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    Clinical Trial Results:
    A randomized, double-blind, multi-center study assessing short (16 weeks) and long-term efficacy (up to 1 year), safety, and tolerability of 2 subcutaneous secukinumab dose regimens in adult patients with moderate to severe hidradenitis suppurativa (SUNSHINE).

    Summary
    EudraCT number
    		 2018-002063-26
    Trial protocol
    		 GB   FR   DE   PT   HU   SK   CZ   BE   GR   AT   SE   ES   BG   IT  
    Global end of trial date
    26 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jul 2023
    First version publication date
    30 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457M2301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03713619
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novarts 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
    Study Director, Novarts Pharma AG, 1 (862) 778-8300, 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
    20 Dec 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy of secukinumab compared to placebo with respect to HiSCR after 16 weeks of treatment.
    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 Jan 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 9
    Country: Number of subjects enrolled
    Australia: 18
    Country: Number of subjects enrolled
    Austria: 8
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    Bulgaria: 8
    Country: Number of subjects enrolled
    Canada: 16
    Country: Number of subjects enrolled
    Czechia: 18
    Country: Number of subjects enrolled
    France: 56
    Country: Number of subjects enrolled
    Germany: 64
    Country: Number of subjects enrolled
    United Kingdom: 26
    Country: Number of subjects enrolled
    Greece: 19
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    India: 10
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Japan: 22
    Country: Number of subjects enrolled
    Korea, Republic of: 9
    Country: Number of subjects enrolled
    Mexico: 8
    Country: Number of subjects enrolled
    Philippines: 8
    Country: Number of subjects enrolled
    Poland: 12
    Country: Number of subjects enrolled
    Portugal: 26
    Country: Number of subjects enrolled
    Russian Federation: 17
    Country: Number of subjects enrolled
    Slovakia: 8
    Country: Number of subjects enrolled
    Spain: 26
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    Switzerland: 11
    Country: Number of subjects enrolled
    Taiwan: 14
    Country: Number of subjects enrolled
    Turkey: 9
    Country: Number of subjects enrolled
    United States: 84
    Worldwide total number of subjects
    541
    EEA total number of subjects
    274
    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)
    534
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 544 enrolled but 1 patient was misrandomized and 2 had severe GCP violations.

    Pre-assignment
    Screening details
    		 There was a screening period of up to 4 weeks.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 secukinumab 1 - Q2W
    Arm description
    		 Secukinumab 300mg every 2 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 300mg every 2 weeks

    Arm title
    		 secukinumab 2 - Q4W
    Arm description
    		 Secukinumab 300mg every 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    secukinumab 300mg every 4 weeks

    Arm title
    		 placebo
    Arm description
    		 Placebo group to secukinumab 300mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    placebo

    Number of subjects in period 1
    		secukinumab 1 - Q2W secukinumab 2 - Q4W placebo
    Started
    181
    180
    180
    Completed
    168
    169
    172
    Not completed
    13
    11
    8
         Physician decision
    1
    1
    1
         Consent withdrawn by subject
    4
    9
    5
         Adverse event, non-fatal
    4
    -
    1
         Technical problems
    1
    -
    -
         Lost to follow-up
    3
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    secukinumab 1 - Q2W
    Reporting group description
    		 Secukinumab 300mg every 2 weeks

    Reporting group title
    secukinumab 2 - Q4W
    Reporting group description
    		 Secukinumab 300mg every 4 weeks

    Reporting group title
    placebo
    Reporting group description
    		 Placebo group to secukinumab 300mg

    Reporting group values
    		 secukinumab 1 - Q2W secukinumab 2 - Q4W placebo Total
    Number of subjects
    		 181 180 180 541
    Age Categorical
    Units: participants
        <=18 years
    		 0 0 0 0
        Between 18 and 65 years
    		 178 177 179 534
        >=65 years
    		 3 3 1 7
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.1 ( 12.53 ) 35.7 ( 11.71 ) 0 ( 0 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 102 100 102 304
        Male
    		 79 80 78 237
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 145 146 139 430
        Black or African American
    		 15 10 12 37
        Asian
    		 19 23 24 66
        American Indian or Alaska Native
    		 1 1 2 4
        Multiple
    		 1 0 3 4
    Subject analysis sets

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo group to secukinumab 300mg every 4 weeks

    Subject analysis set title
    placebo 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo group to secukinumab 300mg

    Subject analysis sets values
    		 Placebo placebo 2
    Number of subjects
    180
    180
    Age Categorical
    Units: participants
        <=18 years
    0
    0
        Between 18 and 65 years
    179
    0
        >=65 years
    1
    0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    35.5 ( 10.75 )
    52.2 ( )
    Sex: Female, Male
    Units: participants
        Female
    102
    0
        Male
    78
    0
    Race/Ethnicity, Customized
    Units: Subjects
        White
    139
    0
        Black or African American
    12
    0
        Asian
    24
    0
        American Indian or Alaska Native
    2
    0
        Multiple
    3
    0

    End points

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    End points reporting groups
    Reporting group title
    secukinumab 1 - Q2W
    Reporting group description
    		 Secukinumab 300mg every 2 weeks

    Reporting group title
    secukinumab 2 - Q4W
    Reporting group description
    		 Secukinumab 300mg every 4 weeks

    Reporting group title
    placebo
    Reporting group description
    		 Placebo group to secukinumab 300mg

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo group to secukinumab 300mg every 4 weeks

    Subject analysis set title
    placebo 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo group to secukinumab 300mg

    Primary: Proportion of participants with Hidradenitis Suppurativa clinical response (HiSCR)

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    End point title
    		 Proportion of participants with Hidradenitis Suppurativa clinical response (HiSCR)
    End point description
    HiSCR at Week 16 is defined as at least a 50% decrease in Abscess and inflammatory Nodule (AN) count compared to baseline with no increase in the number of abscesses and/or in the number of draining fistulas from baseline to Week 16. The baseline is defined as the last assessment (including unscheduled visits) obtained before/on the day of the first administration of the study treatment, or on the randomization date if there had been no drug administration. The primary endpoint was analyzed by logistic regression. Missing data were multiply imputed based on the estimand strategy related to intercurrent events or missing at random assumption for all missing values not related to intercurrent events. The number of participants reported in this record corresponds to the rounded average number of participants with response in 100 imputed data sets.
    End point type
    Primary
    End point timeframe
    Baseline, 16 weeks
    End point values
    		 secukinumab 1 - Q2W secukinumab 2 - Q4W placebo
    Number of subjects analysed
    181
    180
    180
    Units: Rounded average number of subjects
        number (not applicable)
    81.5
    75.2
    60.7
    Statistical analysis title
    		 Proportion of participants with (HiSCR)
    Statistical analysis description
    Logistic regression analysis of HiSCR50 response at Week 16 (multiple imputation)
    Comparison groups
    secukinumab 2 - Q4W v placebo
    Number of subjects included in analysis
    360
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0418
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 2.32
    Statistical analysis title
    		 Proportion of participants with (HiSCR)
    Statistical analysis description
    Logistic regression analysis of HiSCR50 response at Week 16 (multiple imputation)
    Comparison groups
    secukinumab 1 - Q2W v placebo
    Number of subjects included in analysis
    361
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Regression, Logistic
    Parameter type
    		 Log odds ratio
    Point estimate
    1.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.12
         upper limit
    		 2.73

    Secondary: Percentage change from baseline in AN count at Week 16

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    End point title
    		 Percentage change from baseline in AN count at Week 16
    End point description
    The HS affected areas, e.g. right and left axillary (armpit), right and left gluteal ("buttock"), right and left inguinal-femoral (groin), perineal, pubic, sternal, right and left sub-mammary (breast) and others were assessed by the physician for abscesses, inflammatory nodules, draining fistulas, total fistulas, and other lesions. Inflammatory lesions, including abscesses, nodules, draining fistulae, total fistulae and other lesions were counted. The analysis method for percentage change from baseline in abscesses and inflammatory nodules (AN) count at Week 16 was an ANCOVA model.
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    		 secukinumab 1 - Q2W secukinumab 2 - Q4W placebo
    Number of subjects analysed
    181
    180
    180
    Units: percentage change from baseline
        arithmetic mean (standard error)
    -46.8 ( 3.33 )
    -42.4 ( 4.01 )
    -24.3 ( 4.33 )
    Statistical analysis title
    		 Percentage change from baseline in AN count
    Statistical analysis description
    Analysis of covariance of percentage change from baseline in AN count at Week 16 (multiple imputation)
    Comparison groups
    secukinumab 2 - Q4W v placebo
    Number of subjects included in analysis
    360
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean difference
    Point estimate
    -18.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.32
         upper limit
    		 -7.6
    Statistical analysis title
    		 Percentage change from baseline in AN count
    Statistical analysis description
    Analysis of covariance of percentage change from baseline in AN count at Week 16 (multiple imputation)
    Comparison groups
    secukinumab 1 - Q2W v placebo
    Number of subjects included in analysis
    361
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least square Mean Difference
    Point estimate
    -23.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.9
         upper limit
    		 -12.21

    Secondary: Proportion of patients with Hidradenitis Suppurativa (HS) flares

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    End point title
    		 Proportion of patients with Hidradenitis Suppurativa (HS) flares [1]
    End point description
    Flare was defined as at least a 25% increase in AN count with a minimum increase of 2 AN compared to baseline. The proportion of patients with HS flares was analyzed by logistic regression. The number of participants reported in this record corresponds to the rounded average number of participants with response in 100 imputed data sets
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Stats analysis were not planned for all arms
    End point values
    		 secukinumab 1 - Q2W secukinumab 2 - Q4W placebo 2
    Number of subjects analysed
    181
    180
    180
    Units: rounded average number of participants
        number (not applicable)
    27.8
    41.7
    52.2
    Statistical analysis title
    		 Proportion of patients with HS flares
    Statistical analysis description
    Logistic regression analysis of Flare over 16 weeks (multiple imputation)
    Comparison groups
    secukinumab 2 - Q4W v placebo 2
    Number of subjects included in analysis
    360
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0926
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 1.17
    Statistical analysis title
    		 Proportion of patients with HS flares
    Statistical analysis description
    Logistic regression analysis of Flare over 16 weeks (multiple imputation)
    Comparison groups
    secukinumab 1 - Q2W v placebo 2
    Number of subjects included in analysis
    361
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Log odds ratio
    Point estimate
    0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 0.73

    Secondary: Participants achieving NRS30 (Skin pain)

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    End point title
    		 Participants achieving NRS30 (Skin pain)
    End point description
    The Patient's global assessment of skin pain - numerical rating scale (NRS) in the past 24 hours was used to assess pain “at its worst” and the average skin pain due to HS in the last 24 hours. The NRS is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0–10 integers) that best reflects the intensity of their pain ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). NRS30 (skin pain) is defined as at least a 30% reduction and at least 2 units reduction from baseline in Patient's Global Assessment of Skin Pain - at worst. This endpoint was analyzed by logistic regression. The number of participants reported in this record corresponds to the rounded average number of participants with response in 100 imputed data sets.
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    		 secukinumab 1 - Q2W secukinumab 2 - Q4W placebo
    Number of subjects analysed
    181
    180
    180
    Units: rounded average number of participants
        number (not applicable)
    97.2
    84.4
    57.8
    Statistical analysis title
    		 Participants achieving NRS30
    Statistical analysis description
    Logistic regression analysis of skin pain/NRS30 response at Week 16 (pooled data, multiple imputation)
    Comparison groups
    secukinumab 2 - Q4W v placebo
    Number of subjects included in analysis
    360
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0044
    Method
    		 Regression, Logistic
    Parameter type
    		 Log odds ratio
    Point estimate
    1.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.15
         upper limit
    		 2.7
    Statistical analysis title
    		 Participants achieving NRS30
    Statistical analysis description
    Logistic regression analysis of skin pain/NRS30 response at Week 16 (pooled data, multiple imputation)
    Comparison groups
    secukinumab 1 - Q2W v placebo
    Number of subjects included in analysis
    361
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 ANCOVA
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.37
         upper limit
    		 3.16

    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, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
    Adverse event reporting additional description
    AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    AIN457 Q2W
    Reporting group description
    		 Subjects who were randomized to AIN457 (secukinumab) 300mg Q2W dose regimen at the study entry. Adverse events were assessed up to Week 52

    Reporting group title
    AIN457 Q4W
    Reporting group description
    		 Subjects who were randomized to AIN457 (secukinumab) 300mg Q4W dose regimen at the study entry. Adverse events were assessed up to Week 52

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo up to 16 weeks

    Reporting group title
    Any AIN457 Q2W
    Reporting group description
    		 Subjects who received at least 1 dose of secukinumab 300 mg Q2W dose (e.g., subjects who switched from placebo to secukinumab Q2W at Week 16). Adverse events were assessed up to Week 52

    Reporting group title
    Any AIN457 Q4W
    Reporting group description
    		 Subjects who received at least 1 dose of secukinumab 300 mg Q4W dose (e.g., subjects who switched from placebo to secukinumab Q4W at Week 16). Adverse events were assessed up to Week 52

    Reporting group title
    Any AIN457
    Reporting group description
    		 Subjects who received at least 1 dose of secukinumab

    Serious adverse events
    		 AIN457 Q2W AIN457 Q4W Placebo Any AIN457 Q2W Any AIN457 Q4W Any AIN457
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 181 (7.18%)
    9 / 180 (5.00%)
    6 / 180 (3.33%)
    18 / 266 (6.77%)
    19 / 267 (7.12%)
    37 / 533 (6.94%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung cancer metastatic
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    1 / 180 (0.56%)
    0 / 266 (0.00%)
    0 / 267 (0.00%)
    0 / 533 (0.00%)
         occurrences causally related to treatment / all
    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
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    0 / 267 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive emergency
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 180 (0.56%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    0 / 267 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    0 / 267 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    0 / 267 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    0 / 267 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    0 / 267 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    1 / 180 (0.56%)
    0 / 266 (0.00%)
    0 / 267 (0.00%)
    0 / 533 (0.00%)
         occurrences causally related to treatment / all
    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
    Meniscus injury
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    0 / 267 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Pericarditis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 180 (0.56%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    1 / 180 (0.56%)
    0 / 266 (0.00%)
    0 / 267 (0.00%)
    0 / 533 (0.00%)
         occurrences causally related to treatment / all
    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
    Inguinal hernia
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    0 / 267 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    3 / 181 (1.66%)
    3 / 180 (1.67%)
    2 / 180 (1.11%)
    4 / 266 (1.50%)
    4 / 267 (1.50%)
    8 / 533 (1.50%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
    1 / 4
    1 / 4
    1 / 4
    2 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    C3 glomerulopathy
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 180 (0.56%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    1 / 180 (0.56%)
    0 / 266 (0.00%)
    0 / 267 (0.00%)
    0 / 533 (0.00%)
         occurrences causally related to treatment / all
    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
    Musculoskeletal and connective tissue disorders
    Foot deformity
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    0 / 267 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 180 (0.56%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    1 / 267 (0.37%)
    2 / 533 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cellulitis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 180 (0.56%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    1 / 267 (0.37%)
    2 / 533 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 180 (0.56%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    1 / 267 (0.37%)
    2 / 533 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    1 / 180 (0.56%)
    0 / 266 (0.00%)
    0 / 267 (0.00%)
    0 / 533 (0.00%)
         occurrences causally related to treatment / all
    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
    Infection
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine infection
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    0 / 267 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    2 / 267 (0.75%)
    2 / 533 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 180 (0.56%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sweat gland infection
         subjects affected / exposed
    1 / 181 (0.55%)
    3 / 180 (1.67%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    3 / 267 (1.12%)
    4 / 533 (0.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 1
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin candida
         subjects affected / exposed
    0 / 181 (0.00%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    0 / 267 (0.00%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 180 (0.56%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    1 / 267 (0.37%)
    1 / 533 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    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
    		 AIN457 Q2W AIN457 Q4W Placebo Any AIN457 Q2W Any AIN457 Q4W Any AIN457
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    135 / 181 (74.59%)
    132 / 180 (73.33%)
    88 / 180 (48.89%)
    184 / 266 (69.17%)
    183 / 267 (68.54%)
    367 / 533 (68.86%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 181 (3.31%)
    4 / 180 (2.22%)
    2 / 180 (1.11%)
    8 / 266 (3.01%)
    5 / 267 (1.87%)
    13 / 533 (2.44%)
         occurrences all number
    6
    4
    2
    8
    5
    13
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 181 (1.66%)
    4 / 180 (2.22%)
    4 / 180 (2.22%)
    5 / 266 (1.88%)
    4 / 267 (1.50%)
    9 / 533 (1.69%)
         occurrences all number
    5
    4
    4
    8
    4
    12
    Chest pain
         subjects affected / exposed
    0 / 181 (0.00%)
    5 / 180 (2.78%)
    0 / 180 (0.00%)
    0 / 266 (0.00%)
    5 / 267 (1.87%)
    5 / 533 (0.94%)
         occurrences all number
    0
    5
    0
    0
    5
    5
    Fatigue
         subjects affected / exposed
    6 / 181 (3.31%)
    11 / 180 (6.11%)
    8 / 180 (4.44%)
    8 / 266 (3.01%)
    13 / 267 (4.87%)
    21 / 533 (3.94%)
         occurrences all number
    7
    12
    8
    9
    15
    24
    Pyrexia
         subjects affected / exposed
    13 / 181 (7.18%)
    8 / 180 (4.44%)
    2 / 180 (1.11%)
    16 / 266 (6.02%)
    12 / 267 (4.49%)
    28 / 533 (5.25%)
         occurrences all number
    20
    9
    2
    24
    14
    38
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 180 (0.56%)
    4 / 180 (2.22%)
    2 / 266 (0.75%)
    4 / 267 (1.50%)
    6 / 533 (1.13%)
         occurrences all number
    1
    2
    13
    3
    10
    13
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    9 / 181 (4.97%)
    5 / 180 (2.78%)
    3 / 180 (1.67%)
    11 / 266 (4.14%)
    7 / 267 (2.62%)
    18 / 533 (3.38%)
         occurrences all number
    9
    5
    3
    11
    7
    18
    Cough
         subjects affected / exposed
    4 / 181 (2.21%)
    8 / 180 (4.44%)
    1 / 180 (0.56%)
    7 / 266 (2.63%)
    10 / 267 (3.75%)
    17 / 533 (3.19%)
         occurrences all number
    4
    10
    1
    7
    13
    20
    Rhinorrhoea
         subjects affected / exposed
    8 / 181 (4.42%)
    2 / 180 (1.11%)
    2 / 180 (1.11%)
    9 / 266 (3.38%)
    4 / 267 (1.50%)
    13 / 533 (2.44%)
         occurrences all number
    9
    2
    2
    10
    4
    14
    Psychiatric disorders
    Depression
         subjects affected / exposed
    4 / 181 (2.21%)
    2 / 180 (1.11%)
    2 / 180 (1.11%)
    6 / 266 (2.26%)
    3 / 267 (1.12%)
    9 / 533 (1.69%)
         occurrences all number
    4
    2
    2
    6
    3
    9
    Investigations
    Amylase increased
         subjects affected / exposed
    3 / 181 (1.66%)
    4 / 180 (2.22%)
    0 / 180 (0.00%)
    3 / 266 (1.13%)
    5 / 267 (1.87%)
    8 / 533 (1.50%)
         occurrences all number
    3
    4
    0
    3
    5
    8
    SARS-CoV-2 test negative
         subjects affected / exposed
    6 / 181 (3.31%)
    5 / 180 (2.78%)
    2 / 180 (1.11%)
    8 / 266 (3.01%)
    7 / 267 (2.62%)
    15 / 533 (2.81%)
         occurrences all number
    6
    6
    3
    8
    10
    18
    Lipase increased
         subjects affected / exposed
    8 / 181 (4.42%)
    7 / 180 (3.89%)
    2 / 180 (1.11%)
    8 / 266 (3.01%)
    9 / 267 (3.37%)
    17 / 533 (3.19%)
         occurrences all number
    8
    7
    2
    8
    9
    17
    SARS-CoV-2 test positive
         subjects affected / exposed
    2 / 181 (1.10%)
    4 / 180 (2.22%)
    0 / 180 (0.00%)
    4 / 266 (1.50%)
    5 / 267 (1.87%)
    9 / 533 (1.69%)
         occurrences all number
    2
    4
    0
    4
    5
    9
    Weight increased
         subjects affected / exposed
    2 / 181 (1.10%)
    5 / 180 (2.78%)
    2 / 180 (1.11%)
    3 / 266 (1.13%)
    5 / 267 (1.87%)
    8 / 533 (1.50%)
         occurrences all number
    2
    5
    2
    3
    5
    8
    White blood cell count increased
         subjects affected / exposed
    1 / 181 (0.55%)
    2 / 180 (1.11%)
    4 / 180 (2.22%)
    3 / 266 (1.13%)
    2 / 267 (0.75%)
    5 / 533 (0.94%)
         occurrences all number
    1
    2
    6
    3
    2
    5
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    6 / 181 (3.31%)
    4 / 180 (2.22%)
    0 / 180 (0.00%)
    8 / 266 (3.01%)
    4 / 267 (1.50%)
    12 / 533 (2.25%)
         occurrences all number
    6
    4
    0
    8
    4
    12
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 181 (3.31%)
    3 / 180 (1.67%)
    3 / 180 (1.67%)
    7 / 266 (2.63%)
    5 / 267 (1.87%)
    12 / 533 (2.25%)
         occurrences all number
    6
    4
    4
    7
    6
    13
    Headache
         subjects affected / exposed
    33 / 181 (18.23%)
    32 / 180 (17.78%)
    14 / 180 (7.78%)
    39 / 266 (14.66%)
    46 / 267 (17.23%)
    85 / 533 (15.95%)
         occurrences all number
    75
    83
    19
    85
    122
    207
    Migraine
         subjects affected / exposed
    5 / 181 (2.76%)
    1 / 180 (0.56%)
    0 / 180 (0.00%)
    5 / 266 (1.88%)
    3 / 267 (1.12%)
    8 / 533 (1.50%)
         occurrences all number
    6
    1
    0
    6
    3
    9
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    4 / 181 (2.21%)
    5 / 180 (2.78%)
    1 / 180 (0.56%)
    4 / 266 (1.50%)
    9 / 267 (3.37%)
    13 / 533 (2.44%)
         occurrences all number
    4
    6
    1
    4
    10
    14
    Abdominal pain
         subjects affected / exposed
    7 / 181 (3.87%)
    6 / 180 (3.33%)
    1 / 180 (0.56%)
    8 / 266 (3.01%)
    10 / 267 (3.75%)
    18 / 533 (3.38%)
         occurrences all number
    7
    8
    1
    8
    12
    20
    Nausea
         subjects affected / exposed
    4 / 181 (2.21%)
    8 / 180 (4.44%)
    7 / 180 (3.89%)
    6 / 266 (2.26%)
    13 / 267 (4.87%)
    19 / 533 (3.56%)
         occurrences all number
    10
    10
    7
    13
    16
    29
    Diarrhoea
         subjects affected / exposed
    11 / 181 (6.08%)
    16 / 180 (8.89%)
    9 / 180 (5.00%)
    12 / 266 (4.51%)
    24 / 267 (8.99%)
    36 / 533 (6.75%)
         occurrences all number
    14
    24
    9
    15
    32
    47
    Constipation
         subjects affected / exposed
    1 / 181 (0.55%)
    5 / 180 (2.78%)
    0 / 180 (0.00%)
    1 / 266 (0.38%)
    5 / 267 (1.87%)
    6 / 533 (1.13%)
         occurrences all number
    1
    6
    0
    1
    6
    7
    Toothache
         subjects affected / exposed
    7 / 181 (3.87%)
    6 / 180 (3.33%)
    4 / 180 (2.22%)
    9 / 266 (3.38%)
    7 / 267 (2.62%)
    16 / 533 (3.00%)
         occurrences all number
    7
    13
    4
    9
    14
    23
    Vomiting
         subjects affected / exposed
    5 / 181 (2.76%)
    7 / 180 (3.89%)
    0 / 180 (0.00%)
    6 / 266 (2.26%)
    9 / 267 (3.37%)
    15 / 533 (2.81%)
         occurrences all number
    5
    10
    0
    6
    13
    19
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    4 / 181 (2.21%)
    2 / 180 (1.11%)
    2 / 180 (1.11%)
    4 / 266 (1.50%)
    3 / 267 (1.12%)
    7 / 533 (1.31%)
         occurrences all number
    4
    2
    2
    4
    3
    7
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    4 / 181 (2.21%)
    5 / 180 (2.78%)
    2 / 180 (1.11%)
    5 / 266 (1.88%)
    6 / 267 (2.25%)
    11 / 533 (2.06%)
         occurrences all number
    4
    5
    2
    5
    6
    11
    Dermatitis
         subjects affected / exposed
    3 / 181 (1.66%)
    4 / 180 (2.22%)
    1 / 180 (0.56%)
    4 / 266 (1.50%)
    5 / 267 (1.87%)
    9 / 533 (1.69%)
         occurrences all number
    6
    4
    1
    7
    5
    12
    Dermatitis contact
         subjects affected / exposed
    3 / 181 (1.66%)
    6 / 180 (3.33%)
    0 / 180 (0.00%)
    3 / 266 (1.13%)
    6 / 267 (2.25%)
    9 / 533 (1.69%)
         occurrences all number
    4
    6
    0
    4
    6
    10
    Eczema
         subjects affected / exposed
    8 / 181 (4.42%)
    6 / 180 (3.33%)
    1 / 180 (0.56%)
    9 / 266 (3.38%)
    9 / 267 (3.37%)
    18 / 533 (3.38%)
         occurrences all number
    11
    10
    1
    12
    13
    25
    Hidradenitis
         subjects affected / exposed
    16 / 181 (8.84%)
    17 / 180 (9.44%)
    23 / 180 (12.78%)
    28 / 266 (10.53%)
    26 / 267 (9.74%)
    54 / 533 (10.13%)
         occurrences all number
    18
    29
    26
    31
    43
    74
    Pruritus
         subjects affected / exposed
    11 / 181 (6.08%)
    6 / 180 (3.33%)
    2 / 180 (1.11%)
    15 / 266 (5.64%)
    8 / 267 (3.00%)
    23 / 533 (4.32%)
         occurrences all number
    12
    6
    2
    16
    8
    24
    Intertrigo
         subjects affected / exposed
    10 / 181 (5.52%)
    7 / 180 (3.89%)
    2 / 180 (1.11%)
    11 / 266 (4.14%)
    8 / 267 (3.00%)
    19 / 533 (3.56%)
         occurrences all number
    12
    7
    2
    13
    8
    21
    Psoriasis
         subjects affected / exposed
    6 / 181 (3.31%)
    5 / 180 (2.78%)
    1 / 180 (0.56%)
    6 / 266 (2.26%)
    5 / 267 (1.87%)
    11 / 533 (2.06%)
         occurrences all number
    10
    5
    2
    10
    5
    15
    Seborrhoeic dermatitis
         subjects affected / exposed
    4 / 181 (2.21%)
    5 / 180 (2.78%)
    2 / 180 (1.11%)
    6 / 266 (2.26%)
    6 / 267 (2.25%)
    12 / 533 (2.25%)
         occurrences all number
    4
    5
    2
    6
    6
    12
    Rash
         subjects affected / exposed
    4 / 181 (2.21%)
    4 / 180 (2.22%)
    1 / 180 (0.56%)
    6 / 266 (2.26%)
    5 / 267 (1.87%)
    11 / 533 (2.06%)
         occurrences all number
    4
    4
    1
    6
    5
    11
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    7 / 181 (3.87%)
    8 / 180 (4.44%)
    8 / 180 (4.44%)
    7 / 266 (2.63%)
    12 / 267 (4.49%)
    19 / 533 (3.56%)
         occurrences all number
    7
    24
    8
    7
    28
    35
    Arthralgia
         subjects affected / exposed
    11 / 181 (6.08%)
    6 / 180 (3.33%)
    8 / 180 (4.44%)
    14 / 266 (5.26%)
    9 / 267 (3.37%)
    23 / 533 (4.32%)
         occurrences all number
    12
    10
    8
    17
    13
    30
    Pain in extremity
         subjects affected / exposed
    3 / 181 (1.66%)
    4 / 180 (2.22%)
    5 / 180 (2.78%)
    5 / 266 (1.88%)
    5 / 267 (1.87%)
    10 / 533 (1.88%)
         occurrences all number
    3
    5
    5
    5
    7
    12
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    5 / 181 (2.76%)
    6 / 180 (3.33%)
    3 / 180 (1.67%)
    5 / 266 (1.88%)
    8 / 267 (3.00%)
    13 / 533 (2.44%)
         occurrences all number
    6
    6
    3
    6
    8
    14
    COVID-19
         subjects affected / exposed
    5 / 181 (2.76%)
    3 / 180 (1.67%)
    0 / 180 (0.00%)
    6 / 266 (2.26%)
    7 / 267 (2.62%)
    13 / 533 (2.44%)
         occurrences all number
    5
    3
    0
    6
    7
    13
    Cellulitis
         subjects affected / exposed
    4 / 181 (2.21%)
    3 / 180 (1.67%)
    4 / 180 (2.22%)
    6 / 266 (2.26%)
    6 / 267 (2.25%)
    12 / 533 (2.25%)
         occurrences all number
    4
    3
    4
    7
    6
    13
    Conjunctivitis
         subjects affected / exposed
    5 / 181 (2.76%)
    4 / 180 (2.22%)
    1 / 180 (0.56%)
    5 / 266 (1.88%)
    6 / 267 (2.25%)
    11 / 533 (2.06%)
         occurrences all number
    5
    4
    1
    5
    6
    11
    Ear infection
         subjects affected / exposed
    3 / 181 (1.66%)
    4 / 180 (2.22%)
    0 / 180 (0.00%)
    3 / 266 (1.13%)
    4 / 267 (1.50%)
    7 / 533 (1.31%)
         occurrences all number
    3
    6
    0
    3
    6
    9
    Folliculitis
         subjects affected / exposed
    4 / 181 (2.21%)
    4 / 180 (2.22%)
    2 / 180 (1.11%)
    6 / 266 (2.26%)
    4 / 267 (1.50%)
    10 / 533 (1.88%)
         occurrences all number
    4
    4
    2
    7
    4
    11
    Fungal skin infection
         subjects affected / exposed
    4 / 181 (2.21%)
    0 / 180 (0.00%)
    0 / 180 (0.00%)
    4 / 266 (1.50%)
    0 / 267 (0.00%)
    4 / 533 (0.75%)
         occurrences all number
    5
    0
    0
    5
    0
    5
    Gastroenteritis
         subjects affected / exposed
    8 / 181 (4.42%)
    4 / 180 (2.22%)
    1 / 180 (0.56%)
    8 / 266 (3.01%)
    4 / 267 (1.50%)
    12 / 533 (2.25%)
         occurrences all number
    9
    4
    1
    9
    4
    13
    Influenza
         subjects affected / exposed
    1 / 181 (0.55%)
    6 / 180 (3.33%)
    4 / 180 (2.22%)
    1 / 266 (0.38%)
    6 / 267 (2.25%)
    7 / 533 (1.31%)
         occurrences all number
    1
    6
    5
    1
    6
    7
    Nasopharyngitis
         subjects affected / exposed
    32 / 181 (17.68%)
    24 / 180 (13.33%)
    13 / 180 (7.22%)
    40 / 266 (15.04%)
    29 / 267 (10.86%)
    69 / 533 (12.95%)
         occurrences all number
    44
    31
    13
    53
    37
    90
    Sinusitis
         subjects affected / exposed
    4 / 181 (2.21%)
    2 / 180 (1.11%)
    2 / 180 (1.11%)
    7 / 266 (2.63%)
    2 / 267 (0.75%)
    9 / 533 (1.69%)
         occurrences all number
    4
    3
    2
    8
    3
    11
    Pharyngitis
         subjects affected / exposed
    7 / 181 (3.87%)
    5 / 180 (2.78%)
    1 / 180 (0.56%)
    8 / 266 (3.01%)
    7 / 267 (2.62%)
    15 / 533 (2.81%)
         occurrences all number
    8
    5
    1
    9
    7
    16
    Suspected COVID-19
         subjects affected / exposed
    5 / 181 (2.76%)
    3 / 180 (1.67%)
    0 / 180 (0.00%)
    6 / 266 (2.26%)
    7 / 267 (2.62%)
    13 / 533 (2.44%)
         occurrences all number
    5
    3
    0
    6
    9
    15
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 181 (4.97%)
    13 / 180 (7.22%)
    4 / 180 (2.22%)
    12 / 266 (4.51%)
    17 / 267 (6.37%)
    29 / 533 (5.44%)
         occurrences all number
    12
    14
    4
    18
    18
    36
    Tonsillitis
         subjects affected / exposed
    6 / 181 (3.31%)
    2 / 180 (1.11%)
    1 / 180 (0.56%)
    7 / 266 (2.63%)
    4 / 267 (1.50%)
    11 / 533 (2.06%)
         occurrences all number
    9
    2
    1
    10
    5
    15
    Urinary tract infection
         subjects affected / exposed
    9 / 181 (4.97%)
    8 / 180 (4.44%)
    3 / 180 (1.67%)
    10 / 266 (3.76%)
    10 / 267 (3.75%)
    20 / 533 (3.75%)
         occurrences all number
    15
    8
    3
    16
    11
    27
    Vulvovaginal candidiasis
         subjects affected / exposed
    4 / 181 (2.21%)
    2 / 180 (1.11%)
    0 / 180 (0.00%)
    4 / 266 (1.50%)
    3 / 267 (1.12%)
    7 / 533 (1.31%)
         occurrences all number
    4
    2
    0
    4
    3
    7
    Vulvovaginal mycotic infection
         subjects affected / exposed
    6 / 181 (3.31%)
    2 / 180 (1.11%)
    1 / 180 (0.56%)
    7 / 266 (2.63%)
    4 / 267 (1.50%)
    11 / 533 (2.06%)
         occurrences all number
    8
    3
    1
    11
    5
    16
    Metabolism and nutrition disorders
    Hyperuricaemia
         subjects affected / exposed
    4 / 181 (2.21%)
    3 / 180 (1.67%)
    0 / 180 (0.00%)
    4 / 266 (1.50%)
    3 / 267 (1.12%)
    7 / 533 (1.31%)
         occurrences all number
    5
    4
    0
    5
    4
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jun 2020
    The rationale for the amendment reflects the guidance released from several Health Authorities (FDA, EMA, MHRA) to introduce a level of flexibility in drug dispensation, protocol assessments and visit schedule if a major health care event requires it (i.e., COVID-19 pandemic). While adherence to protocol procedure and GCPs remains mandatory, Novartis has edited the wording in some sections of the protocol to allow the subjects in the trial to continue treatment while being monitored for safety in these situations. These changes were introduced to reduce the risk of exposure for subjects and study staff, and potentially the risk for transmission of infectious diseases (e.g., COVID-19). In addition, a ‘special scenario’ was added to the study design to ensure a careful, on site assessment of lesions at Week 52, by allowing for the possibility to perform up to 3 unscheduled visits in case lockdowns or mobility restriction would impede the subject or the site to perform the visit on site. In case of a global health crisis impeding the subjects (or the sites) to attend (or perform) Week 52 study visit on site, the subjects in the study were allowed to receive additional study treatment up to 12 weeks after Week 50, or until they could return to the study site to perform the Week 52 assessment (whichever occurs first). This additional, optional phase permitted the subjects to be assessed for eligibility to roll over to the 4-year long-term extension study. During this period, the subjects were continuously monitored for safety. Lastly, the Amendment 01 allowed for an increase in the number of randomized subjects up to 15% to account for the disruptive impact of the COVID-19 pandemic.
    08 Jan 2021
    The purpose of this amendment was to update the statistical analysis section including adjusting the split of the overall alpha level allocating 80 to testing the high dose secukinumab regimen (300 mg Q2W) versus placebo, based on the recent findings from Study CAIN457A2324 demonstrating an improved benefit of secukinumab 300 mg Q2W when used in subjects with psoriasis over 90 kg. These data were not available at the time of the initial production of the protocol. In addition, following the FDA feedback this amendment introduced the value of the individual lesion count assessed at the baseline visit only to be used as ‘baseline’ in the statistical analyses, instead of the weighted average across the two screening visits and the baseline (randomization) visit. Moreover, a secondary endpoint evaluating only the abscesses and inflammatory nodules (AN) count was added. Analyzing AN count on the original, continuous scale, enabled a more sensitive and granular approach to summarizing the clinical effect of treatment (Revuz 2009, Kimball et al 2018). Lastly, the exploratory objective section has been updated to include a specific analysis to evaluate the benefit of secukinumab in the bio-naive population and in the subjects with body weight above and below 90 kg, and to explore treatment effect with regard to inflammatory markers (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)).

    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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