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Clinical Trials in Poland / NCT05923073
Recruiting Phase 3

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

NCT05923073 · tracked via the Priya Life Science Poland tracker
Phase
Phase 3
Started
2024-03-13
Last updated
2026-09-25

Condition(s) studied

Crohn's Disease

Investigational drug(s) / intervention(s)

Guselkumab →Guselkumab →

Guselkumab: Guselkumab will be administered subcutaneously.

Guselkumab: Guselkumab will be administered intravenously.

Study summary

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

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (85)

FacilityCityRegionStatus
Cedars Sinai Medical Center Los Angeles California Recruiting
Connecticut Children's Medical Center Hartford Connecticut Completed
Emory University Atlanta Georgia Recruiting
Children's Center for Digestive Health Care Atlanta Georgia Recruiting
Riley Hospital for Children Indianapolis Indiana Completed
Boston Childrens Hospital Boston Massachusetts Recruiting
Goryeb Children's Hospital Morristown New Jersey Recruiting
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center New York New York Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
Columbia University Medical Center New York New York Completed
The Children's Medical Center of Dayton Dayton Ohio Completed
Children's Hospital of Philadelphia Philadelphia Pennsylvania Recruiting
Cook Childrens Medical Center Fort Worth Texas Recruiting
University of Vermont Medical Center Colchester Vermont 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 Completed
London Health Sciences Centre Victoria Hospital London Ontario Completed
Hospital For Sick Children Toronto Ontario 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

+ 45 more sites — see the full list on the official registry below.

On this site

📄 Tremfya (guselkumab) drug profile →

More Janssen Research & Development, LLC trials in Poland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05923073 on ClinicalTrials.gov ↗ ← All trials in Poland