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    Clinical Trial Results:
    A randomized, open label multicenter trial to investigate the efficacy of a treat-to-target treatment strategy with secukinumab (AIN457) as a first-line biologic compared to a standard-of-care treatment over 36 weeks in patients with active axial spondyloarthritis (axSpA) - AScalate

    Summary
    EudraCT number
    		 2018-003882-32
    Trial protocol
    		 DE   FR  
    Global end of trial date
    22 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Oct 2023
    First version publication date
    07 Oct 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457HDE01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03906136
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, 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
    22 Sep 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the efficacy of the T2T approach (with secukinumab as first-line biologic) is superior to the SOC approach based on the percentage of patients achieving an ASAS40 response at Week 24.
    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
    04 Jun 2019
    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
    France: 59
    Country: Number of subjects enrolled
    Germany: 245
    Worldwide total number of subjects
    304
    EEA total number of subjects
    304
    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)
    293
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 304 participants were enrolled at sites in Germany (245) and France (59)

    Pre-assignment
    Screening details
    		 The study included an 8-week Screening period.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treat-to-Target (T2T)
    Arm description
    		 Treat To Target approach with secukinumab as first line biologic
    Arm type
    		 Experimental

    Investigational medicinal product name
    adalimumab biosimilar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    adalimumab biosimilar 40 mg

    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
    secukinumab 150 mg, secukinumab 300 mg

    Arm title
    		 Standard-of-care (SOC)
    Arm description
    		 Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    treatment according to local practice standards by their treating physician following the current treatment recommendations.
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    treatment according to local practice standards by their treating physician following the current treatment recommendations.

    Number of subjects in period 1
    		Treat-to-Target (T2T) Standard-of-care (SOC)
    Started
    155
    149
    Completed
    143
    138
    Not completed
    12
    11
         Physician decision
    1
    -
         Consent withdrawn by subject
    3
    7
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    7
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treat-to-Target (T2T)
    Reporting group description
    		 Treat To Target approach with secukinumab as first line biologic

    Reporting group title
    Standard-of-care (SOC)
    Reporting group description
    		 Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations.

    Reporting group values
    		 Treat-to-Target (T2T) Standard-of-care (SOC) Total
    Number of subjects
    		 155 149 304
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 149 144 293
        >=65 years
    		 6 5 11
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 40.0 ( 12.03 ) 38.6 ( 12.17 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 59 51 110
        Male
    		 96 98 194
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 1 0 1
        Black or African American
    		 0 1 1
        White
    		 128 114 242
        More than one race
    		 0 1 1
        Other
    		 26 33 59

    End points

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    End points reporting groups
    Reporting group title
    Treat-to-Target (T2T)
    Reporting group description
    		 Treat To Target approach with secukinumab as first line biologic

    Reporting group title
    Standard-of-care (SOC)
    Reporting group description
    		 Patients received treatment according to local practice standards by their treating physician following the current treatment recommendations.

    Primary: Percentage of patients achieving an ASAS40 response at Week 24

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    End point title
    		 Percentage of patients achieving an ASAS40 response at Week 24
    End point description
    Assessment of SpondyloArthritis International Society criteria (ASAS) consists of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 0 - 10 in at least three of the four ASAS domains and no worsening at all in the remaining domain. A score of 0 indicates less severity; a score of 10 indicates more severity.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Treat-to-Target (T2T) Standard-of-care (SOC)
    Number of subjects analysed
    155
    149
    Units: Participants
    144
    139
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 24
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.119
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 1.1

    Secondary: Percentage of patients achieving ASAS20 response

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    End point title
    		 Percentage of patients achieving ASAS20 response
    End point description
    Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 0 - 10 in at least three of the four ASAS domains and no worsening at all in the remaining domain. A score of 0 indicates less severity; a score of 10 indicates more severity.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    		 Treat-to-Target (T2T) Standard-of-care (SOC)
    Number of subjects analysed
    155
    149
    Units: Participants
        Week 12
    147
    143
        Week 24
    144
    139
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 12
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.154
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 1.14
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 24
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.562
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.39

    Secondary: Percentage of patients achieving an ASAS40 response at Week 12

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    End point title
    		 Percentage of patients achieving an ASAS40 response at Week 12
    End point description
    Assessment of SpondyloArthritis International Society criteria (ASAS) consists of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 0 - 10 in at least three of the four ASAS domains and no worsening at all in the remaining domain. A score of 0 indicates less severity; a score of 10 indicates more severity.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Treat-to-Target (T2T) Standard-of-care (SOC)
    Number of subjects analysed
    155
    149
    Units: Participants
    147
    143
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 12
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.029
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 0.95

    Secondary: Percentage of patients achieving ASAS partial remission

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    End point title
    		 Percentage of patients achieving ASAS partial remission
    End point description
    Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10. A higher score on the VAS signifies higher severity.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    		 Treat-to-Target (T2T) Standard-of-care (SOC)
    Number of subjects analysed
    155
    149
    Units: Participants
        Week 12
    149
    143
        Week 24
    146
    139
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 24
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.264
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 1.25
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 12
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.029
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 0.94

    Secondary: Percentage of patients meeting the Ankylosing Spondylitis Disease Activity Score (ASDAS) definition of inactive disease

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    End point title
    		 Percentage of patients meeting the Ankylosing Spondylitis Disease Activity Score (ASDAS) definition of inactive disease
    End point description
    Parameters used for the ASDAS include spinal pain (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI question 2), the patient’s global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive Protein or Erythrocyte Sedimentation Rate). The 3 values selected to separate disease activity states were < 1.3 between inactive disease and low disease activity, < 2.1 between low disease activity and high disease activity, and > 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change of ≥ 1.1 unit for “minimal clinically important improvement” and a change of ≥ 2.0 units for “major improvement”.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    		 Treat-to-Target (T2T) Standard-of-care (SOC)
    Number of subjects analysed
    155
    149
    Units: Participants
        Week 12
    151
    141
        Week 24
    146
    136
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 24
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.103
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 1.28
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 12
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.008
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 1.28

    Secondary: Percentage of patients with ASDAS major improvement

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    End point title
    		 Percentage of patients with ASDAS major improvement
    End point description
    Parameters used for the ASDAS include spinal pain (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI question 2), the patient’s global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive Protein or Erythrocyte Sedimentation Rate). The 3 values selected to separate disease activity states were < 1.3 between inactive disease and low disease activity, < 2.1 between low disease activity and high disease activity, and > 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change of ≥ 1.1 unit for “minimal clinically important improvement” and a change of ≥ 2.0 units for “major improvement”.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    		 Treat-to-Target (T2T) Standard-of-care (SOC)
    Number of subjects analysed
    155
    149
    Units: Participants
        Week 12
    151
    141
        Week 24
    146
    136
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 24
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.103
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 1.29
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 12
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.263
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 1.28

    Secondary: Percentage of patients with ASDAS low disease activity

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    End point title
    		 Percentage of patients with ASDAS low disease activity
    End point description
    Parameters used for the ASDAS include spinal pain (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI question 2), the patient’s global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive Protein or Erythrocyte Sedimentation Rate). The 3 values selected to separate disease activity states were < 1.3 between inactive disease and low disease activity, < 2.1 between low disease activity and high disease activity, and > 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change of ≥ 1.1 unit for “minimal clinically important improvement” and a change of ≥ 2.0 units for “major improvement”.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    		 Treat-to-Target (T2T) Standard-of-care (SOC)
    Number of subjects analysed
    155
    149
    Units: Participants
        Week 12
    151
    141
        Week 24
    146
    136
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 24
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.409
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 1.31
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 12
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.055
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 1.01

    Secondary: Percentage of patients achieving the Bath Ankylosing Spondylitis Disease Activity Index response 50% (BASDAI 50) at Week 12 and Week 24

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    End point title
    		 Percentage of patients achieving the Bath Ankylosing Spondylitis Disease Activity Index response 50% (BASDAI 50) at Week 12 and Week 24
    End point description
    The BASDAI consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of the disease. BASDAI 50 response is defined as at least 50% improvement (decrease) in total BASDAI score.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    		 Treat-to-Target (T2T) Standard-of-care (SOC)
    Number of subjects analysed
    155
    149
    Units: Participants
        Week 12
    153
    144
        Week 24
    148
    140
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 24
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.968
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.61
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 12
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.477
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.34

    Secondary: Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

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    End point title
    		 Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
    End point description
    The Bath Ankylosing Spondylitis Functional Index (BASFI) is a set of 10 questions designed to determine the degree of functional limitation in those patients with AS. The 10 questions were chosen with major input from patients with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the patients’ ability to cope with everyday life. A 0 through 10 scale (captured as a continuous VAS) is used to answer the questions. The mean of the 10 scales gives the BASFI score – a value between 0 and 10. A higher score on the VAS signifies higher severity.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    		 Treat-to-Target (T2T) Standard-of-care (SOC)
    Number of subjects analysed
    155
    149
    Units: Scores on a scale
    least squares mean (confidence interval 95%)
        Week 12
    -1.69 (-2.01 to -1.37)
    -1.99 (-2.31 to 1.66)
        Week 24
    -1.97 (-2.28 to 1.65)
    -2.33 (-2.66 to 2.01)
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 12
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.205
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.75
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 24
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.108
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.82

    Secondary: Change from Baseline in Bath ankylosing spondylitis metrology index (BASMI)

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    End point title
    		 Change from Baseline in Bath ankylosing spondylitis metrology index (BASMI)
    End point description
    BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    		 Treat-to-Target (T2T) Standard-of-care (SOC)
    Number of subjects analysed
    155
    149
    Units: Scores on a scale
    least squares mean (confidence interval 95%)
        Week 12
    -0.32 (-0.44 to -0.20)
    -0.38 (-0.50 to -0.27)
        Week 24
    -0.41 (-0.55 to -0.27)
    -0.35 (-0.50 to -0.21)
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 24
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.577
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 0.14
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 12
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.525
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.23

    Secondary: Change from Baseline in the ASQoL (Ankylosing Spondylitis Quality of Life instrument)

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    End point title
    		 Change from Baseline in the ASQoL (Ankylosing Spondylitis Quality of Life instrument)
    End point description
    The Ankylosing Spondylitis Quality of Life scores (ASQoL) is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each "yes" response and no points for each "no" response resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower score indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is "at the moment," and the measure requires approximately 6 minutes to complete.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    		 Treat-to-Target (T2T) Standard-of-care (SOC)
    Number of subjects analysed
    155
    149
    Units: Scores on a scale
    least squares mean (confidence interval 95%)
        Week 12
    -3.52 (-4.13 to 2.91)
    -3.39 (-4.02 to 2.76)
        Week 24
    -4.21 (-4.88 to 3.53)
    -3.84 (-4.53 to 3.15)
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 24
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.451
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.34
         upper limit
    		 0.6
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 12
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.768
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.01
         upper limit
    		 0.74

    Secondary: Change from Baseline in chest expansion

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    End point title
    		 Change from Baseline in chest expansion
    End point description
    Chest expansion is measured as the cervical rotation angle (in degrees).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    		 Treat-to-Target (T2T) Standard-of-care (SOC)
    Number of subjects analysed
    155
    149
    Units: degrees
    least squares mean (confidence interval 95%)
        Week 12
    0.46 (-0.54 to 1.46)
    1.35 (0.33 to 2.38)
        Week 24
    0.47 (0.05 to 0.88)
    0.57 (0.14 to 1.00)
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 24
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.745
    Method
    		 Regression, Logistic
    Parameter type
    		 Median difference (net)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.5
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 12
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.22
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    -0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.32
         upper limit
    		 0.54

    Secondary: Change from Baseline in ASAS-HI (Ankylosing Spondyloarthritis International Society Health Index)

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    End point title
    		 Change from Baseline in ASAS-HI (Ankylosing Spondyloarthritis International Society Health Index)
    End point description
    The ASAS-HI is a disease-specific questionnaire that was developed based on the comprehensive International Classification of Functioning, Disability and Health Core Set (also known as the ICF Core Set) for AS. The ASAS HI is a linear composite measure and contains 17 items (dichotomous response option: “I agree” and “I do not agree”), which cover most of the ICF Core Set. The ASAS HI contains items addressing categories of pain, emotional functions, sleep, sexual function, mobility, self-care, and community life. The total sum of the ASAS HI ranges from 0 to 17, with a lower score indicating a better health status. In addition, the Environmental Factor (EF) Item Set contains items addressing categories of support/relationships, attitudes and health services. The EF Item Set contains 9 dichotomous items with an identical response option but without a sum score because of its multidimensional nature.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    		 Treat-to-Target (T2T) Standard-of-care (SOC)
    Number of subjects analysed
    155
    149
    Units: Scores on a scale
    least squares mean (confidence interval 95%)
        Week 12
    -2.55 (-3.05 to 2.05)
    -2.81 (-3.32 to 2.30)
        Week 24
    -3.24 (-3.77 to 2.72)
    -3.07 (-3.61 to 2.54)
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 24
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.666
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.92
         upper limit
    		 0.58
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 12
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.477
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 0.97

    Secondary: Change from Baseline in global disease assessment (patient)

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    End point title
    		 Change from Baseline in global disease assessment (patient)
    End point description
    The patient’s global assessment of disease activity was performed using a 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?” A higher score indicates more disease activity.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    		 Treat-to-Target (T2T) Standard-of-care (SOC)
    Number of subjects analysed
    155
    149
    Units: Scores on a scale
    least squares mean (confidence interval 95%)
        Week 12
    -2.95 (-3.38 to 2.52)
    -3.12 (-3.56 to 2.68)
        Week 24
    -3.27 (-3.69 to 2.85)
    -3.48 (-3.92 to 3.05)
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 24
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.491
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (net)
    Point estimate
    0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.39
         upper limit
    		 0.82
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 12
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.586
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 0.79

    Secondary: Change from Baseline in global disease assessment (physician)

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    End point title
    		 Change from Baseline in global disease assessment (physician)
    End point description
    The physician’s global assessment of disease activity was performed using 100 mm VAS ranging from no disease activity to maximal disease activity, after the question “Considering all the ways the disease affects your patient, draw a line on the scale for how well his or her condition is today.” To enhance objectivity, the physician must not be aware of the specific patient’s global assessment of disease activity when performing his own assessment on that patient. A higher score indicates more disease activity.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12 and 24
    End point values
    		 Treat-to-Target (T2T) Standard-of-care (SOC)
    Number of subjects analysed
    155
    149
    Units: Scores on a scale
    least squares mean (confidence interval 90%)
        Week 12
    -32.46 (-35.98 to 28.94)
    -36.96 (-40.60 to 33.31)
        Week 24
    -35.81 (-39.34 to 32.28)
    -38.54 (-42.57 to 34.89)
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Statistical analysis description
    Week 24
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.292
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (net)
    Point estimate
    2.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.35
         upper limit
    		 7.81
    Statistical analysis title
    		 Comparison of T2T versus SOC
    Comparison groups
    Treat-to-Target (T2T) v Standard-of-care (SOC)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.082
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    4.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.58
         upper limit
    		 9.56
    Notes
    [1] - Week 12

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were reported from first dose of study treatment until end of study treatment plus 20 weeks up to approximately 56 weeks.
    Adverse event reporting additional description
    As Secukinumab 150 mg could also had been provided in the Standard-of-care arm, the number of patients at risk exceeds the number of patients enrolled in the T2T arm. For AEs that occurred while on other treatment in the SoC arm, the specific treatment information was not collected, and AEs summarized under one arm.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Secukinumab 150 mg
    Reporting group description
    		 Secukinumab 150 mg

    Reporting group title
    Secukinumab 300 mg
    Reporting group description
    		 Secukinumab 300 mg

    Reporting group title
    Overall
    Reporting group description
    		 Overall

    Reporting group title
    Other
    Reporting group description
    		 Other

    Reporting group title
    Adalimumab 40 mg
    Reporting group description
    		 Adalimumab 40 mg

    Serious adverse events
    		 Secukinumab 150 mg Secukinumab 300 mg Overall Other Adalimumab 40 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 190 (5.26%)
    4 / 92 (4.35%)
    16 / 303 (5.28%)
    8 / 128 (6.25%)
    5 / 116 (4.31%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 190 (0.53%)
    1 / 92 (1.09%)
    1 / 303 (0.33%)
    0 / 128 (0.00%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibroadenoma of breast
         subjects affected / exposed
    0 / 190 (0.00%)
    0 / 92 (0.00%)
    1 / 303 (0.33%)
    1 / 128 (0.78%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    0 / 190 (0.00%)
    0 / 92 (0.00%)
    1 / 303 (0.33%)
    1 / 128 (0.78%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 92 (0.00%)
    1 / 303 (0.33%)
    0 / 128 (0.00%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scapula fracture
         subjects affected / exposed
    0 / 190 (0.00%)
    0 / 92 (0.00%)
    1 / 303 (0.33%)
    1 / 128 (0.78%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 190 (0.53%)
    1 / 92 (1.09%)
    1 / 303 (0.33%)
    0 / 128 (0.00%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 92 (0.00%)
    1 / 303 (0.33%)
    0 / 128 (0.00%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 190 (0.53%)
    1 / 92 (1.09%)
    1 / 303 (0.33%)
    0 / 128 (0.00%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    0 / 190 (0.00%)
    0 / 92 (0.00%)
    1 / 303 (0.33%)
    1 / 128 (0.78%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 190 (0.53%)
    1 / 92 (1.09%)
    1 / 303 (0.33%)
    0 / 128 (0.00%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Immunisation reaction
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 92 (0.00%)
    1 / 303 (0.33%)
    0 / 128 (0.00%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 190 (0.53%)
    0 / 92 (0.00%)
    1 / 303 (0.33%)
    0 / 128 (0.00%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 190 (0.00%)
    0 / 92 (0.00%)
    1 / 303 (0.33%)
    1 / 128 (0.78%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    2 / 190 (1.05%)
    0 / 92 (0.00%)
    2 / 303 (0.66%)
    2 / 128 (1.56%)
    1 / 116 (0.86%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 190 (0.00%)
    0 / 92 (0.00%)
    1 / 303 (0.33%)
    1 / 128 (0.78%)
    0 / 116 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Secukinumab 150 mg Secukinumab 300 mg Overall Other Adalimumab 40 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    69 / 190 (36.32%)
    38 / 92 (41.30%)
    98 / 303 (32.34%)
    36 / 128 (28.13%)
    35 / 116 (30.17%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 190 (6.32%)
    7 / 92 (7.61%)
    18 / 303 (5.94%)
    6 / 128 (4.69%)
    7 / 116 (6.03%)
         occurrences all number
    13
    8
    20
    6
    8
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    7 / 190 (3.68%)
    3 / 92 (3.26%)
    12 / 303 (3.96%)
    5 / 128 (3.91%)
    6 / 116 (5.17%)
         occurrences all number
    7
    3
    13
    6
    6
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    16 / 190 (8.42%)
    9 / 92 (9.78%)
    24 / 303 (7.92%)
    11 / 128 (8.59%)
    8 / 116 (6.90%)
         occurrences all number
    17
    10
    25
    11
    9
    Nausea
         subjects affected / exposed
    12 / 190 (6.32%)
    6 / 92 (6.52%)
    14 / 303 (4.62%)
    7 / 128 (5.47%)
    3 / 116 (2.59%)
         occurrences all number
    14
    6
    16
    8
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 190 (3.68%)
    6 / 92 (6.52%)
    8 / 303 (2.64%)
    0 / 128 (0.00%)
    3 / 116 (2.59%)
         occurrences all number
    7
    6
    8
    0
    3
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    10 / 190 (5.26%)
    3 / 92 (3.26%)
    10 / 303 (3.30%)
    3 / 128 (2.34%)
    3 / 116 (2.59%)
         occurrences all number
    12
    3
    12
    3
    3
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 190 (5.26%)
    6 / 92 (6.52%)
    12 / 303 (3.96%)
    3 / 128 (2.34%)
    6 / 116 (5.17%)
         occurrences all number
    12
    8
    14
    3
    7
    Nasopharyngitis
         subjects affected / exposed
    24 / 190 (12.63%)
    13 / 92 (14.13%)
    31 / 303 (10.23%)
    10 / 128 (7.81%)
    7 / 116 (6.03%)
         occurrences all number
    28
    14
    38
    14
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Feb 2021
    The main purpose of this amendment was to remove the planned IA that became obsolete due to availability of secukinumab data that fully supported the assumptions for the initial sample size calculation.
    19 May 2021
    The main purpose of this amendment was to incorporate two novel components into the protocol: Patient pain diary and Companion app.

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

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

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