A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)

To be considered for this study, you need to be an adult between 18 and 65 years old and have been diagnosed with ulcerative colitis for at least three months. Your UC should be considered moderate to severe at the time of screening.

A key requirement is that you've already tried and not responded well to, stopped responding to, or couldn't tolerate at least one, but no more than two, specific types of medicines called TNF antagonists. If you haven't tried any 'biologic' medicines before, you generally won't be able to join this study, unless specific conditions are met and discussed with the medical team.

Also, if you're currently taking steroid medications, your dose needs to have been stable for at least two weeks before your initial screening appointment. The study also has some rules about colonoscopies and checking for bowel cancer risk, depending on your personal medical history.

If you join this study, it could last for up to 76 weeks, which is about a year and a half. For the first 8 weeks, you will receive both vedolizumab and tofacitinib. These will be given to you as directed by the study team. After these 8 weeks, your progress will be carefully checked. If your condition has improved, you will then continue taking only vedolizumab for another 44 weeks.

Throughout the study, you'll have regular appointments and checks to see how you're responding to the treatment and to monitor your health. These visits will help the doctors understand if the treatment is working and if there are any side effects. Even after you stop taking the study medicine, you'll be followed up for at least 26 weeks (about six months) to ensure your continued well-being. The study will take place in medical centres in the United States and Canada.