A Study of Mirikizumab (LY3074828) in Children and Teenag... | NCT04004611 | Trialant
NCT04004611
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Mar 26, 2024Actual
Enrollment
26Actual
Phase
Phase 2
Conditions
Ulcerative Colitis
Interventions
Mirikizumab
Countries
United States
Canada
Israel
Japan
South Korea
Protocol Section
Identification Module
NCT ID
NCT04004611
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
17410
Secondary IDs
ID
Type
Description
Link
I6T-MC-AMBU
Other Identifier
Eli Lilly and Company
2019-001298-96
EudraCT Number
Brief Title
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
Official Title
A Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative Colitis
Acronym
SHINE-1
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Mar 2024
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
May 18, 2020Actual
Primary Completion Date
Mar 15, 2023Actual
Completion Date
Mar 15, 2023Actual
First Submitted Date
Jun 29, 2019
First Submission Date that Met QC Criteria
Jun 29, 2019
First Posted Date
Jul 2, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Sep 12, 2023
Results First Submitted that Met QC Criteria
Oct 25, 2023
Results First Posted Date
Oct 27, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 25, 2024
Last Update Posted Date
Mar 26, 2024Actual
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
Yes
Is FDA Regulated Device
No
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
This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab. The study lasted about 52 weeks and included up to 18 visits.
Detailed Description
Not provided
Conditions Module
Conditions
Ulcerative Colitis
Keywords
Interleukin-23 (IL-23) antibody
IL-23p19
Pediatric
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
26Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Open Label (OL) Induction Period: 5 milligram per kilogram (mg/kg) Miri intravenous (IV)
Experimental
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 weeks (Q4W) on weeks 0, 4, 8 for 12 weeks.
Drug: Mirikizumab
Open Label Induction Period: 10 mg/kg Miri IV
Experimental
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
Drug: Mirikizumab
Open Label Induction Period: 300 mg Miri IV
Experimental
Participants (>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
Drug: Mirikizumab
Open Label Maintenance Period: 50 mg Miri subcutaneous (SC)
Experimental
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.
Drug: Mirikizumab
Open Label Maintenance Period: 100 mg Miri SC
Experimental
Participants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Mirikizumab
Drug
Administered IV and SC
Open Label (OL) Induction Period: 5 milligram per kilogram (mg/kg) Miri intravenous (IV)
Open Label Induction Period: 10 mg/kg Miri IV
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Pharmacokinetics (PK): Clearance of Mirikizumab
Clearance of mirikizumab was evaluated. The PK of mirikizumab is characterized at interim analysis points using mixed-effect (population PK) modelling approaches using the available induction and maintenance mirikizumab concentration data.
Predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants in Clinical Remission
Clinical remission at week 52 is defined as achieving a 9-point modified Mayo score (MMS) for rectal bleeding (RB) = 0, stool frequency (SF) = 0 or 1 and endoscopy (ES) = 0 or 1 (excluding friability). The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: SF subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); RB subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); ES subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding,ulceration.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants weighing >10 kg
Participants must have a diagnosis of ulcerative colitis for at least 3 months before the planned start date for the study medications
Participants must have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment
Participants must have evidence of UC extending proximal to the rectum
Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor (JAK-inhibitor) or to biologic therapies for UC
Exclusion Criteria:
Participants must not have a current diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary sclerosing cholangitis
Participants must not have had surgery to remove part of their colon
Participants must not have current evidence of toxic megacolon
Participants must not 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 1 week of screening endoscopy
Participants must not have had an inadequate response to Interleukin-12 p40 subunit antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
2 Years
Maximum Age
17 Years
Standard Ages
Child
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)
Kaplan JL, Bousvaros A, Turner D, Dubinsky M, Larkin A, Johns J, Otani Y, Crandall W, Komocsar WJ, Hyams JS. Efficacy and safety of mirikizumab in paediatric participants with moderately-to-severely active ulcerative colitis (SHINE-1): a multicentre, open-label, non-randomised phase 2 trial. Lancet Gastroenterol Hepatol. 2026 Feb;11(2):100-109. doi: 10.1016/S2468-1253(25)00196-7. Epub 2025 Nov 19.
See Also Links
Label
URL
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
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.
Mirikizumab (Miri) dose groups to which pediatric participants are assigned at week (wk) 0 (for induction period) and at wk 12 (for maintenance period) are dependent on participant' s weight and their clinical response status at wk 12 for maintenance period. All participants who achieved a modified Mayo score (MMS) clinical response at wk 12 or wk 24 [non-responders (NR) at wk 12 who received extended intravenous (IV) induction dosing for 12 more wks] were eligible for the maintenance period.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Open Label (OL) Induction Period: 5 Milligram Per Kilogram (mg/kg) Miri IV
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 weeks (Q4W) on weeks 0, 4, 8 for 12 weeks.
FG001
OL Induction Period: 10 mg/kg Miri IV
Periods
Title
Milestones
Reasons Not Completed
OL Induction Period (Wk 0-12)
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
Prot
Yes
No
No
Study Protocol
Oct 23, 2021
Sep 8, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Mirikizumab
Open Label Maintenance Period: 200 mg Miri SC
Experimental
Participants (>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at Week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Drug: Mirikizumab
Open Label Maintenance Period: Non-Responders: 300 mg Miri IV /200 mg Miri SC
Experimental
Participants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
Drug: Mirikizumab
Open Label Induction Period: 300 mg Miri IV
Open Label Maintenance Period: 100 mg Miri SC
Open Label Maintenance Period: 200 mg Miri SC
Open Label Maintenance Period: 50 mg Miri subcutaneous (SC)
Open Label Maintenance Period: Non-Responders: 300 mg Miri IV /200 mg Miri SC
LY3074828
Week 52
Percentage of Participants in Clinical Response
Clinical response at week 52 is defined as a decrease in the 9-point modified Mayo score (MMS) [rectal bleeding, stool frequency and the endoscopic findings] inclusive of ≥2 points and ≥30% from baseline with either a decrease of rectal bleeding subscore of ≥1 or rectal bleeding subscore of 0 or 1. The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: SF subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); RB subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); ES subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
Week 52
Percentage of Participants Who Are in MMS Clinical Remission Without the Use of Corticosteroids
Corticosteroid-free clinical remission was defined as an SF subscore = 0 or 1, RB subscore = 0, ES ≤ 1 (excluding friability), and have not received corticosteroids for ≥ 12 weeks in the 52-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Week 52
Percentage of Participants in Clinical Remission Based on the Pediatric Ulcerative Colitis Activity Index (PUCAI)
The PUCAI is a clinician-administered, 6-item questionnaire that measures: abdominal pain; RB; stool consistency; number of stools; nocturnal stools; and activity level. For PUCAI score all items are answered as an average over the 'past 2 days'. A total disease activity score is calculated from 0 to 85, with Severe 65-85; Moderate:35-60; Mild:10-30, and None:<10. The clinician will record the participant or caregiver/legal guardian responses for the PUCAI electronically as source data in the tablet device at appropriate visits. PUCAI clinical remission is defined as a PUCAI score of <10 points.
Week 52
Percentage of Participants in Clinical Response Based on the PUCAI
PUCAI clinical response is defined as a reduction in baseline PUCAI score of ≥20 points.
Week 52
Percentage of Participants in Endoscopic Remission
Endoscopic remission at week 52 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 52. ES subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
Week 52
Percentage of Participants in Symptomatic Remission
Symptomatic remission at week 52 is defined as a Mayo score for RB=0, SF=0 or 1 with ≥ 1 point decrease from baseline.
SF subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal).
RB subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed).
Week 52
Height Velocity (in Centimeters/Year)
Observed height velocity by gender and age group was calculated. Age groups for which this was summarized were 2 to <8, 8 to <12, and 12 to <18. Observed height velocity by gender and age group was calculated at baseline according to the following formula: (Present Height [cm] - Previous Height [cm])/Interval (months) Between Measurements × 12.
Week 52
Change From Baseline in Body Weight
Change from Baseline in body weight by gender and age group was calculated.
Baseline, Week 52
Percentage of Participants With Histologic-Endoscopic Mucosal Remission
Histologic-endoscopic mucosal remission is defined as achieving both histologic remission and endoscopic remission. Histologic remission is defined as Geboes histological subscores of 0 for parameters: 2B (neutrophils in lamina propria), 3 (neutrophils in epithelium), 4 (crypt destruction), and 5 (erosion or ulceration).
Week 52
Change From Baseline in 7-day Average of Abdominal Pain Numeric Rating Scale (NRS) Score at Week 12
The Abdominal Pain NRS is a single participant-reported item that measures the "worst abdominal pain in the past 24 hours" using a 6-point scale ranging from 0 (no pain) to 5 (worst possible pain) for 8-11 years old, and 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) for children < 8 years old as completed by a caregiver and those 12-17 years old. Abdominal Pain NRS Score is calculated by averaging data from all available daily diary entries of abdominal pain NRS for a 7 day period. A negative change from baseline indicates improvement in the participant's Abdominal Pain NRS.
Baseline, Week 12
Change From Baseline in 7-day Average of Abdominal Pain NRS Score at Week 52
The Abdominal Pain NRS is a single participant-reported item that measures the "worst abdominal pain in the past 24 hours" using a 6-point scale ranging from 0 (no pain) to 5 (worst possible pain) for 8-11 years old, and 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) for children < 8 years old as completed by a caregiver and those 12-17 years old. Abdominal Pain NRS Score is calculated by averaging data from all available daily diary entries of abdominal pain NRS for a 7 day period. A negative change from baseline indicates improvement in the participant's Abdominal Pain NRS.
Baseline, Week 52
San Francisco
California
94158
United States
Children's Hospital of Colorado
Denver
Colorado
80045
United States
Connecticut Children's Medical Center
Hartford
Connecticut
06106
United States
Emory University
Atlanta
Georgia
30322
United States
Children's Center for Digestive Health Care, LLC
Atlanta
Georgia
30342
United States
University of Chicago Hospital
Chicago
Illinois
60637
United States
Riley Hospital for Children
Carmel
Indiana
46302
United States
Boston Children's Hospital
Boston
Massachusetts
02115
United States
MGH for Children - Waltham
Waltham
Massachusetts
02451
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Goryeb Children's Hospital / Atlantic Health System
Morristown
New Jersey
07960
United States
Icahn Sch of Med at Mt. Sinai
New York
New York
10029
United States
Cincinnati Childrens Hospital Medical Center
Cincinnati
Ohio
45229
United States
The Abbigail Wexner Research Institute at Nationwide Children's Hospital
Columbus
Ohio
43205
United States
Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
19104
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh
Pennsylvania
15224
United States
Cook Children's Hospital
Fort Worth
Texas
76104
United States
Texas Childrens Hospital
Houston
Texas
77030
United States
Pediatrics Specialists of Virginia
Fairfax
Virginia
22031
United States
Children's Hospital of The King's Daughters Inc
Norfolk
Virginia
23507
United States
Seattle Children's Hospital Research Foundation
Seattle
Washington
98105
United States
University of Alberta Hospital
Edmonton
Alberta
T6G 1C9
Canada
IWK Health Centre
Halifax
Nova Scotia
B3K 6R8
Canada
The Hospital for Sick Children
Toronto
Ontario
M5G 1X8
Canada
Rambam Medical Center
Haifa
3109601
Israel
The Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition; Shaare Zedek Medical Center
Jerusalem
Israel
Schneider Children's Medical Center
Petah Tikva
4920235
Israel
Kurume University Hospital
Kurume
Fukuoka
830-0011
Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama
Kanagawa
2308765
Japan
Saitama Children's Medical Center
Saitama-shi
Saitama
330 8777
Japan
Juntendo University Hospital
Bunkyo-ku
Tokyo
113-8431
Japan
Tokyo Medical and Dental University Hospital
Bunkyō
Tokyo
113-8519
Japan
National Center For Child Health And Development
Setagaya-ku
Tokyo
157-8535
Japan
Tokyo Medical University Hospital
Shinjuku-ku
Tokyo
160-0023
Japan
Kyungpook National University Medical Center Chilgok Hospital
Daegu
41404
South Korea
Seoul National University Hospital
Seoul
3080
South Korea
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
FG002
OL Induction Period: 300 mg Miri IV
Participants (>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
FG003
OL Maintenance Period: 50 mg Miri Subcutaneous (SC)
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
FG004
OL Maintenance Period: 100 mg Miri SC
Participants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
FG005
OL Maintenance Period: 200 mg Miri SC
Participants (>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
FG008
OL Maintenance Period: NR: 300 mg Miri IV /200 mg Miri SC
Participants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
FG00010 subjects
FG0015 subjects
FG00211 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
COMPLETED
FG00010 subjects
FG0015 subjects
FG00211 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
OL Maintenance Period (Wk 12-52)
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants were assigned to this arm only during open label induction period.
FG0010 subjectsParticipants were assigned to this arm only during open label induction period.
FG0020 subjectsParticipants were assigned to this arm only during open label induction period.
FG0031 subjectsIncluded only participants who entered open label maintenance period.
FG0048 subjectsIncluded only participants who entered open label maintenance period.
FG0059 subjectsIncluded only participants who entered open label maintenance period.
FG0061 subjectsIncluded only participants who entered open label maintenance period.
FG0071 subjectsIncluded only participants who entered open label maintenance period.
FG0086 subjectsIncluded only participants who entered open label maintenance period.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 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
OL Induction and Maintenance Period
Type
Comment
Milestone Data
STARTED
FG00010 subjectsIncluded only participants who entered open label induction and maintenance period.
FG0015 subjectsIncluded only participants who entered open label induction and maintenance period.
FG00211 subjectsIncluded only participants who entered open label induction and maintenance period.
FG0030 subjectsParticipants were assigned to this arm only during open label maintenance period.
FG0040 subjectsParticipants were assigned to this arm only during open label maintenance period.
FG0050 subjectsParticipants were assigned to this arm only during open label maintenance period.
FG0060 subjectsParticipants were assigned to this arm only during open label maintenance period.
FG0070 subjectsParticipants were assigned to this arm only during open label maintenance period.
FG0080 subjectsParticipants were assigned to this arm only during open label maintenance period.
COMPLETED
FG0009 subjects
FG0014 subjects
FG0026 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0025 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
OL Induction Period: 5 mg/kg Miri IV
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
BG001
OL Induction Period: 10 mg/kg Miri IV
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
BG002
OL Induction Period: 300 mg Miri IV
Participants (>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG0015
BG00211
BG00326
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
BG0009.6± 4.22
BG00111.6± 1.14
BG00214.0± 1.26
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0010
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
Israel
Title
Measurements
BG0000
BG0010
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
Pharmacokinetics (PK): Clearance of Mirikizumab
Clearance of mirikizumab was evaluated. The PK of mirikizumab is characterized at interim analysis points using mixed-effect (population PK) modelling approaches using the available induction and maintenance mirikizumab concentration data.
All randomized participants who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters per hour per kilogram (L/hr/kg)
Predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8
ID
Title
Description
OG000
Mirikizumab
Participants weighing >40 kg received a mirikizumab induction dose of 300 mg via IV infusion and participants weighing ≤40 kg received induction doses of 5 or 10 mg/kg via IV infusion at weeks 0, 4, and 8 for 12 weeks.
Units
Counts
Participants
OG00026
Title
Denominators
Categories
Title
Measurements
OG0000.000190± 59.74
Secondary
Percentage of Participants in Clinical Remission
Clinical remission at week 52 is defined as achieving a 9-point modified Mayo score (MMS) for rectal bleeding (RB) = 0, stool frequency (SF) = 0 or 1 and endoscopy (ES) = 0 or 1 (excluding friability). The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: SF subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); RB subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); ES subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding,ulceration.
Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the clinical remission measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
Maintenance Period: 50 mg Miri SC Q4W
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.
OG001
Maintenance Period: 100 mg Miri SC Q4W
Participants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Secondary
Percentage of Participants in Clinical Response
Clinical response at week 52 is defined as a decrease in the 9-point modified Mayo score (MMS) [rectal bleeding, stool frequency and the endoscopic findings] inclusive of ≥2 points and ≥30% from baseline with either a decrease of rectal bleeding subscore of ≥1 or rectal bleeding subscore of 0 or 1. The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: SF subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); RB subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); ES subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)
mITT: All randomized participants who received at least one dose of study drug and who had the clinical response measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
Maintenance Period: 50 mg Miri SC Q4W
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.
OG001
Maintenance Period: 100 mg Miri SC Q4W
Secondary
Percentage of Participants Who Are in MMS Clinical Remission Without the Use of Corticosteroids
Corticosteroid-free clinical remission was defined as an SF subscore = 0 or 1, RB subscore = 0, ES ≤ 1 (excluding friability), and have not received corticosteroids for ≥ 12 weeks in the 52-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
mITT: All randomized participants who received at least one dose of study drug and who had the modified mayo score clinical remission without the use of corticosteroids measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
Maintenance Period: 50 mg Miri SC Q4W
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.
OG001
Maintenance Period: 100 mg Miri SC Q4W
Participants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
OG002
Secondary
Percentage of Participants in Clinical Remission Based on the Pediatric Ulcerative Colitis Activity Index (PUCAI)
The PUCAI is a clinician-administered, 6-item questionnaire that measures: abdominal pain; RB; stool consistency; number of stools; nocturnal stools; and activity level. For PUCAI score all items are answered as an average over the 'past 2 days'. A total disease activity score is calculated from 0 to 85, with Severe 65-85; Moderate:35-60; Mild:10-30, and None:<10. The clinician will record the participant or caregiver/legal guardian responses for the PUCAI electronically as source data in the tablet device at appropriate visits. PUCAI clinical remission is defined as a PUCAI score of <10 points.
mITT: All randomized participants who received at least one dose of study drug and who had the clinical remission based on the PUCAI measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
Maintenance Period: 50 mg Miri SC Q4W
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.
OG001
Maintenance Period: 100 mg Miri SC Q4W
Participants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Secondary
Percentage of Participants in Clinical Response Based on the PUCAI
PUCAI clinical response is defined as a reduction in baseline PUCAI score of ≥20 points.
mITT: All randomized participants who received at least one dose of study drug and who had the clinical response based on the PUCAI measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
Maintenance Period: 50 mg Miri SC Q4W
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.
OG001
Maintenance Period: 100 mg Miri SC Q4W
Participants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
OG002
Maintenance Period: 200 mg Miri SC Q4W
Participants (>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Secondary
Percentage of Participants in Endoscopic Remission
Endoscopic remission at week 52 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 52. ES subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
mITT: All randomized participants who received at least one dose of study drug and who had the endoscopic remission measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
Maintenance Period: 50 mg Miri SC Q4W
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.
OG001
Maintenance Period: 100 mg Miri SC Q4W
Participants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
OG002
Maintenance Period: 200 mg Miri SC Q4W
Secondary
Percentage of Participants in Symptomatic Remission
Symptomatic remission at week 52 is defined as a Mayo score for RB=0, SF=0 or 1 with ≥ 1 point decrease from baseline.
SF subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal).
RB subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed).
mITT: All randomized participants who received at least one dose of study drug and who had the symptomatic remission measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
Maintenance Period: 50 mg Miri SC Q4W
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.
OG001
Maintenance Period: 100 mg Miri SC Q4W
Participants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
OG002
Maintenance Period: 200 mg Miri SC Q4W
Secondary
Height Velocity (in Centimeters/Year)
Observed height velocity by gender and age group was calculated. Age groups for which this was summarized were 2 to <8, 8 to <12, and 12 to <18. Observed height velocity by gender and age group was calculated at baseline according to the following formula: (Present Height [cm] - Previous Height [cm])/Interval (months) Between Measurements × 12.
mITT: All randomized participants who received at least one dose of study drug and who had the height velocity measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Posted
Mean
Standard Deviation
centimeter per year (cm/year)
Week 52
ID
Title
Description
OG000
OL Induction and Maintenance Period: 5 mg/kg Miri IV
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks followed by IV or SC mirikizumab based on their week 12 response status and weight through week 48 or until loss of response was confirmed.
OG001
OL Induction and Maintenance Period: 10 mg/kg Miri IV
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks followed by IV or SC mirikizumab based on their week 12 response status and weight through week 48 or until loss of response was confirmed.
Secondary
Change From Baseline in Body Weight
Change from Baseline in body weight by gender and age group was calculated.
mITT: All randomized participants who received at least one dose of study drug and who had the body weight measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Posted
Mean
Standard Deviation
kg
Baseline, Week 52
ID
Title
Description
OG000
OL Induction and Maintenance Period: 5 mg/kg Miri IV
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks followed by IV or SC mirikizumab based on their week 12 response status and weight through week 48 or until loss of response was confirmed.
OG001
OL Induction and Maintenance Period: 10 mg/kg Miri IV
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks followed by IV or SC mirikizumab based on their week 12 response status and weight through week 48 or until loss of response was confirmed.
OG002
OL Induction and Maintenance Period: 300 mg Miri IV
Participants (>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks followed by IV or SC mirikizumab based on their week 12 response status and weight through week 48 or until loss of response was confirmed.
Secondary
Percentage of Participants With Histologic-Endoscopic Mucosal Remission
Histologic-endoscopic mucosal remission is defined as achieving both histologic remission and endoscopic remission. Histologic remission is defined as Geboes histological subscores of 0 for parameters: 2B (neutrophils in lamina propria), 3 (neutrophils in epithelium), 4 (crypt destruction), and 5 (erosion or ulceration).
mITT: All randomized participants who received at least one dose of study drug and who had the histologic-endoscopic mucosal remission measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
Maintenance Period: 50 mg Miri SC Q4W
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.
OG001
Maintenance Period: 100 mg Miri SC Q4W
Participants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
OG002
Maintenance Period: 200 mg Miri SC Q4W
Secondary
Change From Baseline in 7-day Average of Abdominal Pain Numeric Rating Scale (NRS) Score at Week 12
The Abdominal Pain NRS is a single participant-reported item that measures the "worst abdominal pain in the past 24 hours" using a 6-point scale ranging from 0 (no pain) to 5 (worst possible pain) for 8-11 years old, and 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) for children < 8 years old as completed by a caregiver and those 12-17 years old. Abdominal Pain NRS Score is calculated by averaging data from all available daily diary entries of abdominal pain NRS for a 7 day period. A negative change from baseline indicates improvement in the participant's Abdominal Pain NRS.
mITT: All randomized participants who received at least one dose of study drug and who had the 7-day average of Abdominal Pain NRS measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Week 12
ID
Title
Description
OG000
Open Label Induction Period: 5 mg/kg Miri IV
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
OG001
Open Label Induction Period: 10 mg/kg Miri IV
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
Secondary
Change From Baseline in 7-day Average of Abdominal Pain NRS Score at Week 52
The Abdominal Pain NRS is a single participant-reported item that measures the "worst abdominal pain in the past 24 hours" using a 6-point scale ranging from 0 (no pain) to 5 (worst possible pain) for 8-11 years old, and 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) for children < 8 years old as completed by a caregiver and those 12-17 years old. Abdominal Pain NRS Score is calculated by averaging data from all available daily diary entries of abdominal pain NRS for a 7 day period. A negative change from baseline indicates improvement in the participant's Abdominal Pain NRS.
mITT: All randomized participants who received at least one dose of study drug and who had the 7-day average of Abdominal Pain NRS measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Week 52
ID
Title
Description
OG000
OL Maintenance Period: 50 mg Miri SC
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.
OG001
OL Maintenance Period: 100 mg Miri SC
Participants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Time Frame
Induction Period (Up to 12 Weeks), Induction and Maintenance Period (Up to 52 Weeks)
Description
All participants who received at least one dose were analyzed by initial treatment group assignment. Induction, combined induction and maintenance periods were pre-specified for safety analyses; data from the maintenance period alone was not analyzed. Per Stat analysis plan, safety summaries are based on treatment assigned at beginning of induction/maintenance and do not include rescue dosing or weight group changes. Gender specific event denominators were 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
OL Induction Period: 5 mg/kg Miri IV
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 Q4W on weeks 0, 4, 8 for 12 weeks.
0
10
0
10
8
10
EG001
OL Induction Period: 10 mg/kg Miri IV
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
0
5
0
5
2
5
EG002
OL Induction Period: 300 mg Miri IV
Participants (>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
0
11
0
11
8
11
EG003
OL Induction and Maintenance Period: 5 mg/kg Miri IV
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks followed by IV or SC mirikizumab based on their week 12 response status and weight through week 48 or until loss of response was confirmed.
0
10
0
10
9
10
EG004
OL Induction and Maintenance Period: 10 mg/kg Miri IV
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks followed by IV or SC mirikizumab based on their week 12 response status and weight through week 48 or until loss of response was confirmed.
0
5
2
5
5
5
EG005
OL Induction and Maintenance Period: 300 mg Miri IV
Participants (>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks followed by IV or SC mirikizumab based on their week 12 response status and weight through week 48 or until loss of response was confirmed.
Participants (>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
OG005
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
Participants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
Units
Counts
Participants
OG0001
OG0018
OG0029
OG0031
OG0041
OG0056
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 79.3)
OG00162.5(30.6 to 86.3)
OG00255.6(26.7 to 81.1)
OG0030.0(0.0 to 79.3)
OG0040.0(0.0 to 79.3)
OG0050.0(0.0 to 39.0)
Participants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
OG002
Maintenance Period: 200 mg Miri SC Q4W
Participants (>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
OG005
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
Participants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
Units
Counts
Participants
OG0001
OG0018
OG0029
OG0031
OG0041
OG0056
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 79.3)
OG00175.0(40.9 to 92.9)
OG00288.9(56.5 to 98.0)
OG0030.0(0.0 to 79.3)
OG0040.0(0.0 to 79.3)
OG0050.0(0.0 to 39.0)
Maintenance Period: 200 mg Miri SC Q4W
Participants (>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Participants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
Units
Counts
Participants
OG0001
OG0018
OG0029
OG0031
OG0041
OG0056
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 79.3)
OG00162.5(30.6 to 86.3)
OG00255.6(26.7 to 81.1)
OG0030.0(0.0 to 79.3)
OG0040.0(0.0 to 79.3)
OG0050.0(0.0 to 39.0)
OG002
Maintenance Period: 200 mg Miri SC Q4W
Participants (>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
OG005
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
Participants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
OG005
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
Participants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
Units
Counts
Participants
OG0001
OG0018
OG0029
OG0031
OG0041
OG0056
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 79.3)
OG00175.0(40.9 to 92.9)
OG00288.9(56.5 to 98.0)
OG0030.0(0.0 to 79.3)
OG0040.0(0.0 to 79.3)
OG0050.0(0.0 to 39.0)
Participants (>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
OG005
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
Participants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
Units
Counts
Participants
OG0001
OG0018
OG0029
OG0031
OG0041
OG0056
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 79.3)
OG00162.5(30.6 to 86.3)
OG00255.6(26.7 to 81.1)
OG0030.0(0.0 to 79.3)
OG0040.0(0.0 to 79.3)
OG0050.0(0.0 to 39.0)
Participants (>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
OG005
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
Participants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
Units
Counts
Participants
OG0001
OG0018
OG0029
OG0031
OG0041
OG0056
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 79.3)
OG00175.0(40.9 to 92.9)
OG00266.7(35.4 to 87.9)
OG0030.0(0.0 to 79.3)
OG0040.0(0.0 to 79.3)
OG0050.0(0.0 to 39.0)
OG002
OL Induction and Maintenance Period: 300 mg Miri IV
Participants (>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks followed by IV or SC mirikizumab based on their week 12 response status and weight through week 48 or until loss of response was confirmed.
Units
Counts
Participants
OG00010
OG0015
OG00211
Title
Denominators
Categories
Female: 2 - <8 years
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000NA± NAIndividual value = 7.85
Female: 8 - <12 years
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Female: 12 - <18 years
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0022
Title
Measurements
OG000
Male: 2 - <8 years
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Male: 8 - <12 years
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
Male: 12 - <18 years
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0024
Title
Measurements
OG000
Units
Counts
Participants
OG00010
OG0015
OG00211
Title
Denominators
Categories
Female: 2 - <8 years
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000NA± NAIndividual value = 5.1
Female: 8 - <12 years
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Female: 12 - <18 years
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0022
Title
Measurements
OG000
Male: 2 - <8 years
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Male: 8 - <12 years
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
Male: 12 - <18 years
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0024
Title
Measurements
OG000
Participants (>40 kg weight) who were responders to mirikizumab at Week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
OG005
Maintenance Period: 300 mg Miri IV/200 mg Miri SC
Participants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
Units
Counts
Participants
OG0001
OG0018
OG0029
OG0031
OG0041
OG0056
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 79.3)
OG00162.5(30.6 to 86.3)
OG00244.4(18.9 to 73.3)
OG0030.0(0.0 to 79.3)
OG0040.0(0.0 to 79.3)
OG0050.0(0.0 to 39.0)
OG002
Open Label Induction Period: 300 mg Miri IV
Participants (>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
Units
Counts
Participants
OG00010
OG0015
OG00211
Title
Denominators
Categories
2 - <8 years
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000-3± 2.1
8 - <12 years
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
12- <18 years
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG00210
Title
Measurements
OG000
OG002
OL Maintenance Period: 200 mg Miri SC
Participants (>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
OG005
OL Maintenance Period: NR: 300 mg Miri IV /200 mg Miri SC
Participants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.