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

RecruitingPhase 3Ages 2 Years - 17 YearsAllJanssen Research & Development, LLC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Guselkumab
  • Guselkumab
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Where

85 sites
Cedars Sinai Medical Center
Los Angeles, United States
Connecticut Children's Medical Center
Hartford, United States
Emory University
Atlanta, United States
Children's Center for Digestive Health Care
Atlanta, United States
Riley Hospital for Children
Indianapolis, United States
Boston Childrens Hospital
Boston, United States
Goryeb Children's Hospital
Morristown, United States
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center
New York, United States

โ€ฆand 77 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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