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

What this study is about

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 join (things the study team will check)

✅ You may be able to join if…

• 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)

🚫 You may not be able to join if…

• 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

Where this trial is running

• Cedars Sinai Medical Center, Los Angeles, California, United States
• Connecticut Children's Medical Center, Hartford, Connecticut, United States
• Emory University, Atlanta, Georgia, United States
• Children's Center for Digestive Health Care, Atlanta, Georgia, United States
• Riley Hospital for Children, Indianapolis, Indiana, United States
• Boston Childrens Hospital, Boston, Massachusetts, United States
• Goryeb Children's Hospital, Morristown, New Jersey, United States
• Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center, New York, New York, United States
• Icahn School of Medicine at Mount Sinai, New York, New York, United States
• Columbia University Medical Center, New York, New York, United States
• The Children's Medical Center of Dayton, Dayton, Ohio, United States
• Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

+ 73 more sites.

Who to contact

Study Contact · 844-434-4210 · Participate-In-This-Study1@its.jnj.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05923073.