Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease

This study is looking for adults aged 18 or older who have been diagnosed with Crohn's disease that affects their small bowel. You must have had an operation on your small bowel for Crohn's disease fairly recently, specifically within the last 5 days to 5 weeks before starting the study.

There are also some reasons why you wouldn't be able to join. For example, if you haven't fully recovered from your recent surgery, or if you have a current stoma (a surgically created opening on your tummy for waste). You also can't take part if you have certain other conditions, like an active anal fistula, or if you're scheduled to receive certain other strong medicines for Crohn's disease besides anti-TNF treatments in the near future.

Finally, if you've had many small bowel operations in the past or a very large amount of your bowel removed, you might not be suitable for this study. If you have any allergies to the study medicine or to soy products, you also wouldn't be able to participate.

If you decide to take part in this study, you'll be assigned by chance to either receive the new medicine EXL01 or a placebo (a dummy pill). Neither you nor your study doctor will know which one you're taking. You'll take this medicine by mouth for up to 24 weeks, which is about six months. You might also continue with other standard treatments for your Crohn's disease, depending on what your doctor decides.

During the study, you'll have several visits to the clinic. At these visits, doctors will check your general health, collect blood and stool samples, and ask you about how you're feeling. A key part of the study is an endoscopy test (where a thin, flexible tube with a camera is used to look inside your bowel) about 24 weeks after your surgery. This test helps doctors see if your Crohn's disease has come back. You'll continue to be monitored for your safety for four weeks after you stop taking the study medicine.