A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
NCT ID: NCT05923073
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2024-03-13
2028-07-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Guselkumab
Guselkumab will be administered intravenously.
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.
Guselkumab
Guselkumab will be administered subcutaneously.
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.
Guselkumab
Guselkumab will be administered subcutaneously.
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.
Guselkumab
Guselkumab will be administered subcutaneously.
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.
Guselkumab
Guselkumab will be administered subcutaneously.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Guselkumab
Guselkumab will be administered subcutaneously.
Guselkumab
Guselkumab will be administered intravenously.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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 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
2 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
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
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
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CNTO1959PBCRD3007
Identifier Type: OTHER
Identifier Source: secondary_id
2021-006282-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-504735-41-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109212
Identifier Type: -
Identifier Source: org_study_id