Study Details
Testing the Study Drug Vixarelimab for People with Moderate to Severe Ulcerative Colitis
(IRB#: IRB_00177806)
Ulcerative colitis is a disease that affects the intestine (helps digest food). This study will test a drug called Vixarelimab for people with moderate to severe ulcerative colitis. The study wants to see if the drug will help people and is safe. People in this study will be randomly chosen to be treated at various time points with Vixarelimab or a placebo. The placebo looks like the study drug but does not have the treatment. The study drug and placebo are given under the skin. People in the study will have a colonoscopy or flexible sigmoidoscopy that is video recorded at screening, week 12, and at the end of the study to assess disease activity. People will use an electronic diary on a handheld device to record study activity. Participation requires attending in-person visits at the study clinic and lasts about 25 weeks or 61 weeks if participants choose to be in an optional study. People are paid for participation. Medical tests will be done to track the health of participants.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 18 years and older
- Diagnosis of ulcerative colitis at least 3 months before participation
- Meet specific criteria for moderate to severe ulcerative colitis
- Must have received a colonoscopy within 2 years before participation or be willing to have a colonoscopy
- Childbearing participants must agree to use specific birth control
Exclusion Criteria
- Pregnant or breastfeeding
- History of alcohol, drug, or chemical abuse 2 years before participation
- Diagnosis of Crohns disease
- Serious uncontrolled medical conditions such as heart failure
- Hospitalization during the study other than required participation
Will I be paid for my time?
Yes
IRB#: IRB_00177806
PI: John Valentine
Department: GASTROENTEROLOGY
Approval Date: 2024-08-14 06:00:00
Specialties: Gastroenterology