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    Clinical Trial Results:
    A Patient and Investigator-blinded, Randomized, Placebo-controlled Study of LLG783 in Patients with Peripheral Artery Disease (PAD) and Intermittent Claudication

    Summary
    EudraCT number
    		 2017-000706-37
    Trial protocol
    		 DE  
    Global end of trial date
    27 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2020
    First version publication date
    01 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLLG783X2201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03194776
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Medizinischer Infoservice (MCC), Novartis Pharma GmbH, +49 1802232300, infoservice.novartis@novartis.com
    Scientific contact
    Medizinischer Infoservice (MCC), Novartis Pharma GmbH, +49 1802232300, infoservice.novartis@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Dec 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was evaluate the safety and tolerability of LLG783 in subjects with PAD and intermittent claudication after 16 weeks of exposure to LLG783 and to evaluate the effect of LLG783 on functional capacity after 3 months of treatment in subjects with PAD and intermittent claudication.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) E6 and Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Sep 2017
    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
    Taiwan: 2
    Country: Number of subjects enrolled
    United States: 4
    Country: Number of subjects enrolled
    Germany: 40
    Worldwide total number of subjects
    46
    EEA total number of subjects
    40
    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)
    14
    From 65 to 84 years
    32
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 46 subjects with clinical evidence of PAD and intermittent claudication were enrolled and randomized in this study.

    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
    		 LLG783 6 mg/kg
    Arm description
    		 Subjects received LLG783 6 milligram per kilogram (mg/kg) as intravenous (IV) infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LLG783
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.

    Number of subjects in period 1
    		LLG783 6 mg/kg Placebo
    Started
    23
    23
    Completed
    23
    23

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LLG783 6 mg/kg
    Reporting group description
    		 Subjects received LLG783 6 milligram per kilogram (mg/kg) as intravenous (IV) infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.

    Reporting group values
    		 LLG783 6 mg/kg Placebo Total
    Number of subjects
    		 23 23 46
    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)
    		 7 7 14
        From 65-84 years
    		 16 16 32
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.0 ± 7.1 66.3 ± 6.9 -
    Gender categorical
    Units: Subjects
        Female
    		 8 5 13
        Male
    		 15 18 33
    Race
    Units: Subjects
        White
    		 23 21 44
        Asian
    		 0 2 2
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 23 23 46
    Maximum walking distance (MWD)
    MWD was determined by 6-minute walking test (6-MWT), an exercise test measuring the distance walked by a participant over a span of 6 minutes.
    Units: meters (m)
        arithmetic mean (standard deviation)
    		 317.3 ± 62.0 311.3 ± 84.0 -
    Pain Free Walking Distance (PWFD)
    PWFD was defined as the distance walked up to the point of onset of claudication symptoms (pain) recorded during the 6MWT.
    Units: meters (m)
        arithmetic mean (standard deviation)
    		 160.7 ± 79.4 156.0 ± 86.7 -

    End points

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    End points reporting groups
    Reporting group title
    LLG783 6 mg/kg
    Reporting group description
    		 Subjects received LLG783 6 milligram per kilogram (mg/kg) as intravenous (IV) infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.

    Primary: Number of Subjects with Adverse Events (AEs), Drug-related AEs, Serious Adverse Events (SAEs) and Deaths

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    End point title
    		 Number of Subjects with Adverse Events (AEs), Drug-related AEs, Serious Adverse Events (SAEs) and Deaths [1]
    End point description
    An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign, including abnormal laboratory findings, symptom or disease) in a subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. An SAE is defined as any AE which is is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect in offspring, requires inpatient hospitalization or prolongation of existing hospitalization and is is medically significant. Safety analysis set included all subjects that received any study treatment.
    End point type
    Primary
    End point timeframe
    Up to 32 Weeks
    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: Only descriptive analysis was planned for this primary endpoint.
    End point values
    		 LLG783 6 mg/kg Placebo
    Number of subjects analysed
    23
    23
    Units: Subjects
        AEs
    18
    17
        Drug-related AEs
    4
    4
        SAEs
    1
    2
        Death
    0
    0
    No statistical analyses for this end point

    Primary: Change from Baseline in Maximum Walking Distance (MWD) as Assessed by 6-minute Walk Test (6MWT) at Week 16

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    End point title
    		 Change from Baseline in Maximum Walking Distance (MWD) as Assessed by 6-minute Walk Test (6MWT) at Week 16
    End point description
    MWD was assessed by the 6MWT prior to dosing was used to evaluate functional capacity of peripheral artery disease (PAD) subjects. 6MWT test included measurement of total distance walked in 6 minutes. Pharmacodynamic (PD) analysis set included all subjects with available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data. Here 'N' (subject analysed) signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16 (Day 113)
    End point values
    		 LLG783 6 mg/kg Placebo
    Number of subjects analysed
    22
    19
    Units: meter (m)
        least squares mean (confidence interval 80%)
    19.10 (5.30 to 32.90)
    36.84 (21.99 to 51.70)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Statistical analysis was done by mixed effect model repeat measurement (MMRM) model analysis.
    Comparison groups
    Placebo v LLG783 6 mg/kg
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2612 [2]
    Method
    		 two-sided test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -17.74
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -38.03
         upper limit
    		 2.55
    Notes
    [2] - P-value of <= 0.2 was considered significant.

    Secondary: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf)

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    End point title
    		 Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) [3]
    End point description
    AUCinf is defined as the area under the serum concentration-time curve from time zero to infinity. Pharmacokinetic (PK) analysis set included all subjects with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data. Here 'N' (subject analysed) signifies number of subjects evaluable for this endpoint and 'n' (number analysed) signifies number of subjects evaluable at specified time points. Abbreviations: mL = milliliter.
    End point type
    Secondary
    End point timeframe
    1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
    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 statistical analysis was planned for this secondary endpoint.
    End point values
    		 LLG783 6 mg/kg
    Number of subjects analysed
    20
    Units: day*microgram per mL (day*mg/mL)
    geometric mean (geometric coefficient of variation)
        Day 1 (n= 15)
    2110 ± 21.1
        Day 85 (n= 20)
    4860 ± 39.1
    No statistical analyses for this end point

    Secondary: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)

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    End point title
    		 Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) [4]
    End point description
    AUClast is defined as the area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration. PK analysis set included all subjects with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
    End point type
    Secondary
    End point timeframe
    1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
    Notes
    [4] - 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 statistical analysis was planned for this secondary endpoint.
    End point values
    		 LLG783 6 mg/kg
    Number of subjects analysed
    23
    Units: day*mcg/mL
    geometric mean (geometric coefficient of variation)
        Day 1
    1660 ± 33.6
        Day 85
    4930 ± 38.9
    No statistical analyses for this end point

    Secondary: Area Under the Serum Concentration-time Curve From Time Zero to Defined Time Point ‘t’ (AUC[0-t])

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    End point title
    		 Area Under the Serum Concentration-time Curve From Time Zero to Defined Time Point ‘t’ (AUC[0-t]) [5]
    End point description
    AUC(0-t)is defined as the area under the serum concentration-time curve from time zero to time 't' where t is a defined time point after administration. PK analysis set included all subjects with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
    End point type
    Secondary
    End point timeframe
    1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
    Notes
    [5] - 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 statistical analysis was planned for this secondary endpoint.
    End point values
    		 LLG783 6 mg/kg
    Number of subjects analysed
    23
    Units: day*mcg/mL
    geometric mean (geometric coefficient of variation)
        Day 1
    1640 ± 34.1
        Day 85
    3130 ± 34.7
    No statistical analyses for this end point

    Secondary: Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)

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    End point title
    		 Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) [6]
    End point description
    AUCtau is defined as the area under the serum concentration-time curve from time zero to the end of the dosing interval tau. PK analysis set included all subjects with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
    End point type
    Secondary
    End point timeframe
    1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
    Notes
    [6] - 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 statistical analysis was planned for this secondary endpoint.
    End point values
    		 LLG783 6 mg/kg
    Number of subjects analysed
    23
    Units: day*mcg/mL
    geometric mean (geometric coefficient of variation)
        Day 1
    1640 ± 34.1
        Day 85
    3130 ± 34.7
    No statistical analyses for this end point

    Secondary: Observed Maximum Serum Concentration (Cmax) Following Drug Administration

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    End point title
    		 Observed Maximum Serum Concentration (Cmax) Following Drug Administration [7]
    End point description
    Cmax is defined as the observed maximum serum concentration following drug administration. PK analysis set included all subjects with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
    End point type
    Secondary
    End point timeframe
    1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
    Notes
    [7] - 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 statistical analysis was planned for this secondary endpoint.
    End point values
    		 LLG783 6 mg/kg
    Number of subjects analysed
    23
    Units: microgram per milliliter (mcg/mL)
    geometric mean (geometric coefficient of variation)
        Day 1
    203 ± 40.0
        Day 85
    268 ± 39.8
    No statistical analyses for this end point

    Secondary: Time to Reach the Maximum Concentration After Drug Administration (Tmax)

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    End point title
    		 Time to Reach the Maximum Concentration After Drug Administration (Tmax) [8]
    End point description
    Tmax is defined as the time to reach the maximum concentration after drug administration. PK analysis set included all subjects with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
    End point type
    Secondary
    End point timeframe
    1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
    Notes
    [8] - 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 statistical analysis was planned for this secondary endpoint.
    End point values
    		 LLG783 6 mg/kg
    Number of subjects analysed
    23
    Units: Days
    median (full range (min-max))
        Day 1
    0.0833 (0.0417 to 3.01)
        Day 85
    0.0833 (0.0431 to 9.94)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Pain-free walking distance (PFWD) as Assessed by 6-minute Walk Test at Week 16

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    End point title
    		 Change from Baseline in Pain-free walking distance (PFWD) as Assessed by 6-minute Walk Test at Week 16
    End point description
    PFWD was defined as the distance walked up to the point of onset of claudication symptoms (pain) recorded during the 6MWT and was used to evaluate symptomatic functional capacity of PAD subjects. The PFWD was measured as the distance walked up to the time/place where the subject first experiences symptoms typical of their claudication which included pain, cramps, or other discomfort in the buttocks, thighs, calves or feet that occurs during the 6MWT exercise period. PD analysis set included all subjects with available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data. Here 'N' (subject analysed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 (Day 113)
    End point values
    		 LLG783 6 mg/kg Placebo
    Number of subjects analysed
    22
    19
    Units: meters
        least squares mean (confidence interval 80%)
    44.77 (20.52 to 69.02)
    57.09 (30.97 to 83.22)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV).  All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    LLG783 i.v. 6 mg/kg
    Reporting group description
    		 LLG783 i.v. 6 mg/kg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 LLG783 i.v. 6 mg/kg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 23 (8.70%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Small cell lung cancer
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Hypochromic anaemia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         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: 0%
    Non-serious adverse events
    		 LLG783 i.v. 6 mg/kg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 23 (78.26%)
    16 / 23 (69.57%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    2
    Peripheral arterial occlusive disease
         subjects affected / exposed
    3 / 23 (13.04%)
    1 / 23 (4.35%)
         occurrences all number
    3
    1
    Peripheral ischaemia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Spider vein
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Medical device site irritation
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 23 (0.00%)
         occurrences all number
    4
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Cough
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Haemoptysis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Adjustment disorder with depressed mood
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Weight increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    2
    Limb injury
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Thermal burn
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Bradycardia
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Pericardial effusion
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Sinus bradycardia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    2 / 23 (8.70%)
    2 / 23 (8.70%)
         occurrences all number
    2
    2
    Neuralgia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Sciatica
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Hypochromic anaemia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    3 / 23 (13.04%)
    1 / 23 (4.35%)
         occurrences all number
    3
    1
    Nausea
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Stasis dermatitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Joint effusion
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Spinal pain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Erysipelas
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Infected bite
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    5 / 23 (21.74%)
    4 / 23 (17.39%)
         occurrences all number
    5
    4
    Paronychia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Root canal infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Tooth abscess
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Iron deficiency
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jul 2017
    The primary purpose of this protocol amendment was to address the request from the Food and Drug Administration (FDA) to include additional safety visits two weeks after the 2nd dose and two weeks after the 3rd dose.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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