NCT05923073RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 20 Jun 2023
- Start date
- 13 Mar 2024
- Primary completion date
- 27 Oct 2027
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Crohn's disease
- NCT number
- NCT05923073
- EU CT number
- 2023-504735-41-00
- EudraCT number
- 2021-006282-37
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 120
- From 13 Mar 2024 to the primary completion date, 27 Oct 2027
- 85 sites in 17 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline
Other illness
- 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.
Other
- Participants must not have an abscess
Who the study is looking for
- 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)
Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (85)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Perth Children's Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| Mater Hospital Brisbane Coordinator of this site? Confirm its status | South Brisbane | Australia | Recruiting |
| The Children's Hospital at Westmead Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro Coordinator of this site? Confirm its status | Campinas | Brazil | Recruiting |
| Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| Universidade Federal de Goias - Hospital das Clinicas da UFG Coordinator of this site? Confirm its status | Goiânia | Brazil | Recruiting |
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Irmandade Santa Casa de Misericordia de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Centro de Ciencias e Saude da Universidade Federal do Espirito Santo-Nucleo de Doencas Infecciosas Coordinator of this site? Confirm its status | Vitória | Brazil | Recruiting |
| Integral Pesquisa e Ensino Coordinator of this site? Confirm its status | Votuporanga | Brazil | Recruiting |
| IWK Health Centre Coordinator of this site? Confirm its status | Halifax | Canada | Recruiting |
| London Health Sciences Centre · Victoria Hospital Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Royal Hospital for Sick Children Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| Great Ormond Street Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Manchester Children's Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Nowgen Centre, Research and Innovation Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
| Sheffield Children's Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Soroka University Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Recruiting |
| Shamir Medical Center Assaf Harofeh Coordinator of this site? Confirm its status | Be’er Ya‘aqov | Israel | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Kaplan Medical Center Coordinator of this site? Confirm its status | Rehovot | Israel | Recruiting |
| Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria Coordinator of this site? Confirm its status | Alexandria | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Hirosaki University Hospital Coordinator of this site? Confirm its status | Hirosaki | Japan | Recruiting |
| Kagoshima University Hospital Coordinator of this site? Confirm its status | Kagoshima | Japan | Recruiting |
| Tsujinaka Hospital Kashiwanoha Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Recruiting |
| Kobe University Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Recruiting |
| Saga University Hospital Coordinator of this site? Confirm its status | Saga | Japan | Recruiting |
| Miyagi Childrens Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| National Center for Child Health and Development Coordinator of this site? Confirm its status | Setagaya-Ku | Japan | Recruiting |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Mie University Hospital Coordinator of this site? Confirm its status | Tsu | Japan | Recruiting |
| Yamaguchi University Hospital Coordinator of this site? Confirm its status | Ube | Japan | Recruiting |
| Saiseikai Yokohamashi Tobu Hospital Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Yokohama City University Medical Center Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Inje University Haeundae Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Erasmus Medisch Centrum 1 Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Akershus University Hospital Coordinator of this site? Confirm its status | Lorenskog | Norway | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Universitetssykehuset Nord-Norge HF Coordinator of this site? Confirm its status | Tromsoe | Norway | Recruiting |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Recruiting |
| Gabinet Lekarski Bartosz Korczowski Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| Instytut Pomnik Centrum Zdrowia Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local de Saude de Sao Joao E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Children's Center for Digestive Health Care Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Boston Childrens Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Vermont Medical Center Coordinator of this site? Confirm its status | Colchester | United States | Recruiting |
| The Children's Medical Center of Dayton Coordinator of this site? Confirm its status | Dayton | United States | Recruiting |
| Cook Childrens Medical Center Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Connecticut Children's Medical Center Coordinator of this site? Confirm its status | Hartford | United States | Recruiting |
| Riley Hospital for Children Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Goryeb Children's Hospital Coordinator of this site? Confirm its status | Morristown | United States | Recruiting |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.