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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, parallel group, Phase II, 24-week study investigating the efficacy, safety and tolerability of AIN457 in patients with active overuse tendinopathy refractory to oral NSAIDs/acetaminophen, physiotherapy or corticosteroid injections

    Summary
    EudraCT number
    		 2017-003099-30
    Trial protocol
    		 DE   NL   GB  
    Global end of trial date
    17 Oct 2019

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457X2201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03344640
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Study Director, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Study Director, Novartis Pharmaceuticals, 41 613241111, novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Aug 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of secukinumab 300 mg subcutaneous (s.c) vs. placebo in patients with overuse rotator cuff tendinopathy in relieving clinical symptoms at Week 14
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Dec 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
    Czech Republic: 15
    Country: Number of subjects enrolled
    Germany: 26
    Country: Number of subjects enrolled
    Netherlands: 16
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 33
    Worldwide total number of subjects
    96
    EEA total number of subjects
    63
    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)
    94
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Of all patients randomized (N= 98; 100%) in the study, a total of 96 patients (98%) were dosed (49 patients in the secukinumab 300 mg group and 47 patients in the placebo group)

    Pre-assignment
    Screening details
    		 2 patients were not dosed, one patient decided to discontinue on Day 1 due to a common cold and one patient was a run-in failure

    Period 1
    Period 1 title
    Overall study
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 secukinumab
    Arm description
    		 AIN457 300 mg subcutaneously (s.c.)
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab 150mg x 2
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab pre-filled injections of 1 ml (150 mg) were supplied to the investigators at dose strength of 300 mg (2 injections of 150 mg) as single-blind packs.

    Arm title
    		 Placebo
    Arm description
    		 Placebo s.c.
    Arm type
    		 Experimental

    Investigational medicinal product name
    placebo S.C. x 2
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo (2 injections) pre-filled injections were supplied as single-blind packs

    Number of subjects in period 1
    		secukinumab Placebo
    Started
    49
    47
    Completed
    46
    44
    Not completed
    3
    3
         Physician decision
    1
    1
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    1
    -
    Period 2
    Period 2 title
    Follow-up epoch
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 secukinumab
    Arm description
    		 AIN457 300 mg subcutaneously (s.c.)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab 300mg (2 x 150 mg/1ml )
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab pre-filled injections of 1 ml (150 mg) were supplied to the investigators at dose strength of 300 mg (2 injections of 150 mg) as single-blind packs

    Arm title
    		 Placebo
    Arm description
    		 Placebo s.c.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo s.c.
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    placebo (2 injections) pre-filledPinjections were supplied as single-blind packs.

    Number of subjects in period 2
    		secukinumab Placebo
    Started
    46
    44
    Completed
    46
    42
    Not completed
    0
    2
         Consent withdrawn by subject
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    secukinumab
    Reporting group description
    		 AIN457 300 mg subcutaneously (s.c.)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo s.c.

    Reporting group values
    		 secukinumab Placebo Total
    Number of subjects
    		 49 47 96
    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)
    		 48 46 94
        From 65-84 years
    		 1 1 2
        85 years and over
    		 0 0 0
    Age Continuous
    Demographic summary (Safety analysis set)
    Units: years
        arithmetic mean (standard deviation)
    		 44.8 ( 11.51 ) 49.1 ( 10.56 ) -
    Sex: Female, Male
    41.7% of participants were female, and 58.3% were male
    Units: Participants
        Female
    		 17 23 40
        Male
    		 32 24 56
    Race/Ethnicity, Customized
    1% Asian, 4.2% Black or African American, 91.7% White, 1% Unknown, 2.1% Other
    Units: Subjects
        Asian
    		 1 0 1
        Black or African American
    		 3 1 4
        White
    		 43 45 88
        Unknown
    		 1 0 1
        Other
    		 1 1 2

    End points

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    End points reporting groups
    Reporting group title
    secukinumab
    Reporting group description
    		 AIN457 300 mg subcutaneously (s.c.)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo s.c.
    Reporting group title
    secukinumab
    Reporting group description
    		 AIN457 300 mg subcutaneously (s.c.)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo s.c.

    Primary: The Western Ontario Rotator Cuff (WORC) patient reported outcome (PRO) score at week 14 in All Patients - Statistical Analysis results of total WORC scores at week 14

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    End point title
    		 The Western Ontario Rotator Cuff (WORC) patient reported outcome (PRO) score at week 14 in All Patients - Statistical Analysis results of total WORC scores at week 14
    End point description
    WORC PRO score at week 14. The WORC Index consists of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). The total scores and sub scores used were the percentages of the normal scores with 0 being worst and 100 being best. All Patients - Statistical analysis results of WORC scores at Week 14
    End point type
    Primary
    End point timeframe
    Week 14 (Day 99)
    End point values
    		 secukinumab Placebo
    Number of subjects analysed
    47
    41
    Units: Scores
        number (confidence interval 90%)
    37.00 (30.10 to 43.90)
    37.77 (30.40 to 45.15)
    Statistical analysis title
    		 WORC score at week 14
    Statistical analysis description
    All Patients at day 99
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.875
    Method
    		 LS mean
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.77
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -8.84
         upper limit
    		 7.3

    Secondary: The Western Ontario Rotator Cuff (WORC) patient reported outcome (PRO) scores over time in All Patients

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    End point title
    		 The Western Ontario Rotator Cuff (WORC) patient reported outcome (PRO) scores over time in All Patients
    End point description
    WORC score at Days 15, 29, 57, 85, 127, and End of Study (day 169)
    End point type
    Secondary
    End point timeframe
    Days 15, 29, 57, 85, 127, and End of Study
    End point values
    		 secukinumab Placebo
    Number of subjects analysed
    47
    41
    Units: Scores
    number (confidence interval 90%)
        Day 15
    12.39 (6.99 to 17.79)
    8.42 (2.66 to 14.18)
        Day 29
    22.35 (16.38 to 28.32)
    19.49 (13.11 to 25.86)
        Day 57
    28.74 (22.19 to 35.29)
    30.11 (23.08 to 37.13)
        Day 85
    34.86 (28.18 to 41.53)
    33.48 (26.35 to 40.61)
        Day 127
    41.86 (34.96 to 48.77)
    38.50 (31.12 to 45.88)
        End of Study
    43.41 (36.21 to 50.61)
    40.97 (33.27 to 48.66)
    Statistical analysis title
    		 WORC score at day 15
    Statistical analysis description
    All patientts at day 15
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.19
    Method
    		 LS mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    3.97
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.03
         upper limit
    		 8.97
    Statistical analysis title
    		 WORC score at day 29
    Statistical analysis description
    All patients at day 29
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    3.97
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.39
         upper limit
    		 9.11
    Statistical analysis title
    		 WORC score at day 57
    Statistical analysis description
    All patients at day 57
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.761
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    0.761
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -8.81
         upper limit
    		 6.08
    Statistical analysis title
    		 WORC score at day 85
    Statistical analysis description
    All patients at day 85
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.765
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    0.765
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -6.27
         upper limit
    		 9.03
    Statistical analysis title
    		 WORC score at day 129
    Statistical analysis description
    All patients at day 127
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.491
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    0.491
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.73
         upper limit
    		 11.45
    Statistical analysis title
    		 WORC score at EoS
    Statistical analysis description
    All patients at end of study
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.639
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    2.44
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -6.19
         upper limit
    		 11.07

    Secondary: Disability of Arm, Shoulder and Hand Questionnaire Score (QuickDASH) over time

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    End point title
    		 Disability of Arm, Shoulder and Hand Questionnaire Score (QuickDASH) over time
    End point description
    Patient Reported Outcome: Disability of Arm, Shoulder and Hand (QuickDASH) Questionnaire score. This questionnaire asks about symptoms as well participant's ability to do certain activities - range from 1 No difficulty to 5 Unable
    End point type
    Secondary
    End point timeframe
    Days 15, 29, 57, 85, 99, 127, and End of Study
    End point values
    		 secukinumab Placebo
    Number of subjects analysed
    47
    41
    Units: Scores
    number (confidence interval 90%)
        Day 15
    -11.64 (-16.14 to -7.14)
    -8.23 (-13.02 to -3.44)
        Day 29
    -18.31 (-23.20 to -13.41)
    -16.95 (-22.18 to -11.73)
        Day 57
    -22.43 (-27.55 to -17.30)
    -24.01 (-29.49 to -18.52)
        Day 85
    -28.14 (-33.55 to -22.73)
    -27.22 (-32.98 to -21.45)
        Day 99
    -29.45 (-34.72 to -24.19)
    -30.69 (-36.30 to -25.07)
        Day 127
    -32.86 (-38.26 to -27.46)
    -31.99 (-37.75 to -26.23)
        End of Study
    -33.89 (-39.27 to -28.50)
    -35.40 (-41.13 to -29.67)
    Statistical analysis title
    		 QuickDASH score over time
    Statistical analysis description
    Statistical analysis results of QuickDASH total score (PD Analysis Set) at day 99
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.735 [1]
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus Placebo
    Point estimate
    1.23
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.81
         upper limit
    		 7.28
    Notes
    [1] - Difference and 90% CI versus placebo
    Statistical analysis title
    		 QuickDASH score at EoS
    Statistical analysis description
    Statistical analysis results of QuickDASH total score (PD analysis set) at End of Study
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.689
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus Placebo
    Point estimate
    1.51
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.76
         upper limit
    		 7.79

    Secondary: American Shoulder and Elbow Surgeons (ASES) Score over time

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    End point title
    		 American Shoulder and Elbow Surgeons (ASES) Score over time
    End point description
    Patient Reported Outcome: American Shoulder and Elbow Surgeons Shoulder Evaluation Form (ASES) score is self-administered and has 17 questions in the areas of shoulder symptoms and functions. The ASES total score ranges from 0 to 100 (best).
    End point type
    Secondary
    End point timeframe
    Days 15, 29, 57, 85, 99, 127, and End of Study
    End point values
    		 secukinumab Placebo
    Number of subjects analysed
    47
    41
    Units: Scores
    number (confidence interval 90%)
        Day 15
    8.66 (3.98 to 13.33)
    5.26 (0.26 to 10.25)
        Day 29
    17.53 (12.35 to 22.71)
    14.37 (8.82 to 19.92)
        Day 57
    24.15 (18.34 to 29.96)
    22.56 (16.31 to 28.81)
        Day 85
    30.50 (24.51 to 36.50)
    26.97 (20.51 to 33.43)
        Day 99
    31.29 (25.28 to 37.31)
    27.79 (21.33 to 34.26)
        Day 127
    34.92 (28.80 to 41.05)
    32.94 (26.33 to 39.56)
        End of Study
    37.29 (30.97 to 43.62)
    36.15 (29.33 to 42.97)
    Statistical analysis title
    		 ASES total score at day 99
    Statistical analysis description
    Statistical analysis results of ASES total score (PD analysis) at day 99
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.411
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI vesus placebo
    Point estimate
    3.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.54
         upper limit
    		 10.54
    Statistical analysis title
    		 ASES score at EoS
    Statistical analysis description
    Statistical analysis results of ASES total score (PD analysis) at End of Study set)
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.804
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    1.14
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -6.5
         upper limit
    		 8.78

    Secondary: Your Health Today score over time

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    End point title
    		 Your Health Today score over time
    End point description
    Patient Reported Outcome: Statistical analysis results of EQ-5D-5L Index score for Your health Today questionnaire, which reflects how good or bad the subjets Health is on a scale from 0 (worst health) to 100 (best health). Your health today reflects how good or bad the subjects health is on a scale from 0 (worst health) to 100 (best health)
    End point type
    Secondary
    End point timeframe
    Days 15, 29, 57, 85, 99, 127, and End of Study
    End point values
    		 secukinumab Placebo
    Number of subjects analysed
    47
    41
    Units: Scores
    number (confidence interval 90%)
        Day 15
    -0.22 (-4.02 to 3.58)
    0.02 (-4.02 to 4.07)
        Day 29
    3.27 (-0.71 to 7.25)
    3.56 (-0.69 to 7.81)
        Day 57
    3.19 (-1.07 to 7.45)
    9.02 (4.45 to 13.59)
        Day 85
    7.36 (2.84 to 11.89)
    7.79 (2.96 to 12.62)
        Day 99
    8.75 (4.13 to 13.38)
    10.01 (5.09 to 14.94)
        Day 127
    9.55 (5.29 to 13.80)
    13.59 (9.05 to 18.13)
        End of Study
    10.22 (4.84 to 15.60)
    12.13 (6.36 to 17.89)
    Statistical analysis title
    		 EQ-5D-5L Index score at day 99
    Statistical analysis description
    Statistical analysis results of Your Health Today EQ-5D-5L Index score at day 99 (PD Analysis Set)
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.706
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    -1.26
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -6.81
         upper limit
    		 4.29
    Statistical analysis title
    		 EQ-5D-5L Index score at End of Study
    Statistical analysis description
    Statistical analysis results of Your Health Today EQ-5D-5L Index score at End of Study
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.647
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    -1.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -8.79
         upper limit
    		 4.99

    Secondary: EQ-5D-5L Index score over time

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    End point title
    		 EQ-5D-5L Index score over time
    End point description
    Patient Reported Outcome: Statistical analysis results of EQ-5D-5L Index score, which contains 6 items to assess Health Status (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Overall scores range from 0 to 1 with lower scores representing a higher Level of disfunction.
    End point type
    Secondary
    End point timeframe
    Days 15, 29, 57, 85, 99, 127 and End of Study
    End point values
    		 secukinumab Placebo
    Number of subjects analysed
    47
    41
    Units: Scores
    number (confidence interval 90%)
        Day 15
    0.07 (0.05 to 0.10)
    0.04 (0.01 to 0.07)
        Day 29
    0.10 (0.07 to 0.13)
    0.09 (0.05 to 0.12)
        Day 57
    0.12 (0.09 to 0.15)
    0.11 (0.08 to 0.15)
        Day 85
    0.16 (0.13 to 0.19)
    0.14 (0.10 to 0.18)
        Day 99
    0.16 (0.13 to 0.20)
    0.15 (0.11 to 0.19)
        Day 127
    0.19 (0.15 to 0.23)
    0.17 (0.13 to 0.21)
        End of Study
    0.19 (0.16 to 0.23)
    0.18 (0.14 to 0.22)
    Statistical analysis title
    		 EQ-5D-5L Index score at day 99
    Statistical analysis description
    Statistical analysis results of of EQ-5D-5L Index score at day 99 (PD Analysis Set)
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.613
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    0.01
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0.06
    Statistical analysis title
    		 EQ-5D-5L Index score at EoS
    Statistical analysis description
    Statistical analysis results of of EQ-5D-5L Index score at End of Study (PD Analysis Set)
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.74
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    0.02
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.06

    Secondary: Pain score over time using a VAS scale

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    End point title
    		 Pain score over time using a VAS scale
    End point description
    Pain intensity is assessed by a Visual Analog Scale (VAS) which is measured on a 10-cm line that represents a continuum between “no pain” and “worst pain"
    End point type
    Secondary
    End point timeframe
    Days 15, 29, 57, 85, 99, 127 and then End of Study
    End point values
    		 secukinumab Placebo
    Number of subjects analysed
    47
    41
    Units: Scores
    number (confidence interval 90%)
        Day 15
    -12.11 (-19.52 to -4.70)
    -9.50 (-17.30 to -1.71)
        Day 29
    -26.04 (-33.97 to -18.11)
    -23.13 (-31.52 to -14.74)
        Day 57
    -35.52 (-43.67 to -27.37)
    -32.83 (-41.52 to -24.15)
        Day 85
    -42.63 (-50.88 to -34.38)
    -37.97 (-46.74 to -29.21)
        Day 99
    -46.11 (-54.10 to -38.12)
    -40.56 (-49.00 to -32.11)
        Day 127
    -49.44 (-57.45 to -41.44)
    -45.27 (-53.75 to -36.79)
        End of Study
    -52.23 (-60.31 to -44.14)
    -50.74 (-59.40 to -42.08)
    Statistical analysis title
    		 VAS score at day 99
    Statistical analysis description
    Statistical analysis results of pain score using VAS scale (PD Analysis Set) at day 99
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.281
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    -5.55
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -14.07
         upper limit
    		 2.97
    Statistical analysis title
    		 VAS score at EoS
    Statistical analysis description
    Statistical analysis results of pain score using VAS scale (PD Analysis Set) at End of Study
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.78
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    -1.49
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -10.33
         upper limit
    		 7.35

    Secondary: Patient global assessment (PGA) score using a VAS scale at End of Study

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    End point title
    		 Patient global assessment (PGA) score using a VAS scale at End of Study
    End point description
    The patient's global assessment of disease activity is performed using a 100 mm Visual Analog Scale (VAS) ranging from "no activity" to "most active" in the last 24 hours.
    End point type
    Secondary
    End point timeframe
    Days 15, 29, 57, 85, 99, 127 and End of Study
    End point values
    		 secukinumab Placebo
    Number of subjects analysed
    47
    41
    Units: Scores
    number (confidence interval 95%)
        Day 15
    -6.33 (-13.44 to 0.79)
    -8.09 (-15.79 to -0.38)
        Day 29
    -22.25 (-29.68 to -14.82)
    -16.38 (-24.43 to -8.33)
        Day 57
    -29.40 (-37.06 to -21.74)
    -25.69 (-34.04 to -17.34)
        Day 85
    -37.57 (-45.01 to -30.12)
    -31.75 (-39.79 to -23.72)
        Day 99
    -38.43 (-45.88 to -30.97)
    -35.10 (-43.14 to -27.07)
        Day 127
    -43.78 (-51.23 to -36.33)
    -38.32 (-46.37 to -30.26)
        End of Study
    -47.72 (-55.15 to -40.28)
    -39.43 (-47.45 to -31.40)
    Statistical analysis title
    		 Pain score at day 99
    Statistical analysis description
    Statistical analysis results of pain score using VAS scale (PD Analysis Set) at day 99
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.489
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    -3.32
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -11.28
         upper limit
    		 4.64
    Statistical analysis title
    		 Pai score at EoS
    Statistical analysis description
    Statistical analysis results of pain score using VAS scale at End of Study
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.087
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    -8.29
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -16.26
         upper limit
    		 -0.32

    Secondary: Physician global assessment (PhGA) score using a VAS scale over time

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    End point title
    		 Physician global assessment (PhGA) score using a VAS scale over time
    End point description
    Physician global assessment (PhGA) score using a VAS scale (considering the last 24 hours)
    End point type
    Secondary
    End point timeframe
    Days 15, 29, 57, 85, 99, 127 and End of Study
    End point values
    		 secukinumab Placebo
    Number of subjects analysed
    47
    41
    Units: Score
    number (confidence interval 90%)
        Day 15
    -13.99 (-20.22 to -7.75)
    -9.11 (-15.80 to -2.42)
        Day 29
    -25.01 (-31.51 to -18.50)
    -19.42 (-26.42 to -12.43)
        Day 57
    -30.78 (-37.57 to -23.99)
    -27.83 (-35.13 to -20.53)
        Day 85
    -33.42 (-40.68 to -26.16)
    -37.88 (-45.66 to -30.11)
        Day 99
    -35.72 (-42.66 to -28.79)
    -41.73 (-49.15 to -34.31)
        Day 127
    -41.72 (-48.32 to -35.12)
    -44.18 (-51.28 to -37.08)
        End of Study
    -44.64 (-51.86 to -37.41)
    -44.26 (-52.02 to -36.51)
    Statistical analysis title
    		 PhGA score using VAS scale at day 99
    Statistical analysis description
    Statistical analysis results of PhGA score using VAS scale at day 99
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.21
    Method
    		 LS Mean
    Parameter type
    		 Difference and 99% CL versus placebo
    Point estimate
    6.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 13.91
    Statistical analysis title
    		 PhGA score using VAS scale at End of Study
    Statistical analysis description
    Statistical analysis results of PhGA score using VAS scale at End of Study
    Comparison groups
    secukinumab v Placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.942
    Method
    		 LS Mean
    Parameter type
    		 Difference and 90% CI versus placebo
    Point estimate
    -0.37
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -8.86
         upper limit
    		 8.11

    Secondary: Pharmacokinetics - Cmin

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    End point title
    		 Pharmacokinetics - Cmin [2]
    End point description
    Mean trough concentrations Cmin is a pharmacokinetics term for the minimum blood plasma concentration reached by a drug prior to administration of a second dose (mass/volume) Serum trough concentrations of secukinumab 300 mg group was measured at Days 1, 29, 85 and EOS No statistical analysis was planned for this primary outcome.
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 85 and EOS
    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: The mean trough concentrations increased rapidly after the first four weekly doses (90.4 (30.7) μg/mL) and were lower at Week 12 (13.2 (6.67) μg/mL).
    End point values
    		 secukinumab
    Number of subjects analysed
    47
    Units: ug/mL
    arithmetic mean (standard deviation)
        Mean trough concentration after first 4 wkly doses
    90.4 ( 30.7 )
        Week 12
    13.2 ( 6.67 )
    No statistical analyses for this end point

    Secondary: Immunogenicity assessment - Treatment emergent ADAs

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    End point title
    		 Immunogenicity assessment - Treatment emergent ADAs
    End point description
    Number of Participants with Treatment emergent Anti-secukinumab antibodies No statistical analysis was planned for this primary outcome.
    End point type
    Secondary
    End point timeframe
    Day 1 and EoS
    End point values
    		 secukinumab Placebo
    Number of subjects analysed
    47
    41
    Units: Participants
        Day 1
    0
    1
        End of Study
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with tendinosis grade score 1, 2 or 3 measured by magnetic resonance imaging (MRI) Sein scores

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    End point title
    		 Number of participants with tendinosis grade score 1, 2 or 3 measured by magnetic resonance imaging (MRI) Sein scores
    End point description
    Assessment of structural changes in the rotator cuff tendinopathy over time The MRI Sein score was used to grade supraspinatus tendinosis using a modified 4-point scale from 0 to 3 and changes in grading over time were captured in the shift table. Grade 0 is normal, grade 1 is mild, Grade 2 is moderate and grade 3 is marked tendinosis. In this Sein score assessment, only data from Day 99 and baseline could be compared, as only those two time points were double read and adjudicated in case the 2 readers had different results. At any other time-points (Day 57 and EOS), images were assessed only by one reader and thus could not be compared to baseline. No statistical analysis was planned for this primary outcome.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 99
    End point values
    		 secukinumab Placebo
    Number of subjects analysed
    47
    41
    Units: participants
        Baseline grade 1
    31
    25
        Baseline grade 2
    11
    10
        Baseline grade 3
    3
    3
        Day 99 grade 1
    31
    26
        Day 99 grade 2
    11
    9
        Day 99 grade 3
    3
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately 40 weeks: 15 Dec 2017 through 17 Oct 2019
    Adverse event reporting additional description
    Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    AIN457 300 mg
    Reporting group description
    		 AIN457 300 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 AIN457 300 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 47 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 AIN457 300 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 49 (73.47%)
    34 / 47 (72.34%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign bone neoplasm
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Benign neoplasm of skin
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 47 (2.13%)
         occurrences all number
    2
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 47 (4.26%)
         occurrences all number
    1
    2
    Feeling hot
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Injection site erythema
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 47 (4.26%)
         occurrences all number
    2
    2
    Injection site haematoma
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 47 (2.13%)
         occurrences all number
    2
    1
    Injection site pain
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Injection site paraesthesia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Injection site pruritus
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 47 (2.13%)
         occurrences all number
    4
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Sinus congestion
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Throat irritation
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Phonophobia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 47 (2.13%)
         occurrences all number
    2
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 47 (2.13%)
         occurrences all number
    1
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    Hand fracture
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Infusion related reaction
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Injection related reaction
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    3
    0
    Limb injury
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Meniscus injury
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 47 (2.13%)
         occurrences all number
    1
    1
    Muscle strain
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Skin abrasion
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Tendon rupture
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Tooth fracture
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Wrist fracture
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 47 (2.13%)
         occurrences all number
    2
    1
    Dizziness postural
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    7 / 49 (14.29%)
    7 / 47 (14.89%)
         occurrences all number
    15
    10
    Paraesthesia
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 47 (2.13%)
         occurrences all number
    1
    1
    Somnolence
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 47 (2.13%)
         occurrences all number
    3
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 47 (2.13%)
         occurrences all number
    2
    1
    Faeces soft
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    6 / 49 (12.24%)
    5 / 47 (10.64%)
         occurrences all number
    9
    5
    Vomiting
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Dermatitis allergic
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Erythema
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Keratolysis exfoliativa acquired
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Skin hyperpigmentation
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Skin ulcer
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 49 (4.08%)
    2 / 47 (4.26%)
         occurrences all number
    4
    2
    Back pain
         subjects affected / exposed
    1 / 49 (2.04%)
    4 / 47 (8.51%)
         occurrences all number
    1
    4
    Muscle spasms
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 47 (2.13%)
         occurrences all number
    3
    7
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 47 (2.13%)
         occurrences all number
    1
    1
    Neck pain
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 47 (2.13%)
         occurrences all number
    3
    1
    Osteoarthritis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Patellofemoral pain syndrome
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Spinal pain
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Tendon disorder
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Fungal infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Fungal skin infection
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 47 (0.00%)
         occurrences all number
    4
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 47 (2.13%)
         occurrences all number
    2
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Gastrointestinal infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Lymphangitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    8 / 49 (16.33%)
    5 / 47 (10.64%)
         occurrences all number
    11
    5
    Oral candidiasis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Periodontitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    Pulpitis dental
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Pustule
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    0
    2
    Sinusitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 49 (4.08%)
    4 / 47 (8.51%)
         occurrences all number
    3
    6
    Urinary tract infection
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    Gout
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Mar 2018
    Updated to reflect current form standards and form prtection added

    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.
    In general “End of Study” is Day 169 (week 24). But in the study it was handled in a way, that whenever a subject discontinued the last visit was the EoS visit.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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