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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.

I AM INTERESTED

  • 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

For more information contact:

Jill Montoya

Jill.Montoya@hsc.utah.edu

  801-587-9092

IRB#: IRB_00177806

PI: John Valentine

Department: GASTROENTEROLOGY

Approval Date: 2024-08-14 06:00:00

Specialties: Gastroenterology

Last Updated: 6/8/23