A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)

To join this study, you would need to be an adult (age 18 or older) with a confirmed diagnosis of ulcerative colitis. Your condition must be considered moderate to severe, and you should have already tried at least two different types of ulcerative colitis medications in the past that either didn't work well enough, stopped working, or caused side effects that you couldn't tolerate.

There are also some reasons why you wouldn't be able to join. For example, if your doctor has diagnosed you with Crohn's disease instead of ulcerative colitis, or if your ulcerative colitis is limited just to the rectum (the very end of the large intestine). You also wouldn't be able to take part if you've had major bowel surgery like removing part or all of your colon. The study is also not suitable if you've already tried three or more advanced types of ulcerative colitis treatments (like certain biologic therapies or JAK inhibitors) that didn't help.

If you decide to take part in this study, you'll be randomly assigned to receive either the new study medicine, Rosnilimab, or a placebo (a dummy treatment). Neither you nor your study doctor will know which one you're receiving, which helps ensure the results are unbiased. You would attend regular appointments at the study clinic for assessments, which might include physical exams, blood tests, and potentially endoscopies (where a small camera is used to look inside your colon). You'd take the study medication as instructed, and the study team would carefully monitor your health and any changes in your symptoms. The full duration of your participation, including follow-up, would be fully explained by the study team.