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    Clinical Trial Results:
    A randomized, open-label, multicenter trial to assess the efficacy of subcutaneous secukinumab after twelve weeks of treatment, and to assess the long-term safety, tolerability and efficacy in subjects from 6 to less than 18 years of age with moderate to severe chronic plaque psoriasis

    Summary
    EudraCT number
    		 2017-004515-39
    Trial protocol
    		 BE   ES   DE   CZ   EE   PL  
    Global end of trial date
    12 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Mar 2024
    First version publication date
    16 Mar 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457A2311
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03668613
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharmaceuticals, 41 613241111, Novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000380-PIP01-08
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Sep 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of secukinumab in pediatric subjects aged 6 years to less than 18 years old with moderate to severe chronic plaque psoriasis with respect to PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoints) at Week 12, compared to placebo (historical control).
    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
    29 Aug 2018
    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
    Czechia: 5
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Estonia: 7
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Peru: 5
    Country: Number of subjects enrolled
    Poland: 17
    Country: Number of subjects enrolled
    Russian Federation: 14
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    United States: 11
    Worldwide total number of subjects
    84
    EEA total number of subjects
    54
    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)
    33
    Adolescents (12-17 years)
    51
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 92 subjects were screened of which 84 subjects completed the screening phase and were randomized to the Secukinumab Low dose and High dose groups in a 1:1 ratio.

    Pre-assignment
    Screening details
    		 A total of 92 subjects were screened of which 84 subjects completed the screening phase and were randomized to the Secukinumab Low dose and High dose groups in a 1:1 ratio.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AIN457 Low dose
    Arm description
    		 Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing < 50kg) or 150 mg (if weighing >= 50kg)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Cosentyx
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing < 50kg) or 150 mg (if weighing >= 50kg)

    Arm title
    		 AIN457 High dose
    Arm description
    		 Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing < 25kg) or 150mg (if weighing 25 to < 50kg) or 300 mg (if weighing >=50 kg)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Cosentyx
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing < 25kg) or 150mg (if weighing 25 to < 50kg) or 300 mg (if weighing >=50 kg)

    Number of subjects in period 1
    		AIN457 Low dose AIN457 High dose
    Started
    42
    42
    Completed
    31
    36
    Not completed
    11
    6
         Physician decision
    1
    -
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    1
    2
         Pregnancy
    -
    2
         Lack of efficacy
    5
    1
         Protocol deviation
    1
    -
         Guardian decision
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AIN457 Low dose
    Reporting group description
    		 Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing < 50kg) or 150 mg (if weighing >= 50kg)

    Reporting group title
    AIN457 High dose
    Reporting group description
    		 Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing < 25kg) or 150mg (if weighing 25 to < 50kg) or 300 mg (if weighing >=50 kg)

    Reporting group values
    		 AIN457 Low dose AIN457 High dose Total
    Number of subjects
    		 42 42 84
    Age Categorical
    Units: Participants
        6 to <12 years
    		 17 16 33
        12 to <18 years
    		 25 26 51
    Sex: Female, Male
    Units: Participants
        Female
    		 20 25 45
        Male
    		 22 17 39
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 39 38 77
        Black or African American
    		 1 0 1
        Asian
    		 1 0 1
        American Indian or Alaska Native
    		 1 4 5

    End points

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    End points reporting groups
    Reporting group title
    AIN457 Low dose
    Reporting group description
    		 Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing < 50kg) or 150 mg (if weighing >= 50kg)

    Reporting group title
    AIN457 High dose
    Reporting group description
    		 Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing < 25kg) or 150mg (if weighing 25 to < 50kg) or 300 mg (if weighing >=50 kg)

    Primary: Number and Percentage of Participants with PASI 75 response

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    End point title
    		 Number and Percentage of Participants with PASI 75 response
    End point description
    Psoriasis Area and Severity Index (PASI):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, trunk, upper limbs and lower limbs); 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,Thickening (plaque elevation, induration) & Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, upper limbs: 0.2 body: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 75 represents the percentage (or number)of patients who have achieved a 75% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 AIN457 Low dose AIN457 High dose
    Number of subjects analysed
    42
    42
    Units: Participants
    39
    39
    Statistical analysis title
    		 AIN457 Low dose v historical placebo
    Statistical analysis description
    Compared to historical placebo
    Comparison groups
    AIN457 Low dose v AIN457 High dose
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Bayesian method using (MAP)
    Parameter type
    		 Predicted Log-OR
    Point estimate
    4.862
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.422
         upper limit
    		 6.782
    Statistical analysis title
    		 AIN457 High dose v historical placebo
    Statistical analysis description
    Compared to historical placebo
    Comparison groups
    AIN457 High dose v AIN457 Low dose
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Bayesian method using (MAP)
    Parameter type
    		 Predicted log-OR
    Point estimate
    4.836
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.422
         upper limit
    		 6.772

    Primary: Number and percentage of participants with IGA mod 2011 0 or 1 response

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    End point title
    		 Number and percentage of participants with IGA mod 2011 0 or 1 response
    End point description
    Investigator will assess the disease using the validated Investigator Global Assessment (IGA) mod 2011 and rate the disease from a score of 0 (clear skin) to 4 (severe disease)
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 AIN457 Low dose AIN457 High dose
    Number of subjects analysed
    42
    42
    Units: Participants
    33
    35
    Statistical analysis title
    		 AIN457 High dose v historical placebo
    Statistical analysis description
    Compared to historical placebo
    Comparison groups
    AIN457 High dose v AIN457 Low dose
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Bayesian method using (MAP)
    Parameter type
    		 Predicted log-OR
    Point estimate
    4.606
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.919
         upper limit
    		 6.78
    Statistical analysis title
    		 AIN457 Low dose v historical placebo
    Statistical analysis description
    Compared to historical placebo
    Comparison groups
    AIN457 Low dose v AIN457 High dose
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Bayesian method using (MAP)
    Parameter type
    		 Predicted log -OR
    Point estimate
    4.292
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.638
         upper limit
    		 6.513

    Secondary: Number and percentage of participants with PASI 90 response

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    End point title
    		 Number and percentage of participants with PASI 90 response
    End point description
    Psoriasis Area and Severity Index (PASI) was assessed/calculated as per the standard procedure. PASI 90 represents the percentage (or number) of patients who have achieved a 90% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 AIN457 Low dose AIN457 High dose
    Number of subjects analysed
    42
    42
    Units: Participants
    29
    32
    Statistical analysis title
    		 AIN457 Low dose v AIN457 High dose
    Comparison groups
    AIN457 High dose v AIN457 Low dose
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Bayesian method using (MAP)
    Parameter type
    		 Predicted log-OR
    Point estimate
    4.709
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.201
         upper limit
    		 6.58
    Statistical analysis title
    		 AIN457 Low dose v AIN457 High dose
    Comparison groups
    AIN457 Low dose v AIN457 High dose
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Bayesian method using (MAP)
    Parameter type
    		 Predicted log-OR
    Point estimate
    4.367
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.916
         upper limit
    		 6.202

    Secondary: Secukinumab concentration in serum

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    End point title
    		 Secukinumab concentration in serum
    End point description
    Mean (Standard Deviation) Secukinumab concentration levels in serum over time.
    End point type
    Secondary
    End point timeframe
    Baleine, Weeks 4, 12, 13, 14, 15, 16, 24, 52, 104, 156, 208
    End point values
    		 AIN457 Low dose AIN457 High dose
    Number of subjects analysed
    42
    42
    Units: mcg/mL
    arithmetic mean (standard deviation)
        Baseline
    0.00 ( 0.00 )
    0.00 ( 0.00 )
        Week 4 (n=40,40)
    74.2 ( 33.0 )
    135 ( 45.3 )
        Week 12 (n=40, 39)
    34.8 ( 10.9 )
    69.6 ( 29.2 )
        Week 13 (n=38,33)
    47.1 ( 17.4 )
    91.2 ( 34.1 )
        Week 14 (n=40, 39)
    40.9 ( 15.5 )
    78.4 ( 29.8 )
        Week 15 (n=38,35)
    34.6 ( 12.4 )
    65.7 ( 28.9 )
        Week 16 (n=40,37)
    30.9 ( 11.2 )
    55.2 ( 24.9 )
        Week 24 (n=42, 38)
    26.0 ( 10.8 )
    48.0 ( 21.4 )
        Week 52 (n=37,38)
    25.0 ( 9.01 )
    42.7 ( 17.0 )
        Week 104 (n=39,33)
    21.9 ( 10.8 )
    39.3 ( 12.1 )
        Week 156 (n=34,32)
    19.3 ( 8.68 )
    35.0 ( 14.1 )
        Week 208 (n=25,28)
    16.7 ( 6.25 )
    38.8 ( 17.2 )
    No statistical analyses for this end point

    Secondary: Summary table of Adverse Events

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    End point title
    		 Summary table of Adverse Events
    End point description
    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
    End point type
    Secondary
    End point timeframe
    Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks.
    End point values
    		 AIN457 Low dose AIN457 High dose
    Number of subjects analysed
    42
    42
    Units: Participants
        Subjects with any AE(s)
    33
    35
        -Deaths
    0
    0
        - Non-fatal SAE(s)
    4
    2
        - Discontinued study treatment due to any AE(s)
    1
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks.
    Adverse event reporting additional description
    Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    AIN457 Low dose
    Reporting group description
    		 AIN457 Low dose

    Reporting group title
    AIN457 High dose
    Reporting group description
    		 AIN457 High dose

    Serious adverse events
    		 AIN457 Low dose AIN457 High dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 42 (9.52%)
    2 / 42 (4.76%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Tibia fracture
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Intentional self-injury
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AIN457 Low dose AIN457 High dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 42 (71.43%)
    27 / 42 (64.29%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 42 (4.76%)
         occurrences all number
    5
    2
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 42 (2.38%)
         occurrences all number
    3
    1
    Neutropenia
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 42 (2.38%)
         occurrences all number
    4
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    6 / 42 (14.29%)
    1 / 42 (2.38%)
         occurrences all number
    8
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 42 (9.52%)
    2 / 42 (4.76%)
         occurrences all number
    4
    2
    Diarrhoea
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 42 (7.14%)
         occurrences all number
    3
    3
    Vomiting
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 42 (4.76%)
         occurrences all number
    3
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    7 / 42 (16.67%)
    2 / 42 (4.76%)
         occurrences all number
    7
    3
    Eczema
         subjects affected / exposed
    4 / 42 (9.52%)
    0 / 42 (0.00%)
         occurrences all number
    5
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 42 (2.38%)
         occurrences all number
    5
    1
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 42 (2.38%)
    7 / 42 (16.67%)
         occurrences all number
    3
    13
    COVID-19
         subjects affected / exposed
    11 / 42 (26.19%)
    9 / 42 (21.43%)
         occurrences all number
    12
    9
    Influenza
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 42 (2.38%)
         occurrences all number
    3
    1
    Nasopharyngitis
         subjects affected / exposed
    13 / 42 (30.95%)
    7 / 42 (16.67%)
         occurrences all number
    23
    12
    Rhinitis
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 42 (7.14%)
         occurrences all number
    1
    4
    Tonsillitis
         subjects affected / exposed
    2 / 42 (4.76%)
    4 / 42 (9.52%)
         occurrences all number
    2
    6
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 42 (0.00%)
    6 / 42 (14.29%)
         occurrences all number
    0
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Sep 2020
    The key features of the amendment dated 25-Sep-2020 were changes required due to the COVID-19 pandemic, the addition of inflammatory bowel disease (IBD) as an example for discontinuation of treatment, removal of a sensitivity analysis, and the addition of growth/weight and maturation measurements to the Safety assessments.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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