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A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
Sponsor: Eli Lilly and Company
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.
Official title: 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
Key Details
Gender
All
Age Range
2 Years - 19 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2021-05-26
Completion Date
2030-12
Last Updated
2026-03-27
Healthy Volunteers
No
Interventions
Mirikizumab
Administered SC
Mirikizumab
Administered IV
Locations (65)
UCSF Medical Center at Mission Bay
San Francisco, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Waltham, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Pediatric Specialists of Virginia
Fairfax, Virginia, United States
Medizinische Universität Wien
Vienna, Austria
UZ Brussel
Brussels, Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium
Antwerp University Hospital
Edegem, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Centro de Pesquisa Sao Lucas
Campinas, Brazil
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância
Curitiba, Brazil
Universidade Federal de Goias
Goiânia, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
Hospital Universitario Cassiano Antonio de Moraes
Vitória, Brazil
Integral Pesquisa e Ensino
Votuporanga, Brazil
London Health Sciences Centre
London, Canada
The Hospital for Sick Children
Toronto, Canada
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Germany
Dr. von Haunersches Kinderspital
Munich, Germany
Rambam Health Care Campus
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Hadassah Medical Center
Jerusalem, Israel
Schneider Children's Medical Center
Petah Tikva, Israel
Yitzhak Shamir Medical Center
Ẕerifin, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Italy
Ospedale Maggiore Azienda USL di Bologna
Bologna, Italy
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, Italy
Ospedale dei Bambini Vittore Buzzi
Milan, Italy
AOU Policlinico Umberto I
Roma, Italy
Ospedale Pediatrico Bambino Gesù IRCCS
Rome, Italy
Institute of Science Tokyo Hospital
Bunkyō, Japan
Juntendo University Hospital
Bunkyō City, Japan
Tsujinaka Hospital - Kashiwanoha
Kashiwa, Japan
National Center for Child Health and Development
Tokyo, Japan
Yokohama City University Medical Center
Yokohama, Japan
Erasmus Medisch Centrum
Rotterdam, Netherlands
Akershus Universitetssykehus
Lørenskog, Norway
Oslo Universitetssykehus Ullevål
Oslo, Norway
Universitetssykehuset Nord-Norge HF
Tromsø, Norway
St. Olavs Hospital
Trondheim, Norway
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Poland
Twoja Przychodnia SCM
Szczecin, Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Poland
Centrum Zdrowia Dziecka w Warszawie
Warsaw, Poland
Centrum Medyczne Oporów
Wroclaw, Poland
2Ca Braga
Braga, Portugal
Centro Hospitalar de Sao Joao - Hospital de Sao Joao
Porto, Portugal
Kyungpook National University Chilgok Hospital
Deagu, South Korea
Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, Spain
Hospital Universitari Parc Tauli
Sabadell, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Royal London Hospital
London, United Kingdom
The John Radcliffe Hospital
Oxford, United Kingdom
Sheffield Children's Hospital
Sheffield, United Kingdom