A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Start Date
3/13/2024
Completion Date
4/1/2028
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.
Detailed Description
Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.
Eligibility Criteria
Age Range: 2 years to 17 years
Interventions
Mirikizumab
Conditions
Locations
Cedars Sinai Medical Center
Los Angeles, California 90048
United States
Connecticut Children's Medical Center
Hartford, Connecticut 06032
United States
Emory University
Atlanta, Georgia 30322
United States
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia 30342
United States
Riley Childrens Hospital
Indianapolis, Indiana 46202
United States
Boston Children's Hospital
Boston, Massachusetts 02115
United States
Atlantic Children's Health--Pediatric Gastroenterology
Morristown, New Jersey 07960
United States
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
New York, New York 10021-5663
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Columbia University Medical Center/New York Presbyterian
New York, New York 10032
United States
Childrens Medical Center
Dayton, Ohio 45404
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19146
United States
Cook Children's Medical Center
Fort Worth, Texas 76104
United States
University of Vermont Medical Center
Burlington, Vermont 05401
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States
AKH - Medizinische Universtität Wien
Vienna, 1090
Austria
Universitair Ziekenhuis Brussel
Brussels, 1090
Belgium
Cliniques universitaires Saint-Luc
Brussels, 1200
Belgium
Universitair Ziekenhuis Gent
Ghent, 9000
Belgium
UZ Leuven
Leuven, 3000
Belgium
Hospital PUC-CAMPINAS
Campinas, 13060-904
Brazil
Hospital Pequeno Príncipe
Curitiba-PR, 80250-060
Brazil
Hospital das Clínicas - UFG (Universidade Federal de Goiás)
Goiânia, 74605-050
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, 90035-903
Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90050-170
Brazil
NDI - Nucleo de Doenças Infecciosas
Santos Dumont, 29040-091
Brazil
Integral Pesquisa e Ensino
Votuporanga, 15501 405
Brazil
IWK Health Centre
Halifax, B3K 6R8
Canada
London Health Sciences Centre (LHSC) - Victoria Hospital
London, N6A 5W9
Canada
The Hospital for Sick Children
Toronto, M5G 1X8
Canada
Children's & Women's Health Centre of British Columbia
Vancouver, V6H 3V4
Canada
URC CIC
Paris, 75015
France
Soroka Medical Center
Beersheba, 8410101
Israel
Shamir Medical Center (Assaf Harofeh)
Israel, 70300
Israel
Shaare Zedek
Jerusalem, 9103102
Israel
Hadassah University Hospital, Ein Kerem,
Jerusalem, 9112001
Israel
Schneider Children's Medical Center
Petah Tikva, 4920235
Israel
Kaplan Medical Center, Pediatric Gastroenterology Dept.
Rehovot, 7661041
Israel
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e C. Arrigo
Alessandria, 15121
Italy
Asst Papa Giovanni Xxiii Bergamo
Bergamo, 24127
Italy
Azienda USL di Bologna
Bologna, 40133
Italy
SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato)
Florence, 50139
Italy
Ospedale dei Bambini Vittore Buzzi
Milan, 20154
Italy
Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)
Roma, CAP 00161
Italy
Juntendo University Hospital
Bunkyō City, 113-8431
Japan
Hirosaki University Hospital
Hirosaki, 036
Japan
Kagoshima University Hospital
Kagoshima, 890-8520
Japan
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, 277-0871
Japan
Kobe University Hospital
Kobe, 650-0017
Japan
Saga University Hospital
Saga, 849-8501
Japan
Miyagi Children's Hospital
Sendai, 989 3126
Japan
National Center for Child Health and Development
Setagaya-ku, 157-8535
Japan
Mie University Hospital
Tsu, 514-8507
Japan
Yamaguchi University Hospital
Ube, 755-8505
Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama, 2308765
Japan
Yokohama City University Medical Center, Center of IBD
Yokohama, 232-0024
Japan
Erasmus Medisch Centrum
Rotterdam, 3015 CN
Netherlands
Akershus Universitetssykehus
Nordbyagen, 01474
Norway
Oslo University Hospital
Oslo, 0450
Norway
Universitetssykehuset Nord-Norge
Tromsø, 9038
Norway
St-Olavs Hospital
Trondheim, 7030
Norway
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302
Poland
Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728
Poland
Instytut Pomnik-Centrum Zdrowia Dziecka
Warsaw, 04-730
Poland
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
Braga, 4710-243
Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035
Portugal
Centro Hospitalar de São João, E.P.E.
Porto, 4200 319
Portugal
Inje University Haeundae Paik Hospital
Busan, 48108
South Korea
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
Seoul National University Hospital
Seoul, 3080
South Korea
Hospital Universitario Reina Sofia
Córdoba, 14004
Spain
Corporacio Sanitaria Parc Tauli
Sabadell, 08208
Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Spain
Royal Hospital for Children and Young People
Edinburgh, EH16 4TJ
United Kingdom
Oxford University Hospitals NHS trust John Radcliffe hospital
Headington, OX3 9DU
United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
London, WC1N 3JH
United Kingdom
Manchester University NHS Foundation Trust
Manchester, M139WL
United Kingdom
Sheffield Children's Hospital
Sheffield, S10 2RX
United Kingdom
Royal London Hospital
Whitechapel, E1 1FR
United Kingdom