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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II

    Summary
    EudraCT number
    		 2018-004489-32
    Trial protocol
    		 GB   DE   AT   HU   NL   PL   IT  
    Global end of trial date
    08 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KVD900-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04208412
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    KalVista Pharmaceuticals Ltd.
    Sponsor organisation address
    Porton Science Park, Bybrook Road, Porton Down, Salisbury, United Kingdom, SP4 0BF
    Public contact
    Vice President, Clinical, KalVista Pharmaceuticals Ltd., +1 857 999 0075, clinical@kalvista.com
    Scientific contact
    Vice President, Clinical, KalVista Pharmaceuticals Ltd., +44 1980 753002, clinical@kalvista.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
    21 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of KVD900 compared to placebo in halting the progression of a peripheral or abdominal attack of hereditary angioedema (HAE).
    Protection of trial subjects
    No specific measures to protect participants other than regular monitoring as per Protocol. The study was conducted in accordance with the principles set forth in the Declaration of Helsinki as amended in 2002, the Guidelines of the International Conference on Harmonisation (ICH) on Good Clinical Practice (GCP) (CPMP/ICH/135/95), as well as the requirements of the European Union Data Protection Directive 95/46/EC, and other applicable regulatory requirements.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A; Placebo-controlled study.
    Actual start date of recruitment
    02 Jul 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 States: 6
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    Czechia: 9
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Italy: 12
    Country: Number of subjects enrolled
    North Macedonia: 3
    Worldwide total number of subjects
    68
    EEA total number of subjects
    51
    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)
    67
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a 25-center study in 10 countries. A total of 68 subjects were entered into Part 1 and subsequently into Part 2, where all 68 subjects were randomized equally to Sequence 1 (600 mg KVD900; Placebo) or Sequence 2 (Placebo; 600 mg KVD900).

    Pre-assignment
    Screening details
    		 A total of 84 subjects were enrolled, of which 16 were screen failures. Main inclusion criteria were: Male or female adult subjects 18 years of age and older with confirmed diagnosis of HAE type I or II and at least 3 documented HAE attacks in the past 93 days. Subjects were required to have adequate organ functions as provided in the Protocol.

    Period 1
    Period 1 title
    Part 1
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The first dose of study drug was the open label single 600 mg oral dose (6 × KVD900 100 mg Film Coated Tablets) administered in the clinic during Part 1, after completion of all pre–dose assessments.

    Arms
    Arm title
    		 Part 1 - KVD900 600 mg
    Arm description
    		 The first dose of study drug was the open label single 600 mg oral dose (6 × KVD900 100 mg Film Coated Tablets) administered in the clinic during Part 1, after completion of all pre–dose assessments.
    Arm type
    		 Experimental

    Investigational medicinal product name
    KVD900
    Investigational medicinal product code
    KVD900
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In Part 1, subjects received a single dose of 600 mg KVD900 on Visit 2 (within 28 days of screening visit; during the intercritical period between HAE attacks). For clinical study use, KVD900 was formulated as film-coated tablets, KVD900 100 mg Film Coated Tablet.

    Number of subjects in period 1
    		Part 1 - KVD900 600 mg
    Started
    68
    Completed
    68
    Period 2
    Period 2 title
    Part 2
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer
    Blinding implementation details
    Subjects were randomized on a 1:1 basis to the two sequences for Part 2 (KVD900 600 mg followed by placebo or placebo followed by KVD900 600 mg). The actual treatment sequence for each subject was determined by the randomization scheme. The randomization scheme was produced by a computer software program that incorporated a standard procedure for generating randomization numbers. The randomization scheme informed the Investigator of the kit ID number allocated to the subject.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part 2 - Study Arm 1
    Arm description
    		 In Part 2, Sequence 1 (Study Arm 1), subjects received a single dose of 600 mg KVD900 to treat the first eligible HAE attack. Following resolution of this attack, subjects received a single dose of placebo to treat the second eligible HAE attack.
    Arm type
    		 Experimental

    Investigational medicinal product name
    KVD900
    Investigational medicinal product code
    KVD900
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In Part 2, Sequence 1 (Study Arm 1), subjects received a single dose of 600 mg KVD900 to treat the first eligible HAE attack. Following resolution of this attack, subjects received a single dose of placebo to treat the second eligible HAE attack. For clinical study use, KVD900 was formulated as film-coated tablets, KVD900 100 mg Film Coated Tablet.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In Part 2, Sequence 1 (Study Arm 1), following resolution of first eligible attack, subjects received a single dose of placebo to treat the second eligible HAE attack. Placebo looked similar to KVD900 100mg film coated tablets.

    Arm title
    		 Part 2 - Study Arm 2
    Arm description
    		 In Part 2, Sequence 2 (Study Arm 2) subjects received a single dose of placebo to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of 600 mg KVD900 to treat the second eligible HAE attack.
    Arm type
    		 Experimental

    Investigational medicinal product name
    KVD900
    Investigational medicinal product code
    KVD900
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In Part 2 Sequence 2 (Study Arm 2), following resolution of first eligible attack, subjects received a second single dose of 600 mg KVD900 (6 × KVD900 100 mg Film Coated Tablets) to treat the second eligible HAE attack. For clinical study use, KVD900 was formulated as film-coated tablets, KVD900 100 mg Film Coated Tablet.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In Part 2, Sequence 2 (Study Arm 2) subjects received a single dose of placebo to treat the first eligible HAE attack.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: A total of 68 subjects entered into Part 1 and subsequently into Part 2 Sequence 1 or 2. Baseline characteristics and demographics were provided for Sequence 1 (Study arm 1 with 34 subjects) and Sequence 2 (Study arm 2 with 34 subjects).
    Number of subjects in period 2
    		Part 2 - Study Arm 1 Part 2 - Study Arm 2
    Started
    34
    34
    Completed
    25
    28
    Not completed
    9
    6
         Consent withdrawn by subject
    1
    -
         Other
    8
    5
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 2 - Study Arm 1
    Reporting group description
    		 In Part 2, Sequence 1 (Study Arm 1), subjects received a single dose of 600 mg KVD900 to treat the first eligible HAE attack. Following resolution of this attack, subjects received a single dose of placebo to treat the second eligible HAE attack.

    Reporting group title
    Part 2 - Study Arm 2
    Reporting group description
    		 In Part 2, Sequence 2 (Study Arm 2) subjects received a single dose of placebo to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of 600 mg KVD900 to treat the second eligible HAE attack.

    Reporting group values
    		 Part 2 - Study Arm 1 Part 2 - Study Arm 2 Total
    Number of subjects
    		 34 34 68
    Age categorical
    All subjects were White (68 subjects [100%]) and the majority were not Hispanic or Latino (66/68 subjects [97.1%]). Overall, approximately half of the subjects were male (31/68 subjects [45.6%]) and half were female (37/68 [54.4%]). More subjects in Sequence 1 were female (22/34 subjects [64.7%]) and more subjects were male in Sequence 2 (19/34 subjects [55.9%]). There were no notable differences between subjects in Sequence 1 and Sequence 2 in age, height, weight or BMI.
    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)
    		 33 34 67
        From 65-84 years
    		 1 0 1
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 41 (19 to 68) 35.5 (19 to 64) -
    Gender categorical
    Units: Subjects
        Female
    		 22 15 37
        Male
    		 12 19 31
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 33 33 66
        Not reported
    		 1 0 1
        Unknown
    		 0 1 1
    Race
    Units: Subjects
        White
    		 34 34 68
    Height
    Units: meter
        arithmetic mean (full range (min-max))
    		 1.711 (1.52 to 1.97) 1.730 (1.52 to 1.91) -
    Weight
    Units: kilogram(s)
        arithmetic mean (full range (min-max))
    		 79.89 (48.1 to 122.4) 82.04 (50.1 to 144.6) -
    BMI
    Units: kg/m2
        arithmetic mean (full range (min-max))
    		 27.242 (18.79 to 40.90) 27.336 (20.33 to 40.06) -

    End points

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    End points reporting groups
    Reporting group title
    Part 1 - KVD900 600 mg
    Reporting group description
    		 The first dose of study drug was the open label single 600 mg oral dose (6 × KVD900 100 mg Film Coated Tablets) administered in the clinic during Part 1, after completion of all pre–dose assessments.
    Reporting group title
    Part 2 - Study Arm 1
    Reporting group description
    		 In Part 2, Sequence 1 (Study Arm 1), subjects received a single dose of 600 mg KVD900 to treat the first eligible HAE attack. Following resolution of this attack, subjects received a single dose of placebo to treat the second eligible HAE attack.

    Reporting group title
    Part 2 - Study Arm 2
    Reporting group description
    		 In Part 2, Sequence 2 (Study Arm 2) subjects received a single dose of placebo to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of 600 mg KVD900 to treat the second eligible HAE attack.

    Subject analysis set title
    FAS KVD900 600 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who took 600 mg KVD900 in Part 2

    Subject analysis set title
    FAS Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who took Placebo in Part 2

    Primary: Time to Conventional Attack Treatment Use within 12 hours of Study Drug

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    End point title
    		 Time to Conventional Attack Treatment Use within 12 hours of Study Drug
    End point description
    Analysis of time to use of conventional attack treatment within 12 hours of study drug
    End point type
    Primary
    End point timeframe
    12 hours
    End point values
    		 FAS KVD900 600 mg FAS Placebo
    Number of subjects analysed
    53
    53
    Units: Number of subjects
        Used conventional attack treatment within 12 hours
    8
    16
        Censored
    45
    37
    Statistical analysis title
    		 Gehan's Generalized Wilcoxon Test
    Comparison groups
    FAS Placebo v FAS KVD900 600 mg
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001 [1]
    Method
    		 Gehan's Generalized Wilcoxon Test
    Confidence interval
    Notes
    [1] - Gehan's Generalized Wilcoxon Test P-value: KVD900 vs Placebo

    Secondary: Worsening of Patient Global Impression of Severity (PGI-S) 5-point Likert scale (5LS)

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    End point title
    		 Worsening of Patient Global Impression of Severity (PGI-S) 5-point Likert scale (5LS)
    End point description
    Analysis of the Proportion of HAE Attacks that Worsen in Severity by One Level or More on the PGI-S or Require Conventional Attack Treatment within 12 hours of Study Drug; Analysis of time to (1) worsening by one level or more from baseline or (2) use of conventional attack treatment, whichever comes first, within 12 hours of study drug
    End point type
    Secondary
    End point timeframe
    12 hours
    End point values
    		 FAS KVD900 600 mg FAS Placebo
    Number of subjects analysed
    53
    53
    Units: Number of subjects
        Worsened in severity by 1 or more (Yes)
    11
    24
        Worsened in severity by 1 or more (No)
    42
    29
    Statistical analysis title
    		 Prescott's Test: KVD900 vs Placebo
    Comparison groups
    FAS KVD900 600 mg v FAS Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0045 [2]
    Method
    		 Prescott's Test
    Confidence interval
    Notes
    [2] - Prescott's Test: KVD900 vs Placebo
    Statistical analysis title
    		 Gehan's Generalized Wilcoxon Test
    Comparison groups
    FAS KVD900 600 mg v FAS Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 Gehan's Generalized Wilcoxon Test
    Confidence interval
    Notes
    [3] - Gehan's Generalized Wilcoxon Test: 600 mg KVD900 vs Placebo

    Secondary: Improvement of Patient Global Impression of Change (PGI-C) 7-point transition question (7TQ)

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    End point title
    		 Improvement of Patient Global Impression of Change (PGI-C) 7-point transition question (7TQ)
    End point description
    Analysis of Time to Symptom Relief defined as HAE Attack Rated as “A Little Better” or Higher on the PGI-C for Two Consecutive Time Points within 12 hours of Study Drug
    End point type
    Secondary
    End point timeframe
    12 hours
    End point values
    		 FAS KVD900 600 mg FAS Placebo
    Number of subjects analysed
    53
    53
    Units: Number of subjects
        HAE attack rated A Little Better or higher
    44
    27
        Censored
    9
    26
    Statistical analysis title
    		 Gehan's Generalized Wilcoxon Test
    Comparison groups
    FAS KVD900 600 mg v FAS Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 Gehan's Generalized Wilcoxon Test
    Confidence interval
    Notes
    [4] - Gehan's Generalized Wilcoxon Test: 600 mg KVD900 vs Placebo

    Secondary: Improvement of Visual Analogue Scale

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    End point title
    		 Improvement of Visual Analogue Scale
    End point description
    Analysis of Time to Symptom Relief defined as 50% Reduction in Composite VAS Score for Three Consecutive Time Points within 12 hours of Study Drug
    End point type
    Secondary
    End point timeframe
    12 hours
    End point values
    		 FAS KVD900 600 mg FAS Placebo
    Number of subjects analysed
    53
    53
    Units: Number of subjects
        ≥ 50% Reduction in Composite VAS Score
    33
    16
        Censored
    20
    37
    Statistical analysis title
    		 Gehan's Generalized Wilcoxon Test
    Comparison groups
    FAS KVD900 600 mg v FAS Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [5]
    Method
    		 Gehan's Generalized Wilcoxon Test
    Confidence interval
    Notes
    [5] - Gehan's Generalized Wilcoxon Test: 600 mg KVD900 vs Placebo

    Other pre-specified: Summary of KVD900 Plasma Concentration Data (PK Set)

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    End point title
    		 Summary of KVD900 Plasma Concentration Data (PK Set)
    End point description
    KVD900 was rapidly absorbed following oral administration, with measurable concentrations detected within 0.25 hours. Following treatment with 600 mg KVD900, mean plasma KVD900 concentration increased from 1710 ng/mL (SD: 2340 ng/mL) at 0.25 hours to a peak of 4920 ng/mL (SD: 3070 ng/mL) at 0.75 hours. Peak median plasma KVD900 concentration was also at 0.75 hours (4690 ng/mL [range: 50.0 to 13600 ng/mL]). Following treatment with 600 mg KVD900, geometric mean plasma KVD900 concentration increased from 501 ng/mL at 0.25 hours to a peak of 4020 ng/mL at 1.5 hours.
    End point type
    Other pre-specified
    End point timeframe
    Samples for pharmacokinetic evaluation of Cmax in all were obtained at following timepoints: Pre- Dose and up to 8 samples over a 4 hour period post dose.
    End point values
    		 FAS KVD900 600 mg
    Number of subjects analysed
    42
    Units: ng/mL
    arithmetic mean (standard deviation)
        Cmax
    4920 ( 3070 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs recorded from the time of signing of the informed consent form up to and including to Visit 4/ED
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Part 1 600mg KVD900
    Reporting group description
    		 -

    Reporting group title
    Part 2 600 mg KVD900
    Reporting group description
    		 -

    Reporting group title
    Part 2 Placebo
    Reporting group description
    		 -

    Reporting group title
    KVD900 Combined
    Reporting group description
    		 Part 1 and 2 KVD900 combined

    Serious adverse events
    		 Part 1 600mg KVD900 Part 2 600 mg KVD900 Part 2 Placebo KVD900 Combined
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 68 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Part 1 600mg KVD900 Part 2 600 mg KVD900 Part 2 Placebo KVD900 Combined
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 68 (10.29%)
    8 / 58 (13.79%)
    5 / 55 (9.09%)
    12 / 68 (17.65%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    2 / 68 (2.94%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    2 / 68 (2.94%)
         occurrences all number
    2
    0
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    1
    0
    0
    1
    Headache
         subjects affected / exposed
    2 / 68 (2.94%)
    3 / 58 (5.17%)
    1 / 55 (1.82%)
    4 / 68 (5.88%)
         occurrences all number
    2
    3
    1
    5
    Tremor
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    1
    0
    0
    1
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    1
    0
    0
    1
    Medical device site rash
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    1
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 58 (1.72%)
    1 / 55 (1.82%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    1
    1
    Anal incontinence
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dry mouth
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    0
    1
    Nausea
         subjects affected / exposed
    1 / 68 (1.47%)
    2 / 58 (3.45%)
    0 / 55 (0.00%)
    3 / 68 (4.41%)
         occurrences all number
    1
    2
    0
    3
    Vomiting
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 58 (1.72%)
    1 / 55 (1.82%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    2
    1
    Skin and subcutaneous tissue disorders
    Night sweats
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    1
    0
    0
    1
    Rash erythematous
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 68 (1.47%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    1
    1
    0
    2
    Infections and infestations
    Cystitis
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 58 (0.00%)
    2 / 55 (3.64%)
    1 / 68 (1.47%)
         occurrences all number
    1
    0
    2
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    1
    0
    0
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 May 2019
    Protocol Version 3.0 (dated 16 May 2019; Austria, Czech republic, Germany, Hungary, Italy, Macedonia, Poland, The Netherlands, UK, US)
    26 Sep 2019
    Protocol Version 4.0 (dated 26 September 2019; Austria, Czech republic, Germany, Hungary, Italy, Macedonia, Poland, The Netherlands, UK, US)

    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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