A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
SHINE-1
A Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative Colitis
3 other identifiers
interventional
26
5 countries
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2020
Typical duration for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2019
CompletedFirst Posted
Study publicly available on registry
July 2, 2019
CompletedStudy Start
First participant enrolled
May 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2023
CompletedResults Posted
Study results publicly available
October 27, 2023
CompletedMarch 26, 2024
March 1, 2024
2.8 years
June 29, 2019
September 12, 2023
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (12)
Percentage of Participants in Clinical Remission
Week 52
Percentage of Participants in Clinical Response
Week 52
Percentage of Participants Who Are in MMS Clinical Remission Without the Use of Corticosteroids
Week 52
Percentage of Participants in Clinical Remission Based on the Pediatric Ulcerative Colitis Activity Index (PUCAI)
Week 52
Percentage of Participants in Clinical Response Based on the PUCAI
Week 52
- +7 more secondary outcomes
Study Arms (9)
Open Label (OL) Induction Period: 5 milligram per kilogram (mg/kg) Miri intravenous (IV)
EXPERIMENTALParticipants (≤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.
Open Label Induction Period: 10 mg/kg Miri IV
EXPERIMENTALParticipants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
Open Label Induction Period: 300 mg Miri IV
EXPERIMENTALParticipants (\>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
Open Label Maintenance Period: 50 mg Miri subcutaneous (SC)
EXPERIMENTALParticipants (≤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.
Open Label Maintenance Period: 100 mg Miri SC
EXPERIMENTALParticipants (\>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.
Open Label Maintenance Period: 200 mg Miri SC
EXPERIMENTALParticipants (\>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.
Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/ 50 mg Miri SC
EXPERIMENTALParticipants (≤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.
Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/100 mg Miri SC
EXPERIMENTALParticipants (≤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.
Open Label Maintenance Period: Non-Responders: 300 mg Miri IV /200 mg Miri SC
EXPERIMENTALParticipants (\>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.
Interventions
Administered IV and SC
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Childrens Hospital of Orange County
Orange, California, 92868, United States
UCSF Medical Center at Mission Bay
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
Related Publications (1)
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.
PMID: 41270771DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2019
First Posted
July 2, 2019
Study Start
May 18, 2020
Primary Completion
March 15, 2023
Study Completion
March 15, 2023
Last Updated
March 26, 2024
Results First Posted
October 27, 2023
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.