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    Clinical Trial Results:
    A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis

    Summary
    EudraCT number
    		 2015-003123-57
    Trial protocol
    		 BE   GB   CZ   HU   NL   LT   DK   PL  
    Global end of trial date
    07 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 May 2020
    First version publication date
    23 May 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I6T-MC-AMAC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02589665
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 15829
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 May 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants with moderate to severe ulcerative colitis (UC). This study will also investigate how the body processes the drug.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Dec 2015
    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
    Belgium: 21
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    Poland: 49
    Country: Number of subjects enrolled
    Georgia: 14
    Country: Number of subjects enrolled
    Lithuania: 9
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    United States: 50
    Country: Number of subjects enrolled
    Czech Republic: 2
    Country: Number of subjects enrolled
    Moldova, Republic of: 24
    Country: Number of subjects enrolled
    Hungary: 18
    Country: Number of subjects enrolled
    Japan: 31
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Canada: 6
    Country: Number of subjects enrolled
    Netherlands: 11
    Worldwide total number of subjects
    249
    EEA total number of subjects
    117
    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)
    232
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No Text Available

    Pre-assignment
    Screening details
    		 No Text Available

    Period 1
    Period 1 title
    Induction Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Induction: Placebo IV Q4W
    Arm description
    		 Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo administered every 4 weeks (Q4W) intravenously (IV).

    Arm title
    		 Induction: 50 mg Mirikizumab IV Q4W
    Arm description
    		 50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).

    Arm title
    		 Induction: 200 mg Mirikizumab IV Q4W
    Arm description
    		 200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).

    Arm title
    		 Induction: 600 mg Mirikizumab IV Q4W
    Arm description
    		 600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).

    Number of subjects in period 1
    		Induction: Placebo IV Q4W Induction: 50 mg Mirikizumab IV Q4W Induction: 200 mg Mirikizumab IV Q4W Induction: 600 mg Mirikizumab IV Q4W
    Started
    63
    63
    62
    61
    Received at least one dose of study drug
    63
    63
    62
    60
    Completed
    60
    61
    60
    57
    Not completed
    3
    2
    2
    4
         Consent withdrawn by subject
    -
    1
    -
    1
         Adverse event, non-fatal
    3
    -
    2
    2
         Did not receive drug
    -
    -
    -
    1
         Protocol deviation
    -
    1
    -
    -
    Period 2
    Period 2 title
    Maintenance Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Maintenance: Placebo SC Q4W
    Arm description
    		 Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo administered subcutaneously (SC) Q4W.

    Arm title
    		 Maintenance: 200 mg Mirikizumab SC Q4W
    Arm description
    		 Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    200 mg mirikizumab administered subcutaneously (SC).

    Arm title
    		 Maintenance: 200 mg Mirikizumab SC Q12W
    Arm description
    		 Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    200 mg mirikizumab administered subcutaneously (SC).

    Number of subjects in period 2
    		Maintenance: Placebo SC Q4W Maintenance: 200 mg Mirikizumab SC Q4W Maintenance: 200 mg Mirikizumab SC Q12W
    Started
    13
    47
    46
    Completed
    0
    0
    0
    Not completed
    13
    47
    46
         Rolled Over to Study AMAP (NCT03519945)
    7
    41
    39
         Consent withdrawn by subject
    4
    2
    4
         Physician decision
    -
    1
    -
         Adverse event, non-fatal
    -
    -
    2
         Reason Not Collected
    -
    1
    1
         Lost to follow-up
    -
    1
    -
         Lack of efficacy
    2
    1
    -
    Period 3
    Period 3 title
    Induction Extension Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Induction Extension: 600mg Mirikizumab IV Q4W
    Arm description
    		 Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    600 mg mirikizumab administered intravenously (IV).

    Arm title
    		 Induction Extension: 1000mg Mirikizumab IV Q4W
    Arm description
    		 Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg mirikizumab administered intravenously (IV).

    Number of subjects in period 3
    		Induction Extension: 600mg Mirikizumab IV Q4W Induction Extension: 1000mg Mirikizumab IV Q4W
    Started
    32
    96
    Completed
    30
    84
    Not completed
    2
    12
         Consent withdrawn by subject
    2
    3
         Physician decision
    -
    1
         Adverse event, non-fatal
    -
    4
         Reason Not Collected
    -
    1
         Lack of efficacy
    -
    3
    Period 4
    Period 4 title
    Maintenance Extension Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 Maintenance Extension: 200mg Mirikizumab SC Q4W
    Arm description
    		 Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    200 mg mirikizumab administered subcutaneously (SC).

    Number of subjects in period 4
    		Maintenance Extension: 200mg Mirikizumab SC Q4W
    Started
    68
    Completed
    0
    Not completed
    68
         Rolled Over to Study AMAP (NCT03519945)
    57
         Consent withdrawn by subject
    4
         Adverse event, non-fatal
    2
         Non-responder
    1
         Lack of efficacy
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Induction: Placebo IV Q4W
    Reporting group description
    		 Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.

    Reporting group title
    Induction: 50 mg Mirikizumab IV Q4W
    Reporting group description
    		 50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

    Reporting group title
    Induction: 200 mg Mirikizumab IV Q4W
    Reporting group description
    		 200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

    Reporting group title
    Induction: 600 mg Mirikizumab IV Q4W
    Reporting group description
    		 600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

    Reporting group values
    		 Induction: Placebo IV Q4W Induction: 50 mg Mirikizumab IV Q4W Induction: 200 mg Mirikizumab IV Q4W Induction: 600 mg Mirikizumab IV Q4W Total
    Number of subjects
    		 63 63 62 61 249
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.62 ( 13.47 ) 41.83 ( 14.06 ) 43.35 ( 14.75 ) 42.44 ( 13.371 ) -
    Gender categorical
    Units: Subjects
        Female
    		 27 25 25 23 100
        Male
    		 36 38 37 38 149
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 3 2 2 7
        Not Hispanic or Latino
    		 60 58 59 54 231
        Unknown or Not Reported
    		 3 2 1 5 11
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 10 5 13 5 33
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 1 1 5 0 7
        White
    		 52 57 44 56 209
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0
    Region of Enrollment
    Units: Subjects
        Hungary
    		 5 3 6 4 18
        Czechia
    		 1 0 0 1 2
        Japan
    		 8 5 13 5 31
        United Kingdom
    		 2 2 0 2 6
        Moldova
    		 5 7 5 7 24
        Canada
    		 2 1 0 3 6
        Netherlands
    		 1 4 4 2 11
        Belgium
    		 4 7 3 7 21
        Denmark
    		 0 0 0 1 1
        Poland
    		 15 14 12 8 49
        Georgia
    		 4 7 2 1 14
        Lithuania
    		 4 1 3 1 9
        Australia
    		 1 3 1 2 7
        United States
    		 11 9 13 17 50

    End points

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    End points reporting groups
    Reporting group title
    Induction: Placebo IV Q4W
    Reporting group description
    		 Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.

    Reporting group title
    Induction: 50 mg Mirikizumab IV Q4W
    Reporting group description
    		 50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

    Reporting group title
    Induction: 200 mg Mirikizumab IV Q4W
    Reporting group description
    		 200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

    Reporting group title
    Induction: 600 mg Mirikizumab IV Q4W
    Reporting group description
    		 600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
    Reporting group title
    Maintenance: Placebo SC Q4W
    Reporting group description
    		 Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.

    Reporting group title
    Maintenance: 200 mg Mirikizumab SC Q4W
    Reporting group description
    		 Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.

    Reporting group title
    Maintenance: 200 mg Mirikizumab SC Q12W
    Reporting group description
    		 Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
    Reporting group title
    Induction Extension: 600mg Mirikizumab IV Q4W
    Reporting group description
    		 Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.

    Reporting group title
    Induction Extension: 1000mg Mirikizumab IV Q4W
    Reporting group description
    		 Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
    Reporting group title
    Maintenance Extension: 200mg Mirikizumab SC Q4W
    Reporting group description
    		 Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label.

    Subject analysis set title
    Placebo IV Q4W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Placebo administered every 4 weeks (Q4W) intravenously (IV).

    Subject analysis set title
    50 mg Mirikizumab IV Q4W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV). Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

    Subject analysis set title
    200 mg Mirikizumab IV Q4W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV). Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

    Subject analysis set title
    600 mg Mirikizumab IV Q4W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV). Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

    Subject analysis set title
    Placebo SC Q4W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Placebo administered subcutaneously (SC) Q4W during the maintenance period.

    Subject analysis set title
    200 mg Mirikizumab SC Q4W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.

    Subject analysis set title
    200 mg Mirikizumab SC Q12W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period

    Primary: Induction Period: Percentage of Participants with Clinical Remission at Week 12

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    End point title
    		 Induction Period: Percentage of Participants with Clinical Remission at Week 12
    End point description
    Clinical remission at week 12 is a defined as achieving a 9-pt Mayo subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1, excluding PGA. •Stool Frequency Subscore , based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); •Rectal Bleeding Subscore , based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); •Endoscopy Subscore , based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); •Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from zero (normal) to 3 (severe disease). The total score ranges from 0 to 9 points, with higher scores representing more severe disease.
    End point type
    Primary
    End point timeframe
    Week 12 Analysis Population Description: All randomized participants.
    End point values
    		 Induction: Placebo IV Q4W Induction: 50 mg Mirikizumab IV Q4W Induction: 200 mg Mirikizumab IV Q4W Induction: 600 mg Mirikizumab IV Q4W
    Number of subjects analysed
    63
    63
    62
    61
    Units: percentage of participants
        number (confidence interval 95%)
    4.8 (0.0 to 10.0)
    15.9 (6.8 to 24.9)
    22.6 (12.2 to 33.0)
    11.5 (3.5 to 19.5)
    Statistical analysis title
    		 Induction Period: Clinical Remission at Week 12
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 600 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 12.27
    Statistical analysis title
    		 Induction Period: Clinical Remission at Week 12
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 200 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    7.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.88
         upper limit
    		 27.65
    Statistical analysis title
    		 Induction Period: Clinical Remission at Week 12
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 50 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 14.17

    Secondary: Induction Period: Percentage of Participants with Clinical Response at Week 12

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    End point title
    		 Induction Period: Percentage of Participants with Clinical Response at Week 12
    End point description
    Clinical response at week 12 is defined as a decrease in the 9-point Mayo subscores (rectal bleeding, stool frequency and the endoscopic findings) inclusive of >= 2 points and >=35% from baseline with either a decrease of rectal bleeding subscore of >=1 or rectal bleeding subscore of 0 or 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores: •Stool Frequency Subscore , based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); •Rectal Bleeding Subscore, based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); •Endoscopy Subscore , based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); The total score ranges from 0 to 9 points, with higher scores representing more severe disease.
    End point type
    Secondary
    End point timeframe
    Week 12 Analysis Population Description: All randomized participants.
    End point values
    		 Induction: Placebo IV Q4W Induction: 50 mg Mirikizumab IV Q4W Induction: 200 mg Mirikizumab IV Q4W Induction: 600 mg Mirikizumab IV Q4W
    Number of subjects analysed
    63
    63
    62
    61
    Units: percentage of participants
        number (confidence interval 95%)
    20.6 (10.6 to 30.6)
    41.3 (29.1 to 53.4)
    59.7 (47.5 to 71.9)
    49.2 (36.6 to 61.7)
    Statistical analysis title
    		 Induction Period: Clinical Response at Week 12
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 600 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.73
         upper limit
    		 8.98
    Statistical analysis title
    		 Induction Period: Clinical Response at Week 12
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 200 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    6.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.94
         upper limit
    		 15.63
    Statistical analysis title
    		 Induction Period: Clinical Response at Week 12
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 50 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.23
         upper limit
    		 6.29

    Secondary: Induction Period: Percentage of Participants with Endoscopic Remission at Week 12

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    End point title
    		 Induction Period: Percentage of Participants with Endoscopic Remission at Week 12
    End point description
    Endoscopic remission at week 12 is defined as achieving a Mayo endoscopic score of 0 at Week 12. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); The total score ranges from 0 to 3 points, with higher scores representing more severe disease. Analysis Population Description: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Induction: Placebo IV Q4W Induction: 50 mg Mirikizumab IV Q4W Induction: 200 mg Mirikizumab IV Q4W Induction: 600 mg Mirikizumab IV Q4W
    Number of subjects analysed
    63
    63
    62
    61
    Units: percentage of participants
        number (confidence interval 95%)
    1.6 (0.0 to 4.7)
    3.2 (0.0 to 7.5)
    3.2 (0.0 to 7.6)
    1.6 (0.0 to 4.8)
    Statistical analysis title
    		 Induction Period: Endoscopic Remission at Week 12
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 600 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.986
    Method
    		 Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Induction Period: Endoscopic Remission at Week 12
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 200 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.553
    Method
    		 Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Induction Period: Endoscopic Remission at Week 12
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 50 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.56
    Method
    		 Mantel-Haenszel
    Confidence interval

    Secondary: Maintenance period: Percentage of Participants with Endoscopic Remission at Week 52

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    End point title
    		 Maintenance period: Percentage of Participants with Endoscopic Remission at Week 52
    End point description
    Endoscopic remission at week 52 is defined as achieving a Mayo endoscopic subscore of 0 at Week 52. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); The total score ranges from 0 to 3 points, with higher scores representing more severe disease. Analysis Population Description: All randomized participants in maintenance period.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Maintenance: Placebo SC Q4W Maintenance: 200 mg Mirikizumab SC Q4W Maintenance: 200 mg Mirikizumab SC Q12W
    Number of subjects analysed
    13
    47
    46
    Units: percentage of participants
        number (confidence interval 95%)
    7.7 (0.0 to 22.2)
    14.9 (4.7 to 25.1)
    28.3 (15.2 to 41.3)
    Statistical analysis title
    		 Maintenance period:Endoscopic Remission at Week 52
    Comparison groups
    Maintenance: 200 mg Mirikizumab SC Q4W v Maintenance: 200 mg Mirikizumab SC Q12W
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 6.55

    Secondary: Induction Period: Change from Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score

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    End point title
    		 Induction Period: Change from Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
    End point description
    The IBDQ is a 32-item subject-completed questionnaire that measures 4 aspects of subjects’ lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function (Guyatt et al. 1989). Responses are graded on a 7-point. Likert scale in which 7 denotes “not a problem at all” and 1 denotes “a very severe problem.” Scores range from 32 to 224; a higher score indicates a better quality of life. LS Mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Geographical Region + Prior Biologic Therapy Group (N) + Treatment + Time + Treatment*Time (Type III sum of squares). Analysis Population Description: All randomized participants who had a baseline and at least one post-baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Induction: Placebo IV Q4W Induction: 50 mg Mirikizumab IV Q4W Induction: 200 mg Mirikizumab IV Q4W Induction: 600 mg Mirikizumab IV Q4W
    Number of subjects analysed
    60
    60
    60
    56
    Units: score on a scale
        least squares mean (standard error)
    22.3 ( 4.41 )
    33.0 ( 4.52 )
    42.8 ( 4.40 )
    45.2 ( 4.54 )
    Statistical analysis title
    		 Induction Period: IBDQ Total Score
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 600 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    22.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11
         upper limit
    		 34.9
    Statistical analysis title
    		 Induction Period: IBDQ Total Score
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 200 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    20.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.7
         upper limit
    		 32.3
    Statistical analysis title
    		 Induction Period: IBDQ Total Score
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 50 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 22.5

    Secondary: Induction Period: Change from Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)

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    End point title
    		 Induction Period: Change from Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
    End point description
    SF-36 Health Status Survey is a generic, health-related scale assessing participant’s quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-15); social functioning (range: 2-10); bodily pain (range: 2-12); vitality (range: 4-20); mental health (range: 5-25). Each raw scale score was converted to a scale score ranging from 0-100 points, with higher values representing a better outcome [(Raw score) − min{raw score}] / (max {raw score} − min{raw score}) x 100]. LS Mean was calculated using Mixed effect Model Repeat Measurement (MMRM) model for post-baseline measures: Variable = Baseline + Geographical Region + Prior Biologic Therapy Group (N) + Treatment + Time + Treatment*Time (Type III sum of squares).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 Analysis Population Description: All randomized participants who had a baseline and at least one post-baseline value.
    End point values
    		 Induction: Placebo IV Q4W Induction: 50 mg Mirikizumab IV Q4W Induction: 200 mg Mirikizumab IV Q4W Induction: 600 mg Mirikizumab IV Q4W
    Number of subjects analysed
    60
    60
    60 [1]
    56
    Units: score on a scale
    least squares mean (standard error)
        Physical Component Score
    3.4 ( 0.83 )
    6.2 ( 0.86 )
    5.9 ( 0.83 )
    6.9 ( 0.85 )
        Mental Component Score
    3.2 ( 1.22 )
    4.5 ( 1.26 )
    6.8 ( 1.20 )
    8.8 ( 1.25 )
        Physical Functioning
    2.1 ( 0.76 )
    3.7 ( 0.78 )
    4.6 ( 0.74 )
    6.2 ( 0.77 )
        Role-Physical
    4.5 ( 1.19 )
    7.5 ( 1.22 )
    7.2 ( 1.17 )
    8.0 ( 1.22 )
        Bodily Pain
    3.7 ( 1.15 )
    7.9 ( 1.18 )
    8.9 ( 1.14 )
    10.0 ( 1.18 )
        General Health
    3.1 ( 0.93 )
    3.8 ( 0.96 )
    4.3 ( 0.92 )
    5.1 ( 0.96 )
        Vitality
    3.3 ( 1.25 )
    6.5 ( 1.28 )
    7.5 ( 1.23 )
    9.7 ( 1.28 )
        Social Functioning
    6.5 ( 1.22 )
    8.0 ( 1.26 )
    9.4 ( 1.21 )
    11.6 ( 1.26 )
        Role-Emotional
    3.0 ( 1.22 )
    3.7 ( 1.26 )
    5.5 ( 1.20 )
    7.6 ( 1.25 )
        Mental Health
    1.9 ( 1.18 )
    3.7 ( 1.22 )
    6.4 ( 1.17 )
    7.6 ( 1.21 )
    Notes
    [1] - Physical Component Score and Mental Component Score n=59.
    No statistical analyses for this end point

    Secondary: Induction Period: Change from Baseline to Week 12 in Patient's Global Impressions of Severity (PGI-S) Score

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    End point title
    		 Induction Period: Change from Baseline to Week 12 in Patient's Global Impressions of Severity (PGI-S) Score
    End point description
    PGI-S is a 1-item subject-rated questionnaire designed to assess the subject’s impression of their disease symptoms at baseline (Guy 1976; Yalcin and Bump 2003). Responses are graded on a 7-point scale in which a score of 1 indicates that the subject’s symptom(s) are “normal,” a score of 2 indicates that the subject feels “borderline ill,” a score of 3 indicates that the subject feels “mildly ill,” a score of 4 indicates that the subject(s) feel “moderately ill,” and scores of 5, 6, and 7 indicate that the subject feels “markedly ill,” “severely ill,” and “extremely ill,” respectively. LS Mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Geographical Region + Prior Biologic Therapy Group (N) + Treatment + Time + Treatment*Time (Type III sum of squares). Analysis Population Description: Induction Period: All randomized participants who had a baseline and at least one post-baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Induction: Placebo IV Q4W Induction: 50 mg Mirikizumab IV Q4W Induction: 200 mg Mirikizumab IV Q4W Induction: 600 mg Mirikizumab IV Q4W
    Number of subjects analysed
    60
    60
    60
    56
    Units: score on a scale
        least squares mean (standard error)
    -0.84 ( 0.19 )
    -1.43 ( 0.20 )
    -1.90 ( 0.18 )
    -1.74 ( 0.19 )
    Statistical analysis title
    		 Induction Period: PGI-S Score
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 600 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.39
         upper limit
    		 -0.41
    Statistical analysis title
    		 Induction Period: PGI-S Score
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 200 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.54
         upper limit
    		 -0.59
    Statistical analysis title
    		 Induction Period: PGI-S Score
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 50 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.07
         upper limit
    		 -0.11

    Secondary: Induction Period: Patient's Global Impressions of Improvement (PGI-I) Score at Week 12

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    End point title
    		 Induction Period: Patient's Global Impressions of Improvement (PGI-I) Score at Week 12
    End point description
    PGI-I scale is a subject-rated instrument designed to assess the subject’s impression of change in their symptom(s) (Guy 1976; Yalcin and Bump 2003). Responses are graded on a 7-point Likert scale in which a score of 1 indicates that the subject’s symptom(s) is “very much better,” a score of 4 indicates that the subject’s symptom(s) has experienced “no change,” and a score of 7 indicates that the subject’s symptom(s) is “very much worse.” Analysis Population Description: All randomized participants who had a baseline and at least one post-baseline PGI-I value.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Induction: Placebo IV Q4W Induction: 50 mg Mirikizumab IV Q4W Induction: 200 mg Mirikizumab IV Q4W Induction: 600 mg Mirikizumab IV Q4W
    Number of subjects analysed
    63
    62
    61
    60
    Units: score on a scale
        arithmetic mean (standard deviation)
    3.37 ( 1.46 )
    2.69 ( 1.31 )
    2.39 ( 0.99 )
    2.53 ( 1.16 )
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, tau) of Mirikizumab

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    End point title
    		 Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, tau) of Mirikizumab [2]
    End point description
    Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, tau) of Mirikizumab Analysis Population Description: All participants who received at least one dose of mirikizumab in the induction and maintenance period.
    End point type
    Secondary
    End point timeframe
    Induction Period: Day (D) 1, D15 ± 2d, D29 ± 2d, D43 ± 2d, D57 ± 2d, D78-85; Maintenance Period: D85-92,D113± 7d,D141± 7d,D169± 7d,D225 ±7d,D281 ±7d,D337 ±7d,D393± 7d,D448± 7d,D504± 7d,D560± 7d,D616± 7d,D672± 7d,D728± 7d,D784± 7d,D840± 7d
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, not all arms were reported for PK data.
    End point values
    		 Induction: 50 mg Mirikizumab IV Q4W Induction: 200 mg Mirikizumab IV Q4W Induction: 600 mg Mirikizumab IV Q4W Maintenance: 200 mg Mirikizumab SC Q4W Maintenance: 200 mg Mirikizumab SC Q12W
    Number of subjects analysed
    63
    62
    61
    47
    46
    Units: Microgram*hour/ml (ug*hr/ml)
        geometric mean (geometric coefficient of variation)
    3330 ( 42.5 )
    10100 ( 35.0 )
    24900 ( 36.6 )
    3700 ( 41.5 )
    1270 ( 42.3 )
    No statistical analyses for this end point

    Secondary: Induction Period: Percentage of Participants With Symptomatic Remission at Week 12

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    End point title
    		 Induction Period: Percentage of Participants With Symptomatic Remission at Week 12
    End point description
    Symptomatic remission is defined as a stool frequency score of 0 or 1 and a rectal bleeding score of 0. •Stool Frequency Subscore is based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal). •Rectal Bleeding Subscore is based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed). The total score ranges from 0 to 1 points, with higher scores representing more severe disease. The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100. Analysis Population Description: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Induction: Placebo IV Q4W Induction: 50 mg Mirikizumab IV Q4W Induction: 200 mg Mirikizumab IV Q4W Induction: 600 mg Mirikizumab IV Q4W
    Number of subjects analysed
    63
    63
    62
    61
    Units: percentage of participants
        number (confidence interval 95%)
    20.6 (10.6 to 30.6)
    36.5 (24.6 to 48.4)
    58.1 (45.8 to 70.3)
    45.9 (33.4 to 58.4)
    Statistical analysis title
    		 Participants With Symptomatic Remission at Week 12
    Comparison groups
    Induction: 600 mg Mirikizumab IV Q4W v Induction: Placebo IV Q4W
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.57
         upper limit
    		 8.31
    Statistical analysis title
    		 Participants With Symptomatic Remission at Week 12
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 200 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    6.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.81
         upper limit
    		 15.2
    Statistical analysis title
    		 Participants With Symptomatic Remission at Week 12
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 50 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.054
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 5.22

    Secondary: Maintenance Period: Percentage of Participants With Symptomatic Remission at Week 52

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    End point title
    		 Maintenance Period: Percentage of Participants With Symptomatic Remission at Week 52
    End point description
    Symptomatic remission is defined as a stool frequency score of 0 or 1 and a rectal bleeding score of 0. •Stool Frequency Subscore , based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); •Rectal Bleeding Subscore , based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); •Endoscopy Subscore , based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); •Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from zero (normal) to 3 (severe disease). The total score ranges from 0 to 1 points, with higher scores representing more severe disease. The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.
    End point type
    Secondary
    End point timeframe
    Week 52 Analysis Population Description: All randomized participants in maintenance period.
    End point values
    		 Maintenance: Placebo SC Q4W Maintenance: 200 mg Mirikizumab SC Q4W Maintenance: 200 mg Mirikizumab SC Q12W
    Number of subjects analysed
    13
    47
    46
    Units: Percentage of Participants
        number (confidence interval 95%)
    53.8 (26.7 to 80.9)
    76.6 (64.5 to 88.7)
    65.2 (51.5 to 79.0)
    Statistical analysis title
    		 Participants With Symptomatic Remission at Week 52
    Comparison groups
    Maintenance: 200 mg Mirikizumab SC Q12W v Maintenance: 200 mg Mirikizumab SC Q4W
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.131
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.19
         upper limit
    		 1.24

    Secondary: Induction Period: Percentage of Participants With Endoscopic Improvement at Week 12

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    End point title
    		 Induction Period: Percentage of Participants With Endoscopic Improvement at Week 12
    End point description
    Endoscopic Improvement defined as achieving an endoscopic findings subscore of 0 or 1. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100. Analysis Population Description: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Induction: Placebo IV Q4W Induction: 50 mg Mirikizumab IV Q4W Induction: 200 mg Mirikizumab IV Q4W Induction: 600 mg Mirikizumab IV Q4W
    Number of subjects analysed
    63
    63
    62
    61
    Units: Percentage of participants
        number (confidence interval 95%)
    6.3 (0.3 to 12.4)
    23.8 (13.3 to 34.3)
    30.6 (19.2 to 42.1)
    13.1 (4.6 to 21.6)
    Statistical analysis title
    		 Participants With Endoscopic Improvement at Week12
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 600 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.215
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 8.07
    Statistical analysis title
    		 Participants With Endoscopic Improvement at Week12
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 200 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.37
         upper limit
    		 25
    Statistical analysis title
    		 Participants With Endoscopic Improvement at Week12
    Comparison groups
    Induction: Placebo IV Q4W v Induction: 50 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.41
         upper limit
    		 15.14

    Secondary: Maintenance Period: Percentage of Participants With Endoscopic Improvement at Week 52

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    End point title
    		 Maintenance Period: Percentage of Participants With Endoscopic Improvement at Week 52
    End point description
    Endoscopic Improvement defined as achieving an endoscopic findings subscore of 0 or 1. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100. Analysis Population Description: All randomized participants in maintenance period.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Maintenance: Placebo SC Q4W Maintenance: 200 mg Mirikizumab SC Q4W Maintenance: 200 mg Mirikizumab SC Q12W
    Number of subjects analysed
    13
    47
    46
    Units: Percentage of Participants
        number (confidence interval 95%)
    15.4 (0.0 to 35.0)
    57.4 (43.3 to 71.6)
    47.8 (33.4 to 62.3)
    Statistical analysis title
    		 Participants With Endoscopic Improvement at Week52
    Comparison groups
    Maintenance: 200 mg Mirikizumab SC Q12W v Maintenance: 200 mg Mirikizumab SC Q4W
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.428
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.31
         upper limit
    		 1.65

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up To 39 Months
    Adverse event reporting additional description
    All participants who received at least one dose of study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Induction: Placebo IV Q4W
    Reporting group description
    		 Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.

    Reporting group title
    Induction: 50 mg Mirikizumab Administered Every 4 Weeks (Q4W)
    Reporting group description
    		 50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

    Reporting group title
    Induction: 200 mg Mirikizumab IV Q4W
    Reporting group description
    		 200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

    Reporting group title
    Induction: 600 mg Mirikizumab IV Q4W
    Reporting group description
    		 600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

    Reporting group title
    Maintenance: Placebo SC Q4W
    Reporting group description
    		 Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.

    Reporting group title
    Maintenance: 200 mg Mirikizumab SC Q4W
    Reporting group description
    		 Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.

    Reporting group title
    Maintenance: 200 mg Mirikizumab SC Q12W
    Reporting group description
    		 Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.

    Reporting group title
    Induction Extension: 600mg Mirikizumab IV Q4W
    Reporting group description
    		 Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.

    Reporting group title
    Induction Extension:1000mg Mirikizumab IV Q4W
    Reporting group description
    		 Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.

    Reporting group title
    Maintenance Extension: 200mg Mirikizumab SC Q4W
    Reporting group description
    		 Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label.

    Serious adverse events
    		 Induction: Placebo IV Q4W Induction: 50 mg Mirikizumab Administered Every 4 Weeks (Q4W) Induction: 200 mg Mirikizumab IV Q4W Induction: 600 mg Mirikizumab IV Q4W Maintenance: Placebo SC Q4W Maintenance: 200 mg Mirikizumab SC Q4W Maintenance: 200 mg Mirikizumab SC Q12W Induction Extension: 600mg Mirikizumab IV Q4W Induction Extension:1000mg Mirikizumab IV Q4W Maintenance Extension: 200mg Mirikizumab SC Q4W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 63 (3.17%)
    0 / 63 (0.00%)
    2 / 62 (3.23%)
    3 / 60 (5.00%)
    2 / 13 (15.38%)
    2 / 47 (4.26%)
    1 / 46 (2.17%)
    1 / 32 (3.13%)
    5 / 96 (5.21%)
    3 / 68 (4.41%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    breast neoplasm
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    1 / 32 (3.13%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rectal cancer
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    2 / 96 (2.08%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    squamous cell carcinoma of skin
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    1 / 60 (1.67%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    platelet count increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    1 / 96 (1.04%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    head injury
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hip fracture
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    transient ischaemic attack
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    colitis ulcerative
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    1 / 60 (1.67%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    1 / 46 (2.17%)
    0 / 32 (0.00%)
    2 / 96 (2.08%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intestinal obstruction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    large intestine perforation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    drug dependence
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    polyarthritis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    1 / 96 (1.04%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    clostridium difficile infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
    1 / 60 (1.67%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    streptococcal bacteraemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Induction: Placebo IV Q4W Induction: 50 mg Mirikizumab Administered Every 4 Weeks (Q4W) Induction: 200 mg Mirikizumab IV Q4W Induction: 600 mg Mirikizumab IV Q4W Maintenance: Placebo SC Q4W Maintenance: 200 mg Mirikizumab SC Q4W Maintenance: 200 mg Mirikizumab SC Q12W Induction Extension: 600mg Mirikizumab IV Q4W Induction Extension:1000mg Mirikizumab IV Q4W Maintenance Extension: 200mg Mirikizumab SC Q4W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 63 (28.57%)
    14 / 63 (22.22%)
    8 / 62 (12.90%)
    14 / 60 (23.33%)
    11 / 13 (84.62%)
    27 / 47 (57.45%)
    30 / 46 (65.22%)
    9 / 32 (28.13%)
    8 / 96 (8.33%)
    30 / 68 (44.12%)
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    4 / 47 (8.51%)
    2 / 46 (4.35%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    4
    2
    0
    0
    0
    General disorders and administration site conditions
    fatigue
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    2 / 13 (15.38%)
    1 / 47 (2.13%)
    3 / 46 (6.52%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    1
    6
    0
    0
    0
    injection site pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    2 / 13 (15.38%)
    3 / 47 (6.38%)
    2 / 46 (4.35%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    14
    2
    0
    0
    0
    injection site reaction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    3 / 47 (6.38%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    Reproductive system and breast disorders
    breast mass
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    vaginal haemorrhage
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [1]
    0 / 27 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 22 (0.00%)
    1 / 5 (20.00%)
    0 / 20 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 33 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 63 (6.35%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    2 / 60 (3.33%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    4
    0
    0
    2
    0
    0
    0
    0
    0
    0
    epistaxis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Investigations
    vitamin b12 decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    vitamin d decreased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    weight increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    contusion
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Cardiac disorders
    tachycardia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 63 (4.76%)
    3 / 63 (4.76%)
    1 / 62 (1.61%)
    4 / 60 (6.67%)
    1 / 13 (7.69%)
    5 / 47 (10.64%)
    3 / 46 (6.52%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    3
    3
    1
    5
    1
    9
    3
    0
    0
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 63 (4.76%)
    4 / 63 (6.35%)
    2 / 62 (3.23%)
    2 / 60 (3.33%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    3
    4
    2
    2
    0
    0
    0
    0
    0
    0
    leukocytosis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    abdominal distension
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    2 / 47 (4.26%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    3
    0
    0
    0
    0
    abdominal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    1 / 47 (2.13%)
    2 / 46 (4.35%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    2
    0
    0
    0
    abdominal pain upper
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    4 / 68 (5.88%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    colitis ulcerative
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    6 / 63 (9.52%)
    2 / 63 (3.17%)
    1 / 62 (1.61%)
    1 / 60 (1.67%)
    7 / 13 (53.85%)
    4 / 47 (8.51%)
    7 / 46 (15.22%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    7 / 68 (10.29%)
         occurrences all number
    6
    2
    1
    1
    10
    4
    7
    0
    0
    7
    constipation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    1 / 47 (2.13%)
    1 / 46 (2.17%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    1
    0
    0
    0
    diarrhoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    3 / 47 (6.38%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    5
    0
    0
    0
    0
    dyspepsia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    flatulence
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    haematochezia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    1 / 46 (2.17%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    mucous stools
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    1 / 46 (2.17%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    nausea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 63 (6.35%)
    2 / 63 (3.17%)
    2 / 62 (3.23%)
    3 / 60 (5.00%)
    2 / 13 (15.38%)
    3 / 47 (6.38%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    5
    2
    2
    3
    2
    3
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    acne
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    1 / 46 (2.17%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    dry skin
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    2 / 32 (6.25%)
    1 / 96 (1.04%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    rash
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    1 / 47 (2.13%)
    1 / 46 (2.17%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    1
    0
    0
    0
    Renal and urinary disorders
    stress urinary incontinence
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    6 / 47 (12.77%)
    1 / 46 (2.17%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    9
    1
    0
    0
    0
    back pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    3 / 13 (23.08%)
    1 / 47 (2.13%)
    3 / 46 (6.52%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    6 / 68 (8.82%)
         occurrences all number
    0
    0
    0
    0
    3
    1
    3
    0
    0
    7
    myalgia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    5 / 68 (7.35%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    5
    spinal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    1 / 47 (2.13%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    clostridium difficile infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    cystitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    2 / 47 (4.26%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    gastroenteritis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    4 / 47 (8.51%)
    1 / 46 (2.17%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    4
    1
    0
    0
    0
    herpes zoster
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    2 / 13 (15.38%)
    1 / 47 (2.13%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    influenza
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    3 / 47 (6.38%)
    4 / 46 (8.70%)
    3 / 32 (9.38%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    5
    5
    3
    0
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    6 / 63 (9.52%)
    5 / 63 (7.94%)
    3 / 62 (4.84%)
    5 / 60 (8.33%)
    1 / 13 (7.69%)
    6 / 47 (12.77%)
    8 / 46 (17.39%)
    5 / 32 (15.63%)
    7 / 96 (7.29%)
    14 / 68 (20.59%)
         occurrences all number
    7
    5
    3
    5
    2
    12
    10
    5
    8
    21
    pharyngitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    2 / 47 (4.26%)
    3 / 46 (6.52%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    4
    0
    0
    0
    pneumonia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    0 / 47 (0.00%)
    0 / 46 (0.00%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    sinusitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 13 (0.00%)
    1 / 47 (2.13%)
    4 / 46 (8.70%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    4 / 68 (5.88%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    5
    0
    0
    8
    upper respiratory tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    3 / 13 (23.08%)
    5 / 47 (10.64%)
    3 / 46 (6.52%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    6 / 68 (8.82%)
         occurrences all number
    0
    0
    0
    0
    7
    7
    3
    0
    0
    7
    urinary tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 13 (7.69%)
    1 / 47 (2.13%)
    3 / 46 (6.52%)
    0 / 32 (0.00%)
    0 / 96 (0.00%)
    0 / 68 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    3
    4
    0
    0
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Oct 2016
    Amendment b: Change in dosing of the Investigational Medicinal Product (IMP) in the extension phase from 600mg IV to 1000mg IV.

    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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