Sunscape 1_UC_EFC18325_Jawitz_PRO00119361 - Clinical Trial
What is the Purpose of this Study?
This study has three smaller parts called Sub Studies. In Sub Study 1, people receive a medicine called duvakitug. In Sub Study 2, people are placed by chance into one of three groups to receive duvakitug or a placebo. In Sub Study 3, people are placed by chance into one of two dose groups to receive duvakitug. The whole study lasts about 35 weeks and includes about 15 visits. During the visits, you will have heart tests, blood tests, an endoscopy with a biopsy, and questionnaires. When you join the study, you will be put into either Sub Study 1 or Sub Study 2. You will take the study medicine every two weeks for 12 weeks. After you finish Sub Study 1 or Sub Study 2, you may be asked to join Sub Study 3 to take duvakitug for another 12 weeks, or you may be asked to join another study called SUNSCAPE 2.
Moderate to severe active Ulcerative Colitis
Who Can Participate in the Study?
People can join this study if they are between 18 and 80 years old and have had ulcerative colitis for at least three months. They must have tried standard treatments, but those treatments either did not work well, stopped working, or caused problems they could not tolerate. They must also weigh more than 88 pounds. People cannot join if they have Crohns disease, indeterminate colitis, ulcerative proctitis, or certain complications of ulcerative colitis at the time of screening.
What is Involved?
This study is being done to learn if a medicine called duvakitug can help people who have moderate to severe ulcerative colitis. Ulcerative colitis is a disease that causes swelling and sores in the large intestine. The study also wants to learn if the medicine is safe for people to use.
Study Details
