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    Clinical Trial Results:
    A multicenter, randomized, double-blind, placebo-controlled, 52-weeks study to demonstrate the efficacy, safety and tolerability of subcutaneous secukinumab injections with 2 mL pre-filled syringes (300 mg) in adult subjects with moderate to severe plaque psoriasis – ALLURE

    Summary
    EudraCT number
    		 2015-005170-38
    Trial protocol
    		 GB   LV   BE   ES   IS  
    Global end of trial date
    08 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jun 2019
    First version publication date
    23 Jun 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457A2323
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02748863
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to demonstrate the efficacy of secukinumab 300 mg when administered as 2 mL pre-filled syringes (PFSs) in patients with plaque-type psoriasis with respect to both PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoint) at Week 12, compared to placebo.
    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
    12 Dec 2016
    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
    Germany: 26
    Country: Number of subjects enrolled
    Spain: 27
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Iceland: 22
    Country: Number of subjects enrolled
    Canada: 15
    Country: Number of subjects enrolled
    Latvia: 27
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    Russian Federation: 24
    Country: Number of subjects enrolled
    United States: 45
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Turkey: 4
    Worldwide total number of subjects
    214
    EEA total number of subjects
    126
    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)
    200
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 251 patients were screened and 214 patients were randomized

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab 2 mL PFS
    Arm description
    		 Secukinumab 300 mg in one 2 mL pre-filled syringe
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2ML PFS

    Arm title
    		 Secukinumab 2 x 1 mL PFS
    Arm description
    		 Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 x 1 mL PFS

    Arm title
    		 Placebo
    Arm description
    		 Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2ML PFS

    Number of subjects in period 1
    		Secukinumab 2 mL PFS Secukinumab 2 x 1 mL PFS Placebo
    Started
    72
    71
    71
    Completed
    72
    69
    68
    Not completed
    0
    2
    3
         Consent withdrawn by subject
    -
    1
    2
         Adverse event, non-fatal
    -
    1
    -
         Lack of efficacy
    -
    -
    1
    Period 2
    Period 2 title
    Treatment Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Secukinumab 2 mL PFS
    Arm description
    		 Secukinumab 300 mg in one 2 mL pre-filled syringe
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    300 mg in one 2 mL pre-filled syringe

    Arm title
    		 Secukinumab 2 x 1 mL PFS
    Arm description
    		 Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)
    Arm type
    		 Experimental

    Investigational medicinal product name
    secuk
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intrauterine use
    Dosage and administration details
    Two 300 mg 1 mL pre-filled syringes

    Arm title
    		 Placebo
    Arm description
    		 Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placeo
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 ml PFS

    Arm title
    		 Secukinumab 2 mL PFS following placebo
    Arm description
    		 Switched from placebo to secukinumab 300 mg, provided in one 2 mL pre-filled syringe
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    300 mg in one 2 mL pre-filled syringe

    Arm title
    		 Secukinumab 2 x 1 mL PFS following placebo
    Arm description
    		 Switched from placebo to secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    secuk
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intrauterine use
    Dosage and administration details
    Two 300 mg 1 mL pre-filled syringes

    Number of subjects in period 2
    		Secukinumab 2 mL PFS Secukinumab 2 x 1 mL PFS Placebo Secukinumab 2 mL PFS following placebo Secukinumab 2 x 1 mL PFS following placebo
    Started
    72
    69
    71
    34
    34
    Completed
    67
    66
    68
    32
    33
    Not completed
    5
    3
    3
    2
    1
         Consent withdrawn by subject
    -
    -
    2
    -
    -
         Adverse event, non-fatal
    3
    2
    -
    -
    -
         Pregnancy
    -
    -
    -
    -
    1
         Lost to follow-up
    2
    -
    -
    2
    -
         Lack of efficacy
    -
    1
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab 2 mL PFS
    Reporting group description
    		 Secukinumab 300 mg in one 2 mL pre-filled syringe

    Reporting group title
    Secukinumab 2 x 1 mL PFS
    Reporting group description
    		 Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe

    Reporting group values
    		 Secukinumab 2 mL PFS Secukinumab 2 x 1 mL PFS Placebo Total
    Number of subjects
    		 72 71 71 214
    Age, Customized
    Units: Subjects
        >65 years
    		 68 64 68 200
        >=65 years
    		 4 7 3 14
        >=75 years
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.0 ( 13.87 ) 46.2 ( 13.90 ) 41.4 ( 12.88 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 28 28 25 81
        Male
    		 44 43 46 133
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 64 66 64 194
        Black
    		 2 1 1 4
        Asian
    		 4 4 4 12
        Pacific Islander
    		 0 0 1 1
        Other
    		 2 0 1 3

    End points

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    End points reporting groups
    Reporting group title
    Secukinumab 2 mL PFS
    Reporting group description
    		 Secukinumab 300 mg in one 2 mL pre-filled syringe

    Reporting group title
    Secukinumab 2 x 1 mL PFS
    Reporting group description
    		 Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe
    Reporting group title
    Secukinumab 2 mL PFS
    Reporting group description
    		 Secukinumab 300 mg in one 2 mL pre-filled syringe

    Reporting group title
    Secukinumab 2 x 1 mL PFS
    Reporting group description
    		 Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe

    Reporting group title
    Secukinumab 2 mL PFS following placebo
    Reporting group description
    		 Switched from placebo to secukinumab 300 mg, provided in one 2 mL pre-filled syringe

    Reporting group title
    Secukinumab 2 x 1 mL PFS following placebo
    Reporting group description
    		 Switched from placebo to secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg

    Primary: Participants with Psoriasis Area and Severity Index (PASI) 75 response after 12 weeks of treatment

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    End point title
    		 Participants with Psoriasis Area and Severity Index (PASI) 75 response after 12 weeks of treatment
    End point description
    Number of participants who achieved ≥ 75% reduction in PASI compared to baseline PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Secukinumab 2 mL PFS Secukinumab 2 x 1 mL PFS Placebo
    Number of subjects analysed
    72
    71
    71
    Units: participants
    64
    58
    1
    Statistical analysis title
    		 Severity (PASI)
    Comparison groups
    Secukinumab 2 mL PFS v Placebo
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    717.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 68
         upper limit
    		 7569.56
    Statistical analysis title
    		 PASI 75
    Comparison groups
    Secukinumab 2 x 1 mL PFS v Placebo
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    419.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 40.87
         upper limit
    		 4302.75

    Primary: Participants with IGA mod 2011 0 or 1 after 12 weeks of treatment

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    End point title
    		 Participants with IGA mod 2011 0 or 1 after 12 weeks of treatment
    End point description
    The Investigator’s Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. Number of participants who achieved IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Secukinumab 2 mL PFS Secukinumab 2 x 1 mL PFS Placebo
    Number of subjects analysed
    72
    71
    71
    Units: participants
    55
    49
    1
    Statistical analysis title
    		 IGA
    Comparison groups
    Secukinumab 2 mL PFS v Placebo
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    400.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 47.48
         upper limit
    		 3379.99

    Secondary: Participants with PASI 90 after 12 weeks of treatment

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    End point title
    		 Participants with PASI 90 after 12 weeks of treatment
    End point description
    Number of participants who achieved ≥ 90% and 100% reduction in PASI compared to baseline
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Secukinumab 2 mL PFS Secukinumab 2 x 1 mL PFS Placebo
    Number of subjects analysed
    72
    71
    71
    Units: participants
    48
    50
    1
    Statistical analysis title
    		 PASI
    Comparison groups
    Secukinumab 2 mL PFS v Placebo
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    168.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.2
         upper limit
    		 1337.22

    Secondary: PASI 100 response after 12 weeks of treatment

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    End point title
    		 PASI 100 response after 12 weeks of treatment
    End point description
    Participants who achieved 100% reduction in PASI compared to baseline
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Secukinumab 2 mL PFS Secukinumab 2 x 1 mL PFS Placebo
    Number of subjects analysed
    72
    71
    71
    Units: participants
    28
    26
    0
    Statistical analysis title
    		 PASI 100
    Comparison groups
    Secukinumab 2 mL PFS v Placebo
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Risk difference (RD)
    Point estimate
    38.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27.41
         upper limit
    		 50.09
    Statistical analysis title
    		 PASI
    Comparison groups
    Secukinumab 2 x 1 mL PFS v Placebo
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Risk difference (RD)
    Point estimate
    36.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25.19
         upper limit
    		 47.76

    Secondary: Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response

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    End point title
    		 Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
    End point description
    PASI response over time up to week 52: Number of participants who achieved ≥ 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline
    End point type
    Secondary
    End point timeframe
    up to week 52
    End point values
    		 Secukinumab 2 mL PFS Secukinumab 2 x 1 mL PFS Placebo Secukinumab 2 mL PFS following placebo Secukinumab 2 x 1 mL PFS following placebo
    Number of subjects analysed
    72
    71
    71
    34
    34
    Units: participants
        Week 1 IGA 0/1
    1
    0
    0
    0
    0
        Week 1 PASI 50
    5
    5
    1
    0
    1
        Week 1 PASI 75
    0
    2
    0
    0
    0
        Week 1 PASI 90
    0
    0
    0
    0
    0
        Week 1 PASI 100
    0
    0
    0
    0
    0
        Week 2 IGA 0/1
    2
    1
    1
    0
    1
        Week 2 PASI 50
    18
    28
    1
    1
    0
        Week 2 PASI 75
    4
    5
    0
    0
    0
        Week 2 PASI 90
    0
    1
    0
    0
    0
        Week 2 PASI 100
    0
    1
    0
    0
    0
        Week 3 IGA 0/1
    6
    11
    1
    0
    1
        Week 3 PASI 50
    39
    40
    5
    3
    1
        Week 3 PASI 75
    14
    17
    0
    0
    0
        Week 3 PASI 90
    4
    4
    0
    0
    0
        Week 3 PASI 100
    0
    1
    0
    0
    0
        Week 4 IGA 0/1
    19
    23
    0
    0
    0
        Week 4 PASI 50
    53
    52
    6
    5
    1
        Week 4 PASI 75
    29
    32
    1
    1
    0
        Week 4 PASI 90
    10
    13
    0
    0
    0
        Week 4 PASI 100
    3
    3
    0
    0
    0
        Week 8 IGA 0/1
    43
    41
    0
    0
    0
        Week 8 PASI 50
    66
    60
    5
    3
    2
        Week 8 PASI 75
    53
    51
    0
    0
    0
        Week 8 PASI 90
    35
    31
    0
    0
    0
        Week 8 PASI 100
    8
    11
    0
    0
    0
        Week 12 IGA 0/1
    55
    49
    1
    0
    0
        Week 12 PASI 50
    67
    61
    5
    2
    2
        Week 12 PASI 75
    64
    58
    1
    0
    0
        Week 12 PASI 90
    48
    50
    1
    0
    0
        Week 12 PASI 100
    28
    26
    0
    0
    0
        Week 16 IGA 0/1
    57
    52
    0
    14
    5
        Week 16 PASI 50
    69
    61
    0
    27
    20
        Week 16 PASI 75
    65
    60
    0
    17
    13
        Week 16 PASI 90
    56
    55
    0
    8
    4
        Week 16 PASI 100
    37
    31
    0
    5
    1
        Week 28 IGA 0/1
    64
    54
    0
    30
    25
        Week 28 PASI 50
    71
    66
    0
    33
    30
        Week 28 PASI 75
    69
    60
    0
    32
    28
        Week 28 PASI 90
    62
    56
    0
    26
    21
        Week 28 PASI 100
    44
    34
    0
    16
    12
        Week 40 IGA 0/1
    60
    55
    0
    28
    25
        Week 40 PASI 50
    69
    67
    0
    33
    33
        Week 40 PASI 75
    66
    63
    0
    31
    31
        Week 40 PASI 90
    58
    57
    0
    27
    24
        Week 40 PASI 100
    40
    37
    0
    20
    17
        Week 52 IGA 0/1
    55
    55
    0
    28
    26
        Week 52 PASI 50
    67
    67
    0
    31
    32
        Week 52 PASI 75
    63
    62
    0
    30
    31
        Week 52 PASI 90
    54
    58
    0
    25
    26
        Week 52 PASI 100
    40
    37
    0
    20
    16
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs and SAEs were collected for maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks
    Adverse event reporting additional description
    All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    AIN457 300 mg (2mL PFS)
    Reporting group description
    		 Treatment period 1 secukinumab 300 mg (2mL PFS)

    Reporting group title
    AIN457 300 mg (2x1mL PFS)
    Reporting group description
    		 Treatment period 1 secukinumab 300 mg (2x1mL PFS)

    Reporting group title
    Placebo
    Reporting group description
    		 Treatment period 1 Placebo

    Reporting group title
    Any AIN457 300 mg (2mL PFS)
    Reporting group description
    		 Any secukinumab 300 mg (2mL PFS)

    Reporting group title
    Any AIN457 300 mg (2x1mL PFS)
    Reporting group description
    		 Any secukinumab 300 mg (2x1mL PFS)

    Reporting group title
    Any AIN457 300 mg
    Reporting group description
    		 Any secukinumab 300 mg

    Serious adverse events
    		 AIN457 300 mg (2mL PFS) AIN457 300 mg (2x1mL PFS) Placebo Any AIN457 300 mg (2mL PFS) Any AIN457 300 mg (2x1mL PFS) Any AIN457 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    2 / 71 (2.82%)
    8 / 106 (7.55%)
    5 / 105 (4.76%)
    13 / 211 (6.16%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Fibula fracture
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 71 (1.41%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 211 (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
    Rib fracture
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    1 / 211 (0.47%)
         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
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    1 / 211 (0.47%)
         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
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    1 / 211 (0.47%)
         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
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 71 (0.00%)
    1 / 106 (0.94%)
    1 / 105 (0.95%)
    2 / 211 (0.95%)
         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
    Crohn's disease
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    1 / 211 (0.47%)
         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
    Diarrhoea
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    1 / 211 (0.47%)
         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
    Gastritis
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    1 / 211 (0.47%)
         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
    Pancreatitis acute
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    1 / 211 (0.47%)
         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
    Vomiting
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    1 / 211 (0.47%)
         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
    Respiratory, thoracic and mediastinal disorders
    Haemothorax
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    1 / 211 (0.47%)
         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
    Hypoventilation
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    1 / 211 (0.47%)
         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
    Pleural effusion
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    1 / 211 (0.47%)
         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
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    1 / 211 (0.47%)
         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
    Depression
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    1 / 211 (0.47%)
         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
    Musculoskeletal and connective tissue disorders
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    1 / 211 (0.47%)
         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 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    1 / 211 (0.47%)
         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
    Diverticulitis
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis bacterial
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    1 / 211 (0.47%)
         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
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 71 (1.41%)
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 211 (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
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 AIN457 300 mg (2mL PFS) AIN457 300 mg (2x1mL PFS) Placebo Any AIN457 300 mg (2mL PFS) Any AIN457 300 mg (2x1mL PFS) Any AIN457 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 72 (45.83%)
    39 / 71 (54.93%)
    29 / 71 (40.85%)
    60 / 106 (56.60%)
    68 / 105 (64.76%)
    128 / 211 (60.66%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 72 (1.39%)
    1 / 71 (1.41%)
    2 / 71 (2.82%)
    2 / 106 (1.89%)
    2 / 105 (1.90%)
    4 / 211 (1.90%)
         occurrences all number
    1
    1
    2
    2
    2
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    2 / 71 (2.82%)
    1 / 106 (0.94%)
    1 / 105 (0.95%)
    2 / 211 (0.95%)
         occurrences all number
    0
    1
    2
    1
    1
    2
    Weight increased
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    3 / 106 (2.83%)
    0 / 105 (0.00%)
    3 / 211 (1.42%)
         occurrences all number
    2
    0
    0
    3
    0
    3
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    1 / 72 (1.39%)
    2 / 71 (2.82%)
    0 / 71 (0.00%)
    1 / 106 (0.94%)
    3 / 105 (2.86%)
    4 / 211 (1.90%)
         occurrences all number
    1
    2
    0
    1
    3
    4
    Limb injury
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    3 / 106 (2.83%)
    0 / 105 (0.00%)
    3 / 211 (1.42%)
         occurrences all number
    0
    0
    0
    3
    0
    3
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    3 / 71 (4.23%)
    3 / 106 (2.83%)
    5 / 105 (4.76%)
    8 / 211 (3.79%)
         occurrences all number
    0
    1
    3
    3
    5
    8
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 72 (8.33%)
    6 / 71 (8.45%)
    3 / 71 (4.23%)
    10 / 106 (9.43%)
    8 / 105 (7.62%)
    18 / 211 (8.53%)
         occurrences all number
    9
    7
    4
    25
    10
    35
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 71 (0.00%)
    1 / 71 (1.41%)
    6 / 106 (5.66%)
    3 / 105 (2.86%)
    9 / 211 (4.27%)
         occurrences all number
    2
    0
    2
    6
    4
    10
    Injection site bruising
         subjects affected / exposed
    2 / 72 (2.78%)
    1 / 71 (1.41%)
    1 / 71 (1.41%)
    2 / 106 (1.89%)
    2 / 105 (1.90%)
    4 / 211 (1.90%)
         occurrences all number
    2
    1
    1
    3
    2
    5
    Injection site erythema
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    1 / 71 (1.41%)
    3 / 106 (2.83%)
    0 / 105 (0.00%)
    3 / 211 (1.42%)
         occurrences all number
    0
    0
    1
    3
    0
    3
    Injection site pruritus
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    2 / 106 (1.89%)
    0 / 105 (0.00%)
    2 / 211 (0.95%)
         occurrences all number
    6
    0
    0
    6
    0
    6
    Injection site swelling
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 71 (2.82%)
    0 / 71 (0.00%)
    0 / 106 (0.00%)
    2 / 105 (1.90%)
    2 / 211 (0.95%)
         occurrences all number
    0
    2
    0
    0
    2
    2
    Pyrexia
         subjects affected / exposed
    2 / 72 (2.78%)
    1 / 71 (1.41%)
    0 / 71 (0.00%)
    2 / 106 (1.89%)
    2 / 105 (1.90%)
    4 / 211 (1.90%)
         occurrences all number
    2
    1
    0
    3
    2
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 72 (2.78%)
    3 / 71 (4.23%)
    0 / 71 (0.00%)
    6 / 106 (5.66%)
    6 / 105 (5.71%)
    12 / 211 (5.69%)
         occurrences all number
    2
    3
    0
    6
    6
    12
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 71 (2.82%)
    2 / 71 (2.82%)
    2 / 106 (1.89%)
    2 / 105 (1.90%)
    4 / 211 (1.90%)
         occurrences all number
    0
    2
    2
    2
    2
    4
    Nausea
         subjects affected / exposed
    2 / 72 (2.78%)
    2 / 71 (2.82%)
    1 / 71 (1.41%)
    3 / 106 (2.83%)
    3 / 105 (2.86%)
    6 / 211 (2.84%)
         occurrences all number
    2
    2
    1
    3
    4
    7
    Toothache
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 71 (0.00%)
    2 / 71 (2.82%)
    3 / 106 (2.83%)
    1 / 105 (0.95%)
    4 / 211 (1.90%)
         occurrences all number
    3
    0
    2
    4
    1
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 72 (1.39%)
    2 / 71 (2.82%)
    0 / 71 (0.00%)
    4 / 106 (3.77%)
    3 / 105 (2.86%)
    7 / 211 (3.32%)
         occurrences all number
    1
    2
    0
    4
    3
    7
    Oropharyngeal pain
         subjects affected / exposed
    3 / 72 (4.17%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    4 / 106 (3.77%)
    1 / 105 (0.95%)
    5 / 211 (2.37%)
         occurrences all number
    3
    0
    0
    5
    1
    6
    Rhinorrhoea
         subjects affected / exposed
    1 / 72 (1.39%)
    1 / 71 (1.41%)
    2 / 71 (2.82%)
    2 / 106 (1.89%)
    2 / 105 (1.90%)
    4 / 211 (1.90%)
         occurrences all number
    1
    1
    2
    3
    2
    5
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    5 / 72 (6.94%)
    3 / 71 (4.23%)
    3 / 71 (4.23%)
    10 / 106 (9.43%)
    4 / 105 (3.81%)
    14 / 211 (6.64%)
         occurrences all number
    6
    3
    4
    13
    4
    17
    Psoriasis
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 71 (2.82%)
    0 / 71 (0.00%)
    0 / 106 (0.00%)
    3 / 105 (2.86%)
    3 / 211 (1.42%)
         occurrences all number
    0
    2
    0
    0
    4
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    1 / 71 (1.41%)
    3 / 106 (2.83%)
    3 / 105 (2.86%)
    6 / 211 (2.84%)
         occurrences all number
    0
    1
    1
    4
    3
    7
    Back pain
         subjects affected / exposed
    4 / 72 (5.56%)
    3 / 71 (4.23%)
    2 / 71 (2.82%)
    6 / 106 (5.66%)
    4 / 105 (3.81%)
    10 / 211 (4.74%)
         occurrences all number
    5
    3
    2
    8
    4
    12
    Myalgia
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    3 / 106 (2.83%)
    1 / 105 (0.95%)
    4 / 211 (1.90%)
         occurrences all number
    2
    0
    0
    3
    2
    5
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 71 (2.82%)
    0 / 71 (0.00%)
    1 / 106 (0.94%)
    2 / 105 (1.90%)
    3 / 211 (1.42%)
         occurrences all number
    0
    2
    0
    1
    3
    4
    Conjunctivitis
         subjects affected / exposed
    1 / 72 (1.39%)
    1 / 71 (1.41%)
    0 / 71 (0.00%)
    3 / 106 (2.83%)
    2 / 105 (1.90%)
    5 / 211 (2.37%)
         occurrences all number
    1
    1
    0
    4
    2
    6
    Folliculitis
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    2 / 106 (1.89%)
    4 / 105 (3.81%)
    6 / 211 (2.84%)
         occurrences all number
    1
    0
    0
    2
    4
    6
    Hordeolum
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 71 (0.00%)
    0 / 106 (0.00%)
    3 / 105 (2.86%)
    3 / 211 (1.42%)
         occurrences all number
    0
    1
    0
    0
    3
    3
    Influenza
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 71 (1.41%)
    0 / 71 (0.00%)
    2 / 106 (1.89%)
    8 / 105 (7.62%)
    10 / 211 (4.74%)
         occurrences all number
    0
    1
    0
    2
    8
    10
    Nasopharyngitis
         subjects affected / exposed
    7 / 72 (9.72%)
    8 / 71 (11.27%)
    8 / 71 (11.27%)
    13 / 106 (12.26%)
    17 / 105 (16.19%)
    30 / 211 (14.22%)
         occurrences all number
    8
    8
    8
    17
    19
    36
    Oral herpes
         subjects affected / exposed
    3 / 72 (4.17%)
    0 / 71 (0.00%)
    2 / 71 (2.82%)
    3 / 106 (2.83%)
    3 / 105 (2.86%)
    6 / 211 (2.84%)
         occurrences all number
    3
    0
    2
    4
    3
    7
    Pharyngitis
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 71 (0.00%)
    2 / 71 (2.82%)
    5 / 106 (4.72%)
    1 / 105 (0.95%)
    6 / 211 (2.84%)
         occurrences all number
    0
    0
    2
    5
    1
    6
    Respiratory tract infection viral
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 71 (0.00%)
    1 / 71 (1.41%)
    2 / 106 (1.89%)
    5 / 105 (4.76%)
    7 / 211 (3.32%)
         occurrences all number
    2
    0
    1
    6
    6
    12
    Rhinitis
         subjects affected / exposed
    1 / 72 (1.39%)
    1 / 71 (1.41%)
    1 / 71 (1.41%)
    4 / 106 (3.77%)
    5 / 105 (4.76%)
    9 / 211 (4.27%)
         occurrences all number
    1
    1
    1
    5
    5
    10
    Sinusitis
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 71 (2.82%)
    0 / 71 (0.00%)
    1 / 106 (0.94%)
    2 / 105 (1.90%)
    3 / 211 (1.42%)
         occurrences all number
    0
    2
    0
    1
    2
    3
    Tonsillitis
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 71 (2.82%)
    0 / 71 (0.00%)
    2 / 106 (1.89%)
    2 / 105 (1.90%)
    4 / 211 (1.90%)
         occurrences all number
    0
    2
    0
    2
    2
    4
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 72 (1.39%)
    1 / 71 (1.41%)
    2 / 71 (2.82%)
    5 / 106 (4.72%)
    5 / 105 (4.76%)
    10 / 211 (4.74%)
         occurrences all number
    1
    1
    2
    6
    8
    14
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 71 (2.82%)
    0 / 71 (0.00%)
    0 / 106 (0.00%)
    2 / 105 (1.90%)
    2 / 211 (0.95%)
         occurrences all number
    0
    2
    0
    0
    2
    2
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 71 (2.82%)
    0 / 71 (0.00%)
    0 / 106 (0.00%)
    2 / 105 (1.90%)
    2 / 211 (0.95%)
         occurrences all number
    0
    2
    0
    0
    2
    2

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    "Other pre-specified outcomes" such as assessment of the subject usability and assessment of Dermatology Life Quality Index (DLQI) scores are exploratory in nature and are not reported in these results
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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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