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Recruiting Phase 3 NCT05923073

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

Phase 3 – large-scale trial before approval
Conditions: Crohn's Disease

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 15
Australia (1)
Perth Children's Hospital
Nedlands
Belgium (1)
Universitair Ziekenhuis Brussel
Brussels
Brazil (1)
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
Campinas
Canada (1)
Iwk Health Centre
Halifax , Nova Scotia
France (1)
CHU Amiens-Hopital Nord
Amiens
Israel (1)
Soroka University Medical Center
Beersheba
Italy (1)
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo
Japan (1)
Hirosaki University Hospital
Hirosaki
Netherlands (1)
Erasmus Medisch Centrum
Rotterdam
Norway (1)
Akershus Universitetssykehus HF
Nordbyhagen
Poland (1)
Korczowski Bartosz Gabinet Lekarski
Rzeszów
South Korea (1)
Inje University Haeundae Paik Hospital
Busan
Spain (1)
Hosp Reina Sofia
Córdoba
United Kingdom (1)
Royal Hospital for Sick Children
Glasgow
United States (1)
Cedars Sinai Medical Center
Los Angeles , California
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
2 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
13.03.2024
Completion date
12.07.2028
Registry ID
NCT05923073
Source
anzctr
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