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

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jun 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called guselkumab to see how well it works for children and teenagers with moderately to severely active Crohn's Disease, a condition that causes inflammation in the digestive tract. The goal is to find out if guselkumab can help improve their condition by the end of a year of treatment, especially for those who showed improvement after the first 12 weeks of therapy. The trial is currently looking for participants aged 2 to 17 who have been diagnosed with Crohn's Disease and have not responded well to other treatments in the past.

To be eligible for this study, participants need to have a specific level of disease activity as measured by a scoring system, and they must have signs of active disease as seen through medical tests. However, those with serious complications from Crohn's Disease or recent surgeries are not eligible. If chosen to participate, families can expect regular check-ups and assessments to monitor how well the treatment is working and to ensure the safety of the participants. This trial represents an important step in finding effective treatments for young patients with Crohn's Disease.

Gender

ALL

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