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    Clinical Trial Results:
    A 52-week (plus extension until commercialization), single-arm study to evaluate psoriasis severity and its psychosocial impact using the Simplified Psoriasis Index (SPI) at 16 weeks, as well as long-term safety, tolerability and efficacy of secukinumab administered subcutaneously in participants suffering from moderate to severe psoriasis

    Summary
    EudraCT number
    		 2014-003666-25
    Trial protocol
    		 FR  
    Global end of trial date
    09 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Feb 2018
    First version publication date
    24 Feb 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457AFR01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02595970
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    CH-4056, Basel, Switzerland,
    Public contact
    Study Director, Novartis Pharmaceuticals, 41 61 324 1111, Novartis.email@novartis.com
    Scientific contact
    Study Director, Novartis Pharmaceuticals, 41 61 324 1111, 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
    07 Nov 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (s), psychosocial (p) and intervention (i) evaluated by both the physician (proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective (both proSPI (s) and saSPI (s)). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed.
    Protection of trial subjects
    This 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
    20 May 2015
    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
    France: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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)
    111
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study centers: This study involved 17 active centers who enrolled (or recruited) patients in France First patient enrolled: 20-May-2015 Last patient completed: 09-Feb-2017

    Pre-assignment
    Screening details
    		 No significant events in the study (for example, wash out, run-in) that occur after participant enrollment, but prior to assignment of participants to the treatment arm

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open label single-arm study; therefore treatment blinding was not necessary.

    Arms
    Arm title
    		 Single Arm secukinumab
    Arm description
    		 Weekly injections of 300mg of secukinumab during the first month (induction period), followed by monthly injections thereafter to week 48. During this extension period, patients continued to receive monthly injections until End of Extension visit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    This was an open label single-arm study; therefore treatment blinding was not necessary.
    Investigational medicinal product code
    AIN457A
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab is administered subcutaneously at a dosage of 300 mg per week during the induction phase (first month) and thereafter at a dosage of 300 mg per month.

    Number of subjects in period 1
    		Single Arm secukinumab
    Started
    120
    Completed
    100
    Not completed
    20
         Consent withdrawn by subject
    2
         Physician decision
    2
         Adverse event, non-fatal
    5
         Lack of efficacy
    7
         Protocol deviation
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Single Arm secukinumab
    Reporting group description
    		 Weekly injections of 300mg of secukinumab during the first month (induction period), followed by monthly injections thereafter to week 48. During this extension period, patients continued to receive monthly injections until End of Extension visit.

    Reporting group values
    		 Single Arm secukinumab Total
    Number of subjects
    		 120 120
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 111 111
        From 65-84 years
    		 9 9
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.9 ± 17.17 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 37 37
        Male
    		 83 83
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 1
        Asian
    		 1 1
        Native Hawaiian or Other Pacific Islander
    		 1 1
        Black or African American
    		 1 1
        White
    		 116 116
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0
    proSPI (s)
    Units: n/a
        arithmetic mean (standard deviation)
    		 24.9 ± 10.71 -
    saSPI (s)
    Units: n/a
        arithmetic mean (standard deviation)
    		 45.9 ± 17.7 -

    End points

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    End points reporting groups
    Reporting group title
    Single Arm secukinumab
    Reporting group description
    		 Weekly injections of 300mg of secukinumab during the first month (induction period), followed by monthly injections thereafter to week 48. During this extension period, patients continued to receive monthly injections until End of Extension visit.

    Primary: Severity component(s) of the Simplified Psoriasis Index (SPI)

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    End point title
    		 Severity component(s) of the Simplified Psoriasis Index (SPI) [1]
    End point description
    The primary efficacy outcome of this study evaluates the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed for the purpose of this study.
    End point type
    Primary
    End point timeframe
    from baseline to 16 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this single arm study
    End point values
    		 Single Arm secukinumab
    Number of subjects analysed
    119
    Units: score SPI(s) (range: 0 to 50)
    arithmetic mean (standard deviation)
        W0|
    24.89 ± 10.747
        W16|
    2.34 ± 6.144
    No statistical analyses for this end point

    Primary: Changes of saSPI (s) at Week 16 compared to Baseline

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    End point title
    		 Changes of saSPI (s) at Week 16 compared to Baseline [2]
    End point description
    The primary efficacy objective of the study was to evaluate the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed. proSPI (s) score range is 0 to 50. Higher score means worse condition
    End point type
    Primary
    End point timeframe
    from baseline to 16 weeks
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this single arm study
    End point values
    		 Single Arm secukinumab
    Number of subjects analysed
    118
    Units: proSPI (s) score
    arithmetic mean (standard deviation)
        W0|
    23.54 ± 10.412
        W16|
    1.99 ± 4.508
    No statistical analyses for this end point

    Secondary: PASI (Psoriasis Area Severity Index) score

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    End point title
    		 PASI (Psoriasis Area Severity Index) score
    End point description
    PASI score range: 0 (no disease) to 72 (maximal disease)
    End point type
    Secondary
    End point timeframe
    week 0, 16, 52
    End point values
    		 Single Arm secukinumab
    Number of subjects analysed
    109
    Units: PASI score
    arithmetic mean (standard deviation)
        W0|
    23.09 ± 10.541
        W16|
    2.23 ± 3.927
        W52|
    3.16 ± 5.427
    No statistical analyses for this end point

    Secondary: Correlation between PASI and proSPI (s)

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    End point title
    		 Correlation between PASI and proSPI (s)
    End point description
    Psoriasis Area Severity Index vs Professional Version of Simplified Psoraisis Index (proSPI) score
    End point type
    Secondary
    End point timeframe
    week 0, 16, 52
    End point values
    		 Single Arm secukinumab
    Number of subjects analysed
    118
    Units: Correlation coefficient
    number (confidence interval 95%)
        WO|
    0.691 (0.58 to 0.78)
        W16|
    0.814 (0.74 to 0.87)
        W52|
    0.927 (0.89 to 0.95)
    No statistical analyses for this end point

    Secondary: proSPI (s, p and i) over time

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    End point title
    		 proSPI (s, p and i) over time
    End point description
    Professional Version of Simplified Psoriasis Index (proSPI)
    End point type
    Secondary
    End point timeframe
    weeks 0, 16, 52
    End point values
    		 Single Arm secukinumab
    Number of subjects analysed
    119
    Units: proSPI score
    arithmetic mean (standard deviation)
        proSPI (s) - W0|
    24.89 ± 10.747
        proSPI (s) - W16|
    1.83 ± 4.427
        proSPI (s) - W52|
    2.93 ± 6.557
        proSPI (p) - W0|
    7.80 ± 1.885
        proSPI (p) - W16|
    1.34 ± 2.201
        proSPI (p) - W52|
    1.59 ± 2.341
        proSPI (i) - W0|
    4.26 ± 1.924
        proSPI (i) - W16|
    4.78 ± 1.633
        proSPI (i) - W52|
    4.67 ± 1.613
    No statistical analyses for this end point

    Secondary: saSPI (s, p and i) over time

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    End point title
    		 saSPI (s, p and i) over time
    End point description
    Self-administered Simplified Psoriasis Index (saSPI)
    End point type
    Secondary
    End point timeframe
    weeks 0, 16, 52
    End point values
    		 Single Arm secukinumab
    Number of subjects analysed
    118
    Units: saSPI score
    arithmetic mean (standard deviation)
        saSPI(s) - W0|
    23.54 ± 10.412
        saSPI(s) - W16|
    1.80 ± 4.319
        saSPI(s) - W52|
    2.15 ± 4.229
        saSPI(p) - W0|
    8.18 ± 1.855
        saSPI(p) - W16|
    1.54 ± 2.299
        saSPI(p) - W52|
    1.47 ± 2.126
        saSPI(i) - W0|
    4.34 ± 1.940
        saSPI(i) - W16|
    4.39 ± 2.221
        saSPI(i) - W52|
    4.33 ± 2.276
    No statistical analyses for this end point

    Secondary: DLQI (Dermatology Life Quality Index) over time

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    End point title
    		 DLQI (Dermatology Life Quality Index) over time
    End point description
    DLQI score has a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired MEANING OF DLQI SCORES 0 – 1 no effect on patient's life 2 – 5 small effect on patient's life 6 – 10 moderate effect on patient's life 11 – 20 very large effect on patient's life 21 – 30 extremely large effect on patient's life
    End point type
    Secondary
    End point timeframe
    weeks 0, 16, 52
    End point values
    		 Single Arm secukinumab
    Number of subjects analysed
    119
    Units: DLQI score (range : 0 - 30)
    arithmetic mean (standard deviation)
        WO|
    13.6 ± 7.33
        W16|
    2.1 ± 3.67
        W52|
    1.9 ± 3.37
    No statistical analyses for this end point

    Secondary: self-administered PASI (SA-PASI)

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    End point title
    		 self-administered PASI (SA-PASI)
    End point description
    self-administered PASI (SA-PASI) score
    End point type
    Secondary
    End point timeframe
    weeks 0, 16, 52
    End point values
    		 Single Arm secukinumab
    Number of subjects analysed
    118
    Units: saPASI score (range: 0 to 72)
    arithmetic mean (standard deviation)
        WO|
    25.8 ± 13.55
        W16|
    2.6 ± 6.66
        W52|
    3.3 ± 7.10
    No statistical analyses for this end point

    Secondary: Psoriasis Symptom Diary (PSD) score

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    End point title
    		 Psoriasis Symptom Diary (PSD) score
    End point description
    assessment of pain, itching and scaling using the Psoriasis Symptom Diary questionnaire over time PSD scores range from 0 to 10, with higher scores indicating a worse condition
    End point type
    Secondary
    End point timeframe
    weeks 0, 16, 52
    End point values
    		 Single Arm secukinumab
    Number of subjects analysed
    119
    Units: PSD scores
    arithmetic mean (standard deviation)
        Intensity of pain recorded in PSD- W0|
    5.2 ± 3.18
        Intensity of pain recorded in PSD - W16|
    0.9 ± 2.00
        Intensity of pain recorded in PSD - W52|
    0.9 ± 1.78
        Intensity of itching recorded in PSD - W0|
    6.7 ± 2.85
        Intensity of itching recorded in PSD - W16|
    1.3 ± 2.21
        Intensity of itching recorded in PSD - W52|
    1.4 ± 2.11
        Intensity of scaling recorded in PSD - W0|
    6.5 ± 2.70
        Intensity of scaling recorded in PSD - W16|
    1.0 ± 1.96
        Intensity of scaling recorded in PSD - W52|
    1.3 ± 2.00
    No statistical analyses for this end point

    Secondary: Correlation between proSPI (for each component: s, p and i) and DLQI

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    End point title
    		 Correlation between proSPI (for each component: s, p and i) and DLQI
    End point description
    Correlation between proSPI (for each component: s, p and i) and DLQI is summarized in table below
    End point type
    Secondary
    End point timeframe
    weeks 0, 16, 52
    End point values
    		 Single Arm secukinumab
    Number of subjects analysed
    118
    Units: correlation coefficient
    number (confidence interval 95%)
        proSPI (s) and DLQI - W0|
    0.224 (0.05 to 0.39)
        proSPI (s) and DLQI - W16|
    0.418 (0.25 to 0.56)
        proSPI (s) and DLQI - W52|
    0.514 (0.34 to 0.65)
        proSPI (p) and DLQI - W0|
    0.492 (0.34 to 0.62)
        proSPI (p) and DLQI - W16|
    0.671 (0.55 to 0.76)
        proSPI (p) and DLQI - W52|
    0.757 (0.65 to 0.83)
        proSPI (i) and DLQI - W0|
    0.102 (-0.08 to 0.28)
        proSPI (i) and DLQI - W16|
    0.016 (-0.17 to 0.20)
        proSPI (i) and DLQI - W52|
    0.131 (-0.08 to 0.33)
    No statistical analyses for this end point

    Secondary: Correlation between proSPI (for components p and i) and PASI

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    End point title
    		 Correlation between proSPI (for components p and i) and PASI
    End point description
    Correlation between proSPI (p, i) and PASI score by visit (Full Analysis Set (observed)) is summarized in table below
    End point type
    Secondary
    End point timeframe
    Over time (from Week 0 to Week 52)
    End point values
    		 Single Arm secukinumab
    Number of subjects analysed
    118
    Units: correlation coefficient
    number (confidence interval 95%)
        proSPI (p) and PASI - W0|
    0.173 (-0.01 to 0.34)
        proSPI (p) and PASI - W16|
    0.678 (0.56 to 0.77)
        proSPI (p) and PASI - W52|
    0.749 (0.64 to 0.83)
        proSPI (i) and PASI - W0|
    0.014 (-0.17 to 0.19)
        proSPI (i) and PASI - W16|
    0.105 (-0.08 to 0.29)
        proSPI (i) and PASI - W52|
    0.172 (-0.04 to 0.36)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    AIN457 300mg
    Reporting group description
    		 AIN457 300mg

    Serious adverse events
    		 AIN457 300mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 120 (10.83%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mycosis fungoides
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Meniscus injury
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Coronary artery occlusion
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebral ischaemia
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Face oedema
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Punctate keratitis
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Stomatitis
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Strangulated umbilical hernia
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Ecchymosis
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Sjogren's syndrome
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AIN457 300mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    86 / 120 (71.67%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    9 / 120 (7.50%)
         occurrences all number
    10
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 120 (7.50%)
         occurrences all number
    13
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    10 / 120 (8.33%)
         occurrences all number
    10
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    12 / 120 (10.00%)
         occurrences all number
    21
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 120 (5.83%)
         occurrences all number
    8
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    11 / 120 (9.17%)
         occurrences all number
    12
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 120 (5.83%)
         occurrences all number
    8
    Back pain
         subjects affected / exposed
    13 / 120 (10.83%)
         occurrences all number
    15
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    11 / 120 (9.17%)
         occurrences all number
    12
    Influenza
         subjects affected / exposed
    10 / 120 (8.33%)
         occurrences all number
    10
    Nasopharyngitis
         subjects affected / exposed
    13 / 120 (10.83%)
         occurrences all number
    13
    Rhinitis
         subjects affected / exposed
    11 / 120 (9.17%)
         occurrences all number
    13
    Viral upper respiratory tract infection
         subjects affected / exposed
    8 / 120 (6.67%)
         occurrences all number
    8

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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.
    None reported
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