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A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Sponsor: Eli Lilly and Company
Summary
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease. Study periods for the intervention-specific appendix (ISA) will be as follows: * A 12-week induction period * A maintenance period from Week 12 to Week 52, and * A safety follow-up period up to 16 weeks. The study will last about 74 weeks and may include up to 19 visits.
Official title: A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-03-13
Completion Date
2028-04
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Mirikizumab
Administered IV or SC
Locations (81)
Cedars Sinai Medical Center
Los Angeles, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Emory University
Atlanta, Georgia, United States
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, United States
Riley Childrens Hospital
Indianapolis, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Atlantic Children's Health--Pediatric Gastroenterology
Morristown, New Jersey, United States
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center/New York Presbyterian
New York, New York, United States
Childrens Medical Center
Dayton, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Seattle Children's Hospital
Seattle, Washington, United States
AKH - Medizinische Universtität Wien
Vienna, Austria
Universitair Ziekenhuis Brussel
Brussels, Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Hospital PUC-CAMPINAS
Campinas, Brazil
Hospital Pequeno Príncipe
Curitiba-PR, Brazil
Hospital das Clínicas - UFG (Universidade Federal de Goiás)
Goiânia, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
NDI - Nucleo de Doenças Infecciosas
Santos Dumont, Brazil
Integral Pesquisa e Ensino
Votuporanga, Brazil
IWK Health Centre
Halifax, Canada
London Health Sciences Centre (LHSC) - Victoria Hospital
London, Canada
The Hospital for Sick Children
Toronto, Canada
Children's & Women's Health Centre of British Columbia
Vancouver, Canada
URC CIC
Paris, France
Soroka Medical Center
Beersheba, Israel
Shamir Medical Center (Assaf Harofeh)
Israel, Israel
Shaare Zedek
Jerusalem, Israel
Hadassah University Hospital, Ein Kerem,
Jerusalem, Israel
Schneider Children's Medical Center
Petah Tikva, Israel
Kaplan Medical Center, Pediatric Gastroenterology Dept.
Rehovot, Israel
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e C. Arrigo
Alessandria, Italy
Asst Papa Giovanni Xxiii Bergamo
Bergamo, Italy
Azienda USL di Bologna
Bologna, Italy
SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato)
Florence, Italy
Ospedale dei Bambini Vittore Buzzi
Milan, Italy
Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)
Roma, Italy
Juntendo University Hospital
Bunkyō City, Japan
Hirosaki University Hospital
Hirosaki, Japan
Kagoshima University Hospital
Kagoshima, Japan
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Japan
Kobe University Hospital
Kobe, Japan
Saga University Hospital
Saga, Japan
Miyagi Children's Hospital
Sendai, Japan
National Center for Child Health and Development
Setagaya-ku, Japan
Mie University Hospital
Tsu, Japan
Yamaguchi University Hospital
Ube, Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Japan
Yokohama City University Medical Center, Center of IBD
Yokohama, Japan
Erasmus Medisch Centrum
Rotterdam, Netherlands
Akershus Universitetssykehus
Nordbyagen, Norway
Oslo University Hospital
Oslo, Norway
Universitetssykehuset Nord-Norge
Tromsø, Norway
St-Olavs Hospital
Trondheim, Norway
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Poland
Warsaw IBD Point Profesor Kierkus
Warsaw, Poland
Instytut Pomnik-Centrum Zdrowia Dziecka
Warsaw, Poland
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
Braga, Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, Portugal
Centro Hospitalar de São João, E.P.E.
Porto, Portugal
Inje University Haeundae Paik Hospital
Busan, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Hospital Universitario Reina Sofia
Córdoba, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Royal Hospital for Children and Young People
Edinburgh, United Kingdom
Oxford University Hospitals NHS trust John Radcliffe hospital
Headington, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
London, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Sheffield Children's Hospital
Sheffield, United Kingdom
Royal London Hospital
Whitechapel, United Kingdom