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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

    Summary
    EudraCT number
    		 2017-003229-14
    Trial protocol
    		 DE   GB   LV   CZ   LT   ES   BE   HU   AT   SK   DK   HR   IT   RO  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Feb 2022
    First version publication date
    06 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I6T-MC-AMAN
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03518086
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 16591
    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
    Interim
    Date of interim/final analysis
    21 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jan 2021
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.
    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
    15 Mar 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 11
    Country: Number of subjects enrolled
    Australia: 14
    Country: Number of subjects enrolled
    Austria: 8
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Canada: 34
    Country: Number of subjects enrolled
    China: 18
    Country: Number of subjects enrolled
    Croatia: 2
    Country: Number of subjects enrolled
    Czechia: 55
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    France: 64
    Country: Number of subjects enrolled
    Germany: 39
    Country: Number of subjects enrolled
    Hungary: 23
    Country: Number of subjects enrolled
    India: 83
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Israel: 17
    Country: Number of subjects enrolled
    Italy: 37
    Country: Number of subjects enrolled
    Japan: 137
    Country: Number of subjects enrolled
    Latvia: 30
    Country: Number of subjects enrolled
    Lithuania: 22
    Country: Number of subjects enrolled
    Malaysia: 6
    Country: Number of subjects enrolled
    Mexico: 12
    Country: Number of subjects enrolled
    Netherlands: 11
    Country: Number of subjects enrolled
    Poland: 136
    Country: Number of subjects enrolled
    Romania: 15
    Country: Number of subjects enrolled
    Russian Federation: 107
    Country: Number of subjects enrolled
    Serbia: 21
    Country: Number of subjects enrolled
    Slovakia: 24
    Country: Number of subjects enrolled
    Korea, Republic of: 28
    Country: Number of subjects enrolled
    Spain: 22
    Country: Number of subjects enrolled
    Switzerland: 11
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    Turkey: 11
    Country: Number of subjects enrolled
    Ukraine: 94
    Country: Number of subjects enrolled
    United Kingdom: 18
    Country: Number of subjects enrolled
    United States: 151
    Worldwide total number of subjects
    1281
    EEA total number of subjects
    505
    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)
    1184
    From 65 to 84 years
    97
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were randomized in a 3:1 ratio to 300 milligram (mg) mirikizumab intravenously (IV) every 4 weeks (Q4W) or placebo IV Q4W. Results for maximum extended enrollment (ME2) participants will be posted after the study completion.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo IV Q4W
    Arm description
    		 Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

    Arm title
    		 300 mg Mirikizumab IV Q4W
    Arm description
    		 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    LY3074828
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

    Number of subjects in period 1
    		Placebo IV Q4W 300 mg Mirikizumab IV Q4W
    Started
    322
    959
    Received at Least One Dose of Study Drug
    321
    958
    Completed
    285
    920
    Not completed
    37
    39
         Consent withdrawn by subject
    8
    5
         Insufficient Diary Data
    -
    2
         Non- compliance to Protocol
    -
    1
         Adverse event, non-fatal
    23
    15
         Site Terminated by Sponsor
    -
    1
         Lost to follow-up
    -
    3
         COVID-19 Related Study Disruption
    -
    2
         Lack of efficacy
    5
    5
         Protocol deviation
    1
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo IV Q4W
    Reporting group description
    		 Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

    Reporting group title
    300 mg Mirikizumab IV Q4W
    Reporting group description
    		 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

    Reporting group values
    		 Placebo IV Q4W 300 mg Mirikizumab IV Q4W Total
    Number of subjects
    		 322 959 1281
    Age categorical
    Units: Subjects
    Age continuous
    All randomized participants.
    Units: years
        arithmetic mean (standard deviation)
    		 41.3 ( 13.78 ) 42.8 ( 13.83 ) -
    Gender categorical
    All randomized participants.
    Units: Subjects
        Female
    		 140 367 507
        Male
    		 182 592 774
    Ethnicity (NIH/OMB)
    All randomized participants with non-missing ethnicity data.
    Units: Subjects
        Hispanic or Latino
    		 9 22 31
        Not Hispanic or Latino
    		 27 92 119
        Unknown or Not Reported
    		 286 845 1131
    Race (NIH/OMB)
    All randomized participants.
    Units: Subjects
        American Indian or Alaska Native
    		 2 10 12
        Asian
    		 68 224 292
        Native Hawaiian or Other Pacific Islander
    		 0 1 1
        Black or African American
    		 2 10 12
        White
    		 247 704 951
        More than one race
    		 2 1 3
        Unknown or Not Reported
    		 1 9 10
    Region of Enrollment
    All randomized participants.
    Units: Subjects
        Argentina
    		 3 8 11
        Australia
    		 4 10 14
        Austria
    		 2 6 8
        Belgium
    		 3 6 9
        Canada
    		 11 23 34
        China
    		 2 16 18
        Croatia
    		 1 1 2
        Czechia
    		 20 35 55
        Denmark
    		 0 7 7
        France
    		 15 49 64
        Germany
    		 6 33 39
        Hungary
    		 7 16 23
        India
    		 21 62 83
        Ireland
    		 0 1 1
        Israel
    		 3 14 17
        Italy
    		 12 25 37
        Japan
    		 35 102 137
        Latvia
    		 6 24 30
        Lithuania
    		 6 16 22
        Malaysia
    		 0 6 6
        Mexico
    		 2 10 12
        Netherlands
    		 2 9 11
        Poland
    		 32 104 136
        Romania
    		 2 13 15
        Russia
    		 28 79 107
        Serbia
    		 8 13 21
        Slovakia
    		 3 21 24
        South Korea
    		 5 23 28
        Spain
    		 7 15 22
        Switzerland
    		 2 9 11
        Taiwan
    		 0 3 3
        Turkey
    		 5 6 11
        Ukraine
    		 26 68 94
        United Kingdom
    		 7 11 18
        United States
    		 36 115 151

    End points

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    End points reporting groups
    Reporting group title
    Placebo IV Q4W
    Reporting group description
    		 Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

    Reporting group title
    300 mg Mirikizumab IV Q4W
    Reporting group description
    		 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

    Primary: Percentage of Participants With Clinical Remission at Week 12

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    End point title
    		 Percentage of Participants With Clinical Remission at Week 12
    End point description
    Clinical remission at week 12 is defined as achieving a modified Mayo score (MMS) subscore for rectal bleeding=0,stool frequency=0 or 1 with ≥ 1 point decrease from baseline,and endoscopy=0 or 1 (excluding friability),excluding consideration of Physician's Global Assessment (PGA).Stool frequency subscore,based on the participants (pts) diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal);Rectal bleeding subscore,based on the pts diary and scored from 0 (no blood seen) to 3 (blood alone passed);Endoscopy subscore,based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease,spontaneous bleeding, ulceration).The confidence interval (CI) of 99.875% was chosen to match the significance level. Analysis population description (APD): Modified Intention-to-treat population (mITT): All randomized pts who received at least one dose of study drug and who had MMS measured correctly at baseline.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Placebo IV Q4W 300 mg Mirikizumab IV Q4W
    Number of subjects analysed
    294 [1]
    868 [2]
    Units: percentage of participants
        number (confidence interval 99.88%)
    13.3 (6.9 to 19.6)
    24.2 (19.5 to 28.9)
    Notes
    [1] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    [2] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    Statistical analysis title
    		 Clinical Remission
    Comparison groups
    Placebo IV Q4W v 300 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    1162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00006
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    11.1
    Confidence interval
         level
    		 99.88%
         sides
    2-sided
         lower limit
    		 3.2
         upper limit
    		 19.1

    Secondary: Percentage of Participants With Clinical Response at Week 12

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    End point title
    		 Percentage of Participants With Clinical Response at Week 12
    End point description
    Clinical response at week 12 is defined as decrease in 9-point MMS [rectal bleeding,stool frequency and endoscopic findings] inclusive of >= 2 points and >=30% from baseline with either decrease of rectal bleeding subscore of >=1 or rectal bleeding subscore of 0 or 1.MMS is composite score of ulcerative colitis disease activity calculated as sum of three subscores:Stool frequency subscore, based on pts diary;scored from 0 (normal number of stools) to 3 (5 or more stools than normal);Rectal bleeding subscore, based on pts diary;scored from 0 (no blood seen) to 3 (blood alone passed);Endoscopy subscore, based on colonoscopy or sigmoidoscopy;scored from 0 (normal or inactive disease) to 3 (severe disease,spontaneous bleeding,ulceration).MMS ranges from 0 to 9 points,with higher scores representing more severe disease. CI of 99.875% chosen to match significance level. APD:mITT: All randomized pts who received at least one dose of study drug and who had MMS measured correctly at baseline.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo IV Q4W 300 mg Mirikizumab IV Q4W
    Number of subjects analysed
    294 [3]
    868 [4]
    Units: percentage of participants
        number (confidence interval 99.88%)
    42.2 (32.9 to 51.5)
    63.5 (58.2 to 68.8)
    Notes
    [3] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    [4] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    Statistical analysis title
    		 Clinical Response
    Comparison groups
    Placebo IV Q4W v 300 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    1162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.00001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    21.4
    Confidence interval
         level
    		 99.88%
         sides
    2-sided
         lower limit
    		 10.8
         upper limit
    		 32

    Secondary: Percentage of Participants With Endoscopic Remission at Week 12

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    End point title
    		 Percentage of Participants With Endoscopic Remission at Week 12
    End point description
    Endoscopic remission at week 12 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) 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 Mayo endoscopic score ranges from 0 to 3 points, with higher scores representing more severe disease. The confidence interval of 99.875% was chosen to match the significance level. APD:mITT: All randomized pts who received at least one dose of study drug and who had MMS measured correctly at baseline.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo IV Q4W 300 mg Mirikizumab IV Q4W
    Number of subjects analysed
    294 [5]
    868 [6]
    Units: percentage of participants
        number (confidence interval 99.88%)
    21.1 (13.4 to 28.8)
    36.3 (31.0 to 41.6)
    Notes
    [5] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    [6] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    Statistical analysis title
    		 Endoscopic Remission
    Comparison groups
    Placebo IV Q4W v 300 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    1162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.00001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    15.4
    Confidence interval
         level
    		 99.88%
         sides
    2-sided
         lower limit
    		 6.3
         upper limit
    		 24.5

    Secondary: Percentage of Participants With Symptomatic Remission at Week 12

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    End point title
    		 Percentage of Participants With Symptomatic Remission at Week 12
    End point description
    Symptomatic remission at week 12 is defined as a Mayo subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline. 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 seen) to 3 (blood alone passed). The confidence interval of 99.875% was chosen to match the significance level. APD:mITT: All randomized pts who received at least one dose of study drug and who had MMS measured correctly at baseline.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo IV Q4W 300 mg Mirikizumab IV Q4W
    Number of subjects analysed
    294 [7]
    868 [8]
    Units: percentage of participants
        number (confidence interval 99.88%)
    27.9 (22.8 to 33.0)
    45.5 (42.2 to 48.8)
    Notes
    [7] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    [8] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    Statistical analysis title
    		 Symptomatic Remission
    Comparison groups
    Placebo IV Q4W v 300 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    1162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    17.5
    Confidence interval
         level
    		 99.88%
         sides
    2-sided
         lower limit
    		 11.4
         upper limit
    		 23.6

    Secondary: Percentage of Participants With Symptomatic Response at Week 12

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    End point title
    		 Percentage of Participants With Symptomatic Response at Week 12
    End point description
    Symptomatic response at week 12 is defined as ≥30% decrease from baseline in the sum of stool frequency and rectal bleeding 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 seen) to 3 (blood alone passed). The sum of stool frequency and rectal bleeding subscores ranges from 0 to 6. APD:mITT: All randomized pts who received at least one dose of study drug and who had MMS measured correctly at baseline.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo IV Q4W 300 mg Mirikizumab IV Q4W
    Number of subjects analysed
    294 [9]
    868 [10]
    Units: percentage of participants
        number (confidence interval 95%)
    52.4 (46.7 to 58.1)
    72.0 (69.0 to 75.0)
    Notes
    [9] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    [10] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    Statistical analysis title
    		 Symptomatic Response
    Comparison groups
    Placebo IV Q4W v 300 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    1162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    20.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.8
         upper limit
    		 26.6

    Secondary: Percentage of Participants with Histologic Remission at Week 12

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    End point title
    		 Percentage of Participants with Histologic Remission at Week 12
    End point description
    Histologic remission was assessed using the Geboes histologic scoring system developed for assessment of histologic disease activity in ulcerative colitis. Remission was defined as Geboes histological subscore of 0 for grades: 2b (lamina propria neutrophils), and 3 (neutrophils in epithelium), and 4 (crypt destruction), and 5 (erosion or ulceration). APD:mITT: All randomized pts who received at least one dose of study drug and who had MMS measured correctly at baseline.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo IV Q4W 300 mg Mirikizumab IV Q4W
    Number of subjects analysed
    294 [11]
    868 [12]
    Units: percentage of participants
        number (confidence interval 95%)
    15.6 (11.5 to 19.8)
    29.3 (26.2 to 32.3)
    Notes
    [11] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    [12] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    Statistical analysis title
    		 Histologic Remission
    Comparison groups
    Placebo IV Q4W v 300 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    1162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    13.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.6
         upper limit
    		 18.7

    Secondary: Percentage of Participants With Endoscopic Response at Week 12

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    End point title
    		 Percentage of Participants With Endoscopic Response at Week 12
    End point description
    Endoscopic response at week 12 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore. The Mayo endoscopic subscore ranges from 0 to 3 points, with higher scores representing more severe disease. APD:mITT: All randomized pts who received at least one dose of study drug and who had MMS measured correctly at baseline.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo IV Q4W 300 mg Mirikizumab IV Q4W
    Number of subjects analysed
    294 [13]
    868 [14]
    Units: percentage of participants
        number (confidence interval 95%)
    36.1 (30.6 to 41.5)
    55.4 (52.1 to 58.7)
    Notes
    [13] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    [14] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    Statistical analysis title
    		 Endoscopic Response
    Comparison groups
    Placebo IV Q4W v 300 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    1162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.00001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    19.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.2
         upper limit
    		 25.8

    Secondary: Change from Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)

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    End point title
    		 Change from Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)
    End point description
    The Urgency NRS is a single participant reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency).Higher scores indicate more severe urgency. Least square (LS) Mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: The MMRM model includes: treatment, baseline value, visit, interaction of baseline value-by-visit, interaction of treatment-by-visit, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other). APD:mITT: All randomized pts who received at least one dose of study drug and had a baseline and at least one post-baseline urgency NRS measurement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo IV Q4W 300 mg Mirikizumab IV Q4W
    Number of subjects analysed
    294 [15]
    868 [16]
    Units: score on a scale
        least squares mean (standard error)
    -1.63 ( 0.141 )
    -2.59 ( 0.083 )
    Notes
    [15] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    [16] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    Statistical analysis title
    		 Bowel Urgency based on NRS
    Comparison groups
    Placebo IV Q4W v 300 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    1162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 < 0.00001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.95
    Confidence interval
         level
    		 99.88%
         sides
    2-sided
         lower limit
    		 -1.47
         upper limit
    		 -0.44
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.159
    Notes
    [17] - The confidence interval of 99.875 % was chosen to match the significance level.

    Secondary: Change from Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score

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    End point title
    		 Change from Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
    End point description
    The IBDQ is a 32-item participant-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. Least square (LS) Mean was calculated using analysis of covariance (ANCOVA) model for post-baseline measures: The ANCOVA model includes: treatment, baseline value, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other). APD: mITT: All randomized pts who received at least one dose of study drug and had a baseline and at least one post-baseline IBDQ measurement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo IV Q4W 300 mg Mirikizumab IV Q4W
    Number of subjects analysed
    294 [18]
    868 [19]
    Units: score on a scale
        least squares mean (standard error)
    25.21 ( 1.798 )
    38.42 ( 1.108 )
    Notes
    [18] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    [19] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    Statistical analysis title
    		 IBDQ Total Score
    Comparison groups
    Placebo IV Q4W v 300 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    1162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    13.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.28
         upper limit
    		 17.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.005

    Secondary: Change from Baseline to Week 12 in Fecal Calprotectin

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    End point title
    		 Change from Baseline to Week 12 in Fecal Calprotectin
    End point description
    Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Least square (LS) Mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: The MMRM model includes: treatment, baseline value, visit, interaction of baseline value-by-visit, interaction of treatment-by-visit, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other). APD: mITT: All randomized pts who received at least one dose of study drug and had a baseline and at least one post-baseline urgency fecal calprotectin measurement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo IV Q4W 300 mg Mirikizumab IV Q4W
    Number of subjects analysed
    206 [20]
    665 [21]
    Units: milligram per kilogram (mg/kg)
        least squares mean (standard error)
    -939.69 ( 196.557 )
    -1875.29 ( 116.138 )
    Notes
    [20] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    [21] - Pts analysed per their assigned treatment arm regardless of the treatment they actually received.
    Statistical analysis title
    		 Fecal Calprotectin
    Comparison groups
    Placebo IV Q4W v 300 mg Mirikizumab IV Q4W
    Number of subjects included in analysis
    871
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -935.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1363.64
         upper limit
    		 -507.55
    Variability estimate
    Standard error of the mean
    Dispersion value
    218.09

    Secondary: Pharmacokinetics (PK): Clearance of Mirikizumab

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    End point title
    		 Pharmacokinetics (PK): Clearance of Mirikizumab [22]
    End point description
    Clearance of mirikizumab was evaluated. Clearance is estimated based on concentration data collected in the time frame of 0-12 weeks. APD: All randomized pts who received at least one dose of study drug and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Weeks 0-12
    Notes
    [22] - 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: No inferential statistics were planned or conducted for this endpoint.
    End point values
    		 300 mg Mirikizumab IV Q4W
    Number of subjects analysed
    952
    Units: Liters per Hour (L/h)
        geometric mean (geometric coefficient of variation)
    0.0224 ( 38 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up To 12 Weeks
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    300 mg Mirikizumab IV Q4W
    Reporting group description
    		 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

    Reporting group title
    Placebo IV Q4W
    Reporting group description
    		 Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

    Serious adverse events
    		 300 mg Mirikizumab IV Q4W Placebo IV Q4W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 958 (2.82%)
    17 / 321 (5.30%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    adenocarcinoma of colon
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    uterine leiomyoma
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    spinal compression fracture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal fracture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    arteriosclerosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    deep vein thrombosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    1 / 321 (0.31%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypertension
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 958 (0.00%)
    1 / 321 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    1 / 321 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    vertigo
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    colitis ulcerative
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    8 / 958 (0.84%)
    10 / 321 (3.12%)
         occurrences causally related to treatment / all
    1 / 8
    3 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lower gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    ovarian enlargement
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    penile vein thrombosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 958 (0.00%)
    1 / 321 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    renal colic
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 958 (0.00%)
    1 / 321 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    ankylosing spondylitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    acute sinusitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 958 (0.00%)
    1 / 321 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cytomegalovirus colitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastroenteritis viral
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intestinal sepsis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    klebsiella infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    2 / 958 (0.21%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sinusitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 958 (0.00%)
    1 / 321 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    viral infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    diabetes mellitus
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    malnutrition
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 958 (0.00%)
    1 / 321 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 958 (0.10%)
    0 / 321 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 300 mg Mirikizumab IV Q4W Placebo IV Q4W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 958 (3.24%)
    18 / 321 (5.61%)
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    31 / 958 (3.24%)
    18 / 321 (5.61%)
         occurrences all number
    32
    18

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Sep 2019
    Description of Change: • Made Follicle Stimulating Hormone (FSH) testing optional in women to confirm nonchild-bearing potential. • Additional assessments added to better understand the possible etiology if a drug hypersensitivity event is observed (this includes additional testing on already collected samples). • Updated the schedule of activities to clarify procedures. • Add Major secondary objective for bowel movement urgency improvement; updated secondary objectives; remove mucosal healing and include Ulcerative Colitis Endoscopic Index of Severity (UCEIS) endoscopic remission. • Add to inclusion criteria, additional requirement to confirm UC diagnosis and clarify other criteria. • Clarification of Exclusion Criteria . • Clarification of term “mucosal healing”. • Added that participants who do not have the report of a completed, a full colonoscopy will be available in source documents to establish the extent of the disease; participants with rectal sparing on baseline endoscopy must have documentation of rectal involvement on a prior endoscopy. • Clarification of discussion of the screening colonoscopy. • Added that at Week 12 (or Early Termination Visit), a flexible sigmoidoscopy is recommended for all participants. • Clarified the need for an early term endoscopy. • Clarification of guidance for latent tuberculosis infection (LTBI). • To clarify some Clinical Laboratory procedures and Prohibited Medications to provide clarifications.
    21 Aug 2020
    Due to the COVID-19 public health emergency that prevents the safe conduct of on-site visits or that otherwise disrupts the ability of the investigators to conduct the trial per the requirements of the protocol, an addendum was written to document allowed changes to the protocol to mitigate COVID-19 restrictions.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    24 Mar 2020
    Lilly made the decision to temporarily pause new participant accrual to LUCENT-1 (all countries with the exception of Japan, S.Korea, Taiwan, China). The interactive web-response system (IWRS) was closed to enter new participants at end of day (8 pm United States Pacific Daylight Time) on 25-March-2020. Enrolled participants could continue in the study provided the investigator affirmed that this was safe and in their best interest and in accordance with any local regulations and health advisories pertaining to the containment of the virus. The interruption was lifted May 7, 2020.
    07 May 2020

    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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