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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab (150 mg) With and Without a Subcutaneous Loading Regimen to Assess Efficacy, Safety, and Tolerability up to 2 Years in Patients With Active Ankylosing Spondylitis

    Summary
    EudraCT number
    2013-005575-41
    Trial protocol
    CZ   DE   AT   NL   FI   NO   DK   GB   ES   SK   BG   PL   GR   IT  
    Global end of trial date
    02 Jan 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Nov 2018
    First version publication date
    24 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457F2320
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02159053
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Novartis Pharma AG, Clinical Disclosure Office, +41 613241111,
    Scientific contact
    Novartis Pharma AG, Clinical Disclosure Office, +41 613241111,
    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
    02 Jan 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the efficacy of secukinumab 150 mg at Week 16 with or without a loading regimen is superior to placebo based on the proportion of subjects achieving an ASAS20 (Assessment of SpondyloArthritis International Society criteria) response.
    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
    18 May 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 15
    Country: Number of subjects enrolled
    Norway: 5
    Country: Number of subjects enrolled
    Poland: 49
    Country: Number of subjects enrolled
    Slovakia: 15
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    Austria: 14
    Country: Number of subjects enrolled
    Bulgaria: 14
    Country: Number of subjects enrolled
    Czech Republic: 49
    Country: Number of subjects enrolled
    Denmark: 5
    Country: Number of subjects enrolled
    Finland: 10
    Country: Number of subjects enrolled
    Germany: 56
    Country: Number of subjects enrolled
    Greece: 6
    Country: Number of subjects enrolled
    Italy: 12
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Russian Federation: 35
    Country: Number of subjects enrolled
    Switzerland: 3
    Country: Number of subjects enrolled
    United States: 24
    Worldwide total number of subjects
    350
    EEA total number of subjects
    280
    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)
    334
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 85 centers in 19 countries.

    Pre-assignment
    Screening details
    A total of 424 subjects were screened, out of which 350 subjects completed the screening phase and were randomized to three treatment groups in 1:1:1 ratio.

    Period 1
    Period 1 title
    Overall Treatment Period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor
    Blinding implementation details
    Randomized treatment assignments were double-blinded to subjects, investigators, and site personnel. Following the Week 16 database lock, the Sponsor was unblinded to treatment assignment. After the Week 52 database lock and analyses was completed, site personnel and patients were unblinded to the original randomized treatment assignment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Secukinumab 150 mg with loading
    Arm description
    Subjects were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.
    Arm type
    Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered with 150 mg secukinumab s.c. using pre-filled syringe.

    Arm title
    Secukinumab 150 mg without loading dose
    Arm description
    Subjects were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.
    Arm type
    Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered with 150 mg secukinumab s.c. using pre-filled syringe.

    Arm title
    Placebo
    Arm description
    Subjects were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Subjects were further administered with 150 mg of secukinumab every four weeks starting at Week 16.
    Arm type
    Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered with 150 mg secukinumab s.c. using pre-filled syringe.

    Number of subjects in period 1
    Secukinumab 150 mg with loading Secukinumab 150 mg without loading dose Placebo
    Started
    116
    117
    117
    Subjects Week 16 onwards
    116
    117
    113
    Completed
    96
    96
    97
    Not completed
    20
    21
    20
         Physician decision
    -
    1
    1
         Adverse event, non-fatal
    7
    6
    5
         Death
    2
    -
    1
         Subject/guardian decision
    8
    10
    6
         Lack of efficacy
    3
    4
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab 150 mg with loading
    Reporting group description
    Subjects were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.

    Reporting group title
    Secukinumab 150 mg without loading dose
    Reporting group description
    Subjects were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.

    Reporting group title
    Placebo
    Reporting group description
    Subjects were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Subjects were further administered with 150 mg of secukinumab every four weeks starting at Week 16.

    Reporting group values
    Secukinumab 150 mg with loading Secukinumab 150 mg without loading dose Placebo Total
    Number of subjects
    116 117 117 350
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    110 114 110 334
        From 65-84 years
    6 3 7 16
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    44.5 ± 11.62 41.2 ± 11.07 43.4 ± 12.46 -
    Gender categorical
    Units: Subjects
        Female
    35 34 41 110
        Male
    81 83 76 240
    Patient's global assessment of disease activity
    The patient’s global assessment of disease activity was performed using a 0-100 mm visual analog scale (VAS) ranging from not severe to very severe, after the question, "How active was your disease on average during the last week?”
    Units: Unit on Scale
        arithmetic mean (standard deviation)
    73.5 ± 15.02 73.2 ± 15.99 73.7 ± 15.05 -
    Total back pain (0-100 mm)
    Total back pain as measured by VAS ≥ 40 mm on a scale of 0-100 mm.
    Units: Unit on Scale
        arithmetic mean (standard deviation)
    74.9 ± 13.07 74.2 ± 14.18 75 ± 13.80 -
    Bath Ankylosing Spondylitis Disease Activity Index
    Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) consisted of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which was used to answer 6 questions pertaining to the 5 major symptoms of Ankylosing Spondylitis: 1. Fatigue 2. Spinal pain 3. Joint pain / swelling 4. Areas of localized tenderness (called enthesitis, or inflammation of tendons and ligaments) 5. Morning stiffness duration 6. Morning stiffness severity
    Units: Unit on Scale
        arithmetic mean (standard deviation)
    7 ± 1.225 6.95 ± 1.306 7.06 ± 1.271 -
    High sensitivity (hs) C-reactive protein
    High sensitivity C-reactive protein assessment was performed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.
    Units: Milligrams per Litre (mg/L)
        arithmetic mean (standard deviation)
    11.78 ± 18.203 13.84 ± 19.795 11.67 ± 16.699 -

    End points

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    End points reporting groups
    Reporting group title
    Secukinumab 150 mg with loading
    Reporting group description
    Subjects were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.

    Reporting group title
    Secukinumab 150 mg without loading dose
    Reporting group description
    Subjects were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.

    Reporting group title
    Placebo
    Reporting group description
    Subjects were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Subjects were further administered with 150 mg of secukinumab every four weeks starting at Week 16.

    Subject analysis set title
    All secukinumab 150 mg treated subjects
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    All subjects who were s.c. administered with secukinumab during the study.

    Primary: Percentage of subjects responded for Assessment of Spondyloarthritis International Society 20 criteria (ASAS20) at 16 weeks

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    End point title
    Percentage of subjects responded for Assessment of Spondyloarthritis International Society 20 criteria (ASAS20) at 16 weeks [1]
    End point description
    ASAS 20 response is validated composite assessment, defined as improvement of ≥20% and ≥1 unit on scale of 10 in 3 main domains and no worsening of ≥20% and 1 unit on scale of 10 in 4th domain. Four main ASAS domains include: 1. Patient’s global assessment of disease activity, measured on 100mm VAS ranging from not severe to very severe 2. Patient’s assessment of back pain, measured on 100mm VAS ranging from no pain to unbearable pain 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by 0-10 VAS scale 4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0- no problem, 10- worst problem) The analysis was performed in Full analysis set (FAS) population, defined as all subjects who were randomized and received study treatment. Here, "Number of subjects analysed" signifies subjects evaluable for endpoint.
    End point type
    Primary
    End point timeframe
    16 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 summary statistics was planned for this outcome measure.
    End point values
    Secukinumab 150 mg with loading Secukinumab 150 mg without loading dose Placebo
    Number of subjects analysed
    114
    110
    112
    Units: Percentage of subjects
        number (confidence interval 95%)
    60.5 (50.9 to 69.4)
    65.5 (55.7 to 74.1)
    49.1 (49.1 to 58.7)
    No statistical analyses for this end point

    Secondary: Percentage of subjects responded for ASAS 40 response at 16 weeks

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    End point title
    Percentage of subjects responded for ASAS 40 response at 16 weeks
    End point description
    ASAS 20 response is a validated composite assessment, defined as an improvement of ≥40% and 2 unit on a scale of 10 in three main domains and no worsening at all in the remaining domain within a defined time frame. Four main ASAS domains include: 1. Patient’s global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe 2. Patient’s assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain 3. Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale 4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem) The analysis was performed in FAS population. Here, "Number of subjects analysed" signifies subjects evaluable for endpoint.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    Secukinumab 150 mg with loading Secukinumab 150 mg without loading dose Placebo
    Number of subjects analysed
    114
    110
    112
    Units: Percentage of subjects
        number (confidence interval 95%)
    39.5 (30.6 to 49.1)
    38.2 (29.2 to 48.0)
    29.5 (21.4 to 38.9)
    No statistical analyses for this end point

    Secondary: Change From Baseline in serum high sensitivity C-reactive protein (hsCRP) at 16 weeks

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    End point title
    Change From Baseline in serum high sensitivity C-reactive protein (hsCRP) at 16 weeks
    End point description
    Blood levels of C-reactive protein (CRP) is an acute phase reactant, which are indicative of inflammation and of its severity, and can be used to monitor treatment response. A hsCRP test is implemented to assess the efficacy of secukinumab (with or without load) versus placebo in reducing ankylosing spondylitis elicited systemic inflammation over the time. The analysis was performed in FAS population. Here, "Number of subjects analysed" signifies subjects evaluable for endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    Secukinumab 150 mg with loading Secukinumab 150 mg without loading dose Placebo
    Number of subjects analysed
    113
    109
    112
    Units: Ratio
        arithmetic mean (standard deviation)
    -4.23 ± 15.007
    -6.57 ± 12.778
    0.62 ± 11.699
    No statistical analyses for this end point

    Secondary: Percentage of subjects responded for ASAS 5/6 response at 16 weeks

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    End point title
    Percentage of subjects responded for ASAS 5/6 response at 16 weeks
    End point description
    ASAS 5/6 response is validated composite assessment, defined as improvement of ≥20% in score in at least 5 of 6 clinical domains relevant to ankylosing spondylitis and no worsening in remaining domain. ASAS domains includes: 1. Patient’s global assessment of disease activity measured on 100 mm VAS ranging from not to very severe 2. Patient’s assessment of back pain, measured on 100 mm VAS ranging from no to unbearable pain 3. Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by 0-10 VAS scale 4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0- no problem, 10- worst problem) 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment 6. CRP The analysis was performed in FAS population. Here, "Number of subjects analysed" signifies subjects evaluable for endpoint.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    Secukinumab 150 mg with loading Secukinumab 150 mg without loading dose Placebo
    Number of subjects analysed
    114
    110
    112
    Units: Percentage of subjects
        number (confidence interval 95%)
    37.7 (29.0 to 47.3)
    45.5 (36.0 to 55.2)
    30.4 (22.2 to 39.9)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 weeks

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    End point title
    Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 weeks
    End point description
    BASDAI is a validated assessment tool using 0 through 10 scales (0- no problem, 10- worst problem) on continuous VAS, to answer 6 questions pertaining to 5 major symptoms of ankylosing spondylitis. Computed composite scores of 4 or greater indicate suboptimal disease control. Questions includes: 1. Fatigue 2. Spinal pain 3. Joint pain / swelling 4. Areas of localized tenderness (called enthesitis, or inflammation of tendons and ligaments) 5. Morning stiffness duration 6. Morning stiffness severity Each symptom has equal weighting, the mean of two scores related to morning stiffness was taken (questions 5 and 6). The resulting 0 to 10 score was added to the scores from questions 1-4. The resulting 0 to 50 score was divided by 5 to give a final 0–10 BASDAI score. BASDAI was a quick and simple index taking between 30 seconds and 2 minutes for completion. The analysis was performed in FAS population. Here, "Number of subjects analysed" signifies subjects evaluable for endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    Secukinumab 150 mg with loading Secukinumab 150 mg without loading dose Placebo
    Number of subjects analysed
    114
    110
    112
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -2.405 ± 2.1206
    -2.533 ± 2.1463
    -1.917 ± 2.2221
    No statistical analyses for this end point

    Secondary: Change From Baseline in Physical Function Component summary (PCS) of the Short-form Health Survey (SF-36)

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    End point title
    Change From Baseline in Physical Function Component summary (PCS) of the Short-form Health Survey (SF-36)
    End point description
    SF-36 is a 36 item questionnaire which measures Quality of Life across eight subscales that were scored individually: Physical Functioning, Role- Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The overall summary scores, SF-36 physical Component Summary (PCS) was used to assess improvement from baseline in the Health-Related Quality Of Life of subjects. The change in SF-36 scores were evaluated using MMRM. The analysis was performed in FAS population. Here, "Number of subjects analysed" signifies subjects evaluable for endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    Secukinumab 150 mg with loading Secukinumab 150 mg without loading dose Placebo
    Number of subjects analysed
    114
    112
    113
    Units: Units on a scale
        arithmetic mean (standard deviation)
    6.754 ± 6.9624
    7.242 ± 8.3627
    4.7 ± 7.5912
    No statistical analyses for this end point

    Secondary: Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 weeks

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    End point title
    Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 weeks
    End point description
    ASQoL is a self-administered 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a subject with ankylosing spondylitis: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score ranges from 0 (good QoL) to 18 (poor QoL). The change in ASQoL scores was evaluated using a mixed effect repeated measures model (MMRM). The analysis was performed in FAS population. Here, "Number of subjects analysed" signifies subjects evaluable for endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    Secukinumab 150 mg with loading Secukinumab 150 mg without loading dose Placebo
    Number of subjects analysed
    114
    112
    113
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -4.2 ± 4.63
    -4.7 ± 5.05
    -3 ± 4.74
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events (AEs), deaths, serious adverse events (SAEs) and related discontinuations at 104 weeks

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    End point title
    Number of subjects with adverse events (AEs), deaths, serious adverse events (SAEs) and related discontinuations at 104 weeks
    End point description
    AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. The analysis was performed on the safety population, defined as all subjects who took at least one dose of study treatment during the treatment period.
    End point type
    Secondary
    End point timeframe
    104 weeks
    End point values
    Secukinumab 150 mg with loading Secukinumab 150 mg without loading dose Placebo All secukinumab 150 mg treated subjects
    Number of subjects analysed
    116
    117
    117
    346
    Units: Number of Subjects
        AEs
    100
    98
    65
    289
        SAEs
    16
    11
    4
    39
        Death
    2
    0
    0
    4
        Discontinued study treatment due to any AEs
    9
    5
    1
    20
    No statistical analyses for this end point

    Secondary: Percentage of subjects responded for ASAS 20 at week 4

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    End point title
    Percentage of subjects responded for ASAS 20 at week 4
    End point description
    ASAS 20 response is a validated composite assessment, defined as an improvement of ≥20% and 1 unit on a scale of 10 in three main domains and no worsening of ≥20% and 1 unit on a scale of 10 in the fourth domain within a defined time frame. Four main ASAS domains include: 1. Patient’s global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe 2. Patient’s assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain 3. Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale 4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem) The analysis was performed in FAS population. Here, "Number of subjects analysed" signifies subjects evaluable for endpoint.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Secukinumab 150 mg with loading Secukinumab 150 mg without loading dose Placebo
    Number of subjects analysed
    116
    114
    115
    Units: Percentage of subjects
        number (confidence interval 95%)
    49.1 (39.8 to 58.5)
    55.3 (45.7 to 64.6)
    40.0 (31.1 to 49.6)
    No statistical analyses for this end point

    Secondary: Percentage of subjects responded for ASAS 40 response at week 4

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    End point title
    Percentage of subjects responded for ASAS 40 response at week 4
    End point description
    ASAS 20 response is a validated composite assessment, defined as an improvement of at least 40% and 2 unit on a scale of 10 in three main domains and no worsening at all in the remaining domain within a defined time frame. Four main ASAS domains include: 1. Patient’s global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe 2. Patient’s assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain 3. Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale 4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem) The analysis was performed in FAS population. Here, "Number of subjects analysed" signifies subjects evaluable for endpoint.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Secukinumab 150 mg with loading Secukinumab 150 mg without loading dose Placebo
    Number of subjects analysed
    116
    114
    115
    Units: Percentage of subjects
        number (confidence interval 95%)
    29.3 (21.4 to 38.6)
    27.2 (19.5 to 36.5)
    18.3 (11.9 to 26.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Secukinumab 150 mg without loading dose
    Reporting group description
    Subjects were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3.

    Reporting group title
    Secukinumab 150 mg with loading
    Reporting group description
    Subjects were s.c. administered with 150 mg of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.

    Reporting group title
    Placebo
    Reporting group description
    Subjects were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Subjects were further administered with 150 mg of secukinumab every four weeks starting at Week 16.

    Reporting group title
    All secukinumab 150 mg treated subjects
    Reporting group description
    All subjects who were s.c. administered with secukinumab during the study.

    Serious adverse events
    Secukinumab 150 mg without loading dose Secukinumab 150 mg with loading Placebo All secukinumab 150 mg treated subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 117 (9.40%)
    18 / 116 (15.52%)
    4 / 117 (3.42%)
    43 / 346 (12.43%)
         number of deaths (all causes)
    0
    2
    0
    4
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma gastric
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    1 / 117 (0.85%)
    0 / 346 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Testis cancer
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 117 (0.00%)
    2 / 116 (1.72%)
    0 / 117 (0.00%)
    2 / 346 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Rectocele
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression suicidal
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Somatic symptom disorder
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Facial bones fracture
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Myocardial ischaemia
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pericarditis
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Basal ganglia haemorrhage
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Migraine
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VIth nerve paralysis
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Acute vestibular syndrome
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Papilloedema
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    1 / 117 (0.85%)
    0 / 346 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    2 / 346 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    1 / 117 (0.85%)
    0 / 346 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Bladder diverticulum
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis membranous
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    1 / 117 (0.85%)
    0 / 346 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoroacetabular impingement
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    1 / 117 (0.85%)
    0 / 346 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myofascial pain syndrome
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 117 (0.00%)
    2 / 116 (1.72%)
    0 / 117 (0.00%)
    2 / 346 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    2 / 346 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic tonsillitis
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 117 (0.00%)
    2 / 116 (1.72%)
    0 / 117 (0.00%)
    3 / 346 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    0 / 0
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tinea pedis
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    1 / 346 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Secukinumab 150 mg without loading dose Secukinumab 150 mg with loading Placebo All secukinumab 150 mg treated subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    89 / 117 (76.07%)
    90 / 116 (77.59%)
    54 / 117 (46.15%)
    254 / 346 (73.41%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 117 (5.13%)
    9 / 116 (7.76%)
    2 / 117 (1.71%)
    18 / 346 (5.20%)
         occurrences all number
    7
    9
    2
    19
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 117 (2.56%)
    4 / 116 (3.45%)
    4 / 117 (3.42%)
    8 / 346 (2.31%)
         occurrences all number
    3
    5
    5
    9
    Influenza like illness
         subjects affected / exposed
    3 / 117 (2.56%)
    2 / 116 (1.72%)
    0 / 117 (0.00%)
    5 / 346 (1.45%)
         occurrences all number
    3
    2
    0
    5
    Non-cardiac chest pain
         subjects affected / exposed
    3 / 117 (2.56%)
    0 / 116 (0.00%)
    1 / 117 (0.85%)
    4 / 346 (1.16%)
         occurrences all number
    3
    0
    3
    5
    Pyrexia
         subjects affected / exposed
    1 / 117 (0.85%)
    3 / 116 (2.59%)
    1 / 117 (0.85%)
    8 / 346 (2.31%)
         occurrences all number
    1
    3
    1
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 117 (3.42%)
    6 / 116 (5.17%)
    2 / 117 (1.71%)
    18 / 346 (5.20%)
         occurrences all number
    4
    9
    2
    22
    Oropharyngeal pain
         subjects affected / exposed
    5 / 117 (4.27%)
    7 / 116 (6.03%)
    1 / 117 (0.85%)
    16 / 346 (4.62%)
         occurrences all number
    5
    10
    1
    19
    Rhinorrhoea
         subjects affected / exposed
    3 / 117 (2.56%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    5 / 346 (1.45%)
         occurrences all number
    3
    2
    0
    6
    Psychiatric disorders
    Depression
         subjects affected / exposed
    5 / 117 (4.27%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    6 / 346 (1.73%)
         occurrences all number
    5
    0
    0
    9
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 117 (3.42%)
    5 / 116 (4.31%)
    1 / 117 (0.85%)
    10 / 346 (2.89%)
         occurrences all number
    4
    7
    1
    12
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 117 (3.42%)
    3 / 116 (2.59%)
    0 / 117 (0.00%)
    8 / 346 (2.31%)
         occurrences all number
    4
    4
    0
    9
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    4 / 117 (3.42%)
    4 / 116 (3.45%)
    0 / 117 (0.00%)
    10 / 346 (2.89%)
         occurrences all number
    5
    5
    0
    13
    Fall
         subjects affected / exposed
    0 / 117 (0.00%)
    4 / 116 (3.45%)
    1 / 117 (0.85%)
    5 / 346 (1.45%)
         occurrences all number
    0
    4
    1
    5
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 117 (0.85%)
    4 / 116 (3.45%)
    0 / 117 (0.00%)
    8 / 346 (2.31%)
         occurrences all number
    1
    4
    0
    8
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 117 (1.71%)
    10 / 116 (8.62%)
    5 / 117 (4.27%)
    18 / 346 (5.20%)
         occurrences all number
    7
    11
    6
    25
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 117 (2.56%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    5 / 346 (1.45%)
         occurrences all number
    3
    1
    0
    5
    Leukopenia
         subjects affected / exposed
    1 / 117 (0.85%)
    4 / 116 (3.45%)
    1 / 117 (0.85%)
    8 / 346 (2.31%)
         occurrences all number
    1
    4
    1
    9
    Neutropenia
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    7 / 346 (2.02%)
         occurrences all number
    0
    1
    0
    8
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    3 / 117 (2.56%)
    3 / 116 (2.59%)
    0 / 117 (0.00%)
    7 / 346 (2.02%)
         occurrences all number
    3
    3
    0
    8
    Eye disorders
    Iridocyclitis
         subjects affected / exposed
    1 / 117 (0.85%)
    3 / 116 (2.59%)
    0 / 117 (0.00%)
    7 / 346 (2.02%)
         occurrences all number
    2
    4
    0
    9
    Iritis
         subjects affected / exposed
    3 / 117 (2.56%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    7 / 346 (2.02%)
         occurrences all number
    4
    2
    0
    9
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 117 (2.56%)
    3 / 116 (2.59%)
    0 / 117 (0.00%)
    8 / 346 (2.31%)
         occurrences all number
    7
    3
    0
    12
    Abdominal pain upper
         subjects affected / exposed
    1 / 117 (0.85%)
    6 / 116 (5.17%)
    0 / 117 (0.00%)
    10 / 346 (2.89%)
         occurrences all number
    1
    8
    0
    13
    Diarrhoea
         subjects affected / exposed
    11 / 117 (9.40%)
    9 / 116 (7.76%)
    6 / 117 (5.13%)
    28 / 346 (8.09%)
         occurrences all number
    17
    15
    6
    42
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 117 (2.56%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    5 / 346 (1.45%)
         occurrences all number
    3
    1
    0
    5
    Mouth ulceration
         subjects affected / exposed
    2 / 117 (1.71%)
    3 / 116 (2.59%)
    1 / 117 (0.85%)
    6 / 346 (1.73%)
         occurrences all number
    3
    3
    2
    7
    Nausea
         subjects affected / exposed
    1 / 117 (0.85%)
    8 / 116 (6.90%)
    2 / 117 (1.71%)
    13 / 346 (3.76%)
         occurrences all number
    1
    9
    6
    16
    Toothache
         subjects affected / exposed
    3 / 117 (2.56%)
    2 / 116 (1.72%)
    0 / 117 (0.00%)
    5 / 346 (1.45%)
         occurrences all number
    3
    2
    0
    5
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    4 / 117 (3.42%)
    2 / 116 (1.72%)
    2 / 117 (1.71%)
    6 / 346 (1.73%)
         occurrences all number
    4
    2
    2
    6
    Eczema
         subjects affected / exposed
    3 / 117 (2.56%)
    4 / 116 (3.45%)
    3 / 117 (2.56%)
    7 / 346 (2.02%)
         occurrences all number
    4
    6
    3
    10
    Pruritus
         subjects affected / exposed
    3 / 117 (2.56%)
    4 / 116 (3.45%)
    2 / 117 (1.71%)
    8 / 346 (2.31%)
         occurrences all number
    4
    4
    2
    9
    Rash
         subjects affected / exposed
    3 / 117 (2.56%)
    3 / 116 (2.59%)
    0 / 117 (0.00%)
    9 / 346 (2.60%)
         occurrences all number
    4
    3
    0
    11
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    3 / 117 (2.56%)
    0 / 116 (0.00%)
    1 / 117 (0.85%)
    3 / 346 (0.87%)
         occurrences all number
    3
    0
    1
    3
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    11 / 117 (9.40%)
    12 / 116 (10.34%)
    5 / 117 (4.27%)
    29 / 346 (8.38%)
         occurrences all number
    18
    24
    5
    49
    Arthralgia
         subjects affected / exposed
    11 / 117 (9.40%)
    2 / 116 (1.72%)
    2 / 117 (1.71%)
    15 / 346 (4.34%)
         occurrences all number
    14
    2
    3
    23
    Arthritis
         subjects affected / exposed
    3 / 117 (2.56%)
    0 / 116 (0.00%)
    0 / 117 (0.00%)
    4 / 346 (1.16%)
         occurrences all number
    4
    0
    0
    7
    Back pain
         subjects affected / exposed
    7 / 117 (5.98%)
    10 / 116 (8.62%)
    5 / 117 (4.27%)
    23 / 346 (6.65%)
         occurrences all number
    7
    10
    6
    25
    Musculoskeletal pain
         subjects affected / exposed
    1 / 117 (0.85%)
    3 / 116 (2.59%)
    2 / 117 (1.71%)
    6 / 346 (1.73%)
         occurrences all number
    1
    3
    4
    6
    Myalgia
         subjects affected / exposed
    2 / 117 (1.71%)
    4 / 116 (3.45%)
    0 / 117 (0.00%)
    8 / 346 (2.31%)
         occurrences all number
    2
    4
    0
    8
    Osteoarthritis
         subjects affected / exposed
    0 / 117 (0.00%)
    3 / 116 (2.59%)
    0 / 117 (0.00%)
    5 / 346 (1.45%)
         occurrences all number
    0
    3
    0
    5
    Pain in extremity
         subjects affected / exposed
    5 / 117 (4.27%)
    2 / 116 (1.72%)
    0 / 117 (0.00%)
    10 / 346 (2.89%)
         occurrences all number
    6
    2
    0
    11
    Spondylitis
         subjects affected / exposed
    3 / 117 (2.56%)
    1 / 116 (0.86%)
    1 / 117 (0.85%)
    4 / 346 (1.16%)
         occurrences all number
    3
    1
    1
    4
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    8 / 117 (6.84%)
    13 / 116 (11.21%)
    1 / 117 (0.85%)
    31 / 346 (8.96%)
         occurrences all number
    8
    17
    1
    37
    Ear infection
         subjects affected / exposed
    0 / 117 (0.00%)
    3 / 116 (2.59%)
    0 / 117 (0.00%)
    4 / 346 (1.16%)
         occurrences all number
    0
    5
    0
    6
    Fungal skin infection
         subjects affected / exposed
    1 / 117 (0.85%)
    5 / 116 (4.31%)
    0 / 117 (0.00%)
    7 / 346 (2.02%)
         occurrences all number
    1
    7
    0
    9
    Gastroenteritis
         subjects affected / exposed
    3 / 117 (2.56%)
    5 / 116 (4.31%)
    2 / 117 (1.71%)
    10 / 346 (2.89%)
         occurrences all number
    4
    7
    2
    13
    Herpes simplex
         subjects affected / exposed
    1 / 117 (0.85%)
    3 / 116 (2.59%)
    0 / 117 (0.00%)
    5 / 346 (1.45%)
         occurrences all number
    1
    3
    0
    5
    Influenza
         subjects affected / exposed
    9 / 117 (7.69%)
    7 / 116 (6.03%)
    5 / 117 (4.27%)
    19 / 346 (5.49%)
         occurrences all number
    13
    11
    5
    31
    Laryngitis
         subjects affected / exposed
    2 / 117 (1.71%)
    3 / 116 (2.59%)
    0 / 117 (0.00%)
    7 / 346 (2.02%)
         occurrences all number
    2
    3
    0
    9
    Nasopharyngitis
         subjects affected / exposed
    29 / 117 (24.79%)
    32 / 116 (27.59%)
    10 / 117 (8.55%)
    80 / 346 (23.12%)
         occurrences all number
    44
    52
    13
    129
    Oral herpes
         subjects affected / exposed
    3 / 117 (2.56%)
    4 / 116 (3.45%)
    2 / 117 (1.71%)
    9 / 346 (2.60%)
         occurrences all number
    4
    6
    2
    15
    Pharyngitis
         subjects affected / exposed
    6 / 117 (5.13%)
    2 / 116 (1.72%)
    3 / 117 (2.56%)
    10 / 346 (2.89%)
         occurrences all number
    6
    2
    3
    12
    Pulpitis dental
         subjects affected / exposed
    0 / 117 (0.00%)
    3 / 116 (2.59%)
    0 / 117 (0.00%)
    3 / 346 (0.87%)
         occurrences all number
    0
    3
    0
    3
    Respiratory tract infection
         subjects affected / exposed
    10 / 117 (8.55%)
    6 / 116 (5.17%)
    3 / 117 (2.56%)
    22 / 346 (6.36%)
         occurrences all number
    14
    10
    4
    33
    Rhinitis
         subjects affected / exposed
    7 / 117 (5.98%)
    3 / 116 (2.59%)
    1 / 117 (0.85%)
    15 / 346 (4.34%)
         occurrences all number
    9
    3
    1
    17
    Sinusitis
         subjects affected / exposed
    4 / 117 (3.42%)
    4 / 116 (3.45%)
    0 / 117 (0.00%)
    9 / 346 (2.60%)
         occurrences all number
    5
    6
    0
    12
    Tonsillitis
         subjects affected / exposed
    3 / 117 (2.56%)
    1 / 116 (0.86%)
    0 / 117 (0.00%)
    10 / 346 (2.89%)
         occurrences all number
    4
    1
    0
    11
    Tooth infection
         subjects affected / exposed
    0 / 117 (0.00%)
    3 / 116 (2.59%)
    0 / 117 (0.00%)
    4 / 346 (1.16%)
         occurrences all number
    0
    3
    0
    4
    Upper respiratory tract infection
         subjects affected / exposed
    17 / 117 (14.53%)
    11 / 116 (9.48%)
    6 / 117 (5.13%)
    37 / 346 (10.69%)
         occurrences all number
    24
    16
    6
    52
    Urinary tract infection
         subjects affected / exposed
    2 / 117 (1.71%)
    3 / 116 (2.59%)
    0 / 117 (0.00%)
    7 / 346 (2.02%)
         occurrences all number
    2
    3
    0
    8
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 117 (0.85%)
    1 / 116 (0.86%)
    3 / 117 (2.56%)
    3 / 346 (0.87%)
         occurrences all number
    1
    1
    3
    3
    Hyperlipidaemia
         subjects affected / exposed
    1 / 117 (0.85%)
    6 / 116 (5.17%)
    1 / 117 (0.85%)
    9 / 346 (2.60%)
         occurrences all number
    1
    6
    1
    9

    More information

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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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    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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