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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, 3-period Crossover Study to Evaluate the Effects of Repeated Doses of Inhaled TD-8236 and Impact on Airway Responses Following Allergen Challenge in Patients with Asthma

    Summary
    EudraCT number
    		 2019-002915-24
    Trial protocol
    		 GB  
    Global end of trial date
    03 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Sep 2021
    First version publication date
    05 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0178
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04150341
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Theravance Biopharma US, Inc
    Sponsor organisation address
    901 Gateway Boulevard, South San Francisco, CA, United States, 94080
    Public contact
    Nathan Pfeifer, Theravance Biopharma US, Inc, 001 (650) 808-3711, npfeifer@theravance.com
    Scientific contact
    Nathan Pfeifer, Theravance Biopharma US, Inc, 001 (650) 808-3711, npfeifer@theravance.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
    15 Mar 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to characterize the late asthmatic response (LAR) in terms of area under the forced expiratory volume (in 1 second) (FEV1) curve after inhaled allergen challenge in mild asthmatic participants receiving 14 days of TD-8236 or placebo.
    Protection of trial subjects
    This study was conducted in accordance with the protocol, the principles of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP), the United States (US) Code of Federal Regulations, the principles of the World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, and all applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Nov 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
    United Kingdom: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    0
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 24 participants were enrolled at 2 sites in the United Kingdom.

    Pre-assignment
    Screening details
    		 Participants were screened with an allergen challenge test within 35 days prior to first dosing. Participants received increasing concentrations of inhaled allergen until a decrease of ≥20% from pre-allergen FEV1 was observed during the 30 minutes following the most recent inhalation, and then monitored for a late asthmatic response (LAR).

    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
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo
    Arm description
    		 Participants were administered inhaled doses of placebo matching TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo blended capsule(s) for inhalation via a dry powder inhaler.

    Arm title
    		 TD-8236 150 mcg
    Arm description
    		 Participants were administered 150 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD-8236
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Blended capsules for inhalation via a dry powder inhaler.

    Arm title
    		 TD-8236 1500 mcg
    Arm description
    		 Participants were administered 1500 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TD-8236
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Blended capsules for inhalation via a dry powder inhaler.

    Number of subjects in period 1
    		Placebo TD-8236 150 mcg TD-8236 1500 mcg
    Started
    24
    23
    24
    Completed
    23
    22
    24
    Not completed
    1
    1
    0
         Physician decision
    -
    1
    -
         Adverse event, non-fatal
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 24 24
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.0 ( 11.21 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 17 17
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 24 24
    Race
    Units: Subjects
        White
    		 19 19
        Black or African American
    		 3 3
        Asian
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were administered inhaled doses of placebo matching TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.

    Reporting group title
    TD-8236 150 mcg
    Reporting group description
    		 Participants were administered 150 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.

    Reporting group title
    TD-8236 1500 mcg
    Reporting group description
    		 Participants were administered 1500 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.

    Primary: Area Under the Curve of Change from Baseline in Forced Expiratory Volume (in 1 Second) (FEV1) from 3 to 8 Hours After Inhaled Allergen Challenge at Day 14

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    End point title
    		 Area Under the Curve of Change from Baseline in Forced Expiratory Volume (in 1 Second) (FEV1) from 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
    End point description
    End point type
    Primary
    End point timeframe
    Day 14 of treatment period: 3 to 8 hours after allergen challenge
    End point values
    		 Placebo TD-8236 150 mcg TD-8236 1500 mcg
    Number of subjects analysed
    22
    22
    20
    Units: liters
        least squares mean (standard error)
    -0.53 ( 0.077 )
    -0.54 ( 0.077 )
    -0.57 ( 0.079 )
    Statistical analysis title
    		 Placebo v TD-8236 150 mcg
    Comparison groups
    Placebo v TD-8236 150 mcg
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.881
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.14
         upper limit
    		 0.12
    Statistical analysis title
    		 Placebo v TD-8236 1500 mcg
    Comparison groups
    Placebo v TD-8236 1500 mcg
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.575
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.1

    Secondary: Area Under the Curve of Percentage Change from Baseline in Forced Expiratory Volume (in 1 Second) (FEV1) from 3 to 8 Hours After Inhaled Allergen Challenge at Day 14

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    End point title
    		 Area Under the Curve of Percentage Change from Baseline in Forced Expiratory Volume (in 1 Second) (FEV1) from 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14 of treatment period: 3 to 8 hours after allergen challenge
    End point values
    		 Placebo TD-8236 150 mcg TD-8236 1500 mcg
    Number of subjects analysed
    22
    22
    20
    Units: percentage change
        least squares mean (standard error)
    -16.92 ( 2.512 )
    -17.50 ( 2.516 )
    -17.97 ( 2.562 )
    No statistical analyses for this end point

    Secondary: Maximum Decline in Forced Expiratory Volume (in 1 Second) (FEV1) from 3 to 8 Hours After Inhaled Allergen Challenge at Day 14

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    End point title
    		 Maximum Decline in Forced Expiratory Volume (in 1 Second) (FEV1) from 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14 of treatment period: 3 to 8 hours after allergen challenge
    End point values
    		 Placebo TD-8236 150 mcg TD-8236 1500 mcg
    Number of subjects analysed
    22
    22
    20
    Units: liters
        least squares mean (standard error)
    -0.83 ( 0.082 )
    -0.86 ( 0.082 )
    -0.85 ( 0.084 )
    No statistical analyses for this end point

    Secondary: Maximum Percentage Decline in Forced Expiratory Volume (in 1 Second) (FEV1) from 3 to 8 Hours After Inhaled Allergen Challenge at Day 14

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    End point title
    		 Maximum Percentage Decline in Forced Expiratory Volume (in 1 Second) (FEV1) from 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14 of treatment period: 3 to 8 hours after allergen challenge
    End point values
    		 Placebo TD-8236 150 mcg TD-8236 1500 mcg
    Number of subjects analysed
    22
    22
    20
    Units: percentage change
        least squares mean (standard error)
    -27.02 ( 2.790 )
    -28.18 ( 2.794 )
    -26.88 ( 2.843 )
    No statistical analyses for this end point

    Secondary: Area Under the Concentration-time Curve Over One 24-hour Dosing Interval (AUC0-24) of TD-8236 in Plasma

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    End point title
    		 Area Under the Concentration-time Curve Over One 24-hour Dosing Interval (AUC0-24) of TD-8236 in Plasma [1]
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No PK data was collected for participants who received the placebo.
    End point values
    		 TD-8236 150 mcg TD-8236 1500 mcg
    Number of subjects analysed
    4
    20
    Units: nanogram hours per milliliter (h*ng/mL)
        geometric mean (geometric coefficient of variation)
    0.482 ( 48.8 )
    1.54 ( 70.6 )
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) of TD-8236 in Plasma During Dosing Interval

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of TD-8236 in Plasma During Dosing Interval [2]
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No PK data was collected for participants who received the placebo.
    End point values
    		 TD-8236 150 mcg TD-8236 1500 mcg
    Number of subjects analysed
    21
    21
    Units: nanograms per milliliter (ng/mL)
        geometric mean (geometric coefficient of variation)
    0.0207 ( 46.4 )
    0.160 ( 54.3 )
    No statistical analyses for this end point

    Secondary: Time to Maximum Observed Concentration (Tmax) of TD-8236 in Plasma Over a Dosing Interval

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    End point title
    		 Time to Maximum Observed Concentration (Tmax) of TD-8236 in Plasma Over a Dosing Interval [3]
    End point description
    End point type
    Secondary
    End point timeframe
    Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No PK data was collected for participants who received the placebo.
    End point values
    		 TD-8236 150 mcg TD-8236 1500 mcg
    Number of subjects analysed
    21
    21
    Units: hours
        median (full range (min-max))
    0.950 (0.483 to 1.03)
    0.550 (0.467 to 1.07)
    No statistical analyses for this end point

    Secondary: Number of Participants who Experienced a Treatment-emergent Adverse Event (TEAE)

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    End point title
    		 Number of Participants who Experienced a Treatment-emergent Adverse Event (TEAE)
    End point description
    A TEAE was defined as any adverse event (AE) that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus the number of days in the follow-up period. The severity of TEAEs were also assessed and were classified as mild, moderate or severe per the definitions below: Mild - The AE is noticeable to the participant and/or the investigator, but does not interfere with routine activity. Moderate - The AE interferes with routine activity, but responds to symptomatic therapy or rest. Severe - The AE significantly limits the participant's ability to perform routine activities despite symptomatic therapy. Clinically significant vital signs, clinical laboratory evaluations and 12-lead electrocardiogram (ECG) changes from baseline were also recorded as TEAEs.
    End point type
    Secondary
    End point timeframe
    Day 1 to end of follow-up (up to approximately 98 days)
    End point values
    		 Placebo TD-8236 150 mcg TD-8236 1500 mcg
    Number of subjects analysed
    24
    23
    24
    Units: participants
        Any TEAE
    10
    9
    9
        Moderate or Severe TEAE
    3
    3
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to end of follow-up (up to approximately 98 days)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were administered inhaled doses of placebo matching TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.

    Reporting group title
    TD-8236 150 mcg
    Reporting group description
    		 Participants were administered 150 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.

    Reporting group title
    TD-8236 1500 mcg
    Reporting group description
    		 Participants were administered 1500 microgram (mcg) inhaled doses of TD-8236 once per day (QD) by dry powder inhaler on Day 1 to Day 14 of the 14 day treatment period. An allergen challenge was performed 1 hour after dosing on Day 14 at the dose of allergen required to achieve a successful response at screening.

    Serious adverse events
    		 Placebo TD-8236 150 mcg TD-8236 1500 mcg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (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
    		 Placebo TD-8236 150 mcg TD-8236 1500 mcg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 24 (41.67%)
    9 / 23 (39.13%)
    9 / 24 (37.50%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    0
    1
    0
    Liver function test abnormal
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    0
    1
    0
    Forced expiratory volume decreased
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    2
    0
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    0
    2
    Injury, poisoning and procedural complications
    Exposure to SARS-CoV-2
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    1
    Injury
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    0
    Joint dislocation
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    0
    Joint injury
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 24 (4.17%)
    5 / 23 (21.74%)
    4 / 24 (16.67%)
         occurrences all number
    1
    7
    5
    Dizziness
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    1
    0
    Fatigue
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    1
    0
    Eye disorders
    Episcleritis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    0
    Asthma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    0
    2
    Cough
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    0
    2
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    0
    Back pain
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    1
    0
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    0
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    0
    Suspected COVID-19
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 23 (8.70%)
    1 / 24 (4.17%)
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    2
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Oct 2019
    The following changes were made: • Fasting time before collection of blood samples for serum chemistry was increased from 8 hours to 9 hours due to the addition of fasting lipid profiling to the serum chemistry panel. • Creatine phosphokinase, low density lipoprotein, high density lipoprotein, and triglycerides were added to the serum chemistry panel; these were inadvertently omitted from the original protocol.
    05 Nov 2019
    The following changes were made: • Clarification was added that male subjects must use acceptable birth control (i.e., condom with spermicide) only with partners of childbearing potential, and added distinction between requirement for vasectomized vs. non vasectomized subjects. • Exclusion criterion was added regarding exposure to biologic therapies within 6 months before Day 1 of Treatment Period 1 to avoid confounding of results. • Guidance was added for rescreening subjects. • Guidance was added regarding the concomitant receipt of heat-killed/inactive vaccines (e.g., seasonal flu vaccine). • Statement was removed that required subjects returning for Treatment Periods 2 and 3 to have their inclusion and exclusion criteria reevaluated.

    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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