A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

To be considered for this study, you need to have a confirmed diagnosis of Crohn's disease for at least three months. You must also have at least one active fistula around your back passage that is draining, which will be confirmed by a special scan called an MRI.

Importantly, you would have previously tried up to two different types of strong medications for your Crohn's (like infliximab, adalimumab, vedolizumab, or similar drugs including JAK inhibitors) but found they either didn't work initially, stopped working over time, or you couldn't tolerate them due to side effects.

There are also some reasons why you might not be able to join. For example, if your Crohn's disease is very severe in other parts of your gut, if you have certain other medical conditions like rectovaginal fistulas, a stoma that is working, severe blockages, or uncontrolled infections. You also wouldn't be able to join if you have a history of certain other illnesses like systemic lupus erythematosus or multiple sclerosis, or if you have complications of Crohn's that might need surgery soon.

If you join this study, you would receive either the study drug, guselkumab, or a placebo (a dummy drug). This will be decided by chance. You would have regular visits to the clinic so the study team can monitor your health, check your Crohn's symptoms, and evaluate how the fistulas are responding. This will involve physical examinations, blood tests, and potentially repeat scans like MRIs. You'll also be asked to report any changes in your health or any side effects you experience. The total length of your participation in the study, including all treatments and follow-up, will be explained in detail by the study team, but typically, studies like this involve regular visits over a period of many months.