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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab to demonstrate efficacy in the treatment of enthesitis at the Achilles tendon up to 1 year in adult patients with active Psoriatic Arthritis (PsA) and axial Spondyloarthritis (axSpA) (ACHILLES)

    Summary
    EudraCT number
    		 2016-000972-91
    Trial protocol
    		 DE   GB   ES   SK   CZ   GR   BG   IT  
    Global end of trial date
    11 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Dec 2020
    First version publication date
    19 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457F3301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02771210
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    CH-4200, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, 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
    18 Sep 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to demonstrate that the efficacy of secukinumab was superior to placebo based on the percentage of patients with resolution of Achilles tendon enthesitis as assessed by the respective subcomponent of the Leeds enthesitis index (LEI) at 24 weeks in patients with active PsA and axSpA.
    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
    30 Aug 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 21
    Country: Number of subjects enrolled
    Czechia: 40
    Country: Number of subjects enrolled
    Germany: 54
    Country: Number of subjects enrolled
    Greece: 11
    Country: Number of subjects enrolled
    Italy: 15
    Country: Number of subjects enrolled
    Slovakia: 2
    Country: Number of subjects enrolled
    Spain: 36
    Country: Number of subjects enrolled
    United Kingdom: 25
    Worldwide total number of subjects
    204
    EEA total number of subjects
    204
    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)
    192
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 304 patients were screened. Of these, 94 patients discontinued during screening phase, 6 patients were re-screened and 204 patients completed the screening phase and were randomized in the trial.

    Pre-assignment
    Screening details
    		 A total of 175 patients (85.8%) completed treatment period 1 (up to Week 24); 29 patients (14.2%) discontinued study treatment in treatment period 1. A total of 170 patients (83.3%) completed treatment period 2 (up to Week 52); 5 patients (2.5%) discontinued in treatment period 2.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab
    Arm description
    		 Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
    Arm type
    		 Experimental

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution and suspension for suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab as one (1.0 mL PFS of 150 mg dose) or two (2 × 1.0 mL PFS of 150 mg dose, 300 mg) s.c. injections according to axSpA or PsA disease at Baseline, Week 1, Week 2, and Week 3, followed by administration every 4 weeks starting at Week 4.

    Arm title
    		 Placebo
    Arm description
    		 Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo as one (1.0 mL PFS of 150 mg dose) or two (2 × 1.0 mL PFS of 150 mg dose, 300 mg) s.c. injections according to axSpA or PsA disease at Baseline, Week 1, Week 2, and Week 3, followed by administration every 4 weeks starting at Week 4.

    Number of subjects in period 1
    		Secukinumab Placebo
    Started
    102
    102
    Completed
    91
    84
    Not completed
    11
    18
         Physician decision
    -
    1
         Consent withdrawn by subject
    -
    3
         Adverse event, non-fatal
    5
    3
         Lost to follow-up
    2
    -
         Withdrawal of informed consent
    1
    5
         Lack of efficacy
    3
    6
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Period 2 has no loading and all patients received Secukinumab - no Placebo in this period. Open-label

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab
    Arm description
    		 From week 24 Secukinumab 150 mg or 300 mg s.c. was administered every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
    Arm type
    		 Experimental

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab as one (1.0 mL PFS of 150 mg dose) or two (2 × 1.0 mL PFS of 150 mg dose, 300 mg) s.c. injections according to axSpA or PsA disease at Baseline, Week 1, Week 2, and Week 3, followed by administration every 4 weeks starting at Week 4.

    Arm title
    		 Placebo/Secukinumab
    Arm description
    		 From week 24 Secukinumab 150 mg or 300 mg s.c. was administered every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe, Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    placebo as one (1.0 mL PFS of 150 mg dose) or two (2 × 1.0 mL PFS of 150 mg dose, 300 mg) s.c. injections according to axSpA or PsA disease at Baseline, Week 1, Week 2, and Week 3, followed by administration every 4 weeks starting at Week 4.

    Number of subjects in period 2
    		Secukinumab Placebo/Secukinumab
    Started
    91
    84
    Completed
    89
    81
    Not completed
    2
    3
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    -
         Withdrawal of informed consent
    -
    2
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab
    Reporting group description
    		 Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

    Reporting group values
    		 Secukinumab Placebo Total
    Number of subjects
    		 102 102 204
    Age Categorical
    Number of participants in each age group
    Units: Participants
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 97 95 192
        >=65 years
    		 5 7 12
    Age Continuous
    Mean age of participants in each group
    Units: Years
        arithmetic mean (standard deviation)
    		 47.8 ( 11.33 ) 47.7 ( 11.02 ) -
    Sex/Gender, Customized
    Number of males vs females in Randomized set
    Units: Participants
        Female
    		 58 55 113
        Male
    		 44 47 91
    Race/Ethnicity, Customized
    Number of participants (Randomized set) by race
    Units: Subjects
        Caucasian
    		 99 99 198
        Black
    		 0 0 0
        Asian
    		 2 1 3
        Other
    		 1 2 3

    End points

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    End points reporting groups
    Reporting group title
    Secukinumab
    Reporting group description
    		 Secukinumab 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo 150 mg or 300 mg s.c., administered at baseline, weeks 1, 2, 3, 4 and every 4 weeks until week 24, respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα
    Reporting group title
    Secukinumab
    Reporting group description
    		 From week 24 Secukinumab 150 mg or 300 mg s.c. was administered every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

    Reporting group title
    Placebo/Secukinumab
    Reporting group description
    		 From week 24 Secukinumab 150 mg or 300 mg s.c. was administered every 4 weeks; respective dose was assigned according to underlying condition, in case of PsA according to severity of concomitant Psoriasis or preexposure to anti-TNFα

    Primary: Number (%) of patients with resolution of Achilles tendon enthesitis

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    End point title
    		 Number (%) of patients with resolution of Achilles tendon enthesitis
    End point description
    Number (%) of patients with resolution of Achilles tendon enthesitis (affected foot) as assessed by respective subcomponent of Leeds enthesitis index (LEI) at Week 24. The primary analysis was performed via a logistic regression model with the factors treatment, country, and stratification factor diagnosis (PsA or axSpA); patients with a missing assessment were considered as responders if they had already met the response criterion at the time of last assessment.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    102
    102
    Units: Participants
    43
    32
    Statistical analysis title
    		 Resolution of achilles tendon enthesitis
    Statistical analysis description
    The primary analysis was performed via a logistic regression model with the factors treatment, country, and stratification factor diagnosis (PsA or axSpA); patients with a missing assessment were considered as responders if they had already met the response criterion at the time of last assessment.
    Comparison groups
    Secukinumab v Placebo
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.136
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 3.08

    Secondary: Mean change of heel pain

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    End point title
    		 Mean change of heel pain
    End point description
    Mean change of heel pain from baseline to Week 24 measured by Numeric Rating Scale (NRS) ranging from 0 to 10, with 0 representing no pain and 10 representing worst pain (e.g. “pain as bad as you can imagine” or “worst pain imaginable”).
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    87
    85
    Units: Mean
        arithmetic mean (standard deviation)
    -2.8 ( 2.99 )
    -1.9 ( 2.69 )
    No statistical analyses for this end point

    Secondary: Number (%) of patients with improvement of bone marrow edema

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    End point title
    		 Number (%) of patients with improvement of bone marrow edema
    End point description
    Number (%) of patients with an improvement of bone marrow edema from baseline to Week 24 as assessed by the respective subcomponent of the Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) in the affected foot.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    44
    36
    Units: Participants
    17
    12
    No statistical analyses for this end point

    Secondary: Number (%) of patients with resolution of enthesitis as assessed by LEI

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    End point title
    		 Number (%) of patients with resolution of enthesitis as assessed by LEI
    End point description
    Number (%) of patients with resolution of enthesitis as assessed by the Leeds enthesitis index (LEI) at Week 24.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    102
    102
    Units: Participants
    31
    21
    No statistical analyses for this end point

    Secondary: Mean change of physician’s global assessment (PhGA) of disease activity

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    End point title
    		 Mean change of physician’s global assessment (PhGA) of disease activity
    End point description
    Mean change of physician’s global assessment (PhGA) of disease activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    88
    85
    Units: mm
        arithmetic mean (standard deviation)
    -34.88 ( 25.927 )
    -18.93 ( 26.257 )
    No statistical analyses for this end point

    Secondary: Mean change of patient’s global assessment (PGA) of disease activity

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    End point title
    		 Mean change of patient’s global assessment (PGA) of disease activity
    End point description
    Mean change of patient’s global assessment (PGA) of disease activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    82
    80
    Units: mm
        arithmetic mean (standard deviation)
    -25.87 ( 31.108 )
    -16.61 ( 29.235 )
    No statistical analyses for this end point

    Secondary: Mean change of physician’s assessment of heel enthesopathy activity

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    End point title
    		 Mean change of physician’s assessment of heel enthesopathy activity
    End point description
    Mean change of physician’s assessment of heel enthesopathy activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    88
    85
    Units: mm
        arithmetic mean (standard deviation)
    -38.40 ( 24.244 )
    -25.19 ( 25.250 )
    No statistical analyses for this end point

    Secondary: Mean change of patient’s assessment of heel enthesopathy activity

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    End point title
    		 Mean change of patient’s assessment of heel enthesopathy activity
    End point description
    Mean change of patient’s assessment of heel enthesopathy activity from baseline to Week 24 measured by Visual Analog Scale (VAS) ranging from 0 to 100, with 0 representing not severe and 100 representing very severe.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    86
    84
    Units: mm
        arithmetic mean (standard deviation)
    -31.05 ( 29.135 )
    -20.77 ( 30.417 )
    No statistical analyses for this end point

    Secondary: Mean change in Short Form-36 (SF-36) v2

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    End point title
    		 Mean change in Short Form-36 (SF-36) v2
    End point description
    Mean change in Short Form-36 (SF-36) v2 as an indicator of overall health status The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Lower scores = more disability, higher scores = less disability
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    87
    85
    Units: scores on a scale
        arithmetic mean (standard deviation)
    8.29 ( 9.759 )
    5.28 ( 7.285 )
    No statistical analyses for this end point

    Secondary: Number (%) of patients with resolution of achilles tendon enthesitis after switching from placebo to secukinumab

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    End point title
    		 Number (%) of patients with resolution of achilles tendon enthesitis after switching from placebo to secukinumab
    End point description
    To describe the increase in percentage of patients with resolution of achilles tendon enthesitis (affected foot) after switching from placebo to secukinumab at Week 24.
    End point type
    Secondary
    End point timeframe
    Weeks 24 and 52
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    102
    102
    Units: Participants
        Week 24
    43
    32
        Week 52
    66
    55
    No statistical analyses for this end point

    Secondary: Mean change of heel pain after switching from placebo to secukinumab

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    End point title
    		 Mean change of heel pain after switching from placebo to secukinumab
    End point description
    To describe the increase in mean change of heel pain after switching from placebo to secukinumab at Week 24.
    End point type
    Secondary
    End point timeframe
    Weeks 24 and 52
    End point values
    		 Secukinumab Placebo
    Number of subjects analysed
    80
    79
    Units: Mean
        arithmetic mean (standard deviation)
    -0.70 ( 2.291 )
    -1.43 ( 2.251 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from first dose of study treatment until end of study at week 52
    Adverse event reporting additional description
    Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Where a patient reported more than 1 AE with the same preferred term, the AE was counted only once; and where a patient reported more than 1 AE within the same primary system organ class, patient was counted only once at the system organ class level.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Secukinumab
    Reporting group description
    		 Secukinumab

    Reporting group title
    Placebo/Placebo-Secukinumab
    Reporting group description
    		 Placebo/Placebo-Secukinumab

    Serious adverse events
    		 Secukinumab Placebo/Placebo-Secukinumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 102 (6.86%)
    6 / 102 (5.88%)
         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)
    Invasive breast carcinoma
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Venous thrombosis limb
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cauda equina syndrome
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine with aura
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammatory bowel disease
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal stenosis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Secukinumab Placebo/Placebo-Secukinumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 102 (32.35%)
    34 / 102 (33.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 102 (5.88%)
    10 / 102 (9.80%)
         occurrences all number
    8
    16
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 102 (7.84%)
    5 / 102 (4.90%)
         occurrences all number
    8
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 102 (6.86%)
    5 / 102 (4.90%)
         occurrences all number
    8
    8
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 102 (12.75%)
    22 / 102 (21.57%)
         occurrences all number
    18
    28
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 102 (5.88%)
    5 / 102 (4.90%)
         occurrences all number
    6
    5

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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