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    Clinical Trial Results:
    A Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Vedolizumab IV for the Treatment of Primary Sclerosing Cholangitis, With Underlying Inflammatory Bowel Disease

    Summary
    EudraCT number
    		 2014-003942-28
    Trial protocol
    		 ES   BE   GB   HU   SE   DE   CZ   AT   PL   FR   IT  
    Global end of trial date
    23 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Sep 2020
    First version publication date
    13 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MLN0002-3023
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03035058
    WHO universal trial number (UTN)
    		 U1111-1161-4900
    Other trial identifiers
    		 NL56650.056.16: CCMO, 16/LO/0288: NRES, 191059: HC-CTD
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    One Takeda Parkway, Deerfield, United States, 60015
    Public contact
    Medical Director, Clinical Science, Takeda Development Centre Europe, Ltd., +44 1256 894003,
    Scientific contact
    Medical Director, Clinical Science, Takeda Development Centre Europe, Ltd., +44 1256 894003,
    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
    23 Feb 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) in non–end-stage primary sclerosing cholangitis (PSC) participants with underlying inflammatory bowel disease (IBD).
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Feb 2017
    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: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.

    Pre-assignment
    Screening details
    		 N/A

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall
    Arm description
    		 Vedolizumab 300 mg, intravenous (IV)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vedolizumab IV
    Investigational medicinal product code
    MLN0002
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage would have been once at Day 1 and Week 2 then once every 4 weeks from Week 6 to Week 102.

    Number of subjects in period 1
    		Overall
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 Vedolizumab 300 mg, intravenous (IV)

    Reporting group values
    		 Overall Total
    Number of subjects
    		 99999 99999
    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)
    		 99999 99999
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 0 ± 0 -
    Gender categorical
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 Vedolizumab 300 mg, intravenous (IV)

    Primary: Percentage of Participants with No Worsening in Ishak Fibrosis Staging Score from Baseline to Week 106 Visit

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    End point title
    		 Percentage of Participants with No Worsening in Ishak Fibrosis Staging Score from Baseline to Week 106 Visit [1]
    End point description
    99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
    End point type
    Primary
    End point timeframe
    N/A
    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 have been specified for this primary end point.
    End point values
    		 Overall
    Number of subjects analysed
    99999 [2]
    Units: number
    99999
    Notes
    [2] - No subjects were enrolled in the trial hence results are not available
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All adverse events occurring during the course of the clinical trial were to be collected.
    Adverse event reporting additional description
    N/A
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Vedolizumab
    Reporting group description
    		 Vedolizumab 300 mg IV

    Serious adverse events
    		 Vedolizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Vedolizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There are no non-serious adverse events recorded for these results.

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
    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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