A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease
- Crohn's Disease
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 120
- Started
- 13 March 2024
- Main results due
- 27 October 2027
- Study sites
- 85
- Registry updated
- 25 September 2026
Can you take part?
- Ages 2 years to 17 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Participants has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery. * Participants must not have an abscess * Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(85)
Cedars Sinai Medical Center
Los Angeles, California, United States
Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Completed
Emory University
Atlanta, Georgia, United States
Recruiting
Children's Center for Digestive Health Care
Atlanta, Georgia, United States
Recruiting
Riley Hospital for Children
Indianapolis, Indiana, United States
Completed
Boston Childrens Hospital
Boston, Massachusetts, United States
Recruiting
Goryeb Children's Hospital
Morristown, New Jersey, United States
Recruiting
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center
New York, New York, United States
Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Recruiting
Columbia University Medical Center
New York, New York, United States
Completed
The Children's Medical Center of Dayton
Dayton, Ohio, United States
Completed
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Recruiting
Cook Childrens Medical Center
Fort Worth, Texas, United States
Recruiting
University of Vermont Medical Center
Colchester, Vermont, United States
Completed
Perth Children's Hospital
Nedlands, Australia
Recruiting
Mater Hospital Brisbane
South Brisbane, Australia
Recruiting
The Children's Hospital at Westmead
Westmead, Australia
Recruiting
AKH - Medizinische Universitat Wien
Vienna, Austria
Completed
Universitair Ziekenhuis Brussel
Brussels, Belgium
Recruiting
Cliniques Universitaires Saint Luc
Brussels, Belgium
Completed
Universitair Ziekenhuis Gent
Ghent, Belgium
Recruiting
UZ Leuven
Leuven, Belgium
Recruiting
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
Campinas, Brazil
Recruiting
Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro
Curitiba, Brazil
Recruiting
Universidade Federal de Goias - Hospital das Clinicas da UFG
Goiânia, Brazil
Recruiting
Hospital De Clinicas De Porto Alegre
Porto Alegre, Brazil
Completed
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Completed
Centro de Ciencias e Saude da Universidade Federal do Espirito Santo-Nucleo de Doencas Infecciosas
Vitória, Brazil
Completed
INTEGRAL Pesquisa e Ensino
Votuporanga, Brazil
Recruiting
Iwk Health Centre
Halifax, Nova Scotia, Canada
Completed
London Health Sciences Centre Victoria Hospital
London, Ontario, Canada
Completed
Hospital For Sick Children
Toronto, Ontario, Canada
Recruiting
CHU Amiens-Hopital Nord
Amiens, France
Recruiting
Hôpital Jeanne de FLANDRE, CHRU LILLE
Lille, France
Recruiting
Hôpital Necker - Enfants Malades
Paris, France
Completed
Hôpital Robert Debré
Paris, France
Recruiting
Soroka University Medical Center
Beersheba, Israel
Completed
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, Israel
Completed
Shaare Zedek Medical Center
Jerusalem, Israel
Recruiting
Hadassah Medical Center
Jerusalem, Israel
Recruiting
Schneider Children's Medical Center
Petah Tikva, Israel
Recruiting
Kaplan Medical Center
Rehovot, Israel
Recruiting
A.O. Santi Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Italy
Recruiting
Ospedale Bellaria, U.O.Cardiologia Az. USL di Bologna
Bologna, Italy
Recruiting
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Florence, Italy
Recruiting
Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore Buzzi
Milan, Italy
Completed
AOU Policlinico Umberto I
Roma, Italy
Completed
Hirosaki University Hospital
Hirosaki, Japan
Completed
Kagoshima University Hospital
Kagoshima, Japan
Recruiting
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Japan
Completed
Kobe University Hospital
Kobe, Japan
Recruiting
Saga University Hospital
Saga, Japan
Recruiting
Miyagi Childrens Hospital
Sendai, Japan
Recruiting
National Center for Child Health and Development
Setagaya Ku, Japan
Completed
Juntendo University Hospital
Tokyo, Japan
Recruiting
Mie University Hospital
Tsu, Japan
Completed
Yamaguchi University Hospital
Ube, Japan
Recruiting
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Japan
Recruiting
Yokohama City University Medical Center
Yokohama, Japan
Recruiting
Showing 60 of 85 sites — filter to narrow it down. 55 of the 85 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05923073. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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