Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis

To join this study, you generally need to be an adult between 18 and 75 years old and have Ulcerative Colitis that is active and moderate to severe, meaning your current treatments haven't worked well enough, you've developed problems with them, or they've stopped working as effectively. You'll need to have had UC for at least three months, and doctors will check this with an internal examination (endoscopy) during the initial screening.

You also need to be on stable doses of any other Ulcerative Colitis medicines you are taking, such as certain steroids or other treatments, for a few weeks before the study starts. Women taking part should not be pregnant or breastfeeding, and both men and women will need to use approved methods of contraception during the study if there's any chance of pregnancy.

There are also some reasons why you might not be able to join. For example, if you have Crohn's disease instead of, or as well as, UC, or if you've had surgery to remove your colon. Other reasons include having certain types of infections, serious complications of UC, or other severe bowel conditions. The study doctors will carefully check all these details to make sure the study is safe and appropriate for you.

If you decide to take part, your total time in the study could be up to 58 weeks, which is just over a year. This includes an initial check-up period of up to 4 weeks, where doctors will confirm you're suitable for the study. After that, you'll enter the main treatment phase, which lasts for up to 52 weeks.

For the first 12 weeks, called the 'induction treatment phase,' you'll receive either one of three different doses of SAR443122 or a placebo. Neither you nor your doctor will know which one you're getting. If your symptoms improve well during these first 12 weeks, you'll then continue with the same treatment (still blinded) for another 40 weeks, which is called the 'maintenance phase'.

If your symptoms don't improve enough after the first 12 weeks, or if they get worse at any point during the maintenance phase, you'll be offered the chance to switch to receive SAR443122 at the highest tested dose, and you'll know what you're receiving at that point. Throughout the study, you'll have regular visits for check-ups, assessments, and to receive your medication. There will also be a follow-up period of 2 weeks after your treatment finishes to make sure you're doing well.