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    Clinical Trial Results:
    A randomised, double-blind (sponsor open) placebo-controlled, parallel group, 8-week treatment study to investigate the safety, pharmacodynamics and effect of the TLR7 agonist, GSK2245035, on the allergen-induced asthmatic response in subjects with mild allergic asthma.

    Summary
    EudraCT number
    		 2015-005645-31
    Trial protocol
    		 GB   DE  
    Global end of trial date
    04 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Feb 2019
    First version publication date
    27 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    205540
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.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
    11 Sep 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 May 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect of treatment with i.n. GSK2245035 compared to placebo on the allergen-induced late asthmatic response (LAR) in subjects with allergic asthma.
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Dec 2016
    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
    Germany: 14
    Country: Number of subjects enrolled
    United Kingdom: 22
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    36
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study investigated the safety, pharmacodynamics, and effect of the Toll-like receptor 7 (TLR7) agonist, GSK2245035, on allergen-induced asthmatic response in participants with mild allergic asthma. Participants received either intranasal 20 nanogram (ng) GSK2245035 or placebo once weekly for 8 weeks.

    Pre-assignment
    Screening details
    		 A total of 36 participants were randomized at different centers in United Kingdom and Germany..

    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
    		 Placebo
    Arm description
    		 Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Participants were administered placebo matching GSK2245035 intranasal spray solution

    Arm title
    		 GSK2245035 20 ng
    Arm description
    		 Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2245035 20 ng
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    Participants were administered 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation)

    Number of subjects in period 1
    		Placebo GSK2245035 20 ng
    Started
    14
    22
    Completed
    13
    19
    Not completed
    1
    3
         Adverse event, non-fatal
    -
    3
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks

    Reporting group title
    GSK2245035 20 ng
    Reporting group description
    		 Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.

    Reporting group values
    		 Placebo GSK2245035 20 ng Total
    Number of subjects
    		 14 22 36
    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)
    		 0 0 0
        Adults (18-64 years)
    		 14 22 36
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 36.6 ( 12.26 ) 36.0 ( 11.65 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 2 1 3
        Male
    		 12 21 33
    Race/Ethnicity, Customized
    Units: Subjects
        African American/African Heritage
    		 0 2 2
        Asian – Central/South Asian Heritage
    		 0 1 1
        White
    		 14 19 33

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks

    Reporting group title
    GSK2245035 20 ng
    Reporting group description
    		 Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.

    Primary: Late Asthmatic Response (LAR): absolute change from saline in minimum forced expiratory volume in 1 second (FEV1) between 4-10 hours following allergen challenge one week after treatment

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    End point title
    		 Late Asthmatic Response (LAR): absolute change from saline in minimum forced expiratory volume in 1 second (FEV1) between 4-10 hours following allergen challenge one week after treatment [1]
    End point description
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to bronchial allergen challenge (BAC) at the one-week follow-up visit (one week after the eighth dose of the study treatment). Minimum FEV1 over 4-10 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 4 and 10 hours post-allergen challenge, inclusive of the 4 and 10 hours timepoints. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. Per-Protocol Population comprises of all randomized participants who received at least one dose of study treatment and commence a BAC at follow-up and comply with the protocol. Only those participants with data available at specified time points were analyzed
    End point type
    Primary
    End point timeframe
    Week 9
    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: There are no statistical analysis to report.
    End point values
    		 Placebo GSK2245035 20 ng
    Number of subjects analysed
    10 [2]
    17 [3]
    Units: Liters
        arithmetic mean (standard deviation)
    -1.107 ( 0.7195 )
    -0.885 ( 0.5353 )
    Notes
    [2] - Per-Protocol Population.
    [3] - Per-Protocol Population.
    No statistical analyses for this end point

    Primary: LAR: absolute change from saline in weighted mean FEV1 between 4-10 hours following allergen challenge one week after treatment

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    End point title
    		 LAR: absolute change from saline in weighted mean FEV1 between 4-10 hours following allergen challenge one week after treatment [4]
    End point description
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to BAC at the one-week follow-up visit (one week after the eighth dose of the study treatment). Weighted mean FEV1 over 4-10 hours post-allergen challenge includes all post-saline time points between 4 and 10 hours post-allergen challenge, inclusive of the 4 and 10 hours timepoints. The weighted mean FEV1 was derived by calculating the area under the curve, and dividing the value by the relevant time interval. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Only those participants with data available at specified time points were analyzed
    End point type
    Primary
    End point timeframe
    Week 9
    Notes
    [4] - 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: There are no statistical analysis to report.
    End point values
    		 Placebo GSK2245035 20 ng
    Number of subjects analysed
    10 [5]
    17 [6]
    Units: Liters
        arithmetic mean (standard deviation)
    -0.546 ( 0.3932 )
    -0.576 ( 0.4018 )
    Notes
    [5] - Per-Protocol Population.
    [6] - Per-Protocol Population.
    No statistical analyses for this end point

    Secondary: Early Asthmatic Response (EAR): absolute change from saline in minimum FEV1 Between 0-2 hours following allergen challenge one week after treatment

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    End point title
    		 Early Asthmatic Response (EAR): absolute change from saline in minimum FEV1 Between 0-2 hours following allergen challenge one week after treatment
    End point description
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to BAC at the one-week follow-up visit (one week after the eighth dose of the study treatment). Minimum FEV1 over 0-2 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 0 and 2 hours post-allergen challenge, inclusive of the 0 and 2 hours timepoints. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. Only those participants with data available at specified time points were analyzed
    End point type
    Secondary
    End point timeframe
    Week 9
    End point values
    		 Placebo GSK2245035 20 ng
    Number of subjects analysed
    10 [7]
    17 [8]
    Units: Liters
        arithmetic mean (standard deviation)
    -1.246 ( 0.6052 )
    -1.096 ( 0.4113 )
    Notes
    [7] - Per-Protocol Population
    [8] - Per-Protocol Population
    No statistical analyses for this end point

    Secondary: EAR: absolute change from saline in weighted mean FEV1 between 0-2 hours following allergen challenge one week after treatment.

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    End point title
    		 EAR: absolute change from saline in weighted mean FEV1 between 0-2 hours following allergen challenge one week after treatment.
    End point description
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to BAC at the one-week follow-up visit (one week after the eighth dose of the study treatment). Weighted mean FEV1 over 0-2 hours post-allergen challenge includes all post-saline time points between 0-2 hours post-allergen challenge, inclusive of 0 and 2 hours timepoints. The weighted mean FEV1 was derived by calculating the area under the curve, and dividing the value by the relevant time interval. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Only those participants with data available at specified time points were analyzed
    End point type
    Secondary
    End point timeframe
    Week 9
    End point values
    		 Placebo GSK2245035 20 ng
    Number of subjects analysed
    10 [9]
    17 [10]
    Units: Liters
        arithmetic mean (standard deviation)
    -0.604 ( 0.2670 )
    -0.587 ( 0.2388 )
    Notes
    [9] - Per-Protocol Population.
    [10] - Per-Protocol Population.
    No statistical analyses for this end point

    Secondary: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported. All Subjects Population comprise of all participants who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Up to Week 20
    End point values
    		 Placebo GSK2245035 20 ng
    Number of subjects analysed
    14 [11]
    22 [12]
    Units: Participants
        Any AE
    10
    21
        Any SAE
    0
    0
    Notes
    [11] - All Subjects Population
    [12] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants with abnormal peak expiratory flow (PEF)

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    End point title
    		 Number of participants with abnormal peak expiratory flow (PEF)
    End point description
    The PEF is defined as the greatest rate of airflow that can be achieved during forced exhalation beginning with the lungs fully inflated. Participants were instructed to record their PEF readings each morning and evening into the diary card that was provided by the investigator. The minimum and maximum range ranges for PEF were <=205 and >=980 liters per minute.
    End point type
    Secondary
    End point timeframe
    Up to Week 12
    End point values
    		 Placebo GSK2245035 20 ng
    Number of subjects analysed
    14 [13]
    22 [14]
    Units: Participants
    0
    0
    Notes
    [13] - All Subjects Population
    [14] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants receiving rescue medication

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    End point title
    		 Number of participants receiving rescue medication
    End point description
    Salbutamol was administered as rescue medication only to participants who experienced serious discomfort. The data below exclude any Salbutamol administered as part of the planned study procedures (for example the Salbutamol administered after the Bronchial Allergen Challenge [BAC] is not counted as a rescue medication).
    End point type
    Secondary
    End point timeframe
    Up to Week 20
    End point values
    		 Placebo GSK2245035 20 ng
    Number of subjects analysed
    14 [15]
    22 [16]
    Units: Participants
    1
    2
    Notes
    [15] - All Subjects Population
    [16] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants with hematology values of potential clinical concern

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    End point title
    		 Number of participants with hematology values of potential clinical concern
    End point description
    Blood samples were collected for analysis of hematology parameters. Hematology parameters included hematocrit, hemoglobin, platelet count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, mean corpuscular volume, mean corpuscular hemoglobin, and red blood cells (RBC).
    End point type
    Secondary
    End point timeframe
    Up to Week 20
    End point values
    		 Placebo GSK2245035 20 ng
    Number of subjects analysed
    14 [17]
    22 [18]
    Units: Participants
    9
    14
    Notes
    [17] - All Subjects Population
    [18] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants with clinical chemistry values of potential clinical concern

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    End point title
    		 Number of participants with clinical chemistry values of potential clinical concern
    End point description
    Blood samples were collected for analysis of clinical chemistry parameters. Clinical chemistry parameters included blood urea nitrogen, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, total and direct bilirubin, albumin, calcium, creatinine, glucose, potassium and sodium.
    End point type
    Secondary
    End point timeframe
    Up to Week 8
    End point values
    		 Placebo GSK2245035 20 ng
    Number of subjects analysed
    14 [19]
    22 [20]
    Units: Participants
    1
    2
    Notes
    [19] - All Subjects Population
    [20] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants with abnormal urine analysis findings

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    End point title
    		 Number of participants with abnormal urine analysis findings
    End point description
    Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal.
    End point type
    Secondary
    End point timeframe
    Up to Week 8
    End point values
    		 Placebo GSK2245035 20 ng
    Number of subjects analysed
    14 [21]
    22 [22]
    Units: Participants
    0
    0
    Notes
    [21] - All Subjects Population
    [22] - All Subjects Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events and non serious adverse events were collected from the start of study treatment up to Week 20
    Adverse event reporting additional description
    All Subjects Population comprised of all participants who received at least one dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    GSK2245035 20 ng
    Reporting group description
    		 Participants received 20 ng GSK2245035 intranasal spray solution at the rate of 1 spray per nostril (10 ng per actuation) once weekly for 8 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matching GSK2245035 intranasal spray solution once weekly for 8 weeks

    Serious adverse events
    		 GSK2245035 20 ng Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 GSK2245035 20 ng Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 22 (95.45%)
    10 / 14 (71.43%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    4
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    Chest discomfort
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Vessel puncture site bruise
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    Hypersensitivity
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    7 / 22 (31.82%)
    0 / 14 (0.00%)
         occurrences all number
    8
    0
    Epistaxis
         subjects affected / exposed
    2 / 22 (9.09%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    Nasal congestion
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Nasal dryness
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Wheezing
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Cough
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Dry throat
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Nasal discomfort
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Nasal inflammation
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Nasal oedema
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Sinonasal obstruction
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Initial insomnia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Peak expiratory flow rate decreased
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Bone contusion
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Iliotibial band syndrome
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Joint injury
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 22 (40.91%)
    8 / 14 (57.14%)
         occurrences all number
    16
    18
    Dizziness
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Facial paralysis
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Parosmia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pruritus
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Vertigo
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Odynophagia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Ingrowing nail
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    8
    0
    Skin exfoliation
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Renal pain
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 22 (18.18%)
    0 / 14 (0.00%)
         occurrences all number
    4
    0
    Femoroacetabular impingement
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Myositis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 22 (27.27%)
    3 / 14 (21.43%)
         occurrences all number
    6
    5
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 22 (13.64%)
    0 / 14 (0.00%)
         occurrences all number
    3
    0
    Rhinitis
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    Bacterial rhinitis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Infection
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jun 2016
    Amendment_01: Section 4.6.1 and Section 7.1.1 have been adjusted slightly to make it clearer that subjects will be provided with a thermometer to be able to record temperature as part of capturing adverse event information. In Section 5.2, exclusion criterion 13 has been updated to reflect the revised recommended alcohol consumption guidelines.
    17 Aug 2016
    Amendment_02: The protocol title and text have been amended to clarify that while the investigator and subjects are blinded the sponsor-is unblinded. Details of the procedures required at early withdrawal visits have been added to the Time and Events Table, Section 7.1. Details around the Safety Review Team have been added to include a consultant external to GSK to Section 6.3. The inclusion and exclusion criteria have been updated in Section 5.1 and Section 5.2. and clarification around prohibited medications has been provided in Section 6.11.2. to align with updated exclusion criteria (Section 5.2). Administrative changes have been made to the T&E table (Section 7.1) and text to ensure consistency throughout.
    26 May 2017
    Amendment_03: Changes in the Primary Medical Monitor and contact details. Alignment of contraception requirements in Section 5.1 and Section 12.5.1 for partners of male subjects that are female of reproductive potential. Section 5.1, Inclusion Criteria, has been updated to align with Section 12.5.1 contraception requirements for partners of male subjects that are female of reproductive potential. Changes made to these sections. Section 5.1 Inclusion Criteria, bullets have been replaced with numbers.
    10 Jul 2017
    Amendment_04: Section 4.4 Design Justification, has been updated to permit earlier interim analysis. Section 5.3, Screening Failures/Re-Screening, has been updated to allow re-screening. Section 7.1.1 Time and Events Table – Screening Visit(s), has been updated to clarify timing of screening visits. Section 10.2 Regulatory and Ethical Considerations, Including the Informed Consent Process, to clarify that a new ICF should be completed for each re-screened subject.

    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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