Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT02849951
Eligibility Criteria:
Key Inclusion Criteria:
1. Established diagnosis of ulcerative colitis (UC), based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings.
2. Active UC with disease confirmed by endoscopy findings and confirmed by central reader.
3. A modified Mayo Score 4-10, and with a centrally read endoscopy score activity of ≥ 2 points.
4. Mesalamine (5-ASA) refractory.
Exclusion Criteria:
1. Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis,
2. Toxic megacolon or fulminant colitis,
3. Prior colon resection,
4. Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile infection) at screening,
5. Known celiac disease
6. Other inflammatory or bleeding disorders of the colon and intestine, or diseases what may cause diarrhea or gastrointestinal bleeding
7. History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack,
8. Subjects with known hypersensitivity to soy,
9. Treatment with methotrexate, azathioprine, 6-mercaptopurine TNF-alpha-antagonists, vedolizumab or certolizumab pegol, tacrolimus, or anti-integrin therapy within last 8 weeks prior to screening,
10. Treatment with any (topical or systemic) corticosteroid formulation for the treatment of IBD within last 7 days prior to endoscopy,
11. Treatment with other investigational drug within last 8 weeks prior to screening,
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02849951
Study Brief:
Protocol Section:
NCT02849951