A Study of Mirikizumab (LY3074828) in Participants With M... | NCT02589665 | Trialant
NCT02589665
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jun 17, 2020Actual
Enrollment
249Actual
Phase
Phase 2
Conditions
Ulcerative Colitis
Interventions
Mirikizumab
Placebo
Countries
United States
Australia
Belgium
Canada
Czechia
Denmark
France
Georgia
Hungary
Japan
Lithuania
Moldova
Netherlands
Poland
Romania
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02589665
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15829
Secondary IDs
ID
Type
Description
Link
I6T-MC-AMAC
Other Identifier
Eli Lilly and Company
2015-003123-57
EudraCT Number
Brief Title
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis
Official Title
A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jun 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 9, 2015Actual
Primary Completion Date
Dec 19, 2017Actual
Completion Date
May 7, 2019Actual
First Submitted Date
Oct 27, 2015
First Submission Date that Met QC Criteria
Oct 27, 2015
First Posted Date
Oct 28, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
May 7, 2020
Results First Submitted that Met QC Criteria
May 7, 2020
Results First Posted Date
May 29, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 30, 2018
Certification/Extension First Submitted that Passed QC Review
Dec 3, 2018
Certification/Extension First Posted Date
Dec 4, 2018Actual
Last Update Submitted Date
Jun 10, 2020
Last Update Posted Date
Jun 17, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
Detailed Description
Not provided
Conditions Module
Conditions
Ulcerative Colitis
Keywords
IL-23 antibody
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
249Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
50 mg Mirikizumab IV Q4W (Induction)
Experimental
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.
Drug: Mirikizumab
200 mg Mirikizumab IV Q4W (induction)
Experimental
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.
Drug: Mirikizumab
600 mg Mirikizumab IV Q4W (Induction)
Experimental
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.
Drug: Mirikizumab
Placebo IV Q4W (Induction)
Placebo Comparator
Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Drug: Placebo
200 mg Mirikizumab SC Q4W (Maintenance)
Experimental
Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Mirikizumab
Drug
1000mg Mirikizumab IV Q4W Extension Open-Label
200 mg Mirikizumab IV Q4W (induction)
200 mg Mirikizumab SC Q12W (Maintenance)
200 mg Mirikizumab SC Q4W (Maintenance)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Induction Period: Percentage of Participants With Clinical Remission at Week 12
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 Physician's Global Assessment (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 0 (normal) to 3 (severe disease).
The total score ranges from 0 to 9 points, with higher scores representing more severe disease.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Induction Period: Percentage of Participants With Clinical Response at Week 12
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have moderate to severe active UC as defined by a Mayo score of 6 to 12 with an endoscopic subscore ≥2 within 14 days before the first dose of study treatment (note: a partial Mayo score of at least 4 and other eligibility criteria must have been met before endoscopy is performed as a study procedure)
Have evidence of UC extending proximal to the rectum (≥15 centimeters [cm] of involved colon)
Up-to-date colorectal cancer surveillance (performed according to local standard), for subjects with family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor
Participants must either: be naive to biologic therapy (eg, tumor necrosis factor [TNF] antagonists or vedolizumab) and have at least 1 of the following: inadequate response or failure to tolerate current treatment with oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine) or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) OR have received treatment with 1 or more biologic agents (eg, TNF antagonists or vedolizumab) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment
Exclusion Criteria:
Have been diagnosed with indeterminate colitis, proctitis (distal disease involving the rectum only; less than 15 cm from the anal verge) or Crohn's Disease
Have had surgery for treatment of UC or are likely to require surgery for UC during the study
Have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening, corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 30 days of screening
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Chua L, Friedrich S, Zhang XC. Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. Clin Pharmacokinet. 2023 Oct;62(10):1479-1491. doi: 10.1007/s40262-023-01281-z. Epub 2023 Aug 23.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
FG001
Induction: 50 mg Mirikizumab IV Q4W
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.
Periods
Title
Milestones
Reasons Not Completed
Induction Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
SAP
No
Yes
No
Statistical Analysis Plan
Jan 29, 2018
May 5, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Puerto Rico
Russia
Ukraine
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Mirikizumab
200 mg Mirikizumab SC Q12W (Maintenance)
Experimental
Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
Drug: Mirikizumab
Placebo SC Q4W (Maintenance)
Placebo Comparator
Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.
Drug: Placebo
600mg Mirikizumab IV Q4W Extension Open-Label
Experimental
Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
Drug: Mirikizumab
1000mg Mirikizumab IV Q4W Extension Open-Label
Experimental
Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
Drug: Mirikizumab
200mg Mirikizumab SC Q4W Extension Open-Label
Experimental
Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label
Drug: Mirikizumab
200mg Mirikizumab SC Q4W Extension Open-Label
50 mg Mirikizumab IV Q4W (Induction)
600 mg Mirikizumab IV Q4W (Induction)
600mg Mirikizumab IV Q4W Extension Open-Label
LY3074828
Placebo
Drug
Placebo IV Q4W (Induction)
Placebo SC Q4W (Maintenance)
Week 12
Induction Period: Percentage of Participants With Endoscopic Remission at Week 12
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.
Week 12
Maintenance Period: Percentage of Participants With Endoscopic Remission at Week 52
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.
Week 52
Induction Period: Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
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).
Baseline, Week 12
Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
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).
Baseline, Week 12
Induction Period: Change From Baseline to Week 12 in Patient's Global Impressions of Severity (PGI-S) Score
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).
Baseline, Week 12
Induction Period: Patient's Global Impressions of Improvement (PGI-I) Score at Week 12
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."
Week 12
Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, Tau) of Mirikizumab
Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, tau) of Mirikizumab
Induction Period: Percentage of Participants With Symptomatic Remission at Week 12
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.
Week 12
Maintenance Period: Percentage of Participants With Symptomatic Remission at Week 52
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.
Week 52
Induction Period: Percentage of Participants With Endoscopic Improvement at Week 12
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.
Week 12
Maintenance Period: Percentage of Participants With Endoscopic Improvement at Week 52
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.
Week 52
La Jolla
California
92093
United States
Inland Empire Liver Foundation
Rialto
California
92377
United States
Borland Groover Clinic
Jacksonville
Florida
32256 6004
United States
University of Chicago Medical Center
Chicago
Illinois
60637
United States
Delta Research Partners LLC
Monroe
Louisiana
71201
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
Minnesota Gastroenterology, P.A.
Plymouth
Minnesota
55446
United States
Columbia University Medical Center
New York
New York
10032
United States
Carolinas Healthcare System
Charlotte
North Carolina
28204
United States
Care Access Research - Salt Lake City
Salt Lake City
Utah
84124
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Concord
2139
Australia
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Fitzroy
3065
Australia
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South Brisbane
4101
Australia
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Woolloongabba
4102
Australia
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Ghent
9000
Belgium
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Leuven
3000
Belgium
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Calgary
T2N 2T9
Canada
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Calgary
t2n2z6
Canada
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Montreal
H1T 2M4
Canada
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Montreal
H3A 1A1
Canada
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Montreal
H3G 1A4
Canada
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Hradec Králové
50012
Czechia
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Prague
140 21
Czechia
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Prague
14021
Czechia
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Prague
14059
Czechia
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Prague
17004
Czechia
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Praha 4 Kralove
14059
Czechia
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Svendborg
5700
Denmark
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Clichy
92110
France
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Montpellier
34295
France
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Nice
06202
France
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Saint-Priest-en-Jarez
42270
France
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Vandœuvre-lès-Nancy
54511
France
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Tbilisi
0112
Georgia
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Békéscsaba
5600
Hungary
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Budapest
1125
Hungary
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Szeged
6720
Hungary
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Szekszárd
7100
Hungary
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Vác
2600
Hungary
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Bunkyō City
113-8519
Japan
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Chūōku
060-0033
Japan
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Kagoshima
892-0846
Japan
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Kamakura-shi
247-0056
Japan
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Kasugai-shi
487-0031
Japan
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Kawasaki
210-0013
Japan
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Mitaka
181-8611
Japan
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Nishinomiya
663-8501
Japan
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Osaka
530-0011
Japan
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Ōita
870-0033
Japan
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Saga
840-8571
Japan
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Sakura
285-8741
Japan
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Shinjuku-ku
169-0073
Japan
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Takasaki
370-0829
Japan
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Toyama
930-8550
Japan
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Toyota-shi
470-1219
Japan
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Tsu
514-8507
Japan
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Yokohama
220-0045
Japan
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Kaunas
LT-50009
Lithuania
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Vilnius
08661
Lithuania
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Chisinau
MD2025
Moldova
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Amsterdam
1105 AZ
Netherlands
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Bydgoszcz
85-168
Poland
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Elblag
82-300
Poland
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Katowice
40 660
Poland
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Krakow
31009
Poland
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Lublin
20-582
Poland
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Rzeszów
35-068
Poland
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Sopot
81-756
Poland
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Warsaw
03 580
Poland
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Warsaw
03-580
Poland
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Wroclaw
53 114
Poland
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Wroclaw
53114
Poland
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Bucharest
020125
Romania
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Oxford
OX3 9DU
United Kingdom
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Dubinsky MC, Panaccione R, Lewis JD, Sands BE, Hibi T, Lee SD, Naegeli AN, Shan M, Green LA, Morris N, Arora V, Bleakman AP, Belin R, Travis S. Impact of Bowel Urgency on Quality of Life and Clinical Outcomes in Patients With Ulcerative Colitis. Crohns Colitis 360. 2022 Jun 3;4(3):otac016. doi: 10.1093/crocol/otac016. eCollection 2022 Jul.
Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Hibi T, D'Haens GR, Tuttle JL, Krueger K, Friedrich S, Durante M, Arora V, Naegeli AN, Schmitz J, Feagan BG. Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):105-115.e14. doi: 10.1016/j.cgh.2020.09.028. Epub 2020 Sep 18.
Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Feagan BG, Hibi T, Tuttle JL, Klekotka P, Friedrich S, Durante M, Morgan-Cox M, Laskowski J, Schmitz J, D'Haens GR. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):537-549.e10. doi: 10.1053/j.gastro.2019.08.043. Epub 2019 Sep 4.
FG002
Induction: 200 mg Mirikizumab IV Q4W
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.
FG003
Induction: 600 mg Mirikizumab IV Q4W
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.
FG004
Maintenance: Placebo SC Q4W
Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.
FG005
Maintenance: 200 mg Mirikizumab SC Q4W
Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
FG006
Maintenance: 200 mg Mirikizumab SC Q12W
Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
FG007
Induction Extension: 600mg Mirikizumab IV Q4W
Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
FG008
Induction Extension: 1000mg Mirikizumab IV Q4W
Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
FG009
Maintenance Extension: 200mg Mirikizumab SC Q4W
Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label.
FG00063 subjects
FG00163 subjects
FG00262 subjects
FG00361 subjects
FG0040 subjectsParticipants were assigned to this arm during maintenance period.
FG0050 subjectsParticipants were assigned to this arm during maintenance period.
FG0060 subjectsParticipants were assigned to this arm during maintenance period.
FG0070 subjects
FG0080 subjects
FG0090 subjects
Received at Least One Dose of Study Drug
FG00063 subjects
FG00163 subjects
FG00262 subjects
FG00360 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG00060 subjects
FG00161 subjects
FG00260 subjects
FG00357 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0003 subjects
FG0012 subjects
FG0022 subjects
FG0034 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Did not receive drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Adverse Event
FG0003 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Maintenance Period
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants were assigned to this arm only during induction period.
FG0010 subjectsParticipants were assigned to this arm only during induction period.
FG0020 subjectsParticipants were assigned to this arm only during induction period.
FG0030 subjectsParticipants were assigned to this arm only during induction period.
FG00413 subjectsOnly participants with a response were re-randomized in maintenance period.
FG00547 subjectsOnly participants with a response were re-randomized in maintenance period.
FG00646 subjectsOnly participants with a response were re-randomized in maintenance period.
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Rolled Over to Study AMAP (NCT03519945)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Induction Extension Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG00732 subjects
FG00896 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Maintenance Extension Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00968 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Rolled Over to Study AMAP (NCT03519945)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Induction: Placebo IV Q4W
Placebo administered every 4 weeks (Q4W) intravenously (IV).
BG001
Induction: 50 mg Mirikizumab IV Q4W
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.
BG002
Induction: 200 mg Mirikizumab IV Q4W
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.
BG003
Induction: 600 mg Mirikizumab IV Q4W
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.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00063
BG00163
BG00262
BG00361
BG004249
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00042.62± 13.47
BG00141.83± 14.06
BG00243.35± 14.75
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00027
BG00125
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Hungary
Title
Measurements
BG0005
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Induction Period: Percentage of Participants With Clinical Remission at Week 12
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 Physician's Global Assessment (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 0 (normal) to 3 (severe disease).
The total score ranges from 0 to 9 points, with higher scores representing more severe disease.
Induction Period: All randomized participants.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo IV Q4W
Placebo administered every 4 weeks (Q4W) intravenously (IV).
OG001
50 mg Mirikizumab IV Q4W
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.
OG002
200 mg Mirikizumab IV Q4W
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.
OG003
600 mg Mirikizumab IV Q4W
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.
Units
Counts
Participants
OG00063
OG00163
OG00262
OG003
Title
Denominators
Categories
Title
Measurements
OG0004.8(0.0 to 10.0)
OG00115.9(6.8 to 24.9)
OG00222.6(12.2 to 33.0)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Odds Ratio (OR)
2.93
2-Sided
95
0.70
12.27
Superiority
OG000
OG002
Secondary
Induction Period: Percentage of Participants With Clinical Response at Week 12
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.
Induction Period: All randomized participants.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo IV Q4W
Placebo administered every 4 weeks (Q4W) intravenously (IV).
OG001
50 mg Mirikizumab IV Q4W
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.
Secondary
Induction Period: Percentage of Participants With Endoscopic Remission at Week 12
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.
Induction Period: All randomized participants.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo IV Q4W
Placebo administered every 4 weeks (Q4W) intravenously (IV).
OG001
50 mg Mirikizumab IV Q4W
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.
OG002
200 mg Mirikizumab IV Q4W
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.
Secondary
Maintenance Period: Percentage of Participants With Endoscopic Remission at Week 52
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.
Maintenance period: All randomized participants in maintenance period.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
Placebo SC Q4W
Placebo administered subcutaneously (SC) Q4W during the maintenance period.
OG001
200 mg Mirikizumab SC Q4W
200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
OG002
200 mg Mirikizumab SC Q12W
200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period
Secondary
Induction Period: Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
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).
Induction Period: All randomized participants who had a baseline and at least one post-baseline IBDQ value.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo IV Q4W
Placebo administered every 4 weeks (Q4W) intravenously (IV).
OG001
50 mg Mirikizumab IV Q4W
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.
OG002
200 mg Mirikizumab IV Q4W
Secondary
Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
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).
Induction Period: All randomized participants who had a baseline and at least one post-baseline SF-36 value.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo IV Q4W
Placebo administered every 4 weeks (Q4W) intravenously (IV).
OG001
50 mg Mirikizumab IV Q4W
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.
Secondary
Induction Period: Change From Baseline to Week 12 in Patient's Global Impressions of Severity (PGI-S) Score
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).
Induction Period: All randomized participants who had a baseline and at least one post-baseline PGI-S value.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo IV Q4W
Placebo administered every 4 weeks (Q4W) intravenously (IV).
OG001
50 mg Mirikizumab IV Q4W
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.
Secondary
Induction Period: Patient's Global Impressions of Improvement (PGI-I) Score at Week 12
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."
Induction Period: All randomized participants who had a baseline and at least one post-baseline PGI-I value.
Posted
Mean
Standard Deviation
score on a scale
Week 12
ID
Title
Description
OG000
Placebo IV Q4W
Placebo administered every 4 weeks (Q4W) intravenously (IV).
OG001
50 mg Mirikizumab IV Q4W
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.
OG002
200 mg Mirikizumab IV Q4W
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.
Secondary
Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, Tau) of Mirikizumab
Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, tau) of Mirikizumab
All participants who received at least one dose of mirikizumab in the induction and maintenance period who had evaluable PK data.
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.
OG001
200 mg Mirikizumab IV Q4W
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.
OG002
600 mg Mirikizumab IV Q4W
Secondary
Induction Period: Percentage of Participants With Symptomatic Remission at Week 12
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.
Induction Period: All randomized participants.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo IV Q4W
Placebo administered every 4 weeks (Q4W) intravenously (IV).
OG001
50 mg Mirikizumab IV Q4W
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.
OG002
200 mg Mirikizumab IV Q4W
Secondary
Maintenance Period: Percentage of Participants With Symptomatic Remission at Week 52
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.
Maintenance period: All randomized participants in maintenance period.
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 52
ID
Title
Description
OG000
Placebo SC Q4W
Placebo administered subcutaneously (SC) Q4W during the maintenance period.
OG001
200 mg Mirikizumab SC Q4W
200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
Secondary
Induction Period: Percentage of Participants With Endoscopic Improvement at Week 12
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.
Induction Period: All randomized participants.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo IV Q4W
Placebo administered every 4 weeks (Q4W) intravenously (IV).
OG001
50 mg Mirikizumab IV Q4W
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.
OG002
200 mg Mirikizumab IV Q4W
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.
Secondary
Maintenance Period: Percentage of Participants With Endoscopic Improvement at Week 52
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.
Maintenance period: All randomized participants in maintenance period.
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 52
ID
Title
Description
OG000
Placebo SC Q4W
Placebo administered subcutaneously (SC) Q4W during the maintenance period.
OG001
200 mg Mirikizumab SC Q4W
200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
OG002
200 mg Mirikizumab SC Q12W
200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period
Time Frame
Up To 39 Months
Description
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Induction: Placebo IV Q4W
Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
0
63
2
63
18
63
EG001
Induction: 50 mg Mirikizumab Administered Every 4 Weeks (Q4W)
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.
0
63
0
63
14
63
EG002
Induction: 200 mg Mirikizumab IV Q4W
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.
0
62
2
62
8
62
EG003
Induction: 600 mg Mirikizumab IV Q4W
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.
0
60
3
60
14
60
EG004
Maintenance: Placebo SC Q4W
Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.
0
13
2
13
11
13
EG005
Maintenance: 200 mg Mirikizumab SC Q4W
Induction mirikizumab responders: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
0
47
2
47
27
47
EG006
Maintenance: 200 mg Mirikizumab SC Q12W
Induction mirikizumab responders: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
0
46
1
46
30
46
EG007
Induction Extension: 600mg Mirikizumab IV Q4W
Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
0
32
1
32
9
32
EG008
Induction Extension:1000mg Mirikizumab IV Q4W
Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) ) once every 4 weeks (Q4W) during the Extension Open-Label.
0
96
5
96
8
96
EG009
Maintenance Extension: 200mg Mirikizumab SC Q4W
Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label.
0
68
3
68
30
68
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Colitis ulcerative
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected63 at risk
EG0021 events1 affected62 at risk
EG0031 events1 affected60 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected47 at risk
EG0061 events1 affected46 at risk
EG0070 events0 affected32 at risk
EG0082 events2 affected96 at risk
EG0090 events0 affected68 at risk
Intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected62 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected63 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected62 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected62 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected62 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected63 at risk
EG0021 events1 affected62 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected62 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected63 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected62 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected62 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected62 at risk
EG003
Platelet count increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected62 at risk
EG003
Polyarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected62 at risk
EG003
Breast neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected62 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected63 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected62 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)