A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease

This study is looking for adults between 18 and 70 years old who have been diagnosed with Crohn's disease for at least three months. Your Crohn's needs to be moderately to severely active when the study starts, and your doctor will check this with an endoscopy (a camera test).

It's important that your Crohn's hasn't responded well to at least one previous type of advanced treatment (like an 'IL antagonist' or 'TNF inhibitor'). This means you might have tried one of these medicines but didn't get better, your symptoms came back during treatment, or you had side effects that stopped you from continuing.

There are also some reasons why you might not be able to join. For example, if you have very severe Crohn's symptoms, certain complications like an abscess or some types of fistulas, or if you're planning to have surgery for your Crohn's soon. Your doctor will carefully review all your medical information to see if this study is suitable for you.

If you decide to take part, the study will last about 76 weeks, which is roughly a year and a half. For the first part of the study, you'll receive a combination of medicines – vedolizumab plus either adalimumab or ustekinumab. These are usually given as injections or infusions, and your study team will explain exactly how often and where you'll receive them.

If the combination treatment helps you, you'll then move into the second part, where you'll only receive vedolizumab. Throughout the study, you'll have regular visits to the clinic. At these visits, doctors and nurses will do checks to see how you're responding to the treatment and to monitor your general health. This will include tests, examinations, and asking about your symptoms. After your last dose of medicine, you'll have follow-up appointments for about 26 weeks to continue checking your health and safety.