A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease
Status: Recruiting
Location: See all (85) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:
• Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
• Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index \[PCDAI\] score greater than or equal to \[\>=\] 30)
• Participants must have endoscopy with evidence of active CD defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score greater than or equal to (\>=) 6 (or \>=4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0
• Participants must have a history of inadequate response, loss of response, or intolerance to immunomodulators (6-MP, AZA, or MTX), oral or IV corticosteroids, or biologic therapy/JAK inhibitor therapy; OR have a history of corticosteroid dependence; OR have a history of inadequate response to exclusive enteral nutrition (EEN)
Locations
United States
California
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Connecticut
Connecticut Children's Medical Center
COMPLETED
Hartford
Georgia
Children's Center for Digestive Health Care
RECRUITING
Atlanta
Emory University
RECRUITING
Atlanta
Indiana
Riley Hospital for Children
COMPLETED
Indianapolis
Massachusetts
Boston Childrens Hospital
RECRUITING
Boston
New Jersey
Goryeb Children's Hospital
RECRUITING
Morristown
New York
Columbia University Medical Center
COMPLETED
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center
RECRUITING
New York
Ohio
The Children's Medical Center of Dayton
COMPLETED
Dayton
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Texas
Cook Childrens Medical Center
RECRUITING
Fort Worth
Vermont
University of Vermont Medical Center
COMPLETED
Colchester
Other Locations
Australia
Perth Children's Hospital
RECRUITING
Nedlands
Mater Hospital Brisbane
RECRUITING
South Brisbane
The Children's Hospital at Westmead
RECRUITING
Westmead
Austria
AKH - Medizinische Universitat Wien
COMPLETED
Vienna
Belgium
Cliniques Universitaires Saint Luc
COMPLETED
Brussels
Universitair Ziekenhuis Brussel
RECRUITING
Brussels
Universitair Ziekenhuis Gent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
Brazil
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
RECRUITING
Campinas
Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro
RECRUITING
Curitiba
Universidade Federal de Goias - Hospital das Clinicas da UFG
RECRUITING
Goiânia
Hospital De Clinicas De Porto Alegre
COMPLETED
Porto Alegre
Irmandade Santa Casa de Misericordia de Porto Alegre
COMPLETED
Porto Alegre
Centro de Ciencias e Saude da Universidade Federal do Espirito Santo-Nucleo de Doencas Infecciosas
COMPLETED
Vitória
INTEGRAL Pesquisa e Ensino
RECRUITING
Votuporanga
Canada
Iwk Health Centre
COMPLETED
Halifax
London Health Sciences Centre Victoria Hospital
COMPLETED
London
Hospital For Sick Children
RECRUITING
Toronto
France
CHU Amiens-Hopital Nord
RECRUITING
Amiens
Hôpital Jeanne de FLANDRE, CHRU LILLE
RECRUITING
Lille
Hôpital Necker - Enfants Malades
COMPLETED
Paris
Hôpital Robert Debré
RECRUITING
Paris
Israel
Shamir Medical Center Assaf Harofeh
COMPLETED
Be’er Ya‘aqov
Soroka University Medical Center
COMPLETED
Beersheba
Hadassah Medical Center
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Schneider Children's Medical Center
RECRUITING
Petah Tikva
Kaplan Medical Center
RECRUITING
Rehovot
Italy
A.O. Santi Antonio e Biagio e Cesare Arrigo
RECRUITING
Alessandria
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
RECRUITING
Bergamo
Ospedale Bellaria, U.O.Cardiologia Az. USL di Bologna
RECRUITING
Bologna
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
RECRUITING
Florence
Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore Buzzi
COMPLETED
Milan
AOU Policlinico Umberto I
COMPLETED
Roma
Japan
Hirosaki University Hospital
COMPLETED
Hirosaki
Kagoshima University Hospital
RECRUITING
Kagoshima
Tsujinaka Hospital Kashiwanoha
COMPLETED
Kashiwa-shi
Kobe University Hospital
RECRUITING
Kobe
Saga University Hospital
RECRUITING
Saga
Miyagi Childrens Hospital
RECRUITING
Sendai
National Center for Child Health and Development
COMPLETED
Setagaya Ku
Juntendo University Hospital
RECRUITING
Tokyo
Mie University Hospital
COMPLETED
Tsu
Yamaguchi University Hospital
RECRUITING
Ube
Saiseikai Yokohamashi Tobu Hospital
RECRUITING
Yokohama
Yokohama City University Medical Center
RECRUITING
Yokohama
Netherlands
Erasmus Medisch Centrum
COMPLETED
Rotterdam
Norway
Akershus Universitetssykehus HF
RECRUITING
Nordbyhagen
Oslo University Hospital
COMPLETED
Oslo
Universitetssykehuset Nord-Norge HF
RECRUITING
Tromsø
St. Olavs Hospital
COMPLETED
Trondheim
Poland
Korczowski Bartosz Gabinet Lekarski
RECRUITING
Rzeszów
Instytut Pomnik Centrum Zdrowia
RECRUITING
Warsaw
WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Warsaw
Portugal
Hospital de Braga
RECRUITING
Braga
Centro Hospitalar de Lisboa Norte Hospital Santa Maria
RECRUITING
Lisbon
Centro Hospitalar de Sao Joao E.P.E.
RECRUITING
Porto
Republic of Korea
Inje University Haeundae Paik Hospital
COMPLETED
Busan
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
COMPLETED
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Spain
Hosp Reina Sofia
RECRUITING
Córdoba
Corporacio Sanitari Parc Tauli
COMPLETED
Sabadell
Hosp. Univ. I Politecni La Fe
RECRUITING
Valencia
United Kingdom
Royal Hospital for Sick Children
RECRUITING
Glasgow
Great Ormond Street Hospital
COMPLETED
London
Nowgen Centre, Research and Innovation
COMPLETED
Manchester
Royal Manchester Children's Hospital
COMPLETED
Manchester
John Radcliffe Hospital
RECRUITING
Oxford
Sheffield Children's Hospital
RECRUITING
Sheffield
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2024-03-13
Estimated Completion Date: 2028-08-14
Participants
Target number of participants: 120
Treatments
Experimental: Open-label induction phase: Guselkumab Intravenously (IV)
Participants will receive guselkumab dose IV based on their body weight during the 12-week open-label induction phase.
Experimental: Open-label induction phase: Guselkumab Subcutaneously (SC)
Participants will receive guselkumab dose SC based on their body weight during the 12-week open-label induction phase.
Experimental: Double-blind maintenance phase: Guselkumab SC Dose Regimen 1
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their body weight up to Week 48.
Experimental: Double-blind Maintenance Phase: Guselkumab SC Dose Regimen 2
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their body weight up to Week 48.
Experimental: Open-label maintenance phase: Guselkumab SC
Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 48.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC