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    Clinical Trial Results:
    A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

    Summary
    EudraCT number
    		 2015-000480-14
    Trial protocol
    		 NL   SK   CZ   BG   GB   DE   BE   SE   DK   LT   ES   HU   RO   HR   IT  
    Global end of trial date
    21 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jun 2019
    First version publication date
    14 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MLN0002SC-3027
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02611830
    WHO universal trial number (UTN)
    		 U1111-1168-0813
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    40 Landsdowne Street, Cambridge, MA, United States, 02139
    Public contact
    Medical Director, Takeda, +1877 8253327, trialdisclosures@takeda.com
    Scientific contact
    Medical Director, Takeda, +1877 8253327, trialdisclosures@takeda.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
    21 Aug 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the trial is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Dec 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 4
    Country: Number of subjects enrolled
    Japan: 49
    Country: Number of subjects enrolled
    Korea, Republic of: 20
    Country: Number of subjects enrolled
    Czech Republic: 19
    Country: Number of subjects enrolled
    Hungary: 12
    Country: Number of subjects enrolled
    Poland: 95
    Country: Number of subjects enrolled
    Serbia: 3
    Country: Number of subjects enrolled
    Slovakia: 10
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 2
    Country: Number of subjects enrolled
    Bulgaria: 6
    Country: Number of subjects enrolled
    Croatia: 10
    Country: Number of subjects enrolled
    Estonia: 2
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    Romania: 7
    Country: Number of subjects enrolled
    Russian Federation: 20
    Country: Number of subjects enrolled
    Turkey: 3
    Country: Number of subjects enrolled
    Ukraine: 23
    Country: Number of subjects enrolled
    Canada: 11
    Country: Number of subjects enrolled
    United States: 45
    Country: Number of subjects enrolled
    Brazil: 8
    Country: Number of subjects enrolled
    Mexico: 3
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Lithuania: 5
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    United Kingdom: 3
    Worldwide total number of subjects
    383
    EEA total number of subjects
    190
    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)
    355
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at one hundred forty-one investigative sites in North America, South America, Western/Northern Europe, Central Europe, Eastern Europe and Africa/Asia/Australia from 18-Dec-2015 to 21-Aug-2018.

    Pre-assignment
    Screening details
    		 A total of 383 participants were enrolled in open-label (OL) induction phase, 353 participants completed. 216 participants achieved clinical response at Week 6 were randomized into maintenance phase and participants who did not achieve clinical response at Week 6, received 3rd dose of open label vedolizumab IV 300 mg and completed Week 14 visit.

    Period 1
    Period 1 title
    OL Induction Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject, Carer, Data analyst, Assessor

    Arms
    Arm title
    		 Open-Label Induction Phase: Vedolizumab 300 mg IV
    Arm description
    		 Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 in the open-label induction phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vedolizumab 300 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab 300 mg IV infusion once at Weeks 0, 2 in the open-label induction phase.

    Number of subjects in period 1
    		Open-Label Induction Phase: Vedolizumab 300 mg IV
    Started
    383
    Completed
    216
    Not completed
    167
         Pretreatment Event/Adverse Event
    10
         Voluntary Withdrawal
    7
         Significant Protocol Deviation
    4
         Did not achieve clinical response
    122
         Lost to follow-up
    2
         Reason not specified
    5
         Lack of efficacy
    17
    Period 2
    Period 2 title
    Overall Study
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Maintenance Phase: Induction IV + Placebo
    Arm description
    		 Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Matching placebo SC injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 70.

    Arm title
    		 Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
    Arm description
    		 Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vedolizumab 108 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Vedolizumab subcutaneous (SC), 108 mg, injection Q2W and placebo-matching IV infusions, Q8W starting at Week 6 up to approximately Week 77.

    Arm title
    		 Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Arm description
    		 Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vedolizumab 300 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab 300 mg IV infusion Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 71.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Baseline characteristics were reported per arm groups of the maintenance phase, therefore it is selected as the baseline period and participants who were not randomized in the maintenance phase are reported as subject analysis set.
    Number of subjects in period 2 [2]
    		Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Started
    56
    106
    54
    Completed
    20
    75
    39
    Not completed
    36
    31
    15
         Pretreatment Event/Adverse Event
    5
    5
    2
         Voluntary Withdrawal
    1
    2
    5
         Significant Protocol Deviation
    -
    1
    1
         Pregnancy
    -
    1
    -
         Reason not specified
    1
    4
    -
         Lost to follow-up
    -
    -
    1
         Lack of efficacy
    29
    18
    6
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics were reported per arm groups of the maintenance phase and participants who were not randomized in the maintenance phase are reported as subject analysis set.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Maintenance Phase: Induction IV + Placebo
    Reporting group description
    		 Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.

    Reporting group title
    Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
    Reporting group description
    		 Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.

    Reporting group title
    Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Reporting group description
    		 Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.

    Reporting group values
    		 Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV Total
    Number of subjects
    		 56 106 54
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 39.4 (21 to 66) 38.1 (18 to 69) 41.6 (18 to 68) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 22 41 23 86
        Male
    		 34 65 31 130
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 1 0 0 1
        Non-Hispanic and Latino
    		 6 7 8 21
        Not Collected
    		 49 99 46 194
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 0 1
        Asian
    		 13 14 5 32
        Black or African American
    		 0 0 2 2
        White
    		 42 92 47 181
    Female Reproductive Status
    Units: Subjects
        Postmenopausal
    		 4 3 8 15
        Surgically Sterile
    		 1 2 3 6
        Female of Childbearing Potential
    		 17 36 12 65
        Participant is a male
    		 34 65 31 130
    Smoking Classification
    Units: Subjects
        Has never smoked
    		 38 70 33 141
        Is a current smoker
    		 0 11 10 21
        is an ex-smoker
    		 18 25 11 54
    Region of Enrollment
    Units: Subjects
        Australia
    		 0 2 1 3
        Japan
    		 10 10 2 22
        Korea, Republic Of
    		 3 4 3 10
        Czech Republic
    		 3 10 4 17
        Hungary
    		 2 2 6 10
        Poland
    		 13 35 10 58
        Serbia
    		 1 0 1 2
        Slovakia
    		 0 4 3 7
        Bosnia
    		 0 2 0 2
        Bulgaria
    		 1 1 1 3
        Croatia
    		 1 0 1 2
        Estonia
    		 0 0 0 0
        Israel
    		 0 0 0 0
        Romania
    		 0 3 0 3
        Russia
    		 0 5 3 8
        Turkey
    		 2 0 0 2
        Ukraine
    		 4 6 2 12
        Canada
    		 3 2 2 7
        United States
    		 6 7 8 21
        Brazil
    		 0 3 1 4
        Mexico
    		 1 0 0 1
        Belgium
    		 2 0 0 2
        Denmark
    		 1 0 0 1
        Germany
    		 3 3 1 7
        Italy
    		 0 2 3 5
        Lithuania
    		 0 4 1 5
        Netherlands
    		 0 0 0 0
        Spain
    		 0 0 0 0
        United Kingdom
    		 0 1 1 2
    Height
    Units: cm
        arithmetic mean (full range (min-max))
    		 172.4 (147 to 194) 171.9 (151 to 197) 171.2 (152 to 196) -
    Weight
    Units: kg
        arithmetic mean (full range (min-max))
    		 73.96 (40.6 to 160.0) 71.58 (44.0 to 131.0) 76.95 (50.6 to 124.8) -
    Body Mass Index (BMI)
    Body Mass Index = weight/height.
    Units: kg/m^2
        arithmetic mean (full range (min-max))
    		 24.66 (14.1 to 51.1) 24.07 (17.0 to 41.0) 26.21 (16.3 to 35.3) -
    Subject analysis sets

    Subject analysis set title
    Vedolizumab 300 mg IV‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 in the open-label induction phase. Participants who did not achieve clinical response at Week 6 were not randomized into the maintenance phase and received a 3rd dose of vedolizumab 300 mg IV infusion at Week 6.

    Subject analysis sets values
    		 Vedolizumab 300 mg IV‌
    Number of subjects
    167
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (full range (min-max))
    42.7 (18 to 79)
    Sex: Female, Male
    Units: Subjects
        Female
    79
        Male
    88
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    0
        Non-Hispanic and Latino
    24
        Not Collected
    143
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    2
        Asian
    39
        Black or African American
    1
        White
    125
    Female Reproductive Status
    Units: Subjects
        Postmenopausal
    17
        Surgically Sterile
    8
        Female of Childbearing Potential
    54
        Participant is a male
    88
    Smoking Classification
    Units: Subjects
        Has never smoked
    107
        Is a current smoker
    7
        is an ex-smoker
    53
    Region of Enrollment
    Units: Subjects
        Australia
    1
        Japan
    27
        Korea, Republic Of
    10
        Czech Republic
    2
        Hungary
    2
        Poland
    37
        Serbia
    1
        Slovakia
    3
        Bosnia
    0
        Bulgaria
    3
        Croatia
    8
        Estonia
    2
        Israel
    2
        Romania
    4
        Russia
    12
        Turkey
    1
        Ukraine
    11
        Canada
    4
        United States
    24
        Brazil
    4
        Mexico
    2
        Belgium
    0
        Denmark
    0
        Germany
    0
        Italy
    4
        Lithuania
    0
        Netherlands
    1
        Spain
    1
        United Kingdom
    1
    Height
    Units: cm
        arithmetic mean (full range (min-max))
    169.3 (145 to 193)
    Weight
    Units: kg
        arithmetic mean (full range (min-max))
    68.20 (37.0 to 150.2)
    Body Mass Index (BMI)
    Body Mass Index = weight/height.
    Units: kg/m^2
        arithmetic mean (full range (min-max))
    23.65 (15.1 to 40.3)

    End points

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    End points reporting groups
    Reporting group title
    Open-Label Induction Phase: Vedolizumab 300 mg IV
    Reporting group description
    		 Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 in the open-label induction phase.
    Reporting group title
    Maintenance Phase: Induction IV + Placebo
    Reporting group description
    		 Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.

    Reporting group title
    Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
    Reporting group description
    		 Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.

    Reporting group title
    Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Reporting group description
    		 Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.

    Subject analysis set title
    Vedolizumab 300 mg IV‌
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 in the open-label induction phase. Participants who did not achieve clinical response at Week 6 were not randomized into the maintenance phase and received a 3rd dose of vedolizumab 300 mg IV infusion at Week 6.

    Primary: Percentage of Participants Achieving Clinical Remission at Week 52

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    End point title
    		 Percentage of Participants Achieving Clinical Remission at Week 52
    End point description
    Clinical remission is defined as a complete Mayo score ≤ 2 points and no individual subscore > 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity). The Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in the FAS; participants were analyzed according to the randomized treatment assignment.
    End point type
    Primary
    End point timeframe
    Week 52
    End point values
    		 Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Number of subjects analysed
    56
    106
    54
    Units: percentage of participants
        number (confidence interval 95%)
    14.3 (6.4 to 26.2)
    46.2 (36.5 to 56.2)
    42.6 (29.2 to 56.8)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Maintenance Phase: Induction IV + Vedolizumab 108 mg SC v Maintenance Phase: Induction IV + Placebo
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    32.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.7
         upper limit
    		 45
    Notes
    [1] - P-value was calculated by Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Maintenance Phase: Induction IV + Placebo v Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    27.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.3
         upper limit
    		 43.5
    Notes
    [2] - P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.

    Secondary: Percentage of Participants Achieving Mucosal Healing at Week 52

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    End point title
    		 Percentage of Participants Achieving Mucosal Healing at Week 52
    End point description
    Mucosal healing is defined as Mayo endoscopic subscore ≤1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. The findings on endoscopy scale ranges from 0 to 3, where 0=normal or inactive disease 1=mild disease (erythema, decreased vascular pattern, mild friability) 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions) 3=severe disease (spontaneous bleeding, ulceration). The FAS included all randomized participants who received at least 1 dose of study drug. Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in the FAS; participants were analyzed according to the randomized treatment assignment.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Number of subjects analysed
    56
    106
    54
    Units: percentage of participants
        number (confidence interval 95%)
    21.4 (11.6 to 34.4)
    56.6 (46.6 to 66.2)
    53.7 (39.6 to 67.4)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Maintenance Phase: Induction IV + Placebo v Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    35.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.1
         upper limit
    		 49.3
    Notes
    [3] - P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Maintenance Phase: Induction IV + Placebo v Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    32.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 15.7
         upper limit
    		 48.7
    Notes
    [4] - P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.

    Secondary: Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52

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    End point title
    		 Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52
    End point description
    Durable clinical response is defined as clinical response at both Weeks 6 and 52, where clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. Index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity). FAS included all randomized participants who received at least 1 dose of study drug. Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in the FAS; participants were analyzed according to the randomized treatment assignment.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 6 and 52
    End point values
    		 Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Number of subjects analysed
    56
    106
    54
    Units: percentage of participants
        number (confidence interval 95%)
    28.6 (17.3 to 42.2)
    64.2 (54.3 to 73.2)
    72.2 (58.4 to 83.5)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Maintenance Phase: Induction IV + Placebo v Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    36.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.2
         upper limit
    		 50.9
    Notes
    [5] - P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Maintenance Phase: Induction IV + Placebo v Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    44.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 28.3
         upper limit
    		 60.6
    Notes
    [6] - P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.

    Secondary: Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52

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    End point title
    		 Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52
    End point description
    Durable clinical remission is defined as clinical remission at both Weeks 6 and 52. Clinical remission is defined as a complete Mayo score of less than or equal to (≤) 2 points and no individual subscore greater than (>) 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity). The FAS included all randomized participants who received at least 1 dose of study drug. Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in the FAS; participants were analyzed according to the randomized treatment assignment.
    End point type
    Secondary
    End point timeframe
    Weeks 6 and 52
    End point values
    		 Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Number of subjects analysed
    56
    106
    54
    Units: percentage of participants
        number (confidence interval 95%)
    5.4 (1.1 to 14.9)
    15.1 (8.9 to 23.4)
    16.7 (7.9 to 29.3)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Maintenance Phase: Induction IV + Placebo v Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.076 [7]
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    9.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.6
         upper limit
    		 25.7
    Notes
    [7] - P-value was calculated by Fisher’s Exact Test.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Maintenance Phase: Induction IV + Placebo v Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.071 [8]
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    11.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.1
         upper limit
    		 29.9
    Notes
    [8] - P-value was calculated by Fisher’s Exact Test.

    Secondary: Percentage of Participants Achieving Corticosteroid-free Remission at Week 52

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    End point title
    		 Percentage of Participants Achieving Corticosteroid-free Remission at Week 52
    End point description
    Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline(Week 0)who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as complete Mayo score of ≤2 points and no individual subscore >1 point. Mayo score is standard assessment tool to measure ulcerative colitis disease activity in clinical trials. Index consists of 4 subscores:rectal bleeding,stool frequency,findings on endoscopy,and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and complete Mayo score ranges from 0 to 12(higher scores indicate greater disease activity). Participants from FAS, who used concomitant oral corticosteroid at Baseline. FAS included all randomized participants who received at least 1 dose of study drug and who only received induction IV therapy, were not randomized into maintenance phase were not included in FAS;participants analyzed according to randomized treatment assignment.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Number of subjects analysed
    24
    45
    21
    Units: percentage of participants
        number (confidence interval 95%)
    8.3 (1.0 to 27.0)
    28.9 (16.4 to 44.3)
    28.6 (11.3 to 52.2)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Maintenance Phase: Induction IV + Placebo v Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.067 [9]
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    20.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.5
         upper limit
    		 43.7
    Notes
    [9] - P-value was calculated by Fisher’s Exact Test.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Maintenance Phase: Induction IV + Placebo v Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.121 [10]
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    20.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.8
         upper limit
    		 47.8
    Notes
    [10] - P-value was calculated by Fisher’s Exact Test.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline up to 18 weeks after the last dose of study drug (Up to approximately 68 weeks)
    Adverse event reporting additional description
    At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any adverse event reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Open-Label Induction Phase: Vedolizumab 300 mg IV
    Reporting group description
    		 Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 in the open-label induction phase.

    Reporting group title
    Maintenance Phase: Induction IV + Placebo
    Reporting group description
    		 Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 70. Participants received vedolizumab in open-label induction phase and achieved clinical response at Week 6 and were randomized to receive placebo in maintenance phase.

    Reporting group title
    Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
    Reporting group description
    		 Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 77. Participants received vedolizumab in open-label induction phase and achieved clinical response at Week 6 and were randomized to receive vedolizumab SC in maintenance phase.

    Reporting group title
    Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Reporting group description
    		 Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 71. Participants received vedolizumab in open-label induction phase and achieved clinical response at Week 6 and were randomized to receive vedolizumab IV in maintenance phase.

    Serious adverse events
    		 Open-Label Induction Phase: Vedolizumab 300 mg IV Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 167 (10.18%)
    6 / 56 (10.71%)
    10 / 106 (9.43%)
    7 / 54 (12.96%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 56 (1.79%)
    0 / 106 (0.00%)
    0 / 54 (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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Rectal adenocarcinoma
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scapula fracture
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 167 (1.20%)
    1 / 56 (1.79%)
    2 / 106 (1.89%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drug resistance
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    12 / 167 (7.19%)
    5 / 56 (8.93%)
    3 / 106 (2.83%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 5
    1 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary sarcoidosis
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Major depression
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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
    		 Open-Label Induction Phase: Vedolizumab 300 mg IV Maintenance Phase: Induction IV + Placebo Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 167 (20.36%)
    31 / 56 (55.36%)
    42 / 106 (39.62%)
    31 / 54 (57.41%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    3 / 54 (5.56%)
         occurrences all number
    1
    0
    2
    3
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    3 / 54 (5.56%)
         occurrences all number
    0
    0
    1
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 167 (2.99%)
    6 / 56 (10.71%)
    9 / 106 (8.49%)
    0 / 54 (0.00%)
         occurrences all number
    8
    6
    12
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    9 / 167 (5.39%)
    2 / 56 (3.57%)
    5 / 106 (4.72%)
    5 / 54 (9.26%)
         occurrences all number
    10
    2
    5
    5
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    7 / 167 (4.19%)
    14 / 56 (25.00%)
    12 / 106 (11.32%)
    5 / 54 (9.26%)
         occurrences all number
    8
    14
    12
    5
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 56 (1.79%)
    1 / 106 (0.94%)
    3 / 54 (5.56%)
         occurrences all number
    0
    1
    1
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 167 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    3 / 54 (5.56%)
         occurrences all number
    0
    0
    1
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 167 (2.40%)
    1 / 56 (1.79%)
    6 / 106 (5.66%)
    4 / 54 (7.41%)
         occurrences all number
    4
    1
    7
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 167 (2.40%)
    11 / 56 (19.64%)
    11 / 106 (10.38%)
    10 / 54 (18.52%)
         occurrences all number
    4
    13
    15
    14
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 167 (1.80%)
    1 / 56 (1.79%)
    10 / 106 (9.43%)
    2 / 54 (3.70%)
         occurrences all number
    4
    2
    13
    3
    Sinusitis
         subjects affected / exposed
    0 / 167 (0.00%)
    3 / 56 (5.36%)
    1 / 106 (0.94%)
    0 / 54 (0.00%)
         occurrences all number
    0
    4
    1
    0
    Urinary tract infection
         subjects affected / exposed
    5 / 167 (2.99%)
    2 / 56 (3.57%)
    0 / 106 (0.00%)
    4 / 54 (7.41%)
         occurrences all number
    5
    3
    0
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Nov 2015
    The following changes were made in the amendment: a. Additional exploratory objectives and endpoints were added to the protocol to gather alternative clinical data. b. Updates were made in the clinical pharmacology background and PK endpoints which reflect the updated dosing simulation modeling. c. Correction of inconsistencies within the original protocol.
    10 Feb 2016
    The following changes were made in the amendment: a. Benefit:Risk assessment was included in new section 4.3 b. Exploratory endpoints were added to section 5.2.4: Proportion of subjects with clinical response at ≥80% study visits, including the final visit and Proportion of subjects with clinical remission at ≥80% study visits, including the final visit.
    12 May 2016
    The following changes were made in the amendment: a. Correctly assigned the definition of clinical remission. b. Addition of exploratory endpoints. c. Correction to Exclusion Criterion #24, Exclusion Criterion #26 removed as this is a repeat of Exclusion Criterion #4 d. Updated and additional text added to Section 7.3.1 Permitted Medications and Treatments. e. Updates made to schedule of assessments.
    26 Jul 2016
    The following changes were made in the amendment: a. Administrative change made.

    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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    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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