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

To join this study, you (or your child) must have been diagnosed with Crohn's disease that currently causes moderate to severe symptoms. Doctors will confirm this using a special scoring system and internal camera tests (endoscopy) to check for active inflammation in the gut.

You would also need to have tried other common treatments for Crohn's disease in the past, such as certain immune-suppressing medicines or steroids, and either they didn't work well enough, stopped working, or caused too many side effects. Alternatively, you might be eligible if you've developed a dependency on steroid medication, or if nutritional therapy hasn't been effective.

However, some things would mean you can't take part. For example, if your Crohn's disease has caused complications like blockages in the gut that might need surgery soon, or if you have an abscess (a collection of pus). You also couldn't join if you’ve had certain types of bowel surgery in the last few months.

If you decide to take part in this study, you would first go through some checks to make sure the study is right for you. This might involve physical exams, blood tests, and an endoscopy (a procedure where a thin, flexible tube with a camera is used to look inside your digestive system) to confirm the level of activity of your Crohn's disease. If you qualify, you or your child would then receive the study medication, guselkumab. The exact way this medicine is given (e.g., by injection) and how often would be explained to you in detail by the study team. You would have regular visits to the clinic for assessments, which include checking your symptoms, blood tests, and sometimes further endoscopies. The study aims to follow how you respond to the treatment over 52 weeks (about one year).