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    Clinical Trial Results:
    An open label extension study to evaluate the safety, tolerability and efficacy of AIN457 in patients with relapsing-remitting multiple sclerosis.

    Summary
    EudraCT number
    		 2011-001629-25
    Trial protocol
    		 CZ  
    Global end of trial date
    02 Jun 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    CAIN457B2201E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01433250
    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,
    Scientific contact
    Clinical Disclosure 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
    02 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jun 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the long term safety and tolerability of secukinumab in patients with RRMS who participated in the core CAIN457B2201 phase II PoC study.
    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
    28 Feb 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 8
    Country: Number of subjects enrolled
    Russian Federation: 20
    Country: Number of subjects enrolled
    Ukraine: 11
    Worldwide total number of subjects
    39
    EEA total number of subjects
    8
    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)
    39
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This was a multicenter, open-label, non-randomized, non-controlled trial that aimed at providing access to active treatment for at least 1 year to patients who had completed the core CAIN457B2201 study (24 weeks), in order to collect long-term safety data

    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
    		 AIN/AIN
    Arm description
    		 AIN core 24 weeks/AIN extension 1 year
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    10 mg/kg i.v. at the start of Week 1 and then

    Arm title
    		 PBO/AIN
    Arm description
    		 placebo first 24 weeks/ AIN extension for 52 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    10 mg/kg i.v. at the start of Week 1 and then

    Number of subjects in period 1
    		AIN/AIN PBO/AIN
    Started
    22
    17
    Completed
    19
    14
    Not completed
    3
    3
         Consent withdrawn by subject
    3
    2
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AIN/AIN
    Reporting group description
    		 AIN core 24 weeks/AIN extension 1 year

    Reporting group title
    PBO/AIN
    Reporting group description
    		 placebo first 24 weeks/ AIN extension for 52 weeks

    Reporting group values
    		 AIN/AIN PBO/AIN Total
    Number of subjects
    		 22 17 39
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 22 17 39
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 36.1 ± 10 34.2 ± 8.71 -
    Gender, Male/Female
    Units: Participants
        Female
    		 12 12 24
        Male
    		 10 5 15
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 0 1
        Not Hispanic or Latino
    		 20 16 36
        Unknown or Not Reported
    		 1 1 2

    End points

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    End points reporting groups
    Reporting group title
    AIN/AIN
    Reporting group description
    		 AIN core 24 weeks/AIN extension 1 year

    Reporting group title
    PBO/AIN
    Reporting group description
    		 placebo first 24 weeks/ AIN extension for 52 weeks

    Primary: Measure: number of subjects with adverse events, number of abnormalities in safety assessments

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    End point title
    		 Measure: number of subjects with adverse events, number of abnormalities in safety assessments [1]
    End point description
    Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome
    End point type
    Primary
    End point timeframe
    up to 97 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 prespecified analysis were planned for this outcome measure
    End point values
    		 AIN/AIN PBO/AIN
    Number of subjects analysed
    22 [2]
    17
    Units: participants
    0
    0
    Notes
    [2] - No prespecified statistical analysis was planned for this outcome measure
    No statistical analyses for this end point

    Secondary: Distribution of patients with relapses to end of study (EOS) (all subjects)

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    End point title
    		 Distribution of patients with relapses to end of study (EOS) (all subjects)
    End point description
    Description: number of relapses based on neurological assessments and EDSS
    End point type
    Secondary
    End point timeframe
    up to 97 weeks
    End point values
    		 AIN/AIN PBO/AIN
    Number of subjects analysed
    22
    17
    Units: Participants
    9
    5
    No statistical analyses for this end point

    Secondary: Number lesions measured in the brain by magnetic resonance imaging. T1 Weighted MRI

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    End point title
    		 Number lesions measured in the brain by magnetic resonance imaging. T1 Weighted MRI
    End point description
    Measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans
    End point type
    Secondary
    End point timeframe
    up to 97 weeks
    End point values
    		 AIN/AIN PBO/AIN
    Number of subjects analysed
    22
    17
    Units: lesions
    arithmetic mean (full range (min-max))
        week 13 T1 (n=22, 16)
    0.8 (0 to 4)
    2 (0 to 15)
        week 25 T1 (n=22, 16)
    0.6 (0 to 5)
    1.9 (0 to 20)
        week 37 T1 (n=22, 15)
    1 (0 to 5)
    0.8 (0 to 4)
        week 53 T1 (n=14, 6)
    0.3 (0 to 3)
    0.3 (0 to 1)
        wk 73 T1 (n=11,9)
    0.6 (0 to 3)
    0.2 (0 to 1)
        EOT (n=15,13)
    0.7 (0 to 5)
    0.5 (0 to 3)
    No statistical analyses for this end point

    Secondary: Number lesions measured in the brain by magnetic resonance imaging. T2 Weighted MRI

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    End point title
    		 Number lesions measured in the brain by magnetic resonance imaging. T2 Weighted MRI
    End point description
    Measures of absolute number of gadolinium [Gd]-enhancing lesions on T2-weighted lesions
    End point type
    Secondary
    End point timeframe
    upto 97 weeks
    End point values
    		 AIN/AIN PBO/AIN
    Number of subjects analysed
    22
    17
    Units: lesions
    arithmetic mean (full range (min-max))
        week 13 T2 (n=22, 16)
    1.3 (0 to 7)
    2.2 (0 to 12)
        week 25 T2 (n=22, 16)
    0.8 (0 to 6)
    2.4 (0 to 21)
        week 37 T2 (n=22, 15)
    1.3 (0 to 5)
    1.3 (0 to 6)
        week 53 T2 (n=14, 6)
    0.4 (0 to 4)
    0.7 (0 to 3)
        wk 73 T2 (n=11,9)
    1.3 (0 to 5)
    0.9 (0 to 5)
        EOT T2 (n=15,13)
    1.1 (0 to 4)
    0.07 (0 to 3)
    No statistical analyses for this end point

    Secondary: Change in Brain Volume at end of study.

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    End point title
    		 Change in Brain Volume at end of study.
    End point description
    Change in volume from start to end of study
    End point type
    Secondary
    End point timeframe
    up to 97 weeks
    End point values
    		 AIN/AIN PBO/AIN
    Number of subjects analysed
    22
    17
    Units: ml
        arithmetic mean (standard deviation)
    -14.8968 ± 63.73027
    -30.4346 ± 31.218
    No statistical analyses for this end point

    Secondary: Measure of disability: Expanded Disability Status Scale (EDSS).

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    End point title
    		 Measure of disability: Expanded Disability Status Scale (EDSS).
    End point description
    The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions.
    End point type
    Secondary
    End point timeframe
    Baseline to End of Study
    End point values
    		 AIN/AIN PBO/AIN
    Number of subjects analysed
    22
    17
    Units: participants
        Baseline score 0
    1
    0
        Baseline score 1.0
    0
    2
        Baseline score 1.5
    5
    5
        Baseline score 2.0
    5
    2
        Baseline score 2.5
    1
    1
        Baseline score 3.0
    2
    4
        Baseline score 3.5
    2
    0
        Baseline score 4.0
    1
    1
        Baseline score 4.5
    2
    2
        Baseline score 5.0
    1
    0
        Baseline score 6.0
    1
    0
        WK25 score 0
    2
    0
        WK25 score 1
    1
    2
        WK25 score 1.5
    4
    5
        WK25 score 2.0
    4
    1
        WK25 score 2.5
    2
    1
        WK25 score 3.0
    2
    4
        WK25 score 4.0
    1
    1
        WK25 score 4.5
    3
    1
        WK25 score 5.0
    1
    0
        WK25 score 5.5
    0
    1
        WK25 score 6.0
    1
    0
        WK25 score 6.5
    1
    0
        Safety Week 53 score 0
    1
    0
        Safety Week 53 score 1.0
    1
    1
        Safety Week 53 score 1.5
    3
    3
        Safety Week 53 score 2.0
    4
    0
        Safety Week 53 score 3.0
    1
    1
        Safety Week 53 score 3.5
    1
    0
        Safety Week 53 score 4.0
    0
    1
        Safety Week 53 score 5.0
    1
    0
        Safety Week 53 score 5.5
    2
    0
        Safety Week 53 score 6.0
    1
    0
        WK73 score 0
    1
    1
        WK73 score 1.0
    2
    1
        WK73 score 1.5
    1
    5
        WK73 score 2.0
    2
    0
        WK73 score 3.0
    0
    1
        WK73 score 4.0
    1
    0
        WK73 score 5.5
    1
    0
        WK73 score 6.0
    1
    0
        End of treatment score 0
    1
    1
        End of treatment score1.0
    2
    1
        End of treatment score 1.5
    2
    5
        End of treatment score 2.0
    2
    1
        End of treatment score 2.5
    2
    1
        End of treatment score 3.0
    0
    3
        End of treatment score 3.5
    1
    0
        End of treatment score 4.0
    2
    0
        End of treatment score 4.5
    0
    1
        End of treatment score 5.5
    0
    1
        End of treatment score 6.0
    1
    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 are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    PBO/AIN
    Reporting group description
    		 PBO/AIN

    Reporting group title
    AIN/AIN
    Reporting group description
    		 AIN/AIN

    Serious adverse events
    		 PBO/AIN AIN/AIN
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 22 (9.09%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteochondrosis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PBO/AIN AIN/AIN
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 17 (47.06%)
    7 / 22 (31.82%)
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Varicose vein
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Cardiomyopathy
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    Migraine
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Uterine cervical erosion
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Anxiety disorder
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Laryngitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 22 (4.55%)
         occurrences all number
    2
    1
    Pharyngitis
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    3
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 22 (9.09%)
         occurrences all number
    2
    3
    Rhinitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Overweight
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Feb 2013
    This amendment was issued in order to prolong access to active treatment to all patients enrolled in the current CAIN457B2201E1 study until they could participate in another extension study. For this purpose additional treatment visits were scheduled and described. All patients continued to receive only active treatment throughout the study course. In addition this amendment included an adjustment of the frequency at which some assessments were scheduled in order to align with the ongoing secukinumab program. These changes were not expected to have an impact on the safety of the intended study population, analysis of results and the scientific value of the trial.

    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.
    Further development of secukinumab in MS is not being pursued and the extension study in MS, CAIN457B2201E1, was terminated. Termination of this study was not related to the safety or tolerability concerns observed in the study.
    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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