Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients

To join this study, you need to be an adult (18 years or older) who has had Crohn's disease for at least three months. Your Crohn's disease must currently be active, meaning you have moderate to severe symptoms like frequent loose stools or regular belly pain. Doctors will use a scoring system to confirm your disease activity.

Another important requirement is that you must have active inflammation deep within your gut walls, which will be checked with a special scan. You also need to have tried and not responded well to, or couldn't tolerate, at least one other standard treatment for Crohn's disease. This includes conventional medicines or certain advanced therapies like biologics.

Some things would mean you couldn't join the study. For example, if you have complications from Crohn's disease that might need surgery soon, like severe blockages or certain types of fistulas (abnormal connections) or abscesses (pockets of infection). If you have an abscess, it needs to be fully treated and cleared up well before the study begins before you can be considered.

If you join this study, you'll receive the study medication, guselkumab. You will have regular visits to the clinic for check-ups, blood tests, and to discuss how you're feeling. A key part of the study involves having special scans, like an MRI, to look at the healing of your digestive tract, especially at 48 weeks. You'll also be asked about your symptoms and quality of life regularly.

The study involves several assessments over a total duration, which will be explained in detail. This includes monitoring for any side effects or changes in your health. All procedures and medication will be provided as part of the study. You'll have a dedicated medical team supporting you throughout your participation.