A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission

To be considered for this study, you need to be an adult (18 years or older) with a confirmed diagnosis of microscopic colitis. It's important that your symptoms are currently under control and you are feeling well. You must also be taking budesonide as part of your current treatment for microscopic colitis, and you should have experienced at least one flare-up requiring budesonide treatment in the past 8 months.

There are some reasons why you might not be able to join. For instance, if your doctor finds other types of bowel inflammation like Crohn's or ulcerative colitis, or if you've had recent infections or other serious health problems. They will also check if you have certain other medical conditions or if you've had major bowel surgery before.

It's also important that your body mass index (BMI) is within a certain range (between 18 and 35) and you don't have a history of drug or alcohol abuse. Certain other conditions, like recent allergic reactions with specific symptoms, a history of organ transplants, or some types of cancer within the last two years, would also mean you couldn't participate. Your study doctor will review all these points carefully with you.

If you decide to take part in this study, you will be in the study for about 32 weeks. During this time, you will have regular visits to the study clinic where the research team will monitor your health. These visits will likely include physical examinations, blood tests, and discussions about how you are feeling and any symptoms you might have. You will be given either the study medication (SAR444336) or a placebo, which you'll take as directed. Throughout the study, you'll continue to receive your usual budesonide treatment. The research team will explain all the procedures in detail and ensure you understand what is involved at each step.