A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
SHINE-2
A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis
3 other identifiers
interventional
63
11 countries
34
Brief Summary
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2023
34 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
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 24, 2023
CompletedStudy Start
First participant enrolled
November 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedJune 3, 2026
June 1, 2026
2.4 years
March 13, 2023
June 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders
Baseline to Week 52
Secondary Outcomes (17)
Percentage of Participants in MMS Clinical Remission
Week 12
Percentage of Participants in MMS Clinical Response
Week 12
Percentage of Participants with Endoscopic Remission
Week 12
Percentage of Participants with Endoscopic Improvement
Week 12
Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response
Week 12
- +12 more secondary outcomes
Study Arms (3)
Mirikizumab Weight-Based Group 1
EXPERIMENTALExperimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).
Mirikizumab Weight-Based Group 2
EXPERIMENTALExperimental: Participants will receive mirikizumab weight-based dosing IV or SC.
Mirikizumab Weight-Based Group 3
EXPERIMENTALExperimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.
Interventions
Administered IV
Administered SC
Eligibility Criteria
You may qualify if:
- Males or females weighing ≥10 kg and ≥2 and \<18 years old at the time of consent for screening.
- Have moderate to severe UC.
- Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) or Janus Kinase (JAK)-Inhibitor treatment.
- Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report.
You may not qualify if:
- Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis.
- Have immune deficiency syndrome.
- Previous bowel resection or intestinal surgery.
- Evidence of toxic megacolon.
- History or current evidence of cancer of the gastrointestinal tract.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
University of California, San Francisco
San Francisco, California, 94158, United States
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, 30342, United States
Riley Childrens Hospital
Indianapolis, Indiana, 46202, United States
Washington University
St Louis, Missouri, 63110-1010, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
UZA
Edegem, 2650, Belgium
UZ Leuven
Leuven, 3000, Belgium
The Hospital for Sick Children
Toronto, M5G 0A4, Canada
Hôpital Necker - Enfants Malades
Paris, 75015, France
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, 55131, Germany
LMU-Campus Innenstadt
München, 80337, Germany
Helios Klinikum Wuppertal
Wuppertal, 42283, Germany
Shaare Zedek
Jerusalem, 9103102, Israel
Hadassah University Hospital, Ein Kerem
Jerusalem, 911200, Israel
Schneider Children's Medical Center
Petah Tikva, 4920235, Israel
King Fahad Medical City
Rishon LeZiyyon, 70300, Israel
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Florence, 50139, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, 00161, Italy
Juntendo University Hospital
Bunkyō City, 113-8431, Japan
Institute of Science Tokyo Hospital
Bunkyō City, 113-8519, Japan
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, 277-0871, Japan
Saga University Hospital
Saga, 849-8501, Japan
National Center for Child Health and Development
Setagaya-ku, 157-8535, Japan
Yokohama City University Medical Center, Center of IBD
Yokohama, 232-0024, Japan
Gabinet Lekarski Bartosz Korczowski
Rzeszów, 35-302, Poland
Twoja Przychodnia-Szczecińskie Centrum Medyczne
Szczecin, 71-434, Poland
Medical Network Spółka z o. o., WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501, Poland
Instytut 'Pomnik - Centrum Zdrowia Dziecka
Warsaw, 04-730, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Sheffield Children's Hospital
Sheffield, S102TH, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2023
First Posted
March 24, 2023
Study Start
November 22, 2023
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
June 3, 2026
Record last verified: 2026-06
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 European Union (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.