A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

This study is looking for men and women between 18 and 75 years old who have been diagnosed with ulcerative colitis for at least a month. Your ulcerative colitis needs to be active, meaning you are currently experiencing symptoms that are moderate to severe.

To be considered, you should have tried at least one other treatment for your ulcerative colitis (such as conventional, biologic, or advanced therapies) but it either didn't work well enough, stopped working, or you couldn't tolerate the side effects.

You cannot join if you have other types of inflammatory bowel disease like Crohn's disease, or if your doctors think your symptoms might be caused by something else. You also can't take part if you have certain complications from your UC that might need surgery, or if you've had certain types of surgery like an ileostomy or colostomy.

If you join the study, you'll be assigned by chance to one of three groups: one group will receive a lower dose of TAK-279, another group will receive a higher dose of TAK-279, and the third group will receive a placebo (dummy pill). For the first 12 weeks (about 3 months), you won't know if you're taking TAK-279 or the placebo, and neither will your study doctor.

After these first 12 weeks, all participants will receive TAK-279 for another 40 weeks (nearly a year). This means you'll be taking the study medicine for a total of 52 weeks (about a year). Throughout the study, you'll have several visits to the clinic so the study team can check your health, see how you're responding to treatment, and monitor for any side effects. After your treatment ends, there will be a final follow-up period of 4 weeks to check on your safety. The whole study, including screening, treatment, and follow-up, will last for about 60 weeks (just over a year).