Study Details
Testing the Drug Obefazimod for People with Moderate to Severe Active Crohn's Disease
(IRB#: IRB_00182438)
Crohns disease (CD) is a lifelong condition that causes inflammation (pain, swelling) of the gastrointestinal tract (how the body digests food) due to an over-reaction of the immune system (the bodys defense system, which fights infection). The most common symptoms of CD include diarrhea, abdominal pain, weight loss, intestinal bleeding, and fatigue. This study will test a study drug called Obefazimod to treat people with this disease. The study wants to see if the drug will help people with the disease and is safe. People in the study will be randomly chosen to be treated with Obefazimod or a placebo. A placebo looks like the study drug but does not have the study medication. Later in the study, participants will all receive the study drug. Being in the study requires at least 15 visits to the study clinic for over about 108 weeks. 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 to 75 years old
- Diagnosis of or moderate to severe Crohns disease
- Available treatments to treat Crohns disease have not worked
- Attend in-person visits at the study clinic
Exclusion Criteria
- Pregnant or breastfeeding
- Current diagnosis of Ulcerative Colitis (bowel disease) or indeterminate colitis (disease unable to be classified as Crohn's disease or Ulcerative Colitis)
- Crohn's disease without ileal (final part of the small intestine) and/or colonic (inflamed or damaged large intestine) involvement
- History of or active cancer
- Illness requiring hospitalization 4 weeks before participation
Will I be paid for my time?
Yes
IRB#: IRB_00182438
PI: John Valentine
Department: GASTROENTEROLOGY
Approval Date: 2025-01-08 07:00:00
Specialties: Gastroenterology
I am Interested