Evaluating Guselkumab for Children with Active Crohn's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness of guselkumab in treating pediatric patients with moderately to severely active Crohn's Disease. Participants who have shown a clinical response to the medication at Week 12 will be evaluated for clinical and endoscopic efficacy at Week 52. The study focuses on children diagnosed with Crohn's Disease, ensuring they meet specific criteria related to disease activity and prior treatment history. The intervention involves administering guselkumab to monitor its impact on disease symptoms and endoscopic findings.

Why it matters

Who can join: the full rules

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

Where it's running

• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Connecticut Children's Medical Center
  Hartford, Connecticut, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Children's Center for Digestive Health Care
  Atlanta, Georgia, United States Recruiting
• Riley Hospital for Children
  Indianapolis, Indiana, United States Recruiting
• Boston Childrens Hospital
  Boston, Massachusetts, United States Recruiting

+35 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Real-world use of guselkumab for adults with moderate-to-severe ulcerative colitis and Crohn's disease in the UK

  This project will see how well guselkumab works for adults with moderate-to-severe ulcerative colitis or Crohn's disease who are starting the treatment in routine UK care.

  Recruiting Janssen-Cilag Ltd. · Harrow · NCT07242248

• Guselkumab treatment for Crohn's disease and ulcerative colitis in Germany

  This project will try to see how well guselkumab works and how it affects symptoms, quality of life, and daily activities for adults with Crohn's disease or ulcerative colitis receiving routine care in Germany.

  Recruiting Janssen-Cilag G.m.b.H · Berlin · NCT07102368

• Long-term evaluation of guselkumab for children with inflammatory bowel disease and juvenile arthritis

  This study tests how safe and effective the medication guselkumab is for children with inflammatory bowel disease or juvenile arthritis over a long period of time.

  Recruiting at 53 sites Phase 3 Janssen Research & Development, LLC · Atlanta, Georgia and 52 other locations · NCT06663332

• Iron treatment for children and young adults with Crohn’s disease and iron deficiency anemia

  This study tests how different iron treatment approaches work for kids and young adults with Crohn’s disease and iron deficiency anemia.

  Recruiting Phase 4 Weill Medical College of Cornell University · New York, New York · NCT07925450

• Long-Term Guselkumab Use in Adults with Inflammatory Bowel Disease

  This study looks at how long adults with Crohn's disease or ulcerative colitis stay on guselkumab in real-world care.

  Recruiting Janssen Research & Development, LLC · Amiens · NCT07822529

• Autologous intestinal organoids applied to Crohn's ulcers in a first-in-human dose-escalation study

  This early-phase study tests a patient-derived intestinal organoid therapy (ATORM-C) delivered during colonoscopy to Crohn’s ulcers to see if it is safe and tolerable and to get a sense of healing.

  Recruiting Phase 1 Organoidsciences LTD. · Seoul · NCT07822087

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.