Purpose of this Study
This study has two parts. In the first part, people will be placed into one of three groups by chance. They may receive two doses of a study medicine called SAR447189, one dose of the study medicine and one dose of a placebo, or two doses of a placebo over about forty weeks. After this part, some people may be able to continue into the second part of the study, where everyone will receive the study medicine for a longer time.
The full study can last several years. During this time, participants will have many clinic visits. At these visits, doctors will do tests such as heart checks, blood tests, procedures to look inside the body, and ask questions about health and how the person feels.
Who Can Participate?
Eligibility
People can join this study if they are adults between 18 and 80 years old and have moderate to severe ulcerative colitis. They must have already taken part in an earlier study called SUNSCAPE 1.
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 testing a medicine called duvakitug for people who have moderate to severe ulcerative colitis, which is a disease that causes swelling and sores in the intestines. Researchers want to learn how safe this medicine is and if it helps reduce symptoms of the disease. The goal is to see if duvakitug can be a helpful treatment option for people with this condition.
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 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants with Moderately to Severely Active Ulcerative Colitis (SUNSCAPE-2)
Principal Investigator
Nicole
Jawitz
Protocol Number
PRO00120447
NCT ID
NCT07185009
Phase
III
Enrollment Status
Pending Open to Enrollment