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A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.
Official title: A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-03-13
Completion Date
2028-07-12
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Guselkumab
Guselkumab will be administered subcutaneously.
Guselkumab
Guselkumab will be administered intravenously.
Locations (83)
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
Atlanta, Georgia, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Boston Childrens Hospital
Boston, Massachusetts, United States
Goryeb Children's Hospital
Morristown, New Jersey, United States
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center
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, New York, United States
The Children's Medical Center of Dayton
Dayton, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Cook Childrens Medical Center
Fort Worth, Texas, United States
University of Vermont Medical Center
Colchester, Vermont, United States
Perth Children's Hospital
Nedlands, Australia
Mater Hospital Brisbane
South Brisbane, Australia
The Children's Hospital at Westmead
Westmead, Australia
AKH - Medizinische Universitat Wien
Vienna, Austria
Universitair Ziekenhuis Brussel
Brussels, Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
Campinas, Brazil
Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro
Curitiba, Brazil
Universidade Federal de Goias - Hospital das Clinicas da UFG
Goiânia, Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Centro de Ciencias e Saude da Universidade Federal do Espirito Santo-Nucleo de Doencas Infecciosas
Vitória, Brazil
INTEGRAL Pesquisa e Ensino
Votuporanga, Brazil
Iwk Health Centre
Halifax, Nova Scotia, Canada
London Health Sciences Centre Victoria Hospital
London, Ontario, Canada
CHU Amiens-Hopital Nord
Amiens, France
Hôpital Jeanne de FLANDRE, CHRU LILLE
Lille, France
Hôpital Necker - Enfants Malades
Paris, France
Hôpital Robert Debré
Paris, France
Soroka University Medical Center
Beersheba, Israel
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Hadassah Medical Center
Jerusalem, Israel
Schneider Children's Medical Center
Petah Tikva, Israel
Kaplan Medical Center
Rehovot, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Italy
Ospedale Bellaria, U.O.Cardiologia Az. USL di Bologna
Bologna, Italy
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Florence, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore Buzzi
Milan, Italy
AOU Policlinico Umberto I
Roma, Italy
Hirosaki University Hospital
Hirosaki, Japan
Kagoshima University Hospital
Kagoshima, Japan
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
Juntendo University Hospital
Tokyo, Japan
Mie University Hospital
Tsu, Japan
Yamaguchi University Hospital
Ube, Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Japan
Yokohama City University Medical Center
Yokohama, Japan
Erasmus Medisch Centrum
Rotterdam, Netherlands
Akershus Universitetssykehus HF
Nordbyhagen, Norway
Oslo University Hospital
Oslo, Norway
Universitetssykehuset Nord-Norge HF
Tromsø, Norway
St. Olavs Hospital
Trondheim, Norway
Korczowski Bartosz Gabinet Lekarski
Rzeszów, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland
Instytut Pomnik Centrum Zdrowia
Warsaw, Poland
Hospital de Braga
Braga, Portugal
Centro Hospitalar de Lisboa Norte Hospital Santa Maria
Lisbon, Portugal
Centro Hospitalar de Sao Joao E.P.E.
Porto, Portugal
Inje University Haeundae Paik Hospital
Busan, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Hosp Reina Sofia
Córdoba, Spain
Corporacio Sanitari Parc Tauli
Sabadell, Spain
Hosp. Univ. I Politecni La Fe
Valencia, Spain
Royal Hospital for Sick Children
Glasgow, United Kingdom
Great Ormond Street Hospital
London, United Kingdom
Nowgen Centre, Research and Innovation
Manchester, United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Sheffield Children's Hospital
Sheffield, United Kingdom