A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
SHINE-ON
A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease
7 other identifiers
interventional
150
16 countries
66
Brief Summary
The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2021
Longer than P75 for phase_3
66 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
April 12, 2021
CompletedFirst Posted
Study publicly available on registry
April 14, 2021
CompletedStudy Start
First participant enrolled
May 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
April 17, 2026
April 1, 2026
9.5 years
April 12, 2021
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission
Clinical Remission based on the MMS
Week 52
Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
Clinical Remission based on the PCDAI
Week 52
Secondary Outcomes (16)
Percentage of Participants with UC in MMS Clinical Response
Week 52
Percentage of Participants with CD in PCDAI Clinical Response
Week 52
Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response
Week 52
Percentage of Participants with UC in PUCAI Clinical Remission
Week 52
Percentage of Participants with UC in Endoscopic Remission
Week 52
- +11 more secondary outcomes
Study Arms (7)
Mirikizumab Dose 1 for UC
EXPERIMENTALDose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight.
Mirikizumab Dose 2 for UC
EXPERIMENTALDose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Mirikizumab Dose 3 for UC
EXPERIMENTALDose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Mirikizumab Dose 4 for CD
EXPERIMENTALDose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Mirikizumab Dose 5 for CD
EXPERIMENTALDose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Mirikizumab Dose 6 for CD
EXPERIMENTALDose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Mirikizumab Dose 7 for UC or CD
EXPERIMENTALIntravenous (IV) rescue dosing, if response is lost.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Participants from originating studies (I6T-MC-AMBA \[NCT05784246\], I6T-MC-AMBU \[NCT04004611\], I6T-MC-AMAM \[NCT03926130\]) , I6T-MC-AMAY \[NCT05509777\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab
- Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.
- Female participants must agree to contraception requirements.
You may not qualify if:
- Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.
- Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.
- Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.
- Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.
- Participants must not have adenomatous polyps that have not been removed.
- Participants must not be pregnant or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
UCSF Medical Center at Mission Bay
San Francisco, California, 94158, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, 30342, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Massachusetts General Hospital
Waltham, Massachusetts, 02451, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Pediatric Specialists of Virginia
Fairfax, Virginia, 22031, United States
Medizinische Universität Wien
Vienna, 1090, Austria
UZ Brussel
Brussels, 1090, Belgium
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
Antwerp University Hospital
Edegem, 2650, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Centro de Pesquisa Sao Lucas
Campinas, 13060-803, Brazil
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância
Curitiba, 80250-060, Brazil
Universidade Federal de Goias
Goiânia, 74605-020, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90050-170, Brazil
Hospital Universitario Cassiano Antonio de Moraes
Vitória, 29040-091, Brazil
Integral Pesquisa e Ensino
Votuporanga, 15500-269, Brazil
London Health Sciences Centre
London, N6A 5W9, Canada
The Hospital for Sick Children
Toronto, M5G 1X8, Canada
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, 55131, Germany
Dr. von Haunersches Kinderspital
Munich, 80337, Germany
Rambam Health Care Campus
Haifa, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, 9013102, Israel
Hadassah Medical Center
Jerusalem, 9112001, Israel
Schneider Children's Medical Center
Petah Tikva, 49202, Israel
Yitzhak Shamir Medical Center
Ẕerifin, 70300, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127, Italy
Ospedale Maggiore Azienda USL di Bologna
Bologna, 40133, Italy
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, 50139, Italy
Ospedale dei Bambini Vittore Buzzi
Milan, 20154, Italy
AOU Policlinico Umberto I
Roma, 00161, Italy
Ospedale Pediatrico Bambino Gesù IRCCS
Rome, 00165, Italy
Institute of Science Tokyo Hospital
Bunkyō, 113-8519, Japan
Juntendo University Hospital
Bunkyō City, 113-8431, Japan
Tsujinaka Hospital - Kashiwanoha
Kashiwa, 273-0011, Japan
Kobe University Hospital
Kobe, 650-0017, Japan
National Center for Child Health and Development
Tokyo, 157-8535, Japan
Yokohama City University Medical Center
Yokohama, 232-0024, Japan
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
Akershus Universitetssykehus
Lørenskog, 1478, Norway
Oslo Universitetssykehus Ullevål
Oslo, 0450, Norway
Universitetssykehuset Nord-Norge HF
Tromsø, 9038, Norway
St. Olavs Hospital
Trondheim, 7030, Norway
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302, Poland
Twoja Przychodnia SCM
Szczecin, 71-434, Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, 04-501, Poland
Centrum Zdrowia Dziecka w Warszawie
Warsaw, 04-730, Poland
Centrum Medyczne Oporów
Wroclaw, 52-416, Poland
2Ca Braga
Braga, 4710-243, Portugal
Centro Hospitalar de Sao Joao - Hospital de Sao Joao
Porto, 4200-319, Portugal
Kyungpook National University Chilgok Hospital
Deagu, 41404, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, 08950, Spain
Hospital Universitari Parc Tauli
Sabadell, 08208, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Royal London Hospital
London, E1 1BB, United Kingdom
The John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
Sheffield Children's Hospital
Sheffield, S10 2TH, 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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
April 12, 2021
First Posted
April 14, 2021
Study Start
May 26, 2021
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
April 17, 2026
Record last verified: 2026-04
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.