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    Clinical Trial Results:
    A Randomized, Double-Blind, Phase 2, Placebo Controlled, 2 Arm Study To Evaluate Dupilumab In Patients With Bilateral Nasal Polyposis And Chronic Symptoms Of Sinusitis

    Summary
    EudraCT number
    2013-001803-35
    Trial protocol
    BE   SE   ES  
    Global end of trial date
    05 Nov 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Apr 2016
    First version publication date
    06 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ACT12340
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01920893
    WHO universal trial number (UTN)
    U1111-1130-6475
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
    Public contact
    Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Aventis Recherche & Developpement, 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
    03 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the efficacy of dupilumab in the treatment of bilateral nasal polyp by assessment of the endoscopic nasal polyp score (NPS) in comparison to placebo.
    Protection of trial subjects
    Subjects 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 subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject 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 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
    Mometasone furoate nasal spray (MFNS - 100 μg in each nostril twice daily) was administered during a 4-week run-in period and then continued throughout the study.
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Aug 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 18
    Country: Number of subjects enrolled
    Sweden: 8
    Country: Number of subjects enrolled
    Belgium: 18
    Country: Number of subjects enrolled
    United States: 16
    Worldwide total number of subjects
    60
    EEA total number of subjects
    44
    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)
    60
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 14 sites in 4 countries. A total of 60 subjects were randomized between August 2013 and March 2014.

    Pre-assignment
    Screening details
    Randomization was stratified according to medical history of asthma (with/without asthma) and by nasal biopsy (biopsy performed Yes/No). Assignment to arms was done centrally using Interactive Voice/Web Response System in 1:1 ratio (dupilumab : placebo) after the 4-week run-in period on MFNS and confirmation of selection criteria.

    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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection every week from Week 1 to 15 in combination with MFNS.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo (for dupilumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection (2 mL) in the abdomen or upper thigh.

    Arm title
    Dupilumab
    Arm description
    Dupilumab, 2 Subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection every week from Week 1 to 15 in combination with MFNS.
    Arm type
    Experimental

    Investigational medicinal product name
    Dupilumab
    Investigational medicinal product code
    SAR231893, REGN668
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection (150 mg/mL) in the abdomen or upper thigh.

    Number of subjects in period 1
    Placebo Dupilumab
    Started
    30
    30
    Treated (safety population)
    30
    30
    Completed
    23
    28
    Not completed
    7
    2
         Adverse event
             5
             2
         Lack of efficacy
             2
             -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection every week from Week 1 to 15 in combination with MFNS.

    Reporting group title
    Dupilumab
    Reporting group description
    Dupilumab, 2 Subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection every week from Week 1 to 15 in combination with MFNS.

    Reporting group values
    Placebo Dupilumab Total
    Number of subjects
    30 30 60
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    49.3 ± 9.1 47.4 ± 9.8 -
    Gender categorical
    Units: Subjects
        Female
    14 12 26
        Male
    16 18 34
    Number of subjects with asthma
    The diagnosis of asthma was based on subject history; subjects with asthma were required to have a forced expiratory volume in 1 second (FEV1) of more than 60% of predicted use, daily inhaled corticosteroids of no more than 1000 μg of fluticasone (or equivalent), and could not have had an asthma exacerbation requiring systemic corticosteroids or hospitalization within the prior 3 months.
    Units: Subjects
        Yes
    19 16 35
        No
    11 14 25

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection every week from Week 1 to 15 in combination with MFNS.

    Reporting group title
    Dupilumab
    Reporting group description
    Dupilumab, 2 Subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection every week from Week 1 to 15 in combination with MFNS.

    Primary: Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16

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    End point title
    Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16
    End point description
    NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 to 4 for each nostril), with a lower score indicating smaller-sized polyps. Analysis population = Intent-to-treat (ITT) population (ie. all randomized subjects analyzed according to the treatment group allocated by randomization). Here, ‘n’ signifies the number of subjects with available data for NPS.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo Dupilumab
    Number of subjects analysed
    30
    30
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n=30, 30)
    5.67 ± 0.88
    5.87 ± 1.01
        Week 16 (n=23, 29)
    5.39 ± 1.47
    3.97 ± 1.9
        Change from baseline at Week 16 (n=23, 29)
    -0.26 ± 1.32
    -1.9 ± 1.76
    Statistical analysis title
    Dupilumab vs Placebo
    Statistical analysis description
    Analysis was performed by a mixed model repeated measures (MMRM) model.
    Comparison groups
    Dupilumab v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.0009
    Method
    Mixed models analysis
    Parameter type
    Least Square (LS) mean difference
    Point estimate
    -1.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.43
         upper limit
    -0.67
    Notes
    [1] - Threshold for significance at 0.05.

    Secondary: Change from Baseline in Bilateral Endoscopic NPS at Week 16 in Subjects with Asthma

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    End point title
    Change from Baseline in Bilateral Endoscopic NPS at Week 16 in Subjects with Asthma
    End point description
    Analysis population = subjects of the ITT population with asthma and with available data at Week 16
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo Dupilumab
    Number of subjects analysed
    15
    15
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.27 ± 0.88
    -2.4 ± 2.03
    No statistical analyses for this end point

    Secondary: Change from Baseline in Subject Reported Symptoms of Sinusitis at Week 16

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    End point title
    Change from Baseline in Subject Reported Symptoms of Sinusitis at Week 16
    End point description
    Morning symptoms of sinusitis (nasal congestion/obstruction, anterior rhinorrhea [runny nose], posterior rhinorrhea [post nasal drip], and loss of sense of smell) were assessed using a 0-3 categorical scale where higher score indicates severe symptoms. Severity of rhinosinusitis symptoms were assessed on a 0-10 Visual Analogue Scale (VAS) where higher score indicates worst thinkable troublesome. Analysis population = ITT population. Here, ‘n’ signifies the number of subjects with available data for individual symptom score.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo Dupilumab
    Number of subjects analysed
    30
    30
    Units: score on a scale
    arithmetic mean (standard deviation)
        Congestion/obstruction (n= 23, 29)
    -0.26 ± 0.7
    -0.95 ± 0.86
        Runny nose (n= 23, 29)
    -0.1 ± 0.58
    -0.62 ± 0.9
        Post nasal drip (23, 29)
    -0.15 ± 0.59
    -0.49 ± 0.78
        Loss of smell (23, 29)
    -0.3 ± 0.6
    -1.36 ± 1.08
        Rhinosinusitis symptoms severity (n=19, 28)
    -1.84 ± 3.6
    -4.32 ± 2.75
    No statistical analyses for this end point

    Secondary: Change from Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16

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    End point title
    Change from Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16
    End point description
    NPIF evaluation represents a physiologic measure of the air flow through both nasal cavities during forced inspiration and/or expiration expressed in liter per minute. Analysis population = subjects from ITT population with data available for NPIF at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo Dupilumab
    Number of subjects analysed
    23
    29
    Units: Liter/minute
    arithmetic mean (standard deviation)
        NPIF-Morning
    28.81 ± 34.26
    61.91 ± 43.39
        NPIF-Evening
    26.65 ± 34.31
    61.25 ± 45.91
    No statistical analyses for this end point

    Secondary: Change from Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) at Week 16

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    End point title
    Change from Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) at Week 16
    End point description
    UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0-40; lower score indicates severe smell loss. Analysis population = subjects from ITT population with data available for UPSIT at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo Dupilumab
    Number of subjects analysed
    23
    28
    Units: score on scale
        arithmetic mean (standard deviation)
    -0.17 ± 5.1
    15.36 ± 9.61
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16

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    End point title
    Change from Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16
    End point description
    CT scan assessment included Lund-Mackay score and percent of the maxillary sinuses occupied by disease. The Lund-Mackay scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses. The total score ranges from 0-24; higher score indicates worse status. Analysis population = subjects from ITT population with CT scan data available at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo Dupilumab
    Number of subjects analysed
    26
    29
    Units: specified in categories
    arithmetic mean (standard deviation)
        Lund-Mackay Score (Unit: score on scale)
    -0.23 ± 3.74
    -9.24 ± 4.58
        Area occupied by disease (unit: percent area)
    -3.92 ± 20.54
    -35.66 ± 24.28
    No statistical analyses for this end point

    Secondary: Time to First Response in NPS: Kaplan-Meier Estimate at Week 16

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    End point title
    Time to First Response in NPS: Kaplan-Meier Estimate at Week 16
    End point description
    NPS response was defined as ≥1 point reduction from baseline. The probability of response at Week 16 is provided. Analysis population = ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    Placebo Dupilumab
    Number of subjects analysed
    30
    30
    Units: Probability of response
        number (confidence interval 95%)
    0.44 (0.242 to 0.638)
    0.828 (0.69 to 0.965)
    No statistical analyses for this end point

    Secondary: Change from Baseline in 22-item Sinonasal Outcome Test (SNOT-22) at Week 16

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    End point title
    Change from Baseline in 22-item Sinonasal Outcome Test (SNOT-22) at Week 16
    End point description
    The SNOT-22 was a validated questionnaire to assess the impact of chronic rhinosinusitis on quality of life. The total score may range from 0-110, higher score represents worst quality of life; minimal clinically important change ≥8.90. Analysis population = subjects from ITT population with SNOT-22 data available at Week 16
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo Dupilumab
    Number of subjects analysed
    23
    29
    Units: score on a scale
        arithmetic mean (standard deviation)
    -8.26 ± 17.63
    -29.1 ± 19.9
    No statistical analyses for this end point

    Post-hoc: Change from Baseline in Nasal Total Symptoms Score (nTSS) at Week 16

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    End point title
    Change from Baseline in Nasal Total Symptoms Score (nTSS) at Week 16
    End point description
    nTSS was the sum of subject-assessed nasal symptom scores for nasal congestion/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge) using a 0-3 categorical scale. Total score ranges from 0 to 9. Higher score indicates severe symptoms. Analysis population =subjects from ITT population with nTSS data available at Week 16.
    End point type
    Post-hoc
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo Dupilumab
    Number of subjects analysed
    23
    29
    Units: score on a scale
    arithmetic mean (standard deviation)
        nTSS - Morning
    -0.68 ± 1.44
    -2.87 ± 2.09
        nTSS - Evening
    -0.77 ± 1.48
    -2.9 ± 2.04
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP).
    Adverse event reporting additional description
    Reported AEs and deaths are treatment-emergent that is AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects exposed to placebo (for dupilumab) in combination with MFNS (mean exposure of 96.2 days).

    Reporting group title
    Dupilumab
    Reporting group description
    Subjects exposed to dupilumab in combination with MFNS (mean exposure of 108.6 days).

    Serious adverse events
    Placebo Dupilumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 30 (13.33%)
    2 / 30 (6.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine Cancer
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Polyps
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mononeuropathy
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain In Extremity
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Herpes Zoster
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Dupilumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 30 (73.33%)
    27 / 30 (90.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Investigations
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences all number
    5
    2
    Epistaxis
         subjects affected / exposed
    2 / 30 (6.67%)
    7 / 30 (23.33%)
         occurrences all number
    2
    8
    Cough
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Nasal Polyps
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Oropharyngeal Pain
         subjects affected / exposed
    2 / 30 (6.67%)
    7 / 30 (23.33%)
         occurrences all number
    2
    7
    Rhinalgia
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Rhinitis Allergic
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Upper-Airway Cough Syndrome
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    3
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 30 (16.67%)
    6 / 30 (20.00%)
         occurrences all number
    5
    14
    Dizziness
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 30 (10.00%)
         occurrences all number
    1
    7
    Sinus Headache
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    8
    3
    General disorders and administration site conditions
    Injection Site Reaction
         subjects affected / exposed
    2 / 30 (6.67%)
    12 / 30 (40.00%)
         occurrences all number
    3
    50
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    4
    Back Pain
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    0
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 30 (13.33%)
    1 / 30 (3.33%)
         occurrences all number
    4
    1
    Nasopharyngitis
         subjects affected / exposed
    10 / 30 (33.33%)
    14 / 30 (46.67%)
         occurrences all number
    13
    20
    Sinusitis
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    3
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 30 (0.00%)
    4 / 30 (13.33%)
         occurrences all number
    0
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Aug 2013
    Addition of a nasal secretion sampling at screening visit for the purpose of assay validation of biomarker in the unique biomatrix; Permitted concomitant medication was changed to provide more information on a potential effect of dupilumab on CYP450 and a list of CYP450 substrates with narrow therapeutic index to ensure monitoring and if needed dose adjustment following the initiation and stopping of dupilumab; Clinical Study Director was changed.
    27 Nov 2013
    Simplification of the protocol concerning tissue collection and processing of nasal polyp biopsies.
    16 Dec 2013
    Simplification of exclusion criteria (clarification for previous treatment with dupilumab, definition of wash-out periods after systematic corticosteroids, details concerning nasal surgeries); Correction of two errors in the Study Flow Chart of the protocol; Clarification for allergen immunotherapy in regards prohibited and permitted concomitant medication; Deletion of one sentence concerning IMP administration at home in the safety instructions as IMP was to be administered at the site only; Forced expiratory volume (FEV) threshold at screening in subjects with asthma was changed from FEV ≥60% to FEV >60% of predicted normal.

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/26836729
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