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    Clinical Trial Results:
    A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of fevipiprant once daily plus standard-of-care (SoC) for assessment of the efficacy in reduction of nasal polyps size in patients with nasal polyposis and concomitant asthma

    Summary
    EudraCT number
    		 2018-002073-22
    Trial protocol
    		 DE   NL   CZ   BE   IT  
    Global end of trial date
    10 Jun 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Dec 2020
    First version publication date
    25 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CQAW039A2322
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03681093
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.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
    10 Jun 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the efficacy and safety of fevipiprant 150 mg and 450 mg compared to placebo in the reduction of nasal polyps size and the effect on symptoms, quality of life and smell via patient-reported outcomes in patients with nasal polyposis and concomitant asthma.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial. At the start of the Run-in period, all patients were provided with a short-acting bronchodilator (SABA, such as salbutamol 100 mcg or albuterol 90 mcg) which they were instructed to use throughout the study as rescue medication on an ‘as needed basis’.
    Background therapy
    		 During the Run-in period and Treatment period patients utilized mometasone furoate spray (200 μg once daily, administered as two 50 μg actuations into each nostril).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Mar 2019
    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: 38
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    Czechia: 13
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Netherlands: 8
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    98
    EEA total number of subjects
    52
    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)
    82
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in 25 investigative sites in 9 countries.

    Pre-assignment
    Screening details
    		 After the screening, participants went through a Run-in period of 4 weeks where they utilized mometasone furoate spray into each nostril. Afterwards, patients were randomized in 1:1:1 ratio in either of the 3 arms and continued to use the mometasone furoate spray.

    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, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fevipiprant 150 mg
    Arm description
    		 Fevipiprant (QAW039) 150 mg once daily orally
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fevipiprant
    Investigational medicinal product code
    QAW039
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Fevipiprant (QAW039) 150 mg once daily administered orally for 16 weeks.

    Arm title
    		 Fevipiprant 450 mg
    Arm description
    		 Fevipiprant (QAW039) 450 mg once daily orally
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fevipiprant
    Investigational medicinal product code
    QAW039
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Fevipiprant (QAW039) 450 mg once daily administered orally for 16 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Placebo once daily orally
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo once daily administered orally for 16 weeks.

    Number of subjects in period 1
    		Fevipiprant 150 mg Fevipiprant 450 mg Placebo
    Started
    32
    34
    32
    Completed
    32
    32
    31
    Not completed
    0
    2
    1
         Subject decision
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fevipiprant 150 mg
    Reporting group description
    		 Fevipiprant (QAW039) 150 mg once daily orally

    Reporting group title
    Fevipiprant 450 mg
    Reporting group description
    		 Fevipiprant (QAW039) 450 mg once daily orally

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily orally

    Reporting group values
    		 Fevipiprant 150 mg Fevipiprant 450 mg Placebo Total
    Number of subjects
    		 32 34 32 98
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 27 28 27 82
        From 65-84 years
    		 5 6 5 16
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.8 ± 13.36 50.9 ± 13.10 48.5 ± 13.43 -
    Sex: Female, Male
    Units: participants
        Female
    		 16 15 12 43
        Male
    		 16 19 20 55
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 32 34 31 97
        Black
    		 0 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Fevipiprant 150 mg
    Reporting group description
    		 Fevipiprant (QAW039) 150 mg once daily orally

    Reporting group title
    Fevipiprant 450 mg
    Reporting group description
    		 Fevipiprant (QAW039) 450 mg once daily orally

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily orally

    Primary: Change from baseline in Nasal Polyp Score at Week 16

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    End point title
    		 Change from baseline in Nasal Polyp Score at Week 16
    End point description
    Nasal Polyp Score (NPS) is 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 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps. Baseline NPS is defined as the last measurement performed on or before the date of randomization. A negative change from baseline in NPS is considered a favorable outcome.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Fevipiprant 150 mg Fevipiprant 450 mg Placebo
    Number of subjects analysed
    31
    32
    28
    Units: score on scale
        least squares mean (standard error)
    0.20 ± 0.224
    -0.10 ± 0.216
    0.14 ± 0.233
    Statistical analysis title
    		 Change NPS score - fevipiprant 150 mg vs placebo
    Comparison groups
    Fevipiprant 150 mg v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.979 [1]
    Method
    		 Mixed Model for Repeated Measures (MMRM)
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.59
         upper limit
    		 0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.323
    Notes
    [1] - Adjusted p-value is reported. The adjusted p-value was obtained from the Dunnet Multiplicity Correction applied to control the Type I error for the primary analysis.
    Statistical analysis title
    		 Change NPS score - fevipiprant 450 mg vs placebo
    Comparison groups
    Fevipiprant 450 mg v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.656 [2]
    Method
    		 MMRM
    Parameter type
    		 LS Mean
    Point estimate
    -0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.88
         upper limit
    		 0.39
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.319
    Notes
    [2] - Adjusted p-value is reported. The adjusted p-value was obtained from the Dunnet Multiplicity Correction applied to control the Type I error for the primary analysis.

    Secondary: Change from baseline in Nasal Congestion Score at Week 16

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    End point title
    		 Change from baseline in Nasal Congestion Score at Week 16
    End point description
    The nasal congestion score (NCS) is assessed via a questionnaire where patients are asked "Is your nose blocked?" with responses ranging from 0 = not at all, to 3=severe. Baseline NCS is defined as the last assessment performed on or before the date of randomization. A negative change from baseline in NCS is considered a favorable outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Fevipiprant 150 mg Fevipiprant 450 mg Placebo
    Number of subjects analysed
    31
    32
    28
    Units: score on scale
        least squares mean (standard error)
    -0.15 ± 0.172
    -0.35 ± 0.171
    -0.80 ± 0.181
    Statistical analysis title
    		 Change NCS score - fevipiprant 150 mg vs placebo
    Comparison groups
    Fevipiprant 150 mg v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012 [3]
    Method
    		 MMRM
    Parameter type
    		 LS Mean
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 1.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.249
    Notes
    [3] - Unadjusted p-value
    Statistical analysis title
    		 Change NCS score - fevipiprant 450 mg vs placebo
    Comparison groups
    Fevipiprant 450 mg v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.074 [4]
    Method
    		 MMRM
    Parameter type
    		 LS Mean
    Point estimate
    0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.94
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.248
    Notes
    [4] - Unadjusted p-value

    Secondary: Change from baseline in Quality of Life as assessed by the SNOT-22 questionnaire at Week 16

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    End point title
    		 Change from baseline in Quality of Life as assessed by the SNOT-22 questionnaire at Week 16
    End point description
    SNOT-22 (Sino-Nasal Outcome Test) Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been for them over the past 2 weeks on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. Baseline SNOT-22 is defined as the last assessment performed on or before the date of randomization. A negative change from baseline in SNOT-22 is considered a favorable outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Fevipiprant 150 mg Fevipiprant 450 mg Placebo
    Number of subjects analysed
    31
    32
    28
    Units: score on scale
        least squares mean (standard error)
    -3.23 ± 3.349
    -10.61 ± 3.358
    -8.44 ± 3.571
    Statistical analysis title
    		 Change SNOT-22 - fevipiprant 150 mg vs placebo
    Comparison groups
    Fevipiprant 150 mg v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.288 [5]
    Method
    		 MMRM
    Parameter type
    		 LS Mean
    Point estimate
    5.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.49
         upper limit
    		 14.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.881
    Notes
    [5] - Unadjusted p-value
    Statistical analysis title
    		 Change SNOT-22 - fevipiprant 450 mg vs placebo
    Comparison groups
    Fevipiprant 450 mg v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.661 [6]
    Method
    		 MMRM
    Parameter type
    		 LS Mean
    Point estimate
    -2.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.99
         upper limit
    		 7.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.936
    Notes
    [6] - Unadjusted p-value

    Secondary: Change from baseline in sense of smell as assessed by the University of Pennsylvania Smell Identification Test (UPSIT) at Week 16

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    End point title
    		 Change from baseline in sense of smell as assessed by the University of Pennsylvania Smell Identification Test (UPSIT) at Week 16
    End point description
    The UPSIT (University of Pennsylvania Smell Identification Test) is a test that measures an individual's ability to detect odors. It consists of 4 workbooks of 10 pages each. On each page there is a different "scratch and sniff" strip which is embedded with a microencapsulated odorant and a question regarding the smell detected with a four-choice option for the response. The total number of questions in UPSIT is 40. The number of correct responses regarding the smells being experienced is summed to provide a total score that ranges from 0 to 40, with a higher score indicating a better sense of smell. Baseline UPSIT is defined as the last assessment performed on or before the date of randomization. A positive change from baseline in UPSIT is considered a favorable outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Fevipiprant 150 mg Fevipiprant 450 mg Placebo
    Number of subjects analysed
    31
    32
    28
    Units: score on scale
        least squares mean (standard error)
    1.05 ± 1.242
    4.95 ± 1.259
    0.44 ± 1.315
    Statistical analysis title
    		 Change UPSIT - fevipiprant 150 mg vs placebo
    Comparison groups
    Fevipiprant 150 mg v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.735 [7]
    Method
    		 MMRM
    Parameter type
    		 LS Mean
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.98
         upper limit
    		 4.21
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.809
    Notes
    [7] - Unadjusted p-value
    Statistical analysis title
    		 Change UPSIT - fevipiprant 450 mg vs placebo
    Comparison groups
    Fevipiprant 450 mg v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.015 [8]
    Method
    		 MMRM
    Parameter type
    		 LS Mean
    Point estimate
    4.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 8.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.821
    Notes
    [8] - Unadjusted p-value

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18.
    Adverse event reporting additional description
    Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Fevipiprant 150 mg
    Reporting group description
    		 Fevipiprant (QAW039) 150 mg once daily orally

    Reporting group title
    Fevipiprant 450 mg
    Reporting group description
    		 Fevipiprant (QAW039) 450 mg once daily orally

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily orally

    Serious adverse events
    		 Fevipiprant 150 mg Fevipiprant 450 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Fevipiprant 150 mg Fevipiprant 450 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 32 (53.13%)
    13 / 34 (38.24%)
    11 / 32 (34.38%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Peripheral swelling
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 34 (8.82%)
    1 / 32 (3.13%)
         occurrences all number
    2
    3
    1
    Cough
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal congestion
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    Paranasal sinus inflammation
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    0
    2
    Respiratory disorder
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Amylase increased
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    Lipase increased
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    0
    Weight increased
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    Facial paralysis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Headache
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    4
    0
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    Tongue discomfort
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Scab
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    Bursitis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    1
    Bronchitis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Ear infection
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    1
    Gastric infection
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    Gingivitis
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 34 (2.94%)
    2 / 32 (6.25%)
         occurrences all number
    2
    1
    2
    Laryngitis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    1
    0
    2
    Oral herpes
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 34 (5.88%)
    0 / 32 (0.00%)
         occurrences all number
    1
    2
    0
    Otitis media
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 34 (2.94%)
    2 / 32 (6.25%)
         occurrences all number
    3
    1
    2
    Tonsillitis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolic syndrome
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Dec 2018
    The protocol was amended based on health authority feedback. Additional exclusion criteria were added to ensure that patients taking any of the prohibited medications were appropriately excluded.
    30 Jan 2019
    To align the safety requirements with other studies in the QAW039 program including addition of exclusion criteria.
    24 Sep 2019
    To provide clarification on the process for assessment of nasal endoscopy at baseline and management of protocol deviations in relation to the statistical analysis sets.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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