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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
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

Full criteria on ClinicalTrials.gov

Sites (85)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Vienna
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ViennaAustriaRecruiting
Perth Children's Hospital
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NedlandsAustraliaRecruiting
Mater Hospital Brisbane
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South BrisbaneAustraliaRecruiting
The Children's Hospital at Westmead
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WestmeadAustraliaRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
UZ Brussel
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JetteBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
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CampinasBrazilRecruiting
Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro
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CuritibaBrazilRecruiting
Universidade Federal de Goias - Hospital das Clinicas da UFG
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GoiâniaBrazilRecruiting
Hospital de Clinicas de Porto Alegre
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Porto AlegreBrazilRecruiting
Irmandade Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilRecruiting
Centro de Ciencias e Saude da Universidade Federal do Espirito Santo-Nucleo de Doencas Infecciosas
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VitóriaBrazilRecruiting
Integral Pesquisa e Ensino
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VotuporangaBrazilRecruiting
IWK Health Centre
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HalifaxCanadaRecruiting
London Health Sciences Centre · Victoria Hospital
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LondonCanadaRecruiting
Hospital for Sick Children
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TorontoCanadaRecruiting
Hospital Universitario Reina Sofia
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CórdobaSpainRecruiting
Parc Tauli Hospital Universitari
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SabadellSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Royal Hospital for Sick Children
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GlasgowUnited KingdomRecruiting
Great Ormond Street Hospital
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LondonUnited KingdomRecruiting
Royal Manchester Children's Hospital
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ManchesterUnited KingdomRecruiting
Nowgen Centre, Research and Innovation
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ManchesterUnited KingdomRecruiting
John Radcliffe Hospital
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OxfordUnited KingdomRecruiting
Sheffield Children's Hospital
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SheffieldUnited KingdomRecruiting
Soroka University Medical Center
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BeershebaIsraelRecruiting
Shamir Medical Center Assaf Harofeh
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Be’er Ya‘aqovIsraelRecruiting
Shaare Zedek Medical Center
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JerusalemIsraelRecruiting
Hadassah medical Center
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JerusalemIsraelRecruiting
Schneider Children's Medical Center
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Petah TikvaIsraelRecruiting
Kaplan Medical Center
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RehovotIsraelRecruiting
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
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AlexandriaItalyRecruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyRecruiting
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyRecruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
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FlorenceItalyRecruiting
ASST Fatebenefratelli Sacco
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MilanItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyRecruiting
Ospedale Pediatrico Bambino Gesù
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RomeItalyRecruiting
Hirosaki University Hospital
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HirosakiJapanRecruiting
Kagoshima University Hospital
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KagoshimaJapanRecruiting
Tsujinaka Hospital Kashiwanoha
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Kashiwa-shiJapanRecruiting
Kobe University Hospital
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KobeJapanRecruiting
Saga University Hospital
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SagaJapanRecruiting
Miyagi Childrens Hospital
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SendaiJapanRecruiting
National Center for Child Health and Development
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Setagaya-KuJapanRecruiting
Juntendo University Hospital
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TokyoJapanRecruiting
Mie University Hospital
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TsuJapanRecruiting
Yamaguchi University Hospital
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UbeJapanRecruiting
Saiseikai Yokohamashi Tobu Hospital
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YokohamaJapanRecruiting
Yokohama City University Medical Center
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YokohamaJapanRecruiting
Inje University Haeundae Paik Hospital
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BusanSouth KoreaRecruiting
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Erasmus Medisch Centrum 1
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RotterdamNetherlandsRecruiting
Akershus University Hospital
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LorenskogNorwayRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
Universitetssykehuset Nord-Norge HF
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TromsoeNorwayRecruiting
St. Olavs hospital HF
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TrondheimNorwayRecruiting
Gabinet Lekarski Bartosz Korczowski
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RzeszówPolandRecruiting
Instytut Pomnik Centrum Zdrowia Dziecka
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WarsawPolandRecruiting
Medical Network Sp z o o
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WarsawPolandRecruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalRecruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalRecruiting
Unidade Local de Saude de Sao Joao E.P.E.
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PortoPortugalRecruiting
Children's Center for Digestive Health Care
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AtlantaUnited StatesRecruiting
Emory University
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AtlantaUnited StatesRecruiting
Boston Childrens Hospital
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BostonUnited StatesRecruiting
University of Vermont Medical Center
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ColchesterUnited StatesRecruiting
The Children's Medical Center of Dayton
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DaytonUnited StatesRecruiting
Cook Childrens Medical Center
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Fort WorthUnited StatesRecruiting
Connecticut Children's Medical Center
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HartfordUnited StatesRecruiting
Riley Hospital for Children
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IndianapolisUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
Goryeb Children's Hospital
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MorristownUnited StatesRecruiting
Columbia University Medical Center
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New YorkUnited StatesRecruiting
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center
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New YorkUnited StatesRecruiting
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesRecruiting
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.