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    Clinical Trial Results:
    A 12-week, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of QAW039 when added to standard-of-care asthma therapy in patients with uncontrolled asthma

    Summary
    EudraCT number
    		 2017-001273-16
    Trial protocol
    		 DE   HU   SK  
    Global end of trial date
    30 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Feb 2020
    First version publication date
    15 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CQAW039A2316
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03215758
    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,
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy of fevipiprant 150 mg once daily as measured by change from baseline in pre-dose FEV1, compared with placebo, at the end of the 12-week active-treatment period
    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
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2017
    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
    Argentina: 195
    Country: Number of subjects enrolled
    Germany: 51
    Country: Number of subjects enrolled
    Hungary: 38
    Country: Number of subjects enrolled
    Mexico: 10
    Country: Number of subjects enrolled
    Philippines: 57
    Country: Number of subjects enrolled
    Slovakia: 67
    Country: Number of subjects enrolled
    South Africa: 26
    Country: Number of subjects enrolled
    Turkey: 11
    Country: Number of subjects enrolled
    United States: 220
    Worldwide total number of subjects
    675
    EEA total number of subjects
    156
    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)
    30
    Adults (18-64 years)
    553
    From 65 to 84 years
    91
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from centers in Argentina (20), Germany (12), Hungary (4), Mexico (2), Philippines (4), Slovakia (7), South Africa (5), Turkey (5), United States (29)

    Pre-assignment
    Screening details
    		 Screening period of up to 2 weeks to assess eligibility during which patients practice completing the electronic peak expiratory flow eDiary/ePEF device.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 QAW039
    Arm description
    		 QAW039 once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fevipiprant
    Investigational medicinal product code
    QAW039
    Other name
    QAW039
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150mg tablets

    Arm title
    		 Placebo
    Arm description
    		 Placebo once daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Placebo
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    matching placebo

    Number of subjects in period 1
    		QAW039 Placebo
    Started
    339
    336
    Completed
    334
    328
    Not completed
    5
    8
         Adverse event, serious fatal
    -
    1
         Physician decision
    -
    1
         Adverse event, non-fatal
    1
    2
         Technical Problems
    1
    -
         Protocol deviation
    -
    1
         Subject/Guardian Decision
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    QAW039
    Reporting group description
    		 QAW039 once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily

    Reporting group values
    		 QAW039 Placebo Total
    Number of subjects
    		 339 336 675
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 15 15 30
        Adults (18-64 years)
    		 278 275 553
        From 65-84 years
    		 45 46 91
        85 years and over
    		 1 0 1
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 48.1 ( 15.15 ) 47.7 ( 15.40 ) -
    Sex: Female, Male
    Units:
        Female
    		 217 216 433
        Male
    		 122 120 242
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 274 281 555
        Black
    		 18 12 30
        Asian
    		 39 34 73
        Native American
    		 1 0 1
        Pacific Islander
    		 2 0 2
        Unknown
    		 0 3 3
        Other
    		 5 6 11

    End points

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    End points reporting groups
    Reporting group title
    QAW039
    Reporting group description
    		 QAW039 once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily

    Primary: Change from baseline in pre-dose FEV1 at week 12

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    End point title
    		 Change from baseline in pre-dose FEV1 at week 12
    End point description
    Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 QAW039 Placebo
    Number of subjects analysed
    339
    336
    Units: Liters
        least squares mean (standard error)
    0.112 ( 0.0167 )
    0.071 ( 0.0169 )
    Statistical analysis title
    		 change from baseline in pre-dose FEV1
    Comparison groups
    Placebo v QAW039
    Number of subjects included in analysis
    675
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.088
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.0238
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.006
         upper limit
    		 0.088

    Secondary: Change from baseline in daytime asthma symptom score

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    End point title
    		 Change from baseline in daytime asthma symptom score
    End point description
    Daytime asthma symptoms are evaluated through four questions and each of them will be rated on a scale of 0 to 6. Higher scores indicate more severe asthma-related symptoms. A mean score is calculated for the responses to 4 questions.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 QAW039 Placebo
    Number of subjects analysed
    339
    336
    Units: Score
        least squares mean (standard error)
    -0.56 ( 0.036 )
    -0.51 ( 0.037 )
    Statistical analysis title
    		 Change from baseline in daytime asthma symptoms
    Comparison groups
    QAW039 v Placebo
    Number of subjects included in analysis
    675
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.278
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.05

    Secondary: Change from baseline in daily use of SABA

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    End point title
    		 Change from baseline in daily use of SABA
    End point description
    Daily use of SABA (the number of rescue medication puffs taken in the previous 12 hours) was recorded using a patient electronic diary (referred to as eDiary or eDiary/ePEF). Patients were instructed to routinely complete the patient diary twice daily – at the same time each morning and each evening, approximately 12 hours apart.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 QAW039 Placebo
    Number of subjects analysed
    339
    336
    Units: Number of puffs
        least squares mean (standard error)
    -1.11 ( 0.075 )
    -1.02 ( 0.076 )
    Statistical analysis title
    		 change from baseline in use of SABA
    Comparison groups
    QAW039 v Placebo
    Number of subjects included in analysis
    675
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.429
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.13

    Secondary: Change from baseline in Asthma Quality of Life (AQLQ+12) score

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    End point title
    		 Change from baseline in Asthma Quality of Life (AQLQ+12) score
    End point description
    AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 QAW039 Placebo
    Number of subjects analysed
    339
    336
    Units: units on a scale
        least squares mean (standard error)
    0.91 ( 0.048 )
    0.89 ( 0.049 )
    Statistical analysis title
    		 change from baseline in AQLQ+12
    Comparison groups
    QAW039 v Placebo
    Number of subjects included in analysis
    675
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.777
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.069
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.15

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    After signing informed consent to 30 days after last dose
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    QAW039 150 mg
    Reporting group description
    		 QAW039 150 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 QAW039 150 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 339 (0.29%)
    5 / 336 (1.49%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Electrocardiogram T wave inversion
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Astrocytoma
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 336 (0.30%)
         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 / 339 (0.29%)
    2 / 336 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infections and infestations
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    0 / 339 (0.00%)
    1 / 336 (0.30%)
         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: 1%
    Non-serious adverse events
    		 QAW039 150 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    94 / 339 (27.73%)
    102 / 336 (30.36%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 339 (0.59%)
    5 / 336 (1.49%)
         occurrences all number
    2
    5
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 339 (0.29%)
    5 / 336 (1.49%)
         occurrences all number
    1
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 339 (1.77%)
    7 / 336 (2.08%)
         occurrences all number
    6
    9
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 339 (0.59%)
    4 / 336 (1.19%)
         occurrences all number
    2
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 339 (0.59%)
    4 / 336 (1.19%)
         occurrences all number
    2
    4
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    43 / 339 (12.68%)
    45 / 336 (13.39%)
         occurrences all number
    50
    57
    Cough
         subjects affected / exposed
    2 / 339 (0.59%)
    5 / 336 (1.49%)
         occurrences all number
    2
    5
    Nasal congestion
         subjects affected / exposed
    0 / 339 (0.00%)
    4 / 336 (1.19%)
         occurrences all number
    0
    4
    Rhinitis allergic
         subjects affected / exposed
    12 / 339 (3.54%)
    6 / 336 (1.79%)
         occurrences all number
    12
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 339 (0.29%)
    4 / 336 (1.19%)
         occurrences all number
    1
    4
    Back pain
         subjects affected / exposed
    4 / 339 (1.18%)
    4 / 336 (1.19%)
         occurrences all number
    4
    4
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    4 / 339 (1.18%)
    1 / 336 (0.30%)
         occurrences all number
    4
    1
    Bronchitis
         subjects affected / exposed
    12 / 339 (3.54%)
    10 / 336 (2.98%)
         occurrences all number
    12
    10
    Nasopharyngitis
         subjects affected / exposed
    13 / 339 (3.83%)
    12 / 336 (3.57%)
         occurrences all number
    14
    12
    Rhinitis
         subjects affected / exposed
    1 / 339 (0.29%)
    5 / 336 (1.49%)
         occurrences all number
    1
    5
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 339 (1.77%)
    10 / 336 (2.98%)
         occurrences all number
    6
    11
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    5 / 339 (1.47%)
    5 / 336 (1.49%)
         occurrences all number
    5
    5
    Viral upper respiratory tract infection
         subjects affected / exposed
    7 / 339 (2.06%)
    6 / 336 (1.79%)
         occurrences all number
    9
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
    For support, Contact us.
    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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