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    Clinical Trial Results:
    A 24-week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of secukinumab in controlling spinal pain in patients with axial spondyloarthritis

    Summary
    EudraCT number
    		 2017-000401-21
    Trial protocol
    		 ES   CZ   FI   GB   LV   LT   GR   BE   SE   BG   PL   HR   IT  
    Global end of trial date
    15 Feb 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Aug 2021
    First version publication date
    21 Feb 2020
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Updates to align with amended clinical study report

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457H3301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03136861
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 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
    15 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Feb 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 assess the superiority of secukinumab 150 mg compared to placebo in achieving a spinal pain score of < 4 on a 0-10 numerical rating scale (NRS) at Week 8.
    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 Jun 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    Bulgaria: 17
    Country: Number of subjects enrolled
    Croatia: 11
    Country: Number of subjects enrolled
    Czech Republic: 21
    Country: Number of subjects enrolled
    Estonia: 24
    Country: Number of subjects enrolled
    Finland: 8
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    Greece: 21
    Country: Number of subjects enrolled
    Ireland: 6
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Latvia: 16
    Country: Number of subjects enrolled
    Lithuania: 26
    Country: Number of subjects enrolled
    Poland: 116
    Country: Number of subjects enrolled
    Russian Federation: 38
    Country: Number of subjects enrolled
    Spain: 42
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    Switzerland: 6
    Worldwide total number of subjects
    380
    EEA total number of subjects
    336
    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)
    368
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 66 centers in 17 countries worldwide: Spain(14), Czech Republic(3), Finland(2), Lithuania(2), Estonia(3), Latvia(3), Switzerland(1), Russia(4), Sweden(4), United Kingdom(5), Belgium(2), Ireland(2), Poland(7), Croatia(3), Bulgaria(5), Greece(5), Italy(1).

    Pre-assignment
    Screening details
    		 At Baseline, patients were randomized to either secukinumab 150 mg or placebo (Group A or B). At Week 8, patients were re-randomized or re-assigned respectively to 1 of 5 treatment arms to receive either secukinumab 150 mg or secukinumab 300 mg (Arm A1 to B2).

    Period 1
    Period 1 title
    Treatment Period 1 (TP1)(Baseline-Wk 8)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab 150 mg (Group A)
    Arm description
    		 Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4
    Arm type
    		 Experimental

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Secukinumab
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab sc injections weekly up to week 4.

    Arm title
    		 Placebo (Group B)
    Arm description
    		 Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo sc injections weekly up to week 4.

    Number of subjects in period 1
    		Secukinumab 150 mg (Group A) Placebo (Group B)
    Started
    285
    95
    Completed
    278
    89
    Not completed
    7
    6
         Adverse event, non-fatal
    3
    2
         Protocol Deviation
    2
    1
         Subject/Guardian Decision
    -
    1
         Lost to follow-up
    1
    1
         Withdrawal of Informed Consent
    1
    1
    Period 2
    Period 2 title
    Treatment Period 2 (TP2) (Wk 8-Wk 24)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A1
    Arm description
    		 Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
    Arm type
    		 Active comparator

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Secukinumab
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab sc injections every 4 weeks between week 8 and week 20.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo sc injections every 4 weeks between week 8 and week 20.

    Arm title
    		 Arm A2
    Arm description
    		 Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
    Arm type
    		 Active comparator

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Secukinumab
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab sc injections every 4 weeks between week 8 and week 20.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo sc injections every 4 weeks between week 8 and week 20.

    Arm title
    		 Arm A3
    Arm description
    		 Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
    Arm type
    		 Active comparator

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Secukinumab
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 secukinumab sc injections every 4 weeks between week 8 and week 20.

    Arm title
    		 Arm B1
    Arm description
    		 Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
    Arm type
    		 Active comparator

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Secukinumab
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab sc injections every 4 weeks between week 8 and week 20.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo sc injections every 4 weeks between week 8 and week 20.

    Arm title
    		 Arm B2
    Arm description
    		 Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
    Arm type
    		 Active comparator

    Investigational medicinal product name
    AIN457
    Investigational medicinal product code
    Other name
    Secukinumab
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 secukinumab sc injections every 4 weeks between week 8 and week 20.

    Number of subjects in period 2
    		Arm A1 Arm A2 Arm A3 Arm B1 Arm B2
    Started
    90
    94
    94
    45
    44
    Completed
    88
    93
    92
    45
    43
    Not completed
    2
    1
    2
    0
    1
         Adverse event, non-fatal
    -
    1
    2
    -
    1
         Lost to follow-up
    1
    -
    -
    -
    -
         Withdrawal of Informed Consent
    1
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab 150 mg (Group A)
    Reporting group description
    		 Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4

    Reporting group title
    Placebo (Group B)
    Reporting group description
    		 Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4

    Reporting group values
    		 Secukinumab 150 mg (Group A) Placebo (Group B) Total
    Number of subjects
    		 285 95 380
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 274 94 368
        From 65-84 years
    		 11 1 12
        85 years and over
    		 0 0 0
    Age Continuous
    Age continuous at Baseline Treatment Period 1
    Units: Years
        arithmetic mean (standard deviation)
    		 42.3 ± 11.88 40.9 ± 12.20 -
    Sex: Female, Male
    Gender at Baseline Treatment Period 1
    Units: Participants
        Female
    		 106 39 145
        Male
    		 179 56 235
    Race/Ethnicity, Customized
    Race at Baseline Treatment Period 1
    Units: Subjects
        Caucasian
    		 267 93 360
        Asian
    		 2 1 3
        Other
    		 16 1 17

    End points

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    End points reporting groups
    Reporting group title
    Secukinumab 150 mg (Group A)
    Reporting group description
    		 Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4

    Reporting group title
    Placebo (Group B)
    Reporting group description
    		 Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
    Reporting group title
    Arm A1
    Reporting group description
    		 Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20

    Reporting group title
    Arm A2
    Reporting group description
    		 Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20

    Reporting group title
    Arm A3
    Reporting group description
    		 Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20

    Reporting group title
    Arm B1
    Reporting group description
    		 Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20

    Reporting group title
    Arm B2
    Reporting group description
    		 Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20

    Primary: Percentage of participants with a spinal pain numerical rating scale (NRS) score below 4 at Week 8

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    End point title
    		 Percentage of participants with a spinal pain numerical rating scale (NRS) score below 4 at Week 8
    End point description
    The spinal pain numerical rating scale (NRS) is an 11-point scale to assess pain intensity in patients who are able to self-report. To calculate the average spinal pain, the patient is asked to answer 2 questions to get 2 pain ratings, the total spinal pain corresponding to the intensity of spinal pain experienced on an average over 24 hours during the previous week and the nocturnal back pain corresponding to the intensity of spinal pain experienced on an average over the night during the previous week.
    End point type
    Primary
    End point timeframe
    Week 8
    End point values
    		 Secukinumab 150 mg (Group A) Placebo (Group B)
    Number of subjects analysed
    279
    92
    Units: Participants
        Average Spinal Pain Score|Yes
    91
    19
        Total Spinal Pain Score|Yes
    77
    17
        Nocturnal Spinal Pain Score|Yes
    92
    16
        Average Spinal Pain Score|No
    188
    73
        Total Spinal Pain Score|No
    202
    75
        Nocturnal Spinal Pain Score|No
    187
    76
    Statistical analysis title
    		 Average Spinal Pain Score <4 at Week 8
    Comparison groups
    Placebo (Group B) v Secukinumab 150 mg (Group A)
    Number of subjects included in analysis
    371
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0264
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.08
         upper limit
    		 3.33
    Statistical analysis title
    		 Total Spinal Pain Score <4 at Week 8
    Comparison groups
    Secukinumab 150 mg (Group A) v Placebo (Group B)
    Number of subjects included in analysis
    371
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.072
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 3.1
    Statistical analysis title
    		 Nocturnal Spinal Pain Score
    Comparison groups
    Secukinumab 150 mg (Group A) v Placebo (Group B)
    Number of subjects included in analysis
    371
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0043
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.31
         upper limit
    		 4.31

    Secondary: Percentage of participants with a Bath ankylosing spondylitis disease activity index score below 4 at Week 8

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    End point title
    		 Percentage of participants with a Bath ankylosing spondylitis disease activity index score below 4 at Week 8
    End point description
    The Bath ankylosing spondylitis disease activity index (BASDAI) consists of a 0 through 10 scale, which is used to answer 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis. To give each symptom equal weighting, the mean (average) of the 2 scores relating to morning stiffness (questions 5 and 6) is taken. The mean of questions 5 and 6 is added to the scores from questions 1-4. The resulting 0 to 50 score is divided by 5 to give a final 0 – 10 BASDAI score.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Secukinumab 150 mg (Group A) Placebo (Group B)
    Number of subjects analysed
    280
    92
    Units: Participants
        Yes (n=95,22)
    95
    22
        No (n=185,70)
    185
    70
    Statistical analysis title
    		 BASDAI Score <4 at Week 8
    Comparison groups
    Secukinumab 150 mg (Group A) v Placebo (Group B)
    Number of subjects included in analysis
    372
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0466
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 3.04

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Secukinumab 150 mg
    Reporting group description
    		 Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4

    Reporting group title
    Placebo
    Reporting group description
    		 Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4

    Reporting group title
    Arm A1
    Reporting group description
    		 Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20

    Reporting group title
    Arm A2
    Reporting group description
    		 Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20

    Reporting group title
    Arm A3
    Reporting group description
    		 Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20

    Reporting group title
    Arm B1
    Reporting group description
    		 Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20

    Reporting group title
    Arm B2
    Reporting group description
    		 Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20

    Serious adverse events
    		 Secukinumab 150 mg Placebo Arm A1 Arm A2 Arm A3 Arm B1 Arm B2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 285 (1.40%)
    0 / 95 (0.00%)
    3 / 90 (3.33%)
    1 / 94 (1.06%)
    1 / 94 (1.06%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    1 / 94 (1.06%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Facial bones fracture
         subjects affected / exposed
    1 / 285 (0.35%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 285 (0.35%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 285 (0.35%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Hemiparesis
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    1 / 94 (1.06%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    1 / 90 (1.11%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    1 / 90 (1.11%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    1 / 90 (1.11%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal mass
         subjects affected / exposed
    1 / 285 (0.35%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 285 (0.35%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Secukinumab 150 mg Placebo Arm A1 Arm A2 Arm A3 Arm B1 Arm B2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    59 / 285 (20.70%)
    23 / 95 (24.21%)
    21 / 90 (23.33%)
    24 / 94 (25.53%)
    23 / 94 (24.47%)
    9 / 45 (20.00%)
    13 / 44 (29.55%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 285 (1.05%)
    1 / 95 (1.05%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 285 (2.11%)
    0 / 95 (0.00%)
    1 / 90 (1.11%)
    1 / 94 (1.06%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    6
    0
    1
    1
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    2 / 285 (0.70%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    3 / 94 (3.19%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    0
    0
    4
    0
    0
    Reproductive system and breast disorders
    Vulvovaginal pruritus
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    2 / 285 (0.70%)
    0 / 95 (0.00%)
    3 / 90 (3.33%)
    1 / 94 (1.06%)
    1 / 94 (1.06%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    3
    1
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    8 / 285 (2.81%)
    1 / 95 (1.05%)
    4 / 90 (4.44%)
    2 / 94 (2.13%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    9
    1
    4
    2
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 285 (0.35%)
    1 / 95 (1.05%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    2 / 94 (2.13%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    1
    1
    0
    0
    2
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    2 / 94 (2.13%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 285 (0.35%)
    1 / 95 (1.05%)
    0 / 90 (0.00%)
    1 / 94 (1.06%)
    2 / 94 (2.13%)
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences all number
    1
    2
    0
    1
    2
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    4 / 285 (1.40%)
    0 / 95 (0.00%)
    3 / 90 (3.33%)
    1 / 94 (1.06%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    2 / 44 (4.55%)
         occurrences all number
    4
    0
    3
    1
    0
    0
    2
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Foot fracture
         subjects affected / exposed
    0 / 285 (0.00%)
    1 / 95 (1.05%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    Limb injury
         subjects affected / exposed
    1 / 285 (0.35%)
    0 / 95 (0.00%)
    2 / 90 (2.22%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 285 (3.51%)
    1 / 95 (1.05%)
    2 / 90 (2.22%)
    2 / 94 (2.13%)
    3 / 94 (3.19%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    12
    1
    2
    2
    3
    0
    2
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 285 (0.35%)
    1 / 95 (1.05%)
    1 / 90 (1.11%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    1
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Eye disorders
    Blepharitis
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    2 / 94 (2.13%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Iritis
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 285 (1.05%)
    1 / 95 (1.05%)
    0 / 90 (0.00%)
    1 / 94 (1.06%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    3
    1
    0
    1
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    6 / 285 (2.11%)
    1 / 95 (1.05%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    1 / 94 (1.06%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    9
    1
    0
    0
    1
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Toothache
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    2 / 94 (2.13%)
    1 / 94 (1.06%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    0
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 285 (0.35%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    1 / 94 (1.06%)
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 285 (0.70%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 285 (0.35%)
    0 / 95 (0.00%)
    1 / 90 (1.11%)
    0 / 94 (0.00%)
    3 / 94 (3.19%)
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    1
    0
    3
    1
    0
    Proteinuria
         subjects affected / exposed
    3 / 285 (1.05%)
    1 / 95 (1.05%)
    0 / 90 (0.00%)
    2 / 94 (2.13%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    3
    1
    0
    3
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Arthralgia
         subjects affected / exposed
    4 / 285 (1.40%)
    2 / 95 (2.11%)
    0 / 90 (0.00%)
    3 / 94 (3.19%)
    1 / 94 (1.06%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    4
    2
    0
    3
    1
    0
    0
    Back pain
         subjects affected / exposed
    1 / 285 (0.35%)
    3 / 95 (3.16%)
    0 / 90 (0.00%)
    2 / 94 (2.13%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    1
    5
    0
    2
    0
    0
    0
    Bursitis
         subjects affected / exposed
    1 / 285 (0.35%)
    0 / 95 (0.00%)
    1 / 90 (1.11%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    Foot deformity
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Muscle contracture
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Osteoarthritis
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    6 / 285 (2.11%)
    0 / 95 (0.00%)
    1 / 90 (1.11%)
    1 / 94 (1.06%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    6
    0
    1
    2
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 285 (0.00%)
    1 / 95 (1.05%)
    1 / 90 (1.11%)
    1 / 94 (1.06%)
    0 / 94 (0.00%)
    1 / 45 (2.22%)
    0 / 44 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    2 / 90 (2.22%)
    2 / 94 (2.13%)
    1 / 94 (1.06%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    0
    0
    2
    2
    1
    0
    0
    Herpes simplex
         subjects affected / exposed
    1 / 285 (0.35%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    6 / 285 (2.11%)
    1 / 95 (1.05%)
    1 / 90 (1.11%)
    3 / 94 (3.19%)
    4 / 94 (4.26%)
    2 / 45 (4.44%)
    2 / 44 (4.55%)
         occurrences all number
    7
    1
    1
    3
    4
    2
    2
    Otitis externa
         subjects affected / exposed
    1 / 285 (0.35%)
    0 / 95 (0.00%)
    1 / 90 (1.11%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    3 / 285 (1.05%)
    0 / 95 (0.00%)
    2 / 90 (2.22%)
    2 / 94 (2.13%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    3
    0
    2
    2
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 285 (0.35%)
    0 / 95 (0.00%)
    2 / 90 (2.22%)
    2 / 94 (2.13%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    2
    2
    0
    0
    0
    Tooth infection
         subjects affected / exposed
    0 / 285 (0.00%)
    2 / 95 (2.11%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 285 (1.40%)
    5 / 95 (5.26%)
    1 / 90 (1.11%)
    0 / 94 (0.00%)
    3 / 94 (3.19%)
    0 / 45 (0.00%)
    0 / 44 (0.00%)
         occurrences all number
    4
    5
    1
    0
    3
    0
    0
    Viral pharyngitis
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    1 / 94 (1.06%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Lactose intolerance
         subjects affected / exposed
    0 / 285 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1

    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.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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