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    Clinical Trial Results:
    A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457(secukinumab) in patients with relapsing multiple sclerosis

    Summary
    EudraCT number
    2012-004019-29
    Trial protocol
    BE   IT   SE   DE   CZ   FI   ES   PL  
    Global end of trial date
    17 Apr 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    18 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457B2203
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01874340
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Dsiclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Dsiclosure Office, Novartis Pharma AG, 41 613241111,
    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
    17 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the effect of three AIN457 doses (3, 7, and 15 mg/kg i.v.), compared to placebo, in reducing the cumulative number of new Gadolinium-enhancing T1-weighted lesions recorded on all available MRI scans at Months 3, 4, 5 and 6 in patients with RMS.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Delcaration of Helskinki 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
    18 Jun 2013
    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
    Japan: 1
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    Russian Federation: 9
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    Turkey: 1
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Italy: 3
    Worldwide total number of subjects
    28
    EEA total number of subjects
    17
    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)
    28
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    patients were randomly assigned to treatment arms in a ratio of 1:1:1:1

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    AIN457 15 mg/kg
    Arm description
    AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
    Arm type
    Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.

    Arm title
    AIN457 7 mg/kg
    Arm description
    AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
    Arm type
    Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.

    Arm title
    AIN457 3 mg/kg
    Arm description
    AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
    Arm type
    Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.

    Arm title
    Placebo
    Arm description
    Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
    Arm type
    Placebo

    Investigational medicinal product name
    Matching Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.

    Number of subjects in period 1
    AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
    Started
    6
    8
    8
    6
    Completed
    0
    0
    0
    1
    Not completed
    6
    8
    8
    5
         Consent withdrawn by subject
             -
             -
             -
             1
         Study terminated by Sponsor
             6
             8
             8
             4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AIN457 15 mg/kg
    Reporting group description
    AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.

    Reporting group title
    AIN457 7 mg/kg
    Reporting group description
    AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.

    Reporting group title
    AIN457 3 mg/kg
    Reporting group description
    AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.

    Reporting group title
    Placebo
    Reporting group description
    Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.

    Reporting group values
    AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo Total
    Number of subjects
    6 8 8 6 28
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0
        Adults (18-64 years)
    6 8 8 6 28
        From 65-84 years
    0 0 0 0 0
        85 years and over
    0 0 0 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    28.8 ± 7.73 34.5 ± 8.64 35.5 ± 9.71 34 ± 9.3 -
    Gender, Male/Female
    Units: Participants
        Male
    2 4 2 2 10
        Female
    4 4 6 4 18

    End points

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    End points reporting groups
    Reporting group title
    AIN457 15 mg/kg
    Reporting group description
    AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.

    Reporting group title
    AIN457 7 mg/kg
    Reporting group description
    AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.

    Reporting group title
    AIN457 3 mg/kg
    Reporting group description
    AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.

    Reporting group title
    Placebo
    Reporting group description
    Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.

    Primary: Cumulative number of new Gadolinium [Gd]-enhancing T1-weighted lesions

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    End point title
    Cumulative number of new Gadolinium [Gd]-enhancing T1-weighted lesions [1]
    End point description
    Due to early termination this trial was not powered for efficacy no statistical analysis was performed
    End point type
    Primary
    End point timeframe
    Months 3, 4, 5, 6
    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: Due to early termination, no statistical analysis was planned for this primary endpoint.
    End point values
    AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    Units: T1 lesions
    Notes
    [2] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    [3] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    [4] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    [5] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    No statistical analyses for this end point

    Secondary: Annualized relapse rate

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    End point title
    Annualized relapse rate
    End point description
    Due to early termination this trial was not powered for efficacy no statistical analysis was performed
    End point type
    Secondary
    End point timeframe
    6 Months
    End point values
    AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
    Number of subjects analysed
    0 [6]
    0 [7]
    0 [8]
    0 [9]
    Units: Number of Relapses
    Notes
    [6] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    [7] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    [8] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    [9] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    No statistical analyses for this end point

    Secondary: Combined unique active lesions (CUAL)

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    End point title
    Combined unique active lesions (CUAL)
    End point description
    Due to early termination this trial was not powered for efficacy no statistical analysis was performed
    End point type
    Secondary
    End point timeframe
    Months 3, 4, 5, 6
    End point values
    AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
    Number of subjects analysed
    0 [10]
    0 [11]
    0 [12]
    0 [13]
    Units: Active Lesions
    Notes
    [10] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    [11] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    [12] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    [13] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    No statistical analyses for this end point

    Secondary: Change in total volume of T2-weighted lesions

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    End point title
    Change in total volume of T2-weighted lesions
    End point description
    Due to early termination this trial was not powered for efficacy no statistical analysis was performed
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
    Number of subjects analysed
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    Units: T2 Weighted Lesions
    Notes
    [14] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    [15] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    [16] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    [17] - No statistical analyses could be performed for the efficacy endpoints defined in the protocol.
    No statistical analyses for this end point

    Secondary: Number of particpants with Adverse events as a measure of safety and tolerability

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    End point title
    Number of particpants with Adverse events as a measure of safety and tolerability
    End point description
    Number of particpants with Adverse events as a measure of safety and tolerability
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    AIN457 15 mg/kg AIN457 7 mg/kg AIN457 3 mg/kg Placebo
    Number of subjects analysed
    6
    8
    8
    6
    Units: Participants
        Adverse Events (AE)
    1
    3
    3
    2
        Death
    0
    0
    0
    0
        Non-Fatal Seriuos Aderse Event (SAE)
    0
    1
    0
    0
    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.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    AIN457 15 mg/kg
    Reporting group description
    AIN457 15 mg/kg

    Reporting group title
    AIN457 7 mg/kg
    Reporting group description
    AIN457 7 mg/kg

    Reporting group title
    Placebo
    Reporting group description
    Placebo

    Reporting group title
    AIN457 3 mg/kg
    Reporting group description
    AIN457 3 mg/kg

    Serious adverse events
    AIN457 15 mg/kg AIN457 7 mg/kg Placebo AIN457 3 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Gastrointestinal disorders
    GASTRITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    AIN457 15 mg/kg AIN457 7 mg/kg Placebo AIN457 3 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 8 (25.00%)
    2 / 6 (33.33%)
    3 / 8 (37.50%)
    Investigations
    C-REACTIVE PROTEIN INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    WHITE BLOOD CELL COUNT INCREASED
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    PYREXIA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    NAUSEA
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    RASH
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    BACK PAIN
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolism and nutrition disorders
    HYPERPHAGIA
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    NASOPHARYNGITIS
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    0
    1
    BRONCHITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    VAGINAL INFECTION
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    TINEA VERSICOLOUR
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    1
    PHARYNGITIS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Feb 2013
    The Amendment was issued prior to any patients enrolling in the study, introduced

    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.
    Study terminated early based upon development of another anti-IL17 fully human monoclonal antibody with better potential for treating MS patients. Due to early termination this trial was not powered for efficacy no statistical analysis was performed.
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