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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of dupilumab in patients with uncontrolled, chronic rhinosinusitis without nasal polyposis (CRSsNP)

    Summary
    EudraCT number
    		 2020-003117-35
    Trial protocol
    		 BE   PT   SE   HU   PL  
    Global end of trial date
    29 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2025
    First version publication date
    05 Jan 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EFC16723
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04678856
    WHO universal trial number (UTN)
    		 U1111-1246-7522
    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
    12 Mar 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only.
    Protection of trial subjects
    Participants were fully informed of all pertinent aspects of 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 trail, 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
    02 Dec 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 2
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    Chile: 5
    Country: Number of subjects enrolled
    China: 7
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Portugal: 13
    Country: Number of subjects enrolled
    Russian Federation: 8
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    Ukraine: 7
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    71
    EEA total number of subjects
    25
    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)
    57
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 57 centers in 13 countries. A total of 269 participants were screened between 02 December 2020 to 26 April 2023, of which 198 participants were screen failures. Screen failures were mainly due to not meeting the eligibility criteria.

    Pre-assignment
    Screening details
    		 A total of 71 participants were randomized in a ratio of 1:1 to receive dupilumab or matching placebo. Randomization was stratified by screening blood eosinophil count (≥300 cells per cubic millimeter [/mm^3] or <300 cells/mm^3), background intranasal corticosteroids (INCS) use (yes or no), and region.

    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
    		 Placebo
    Arm description
    		 Participants received matching placebo via subcutaneous (SC) injection every 2 weeks (q2w) for up to 53.2 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo matched to dupilumab was available as pre-filled syringe and was administered as a SC injection q2w.

    Arm title
    		 Dupilumab 300 mg q2w
    Arm description
    		 Participants received dupilumab 300 milligrams (mg) via SC injection q2w for up to 53.1 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SAR231893, Dupixent, REGN668
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dupilumab was available as pre-filled syringe and was administered as a SC injection q2w.

    Number of subjects in period 1
    		Placebo Dupilumab 300 mg q2w
    Started
    33
    38
    Completed
    25
    37
    Not completed
    8
    1
         Consent withdrawn by subject
    5
    1
         Not related to Coronavirus Disease-2019 (COVID-19)
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo via subcutaneous (SC) injection every 2 weeks (q2w) for up to 53.2 weeks.

    Reporting group title
    Dupilumab 300 mg q2w
    Reporting group description
    		 Participants received dupilumab 300 milligrams (mg) via SC injection q2w for up to 53.1 weeks.

    Reporting group values
    		 Placebo Dupilumab 300 mg q2w Total
    Number of subjects
    		 33 38 71
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 24 33 57
        From 65-84 years
    		 9 5 14
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 47.45 ( 17.46 ) 46.45 ( 12.60 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 16 25 41
        Male
    		 17 13 30
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 3 5 8
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 1 1
        White
    		 30 31 61
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 1 1
    Lund-Mackay (LMK) Score
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 11.50 ( 3.19 ) 11.41 ( 3.69 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo via subcutaneous (SC) injection every 2 weeks (q2w) for up to 53.2 weeks.

    Reporting group title
    Dupilumab 300 mg q2w
    Reporting group description
    		 Participants received dupilumab 300 milligrams (mg) via SC injection q2w for up to 53.1 weeks.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received matching placebo via SC injection q2w for up to 53.2 weeks (Intent-to-treat [ITT] population with screening blood eosinophil count ≥300 cells/mm^3).

    Subject analysis set title
    Dupilumab 300 mg q2w
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received dupilumab 300 mg via SC injection q2w for up to 53.1 weeks (ITT population with screening blood eosinophil count ≥300 cells/mm^3).

    Primary: Change From Baseline to Week 24 in Opacification of Sinuses Assessed by Computed Tomography (CT) Scan Using the Lund Mackay (LMK) Score in Dupilumab Group

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    End point title
    		 Change From Baseline to Week 24 in Opacification of Sinuses Assessed by Computed Tomography (CT) Scan Using the Lund Mackay (LMK) Score in Dupilumab Group [1]
    End point description
    The CT scan LMK staging system represented most widely established method of sinus CT scoring. LMK total score is based on assessment of CT scan findings for each sinus area(maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinus on each side).Extent of mucosal opacification is rated on a 3-point scale ranging from 0=normal to 2=total opacification. In addition,ostiomeatal complex is graded as 0=not occluded or 2=occluded.The maximum score is therefore 12 per side; total score ranges=0 (normal) to 24 (more opacified),corresponding to the sum of all sinuses and the ostiomeatal unit. Higher score=worse outcome.Baseline=last available value up to randomization date and prior to first dose of study medication.ITT population with screening blood eosinophil count ≥300 cells/mm^3=all randomized participants with screening blood eosinophil count ≥300 cells/mm^3 analyzed according to treatment group allocated by randomization regardless if treatment kit was used or not.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and Week 24
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was reported.
    End point values
    		 Dupilumab 300 mg q2w
    Number of subjects analysed
    16
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -6.63 ( 3.91 )
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 24 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score

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    End point title
    		 Change From Baseline to Week 24 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score
    End point description
    LMK total score is based on assessment of CT scan findings for each sinus area (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinus on each side). Extent of mucosal opacification is rated on a 3-point scale ranging from 0 = normal to 2 = total opacification. In addition, the ostiomeatal complex is graded as 0 = not occluded or 2 = occluded. Maximum score is therefore 12 per side;total score ranges from 0 (normal) to 24 (more opacified), corresponding to sum of all sinuses and the ostiomeatal unit. Higher score=worse outcome. Baseline=last available value up to randomization date and prior to the first dose of study medication. ITT population with screening blood eosinophil count ≥300 cells/mm^3 included all randomized participants with screening blood eosinophil count ≥300 cells/mm^3 analyzed according to treatment group allocated by randomization regardless if treatment kit was used or not. Only those 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
    		 Placebo Dupilumab 300 mg q2w
    Number of subjects analysed
    14
    16
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -0.68 ( 2.26 )
    -6.63 ( 3.91 )
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 24 in Sinus Total Symptom Score (sTSS)

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    End point title
    		 Change From Baseline to Week 24 in Sinus Total Symptom Score (sTSS)
    End point description
    The sTSS is a composite score derived from the following individual items: nasal congestion (NC), anterior/posterior rhinorrhea, and facial pain/pressure. Each of the individual items were scored from 0 (no symptoms) to 3 (severe symptoms). The total score ranges from 0 to 9 and consists of the sum of NC, the averaged rhinorrhea item scores, and facial pain/pressure scores. Higher scores on sTSS indicated greater overall symptom severity. Baseline was defined as the last available value up to randomization date and prior to the first dose of study medication. ITT population with screening blood eosinophil count ≥300 cells/mm^3 included all randomized participants with screening blood eosinophil count ≥300 cells/mm^3 analyzed according to the treatment group allocated by randomization regardless if treatment kit was used or not. Only those 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
    		 Placebo Dupilumab 300 mg q2w
    Number of subjects analysed
    14
    16
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -1.75 ( 2.19 )
    -3.18 ( 2.68 )
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious AEs (TESAEs), and TEAEs Leading to Treatment Discontinuation

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    End point title
    		 Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious AEs (TESAEs), and TEAEs Leading to Treatment Discontinuation
    End point description
    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were AEs that developed, worsened or became serious during the treatment-emergent period. A SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. Safety population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    From the first dose of study drug (Day 1) up to the last dose of study drug administration (373 days) + 98 days, up to 471 days
    End point values
    		 Placebo Dupilumab 300 mg q2w
    Number of subjects analysed
    33
    38
    Units: Participants
        TEAEs
    27
    29
        TESAEs
    6
    3
        TEAEs leading to treatment discontinuation
    0
    1
    No statistical analyses for this end point

    Secondary: Serum Concentration of Dupilumab Over Time

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    End point title
    		 Serum Concentration of Dupilumab Over Time [2]
    End point description
    Blood samples were collected at the specified timepoints to evaluate serum concentration of dupilumab. Pharmacokinetic (PK) population included all participants in the safety population with at least 1 non-missing result for functional dupilumab concentration in serum after the first dose of the study intervention. Only those participants with data collected at specified timepoints are reported. Here, n = number of participants with data collected for each specified category.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Weeks 12, 24 and 52
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those participants in the dupilumab group were involved in this analysis.
    End point values
    		 Dupilumab 300 mg q2w
    Number of subjects analysed
    28
    Units: Nanograms per milliliter
    arithmetic mean (standard deviation)
        Baseline (n=22)
    0.00 ( 0.00 )
        Week 12 (n=25)
    54733.20 ( 26222.53 )
        Week 24 (n=28)
    62192.86 ( 23979.23 )
        Week 52 (n=20)
    68365.00 ( 30613.86 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Antidrug Antibody (ADA) Response to Dupilumab and Positive Neutralizing Antibody (Nab)

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    End point title
    		 Number of Participants With Antidrug Antibody (ADA) Response to Dupilumab and Positive Neutralizing Antibody (Nab)
    End point description
    Plasma samples were collected to evaluate antibodies to dupilumab. Pre-existing immunoreactivity was defined as an ADA positive response in the assay at baseline with all post first dose ADA results negative, OR an ADA positive response at baseline with all post first dose ADA responses less than 4-fold over baseline titer levels. Treatment-emergent ADA responses were defined as a positive response in the ADA assay post first dose, when baseline results were negative or missing. Treatment-boosted response was defined as an ADA positive response in the assay post first dose that was greater-than or equal to 4-fold over baseline titer levels, when baseline results were positive. Samples positive in the ADA assay were further characterized for the presence of NAbs. ADA population included all participants in the safety population who had at least 1 non-missing result in the ADA assay after the first dose of the study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and up to Week 52
    End point values
    		 Placebo Dupilumab 300 mg q2w
    Number of subjects analysed
    33
    38
    Units: Participants
        Pre-existing immunoreactivity
    1
    0
        Treatment-emergent ADA response
    1
    1
        Treatment-boosted ADA response
    1
    0
        Positive Nab
    3
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    TEAEs and TESAEs: first dose of study drug (Day 1) up to last dose of study drug administration (373 days) + 98 days, up to 471 days. All-cause mortality (deaths): participant’s screening (Day -28) to end of follow-up for each participant,up to 476 days.
    Adverse event reporting additional description
    Analysis was performed on safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Dupilumab 300 mg q2w
    Reporting group description
    		 Participants received dupilumab 300 mg via SC injection q2w for up to 53.1 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo via SC injection q2w for up to 53.2 weeks.

    Serious adverse events
    		 Dupilumab 300 mg q2w Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 38 (7.89%)
    6 / 33 (18.18%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Congenital, familial and genetic disorders
    Myocardial Bridging
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral Arterial Occlusive Disease
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Neuropathy
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Chronic Gastritis
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis Acute
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biloma
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Foot Deformity
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Osteoarthritis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Chronic Sinusitis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dupilumab 300 mg q2w Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 38 (52.63%)
    12 / 33 (36.36%)
    Injury, poisoning and procedural complications
    Accidental Overdose
         subjects affected / exposed
    2 / 38 (5.26%)
    3 / 33 (9.09%)
         occurrences all number
    2
    3
    Fall
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 33 (6.06%)
         occurrences all number
    1
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 33 (6.06%)
         occurrences all number
    2
    2
    General disorders and administration site conditions
    Injection Site Swelling
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    23
    Fatigue
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 33 (0.00%)
         occurrences all number
    3
    0
    Injection Site Erythema
         subjects affected / exposed
    4 / 38 (10.53%)
    1 / 33 (3.03%)
         occurrences all number
    9
    20
    Injection Site Reaction
         subjects affected / exposed
    3 / 38 (7.89%)
    1 / 33 (3.03%)
         occurrences all number
    12
    8
    Gastrointestinal disorders
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 33 (3.03%)
         occurrences all number
    2
    1
    Back Pain
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 33 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    Covid-19
         subjects affected / exposed
    8 / 38 (21.05%)
    7 / 33 (21.21%)
         occurrences all number
    9
    8
    Gastroenteritis
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 33 (0.00%)
         occurrences all number
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 33 (6.06%)
         occurrences all number
    3
    2
    Otitis Media
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 33 (3.03%)
         occurrences all number
    2
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 38 (0.00%)
    3 / 33 (9.09%)
         occurrences all number
    0
    3
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 33 (6.06%)
         occurrences all number
    2
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jul 2021
    Changed the primary analysis population to the ITT population in Part A and removed comorbid asthma as inclusion criterion as per a Health Authority request. Changed the handling of sinonasal surgery from composite strategy to hypothetical strategy in the primary estimand to better reflect the clinical scenario.
    23 Feb 2023
    Removed Part B. Updated the primary analysis population to the elevated baseline eosinophils population in Part A, and consequently update the sample size to have approximately 30 participants with elevated eosinophils (≥300 cells/mm^3), which coupled to the existing low eosinophils population will bring the total sample size to 70. Modified primary objectives and endpoints: Removed comparison to placebo group at Week 24 in reduction at Week 24 in sinus opacification in the primary objective; Removed assessing of the sTSS at Week 24 in the primary objective and moved sTSS as an endpoint to secondary endpoint. For all the secondary objective and endpoints, deleted the Week 52 objective/endpoints and requalified to exploratory, except the following endpoints: Change from baseline to Week 24 in opacification of sinuses assessed by CT scan using LMK score; Change from baseline to Week 24 in sTSS. In addition, in the asthma subgroup objective and endpoints removed comparison to placebo, and for endpoints evaluating the ≥300 cells/mm^3 population changed to ITT. Shortened treatment period from 52 weeks to at least 24 and no more than 52 weeks. Modified overall study phase from Phase 2/3 to Phase 2.

    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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