thus, each participant received a score out of 40 possible correct answers. The total UPSIT score ranged from 0 (loss of smell/anosmia) to 40 (normal sense of smell/normosmia). Higher scores indicated better olfactory function. Positive change from baseline indicated normal olfactory function. Baseline was defined as the last available valid (non-missing) value up to and including the day of first administration of study treatment. The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and Week 24
    End point values
    		 Dupilumab 300 mg Q2W Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects analysed
    173
    166
    Units: score on a scale
        least squares mean (confidence interval 95%)
    12.7 (11.3 to 14.1)
    4.7 (3.2 to 6.1)
    Statistical analysis title
    		 Treatment difference in UPSIT
    Statistical analysis description
    Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
    Comparison groups
    Dupilumab 300 mg Q2W v Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects included in analysis
    339
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.001 [4]
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.3
         upper limit
    		 9.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.88
    Notes
    [3] - At each post-baseline visit, each of the imputed complete data was analyzed by fitting an ANCOVA model with the corresponding baseline value, study treatment (dupilumab, omalizumab), prior surgery (yes, no), ICS doses (low, medium/high), presence of AERD (yes, no), region (EE, ROW) as covariates.
    [4] - The threshold for statistical significance was 0.05 level.

    Secondary: Change From Baseline to Week 24 in the Loss of Smell Score of the Chronic Rhinosinusitis With Nasal Polyp (CRSwNP) Nasal Symptom Diary

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    End point title
    		 Change From Baseline to Week 24 in the Loss of Smell Score of the Chronic Rhinosinusitis With Nasal Polyp (CRSwNP) Nasal Symptom Diary
    End point description
    The nasal symptom diary was designed to assess the severity of chronic rhinosinusitis nasal symptoms daily. These symptoms included nasal congestion (NC)/obstruction, loss of smell, anterior rhinorrhea, and posterior rhinorrhea. The severity of loss of smell was scored by participants using a scale ranged from 0 to 3 (where, 0= no symptoms, 1= mild symptoms, 2= moderate symptoms and 3= severe symptoms that were hard to tolerate, caused interference with activities, or daily living). Higher scores indicated greater symptom severity. Negative change from baseline indicated less severe symptom. Baseline value was calculated by averaging the data collected/recorded from Day -6 to Day 1. The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline (average of Day -6 to Day 1) and Week 24
    End point values
    		 Dupilumab 300 mg Q2W Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects analysed
    170
    164
    Units: score on a scale
        least squares mean (confidence interval 95%)
    -1.55 (-1.71 to -1.38)
    -0.74 (-0.90 to -0.57)
    Statistical analysis title
    		 Treatment difference in Loss of Smell Score
    Statistical analysis description
    Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
    Comparison groups
    Dupilumab 300 mg Q2W v Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 < 0.001 [6]
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.01
         upper limit
    		 -0.61
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.101
    Notes
    [5] - Each of the imputed complete data was analyzed by fitting an ANCOVA model with the corresponding baseline value, study treatment (dupilumab, omalizumab), prior surgery (yes, no), ICS doses (low, medium/high), presence of AERD (yes, no), region (EE, ROW) as covariates.
    [6] - The threshold for statistical significance was 0.05 level.

    Secondary: Change From Baseline to Week 24 in the Nasal Congestion Score of the Chronic Rhinosinusitis With Nasal Polyp Nasal Symptom Diary

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    End point title
    		 Change From Baseline to Week 24 in the Nasal Congestion Score of the Chronic Rhinosinusitis With Nasal Polyp Nasal Symptom Diary
    End point description
    The nasal symptom diary was designed to assess the severity of chronic rhinosinusitis nasal symptoms daily. These symptoms included nasal congestion (NC)/obstruction, loss of smell, anterior rhinorrhea, and posterior rhinorrhea. The severity of nasal congestion was scored by participants using a scale ranged from 0 to 3 (where, 0= no symptoms, 1= mild symptoms, 2= moderate symptoms and 3= severe symptoms that were hard to tolerate, caused interference with activities, or daily living). Higher scores indicated greater symptom severity. Negative change from baseline indicated less severe symptom. Baseline value was calculated by averaging the data collected/recorded from Day -6 to Day 1. The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline (average of Day -6 to Day 1) and Week 24
    End point values
    		 Dupilumab 300 mg Q2W Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects analysed
    170
    164
    Units: score on a scale
        least squares mean (confidence interval 95%)
    -1.63 (-1.76 to -1.49)
    -1.05 (-1.18 to -0.91)
    Statistical analysis title
    		 Treatment difference in NC score
    Statistical analysis description
    Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
    Comparison groups
    Dupilumab 300 mg Q2W v Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 < 0.001 [8]
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.74
         upper limit
    		 -0.42
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.082
    Notes
    [7] - Each of the imputed complete data was analyzed by fitting an ANCOVA model with the corresponding baseline value, study treatment (dupilumab, omalizumab), prior surgery (yes, no), ICS doses (low, medium/high), presence of AERD (yes, no), region (EE, ROW) as covariates.
    [8] - The threshold for statistical significance was 0.05 level.

    Secondary: Change From Baseline to Week 24 in Total Symptom Score (TSS) Derived From the Chronic Rhinosinusitis With Nasal Polyp Nasal Symptom Diary

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    End point title
    		 Change From Baseline to Week 24 in Total Symptom Score (TSS) Derived From the Chronic Rhinosinusitis With Nasal Polyp Nasal Symptom Diary
    End point description
    The TSS is a composite score consisted of the following symptoms assessed daily in the morning: NC/obstruction, decreased/loss of sense of smell, and rhinorrhea (average of anterior/posterior nasal discharge). Each item was scored on a scale ranged from 0 to 3 (where, 0= no symptoms, 1= mild symptoms, 2= moderate symptoms and 3= severe symptoms that were hard to tolerate, and caused interference with activities, or daily living). Higher score indicated greater symptom severity. The TSS score was calculated by summing the individual symptom score and ranged from 0 (no symptoms) to 9 (severe symptoms). Higher scores on the TSS indicated greater symptom severity. Negative change from baseline indicated less severe symptom. Baseline was calculated by averaging the data collected/recorded from Day -6 to Day 1. The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline (average of Day -6 to Day 1) and Week 24
    End point values
    		 Dupilumab 300 mg Q2W Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects analysed
    170
    164
    Units: score on a scale
        least squares mean (confidence interval 95%)
    -4.48 (-4.82 to -4.14)
    -2.73 (-3.09 to -2.38)
    Statistical analysis title
    		 Treatment difference in TSS
    Statistical analysis description
    Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
    Comparison groups
    Dupilumab 300 mg Q2W v Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 < 0.001 [10]
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -1.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.15
         upper limit
    		 -1.33
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.21
    Notes
    [9] - Each of the imputed complete data was analyzed by fitting an ANCOVA model with the corresponding baseline value, study treatment (dupilumab, omalizumab), prior surgery (yes, no), ICS doses (low, medium/high), presence of AERD (yes, no), region (EE, ROW) as covariates.
    [10] - The threshold for statistical significance was 0.05 level.

    Secondary: Change From Baseline to Week 24 in Sino-Nasal Outcome Test 22-Items (SNOT-22) Total Score

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    End point title
    		 Change From Baseline to Week 24 in Sino-Nasal Outcome Test 22-Items (SNOT-22) Total Score
    End point description
    The SNOT-22 is a patient-reported outcome questionnaire designed to assess impact of chronic rhinosinusitis on participants' health-related quality of life. The SNOT-22 consisted of 22 items covering symptoms, social/emotional impact, productivity, and sleep consequences of chronic rhinosinusitis. Each item was rated on a 6-point Likert scale response option, score ranged from 0 (no problem) to 5 (problem as bad as it can be). The SNOT-22 total score was sum of each item score, and it ranged from 0 (no problem) to 110 (problem as bad as it can be). Higher scores indicated greater rhinosinusitis-related health burden, meaning for this parameter lower score indicated better condition. Negative change from baseline indicated improvement in health-related quality of life. Baseline was defined as last available valid (non-missing) value up to and including day of first administration of study treatment. The ITT analysis set. Only participants with data collected at Week 24 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 24
    End point values
    		 Dupilumab 300 mg Q2W Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects analysed
    161
    158
    Units: score on a scale
        least squares mean (confidence interval 95%)
    -44.6 (-47.9 to -41.3)
    -31.9 (-35.2 to -28.5)
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 24 in Sino-Nasal Outcome Test 22-Items: Nasal Domain Score

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    End point title
    		 Change From Baseline to Week 24 in Sino-Nasal Outcome Test 22-Items: Nasal Domain Score
    End point description
    SNOT-22:a patient-reported outcome questionnaire designed to assess impact of chronic rhinosinusitis on participants' health-related quality of life (HRQoL). SNOT-22:categorized into 5 domains: Nasal(items 1,2,3,4,5,6,7 and 12); Ear/Facial(items 8,9,10 and 11); Sleep(items 13,14,15 and 16); Function(items 17,18 and 19); Emotion(items 20,21 and 22). Each item of Nasal domain was rated on 6-point Likert scale ranged from 0 (no problem) to 5 (problem as bad as it can be) with higher score=greater rhinosinusitis-related health burden. Total score of Nasal domain was average score of items of nasal domain and ranged from 0 (no problem) to 5 (problem as bad as it can be), where higher score=greater rhinosinusitis-related health burden. Negative change from baseline indicated improvement in HRQoL. Baseline:last available valid (non-missing) value up to and including day of 1st administration of study treatment. ITT analysis set. Only participants with data collected at Week 24 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 24
    End point values
    		 Dupilumab 300 mg Q2W Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects analysed
    161
    158
    Units: score on a scale
        least squares mean (confidence interval 95%)
    -2.4 (-2.6 to -2.2)
    -1.6 (-1.8 to -1.4)
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 24 in Nasal Peak Inspiratory Flow (NPIF)

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    End point title
    		 Change From Baseline to Week 24 in Nasal Peak Inspiratory Flow (NPIF)
    End point description
    The NPIF evaluation represented a physiologic measure of the air flow through both nasal cavities during forced inspiration. The NPIF is the best validated technique for the evaluation of nasal flow through the nose. Participants were issued an NPIF meter and were instructed on the use of the device and written instructions on the use of the NPIF meter was provided. Higher NPIF values were indicative of better nasal air flow. Positive change from baseline indicated better nasal air flow. Baseline was the mean measurement recorded for the 7 days (Day -6 to Day 1) prior to first dose of study treatment. The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline (average of Day -6 to Day 1) and Week 24
    End point values
    		 Dupilumab 300 mg Q2W Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects analysed
    169
    163
    Units: Liters per minute
        least squares mean (confidence interval 95%)
    68.96 (60.90 to 77.02)
    37.69 (29.28 to 46.09)
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 24 in Rhinosinusitis Visual Analogue Scale (Rhinosinusitis VAS)

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    End point title
    		 Change From Baseline to Week 24 in Rhinosinusitis Visual Analogue Scale (Rhinosinusitis VAS)
    End point description
    The rhinosinusitis severity VAS was used to evaluate the overall severity of the rhinosinusitis. It is a recommended scale to determine the participant’s disease severity and to guide the treatment for chronic rhinosinusitis. The participants were asked to answer the following question: “How troublesome are your symptoms of your rhinosinusitis” on a 10-centimeter VAS from 0 (not troublesome) to 10 (worst thinkable troublesome). Higher scores on the VAS score indicated more severe chronic rhinosinusitis. Negative change from baseline indicated less severity of rhinosinusitis. Baseline was defined as the last available valid (non-missing) value up to and including the day of first administration of study treatment. The ITT analysis set included all randomized participants. Only participants with data collected at Week 24 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 24
    End point values
    		 Dupilumab 300 mg Q2W Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects analysed
    161
    158
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -5.43 (-5.96 to -4.90)
    -3.56 (-4.11 to -3.01)
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs)

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to Sponsor’s product or program, for which ongoing monitoring and immediate notification by Investigator to Sponsor was required. TEAEs was defined as an AEs that occurred from first administration of study treatment (on Day 1) up to 98 days after last dose of study treatment administration. Safety analysis set included all randomized participants who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    From first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering the maximum duration of treatment exposure) i.e., up to approximately 329 days
    End point values
    		 Dupilumab 300 mg Q2W Omalizumab 75 to 600 mg Q2W/Q4W
    Number of subjects analysed
    179
    173
    Units: participants
        Any TEAE
    115
    116
        Any Serious TEAE
    3
    7
        Any Treatment-Emergent AESI
    4
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious AEs and other AEs were collected from first dose of study treatment administration (Day 1) up to 98 days after the last dose of study treatment administration (considering maximum duration of treatment exposure) i.e., up to approximately 329 days.
    Adverse event reporting additional description
    Deaths (all causes) were collected from first dose of study treatment (Day 1) up to end of follow-up for death for each participant, i.e., up to approximately 39 months. Analysis was performed on the safety analysis set.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Omalizumab 75 to 600 mg Q2W/Q4W
    Reporting group description
    		 Participants received omalizumab 75 to 600 mg SC injection Q2W/Q4W based on their serum IgE levels and body weight for 24 weeks.

    Reporting group title
    Dupilumab 300 mg Q2W
    Reporting group description
    		 Participants received dupilumab 300 mg SC injection Q2W for 24 weeks.

    Serious adverse events
    		 Omalizumab 75 to 600 mg Q2W/Q4W Dupilumab 300 mg Q2W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 173 (4.05%)
    3 / 179 (1.68%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Granulomatosis With Polyangiitis
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Eosinophilic Granulomatosis With Polyangiitis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis Acute
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Mycobacterium Avium Complex Infection
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroborreliosis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Klebsiella
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 173 (1.16%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Omalizumab 75 to 600 mg Q2W/Q4W Dupilumab 300 mg Q2W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 173 (30.64%)
    48 / 179 (26.82%)
    Injury, poisoning and procedural complications
    Accidental Overdose
         subjects affected / exposed
    21 / 173 (12.14%)
    12 / 179 (6.70%)
         occurrences all number
    24
    14
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 173 (7.51%)
    10 / 179 (5.59%)
         occurrences all number
    17
    12
    Infections and infestations
    Upper Respiratory Tract Infection
         subjects affected / exposed
    8 / 173 (4.62%)
    10 / 179 (5.59%)
         occurrences all number
    8
    12
    Nasopharyngitis
         subjects affected / exposed
    20 / 173 (11.56%)
    21 / 179 (11.73%)
         occurrences all number
    22
    25

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jun 2021
    Updated the exclusion criteria to exclude participants with infections receiving symptomatic treatment.
    14 May 2024
    Reduced the sample size due to enrollment challenges and optimization of the targeted participant population to focus on nasal function endpoints while maintaining the favorable benefit-risk of the study.

    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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