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.
Who Can Participate?
Eligibility
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.
Age Range
18-80
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A multicenter, multinational, randomized, double-blind,
placebo-controlled Phase 3, induction study to evaluate
the efficacy and safety of duvakitug in participants with
moderately to severely active Ulcerative Colitis
placebo-controlled Phase 3, induction study to evaluate
the efficacy and safety of duvakitug in participants with
moderately to severely active Ulcerative Colitis
Principal Investigator
Nicole
Jawitz
Protocol Number
PRO00119361
NCT ID
NCT07184996
Phase
III
Enrollment Status
Pending Open to Enrollment