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A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

NCT05923073 · Janssen Research & Development, LLC
In plain English

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Official title
A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease
About this study
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 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
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: triple
Age groups: child
Timeline
Starts: 2024-03-13
Estimated completion: 2028-07-12
Last updated: 2026-04-13
Interventions
Drug: GuselkumabDrug: Guselkumab
Primary outcomes
  • Percentage of Participants with Clinical Remission at Week 52 (Week 52)
  • Percentage of Participants Who Achieve Endoscopic Response at Week 52 (Week 52)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorClinical Trial · study_director, Janssen Research & Development, LLC
All locations (84)
Cedars Sinai Medical CenterRecruiting
Los Angeles, California, United States
Connecticut Children's Medical CenterRecruiting
Hartford, Connecticut, United States
Emory UniversityActive Not Recruiting
Atlanta, Georgia, United States
Children's Center for Digestive Health CareRecruiting
Atlanta, Georgia, United States
Riley Hospital for ChildrenRecruiting
Indianapolis, Indiana, United States
Boston Childrens HospitalRecruiting
Boston, Massachusetts, United States
Goryeb Children's HospitalRecruiting
Morristown, New Jersey, United States
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis CenterRecruiting
New York, New York, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
Columbia University Medical CenterRecruiting
New York, New York, United States
The Children's Medical Center of DaytonRecruiting
Dayton, Ohio, United States
Children's Hospital of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
Cook Childrens Medical CenterRecruiting
Fort Worth, Texas, United States
University of Vermont Medical CenterRecruiting
Colchester, Vermont, United States
Perth Children's HospitalRecruiting
Nedlands, Australia
Mater Hospital BrisbaneRecruiting
South Brisbane, Australia
The Children's Hospital at WestmeadRecruiting
Westmead, Australia
AKH - Medizinische Universitat WienRecruiting
Vienna, Austria
Universitair Ziekenhuis BrusselRecruiting
Brussels, Belgium
Cliniques Universitaires Saint LucRecruiting
Brussels, Belgium
Universitair Ziekenhuis GentRecruiting
Ghent, Belgium
UZ LeuvenRecruiting
Leuven, Belgium
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso PierroRecruiting
Campinas, Brazil
Associacao Hospitalar de Protecao a Infancia Dr. Raul CarneiroRecruiting
Curitiba, Brazil
Universidade Federal de Goias - Hospital das Clinicas da UFGRecruiting
Goiânia, Brazil
Hospital De Clinicas De Porto AlegreRecruiting
Porto Alegre, Brazil
Irmandade Santa Casa de Misericordia de Porto AlegreRecruiting
Porto Alegre, Brazil
Centro de Ciencias e Saude da Universidade Federal do Espirito Santo-Nucleo de Doencas InfecciosasRecruiting
Vitória, Brazil
INTEGRAL Pesquisa e EnsinoRecruiting
Votuporanga, Brazil
Iwk Health CentreRecruiting
Halifax, Nova Scotia, Canada
London Health Sciences Centre Victoria HospitalRecruiting
London, Ontario, Canada
Hospital For Sick ChildrenRecruiting
Toronto, Ontario, Canada
CHU Amiens-Hopital NordRecruiting
Amiens, France
Hôpital Jeanne de FLANDRE, CHRU LILLERecruiting
Lille, France
Hôpital Necker - Enfants MaladesRecruiting
Paris, France
Hôpital Robert DebréRecruiting
Paris, France
Soroka University Medical CenterRecruiting
Beersheba, Israel
Shamir Medical Center Assaf HarofehRecruiting
Be’er Ya‘aqov, Israel
Shaare Zedek Medical CenterRecruiting
Jerusalem, Israel
Hadassah Medical CenterRecruiting
Jerusalem, Israel
Schneider Children's Medical CenterRecruiting
Petah Tikva, Israel
Kaplan Medical CenterRecruiting
Rehovot, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)Recruiting
Bergamo, Italy
Ospedale Bellaria, U.O.Cardiologia Az. USL di BolognaRecruiting
Bologna, Italy
Azienda Ospedaliero Universitaria Ospedale Pediatrico MeyerRecruiting
Florence, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore BuzziRecruiting
Milan, Italy
AOU Policlinico Umberto IRecruiting
Roma, Italy
Hirosaki University HospitalRecruiting
Hirosaki, Japan
Kagoshima University HospitalRecruiting
Kagoshima, Japan
Tsujinaka Hospital KashiwanohaRecruiting
Kashiwa-shi, Japan
Kobe University HospitalRecruiting
Kobe, Japan
Saga University HospitalRecruiting
Saga, Japan
Miyagi Children's HospitalRecruiting
Sendai, Japan
National Center for Child Health and DevelopmentRecruiting
Setagaya Ku, Japan
Juntendo University HospitalRecruiting
Tokyo, Japan
Mie University HospitalRecruiting
Tsu, Japan
Yamaguchi University HospitalRecruiting
Ube, Japan
Saiseikai Yokohamashi Tobu HospitalRecruiting
Yokohama, Japan
Yokohama City University Medical CenterRecruiting
Yokohama, Japan
Erasmus Medisch CentrumRecruiting
Rotterdam, Netherlands
Akershus Universitetssykehus HFRecruiting
Nordbyhagen, Norway
Oslo University HospitalRecruiting
Oslo, Norway
Universitetssykehuset Nord-Norge HFRecruiting
Tromsø, Norway
St. Olavs HospitalRecruiting
Trondheim, Norway
Korczowski Bartosz Gabinet LekarskiRecruiting
Rzeszów, Poland
WIP Warsaw IBD Point Profesor KierkusRecruiting
Warsaw, Poland
Instytut Pomnik Centrum ZdrowiaRecruiting
Warsaw, Poland
Hospital de BragaRecruiting
Braga, Portugal
Centro Hospitalar de Lisboa Norte Hospital Santa MariaRecruiting
Lisbon, Portugal
Centro Hospitalar de Sao Joao E.P.E.Recruiting
Porto, Portugal
Inje University Haeundae Paik HospitalRecruiting
Busan, South Korea
Kyungpook National University Chilgok HospitalRecruiting
Daegu, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
Seoul, South Korea
Hosp Reina SofiaRecruiting
Córdoba, Spain
Corporacio Sanitari Parc TauliRecruiting
Sabadell, Spain
Hosp. Univ. I Politecni La FeRecruiting
Valencia, Spain
Royal Hospital for Sick ChildrenRecruiting
Glasgow, United Kingdom
Great Ormond Street HospitalRecruiting
London, United Kingdom
Nowgen Centre, Research and InnovationRecruiting
Manchester, United Kingdom
Royal Manchester Children's HospitalRecruiting
Manchester, United Kingdom
John Radcliffe HospitalRecruiting
Oxford, United Kingdom
Sheffield Children's HospitalRecruiting
Sheffield, United Kingdom
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease · TrialPath