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:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT03169894
Eligibility Criteria:
Inclusion Criteria:
1. Subject is male or female, ≥ 18 to ≤ 75 years of age.
2. Subject has a documented diagnosis of CD via endoscopy/colonoscopy and histological confirmation, or subject has received a diagnosis of UC for 90 days or greater prior to Visit 1, confirmed by endoscopy during the Screening Period, with exclusion of current infection, dysplasia and/or malignancy.
3. Subject has moderate to severe, active CD as evidenced Simple Endoscopy Score for Crohn's Disease (SES-CD) score of ≥7, and histological confirmation, or subject has moderately to severely active UC, as defined by a Modified Mayo Score (excluding the PGA component) of 5 to 9 points at Visit 1.
4. Subject has failed treatment with an approved therapeutic dose of an anti-TNFα monoclonal antibody treatment.
Exclusion Criteria:
1. Subject has a diagnosis of ulcerative colitis (UC) or indeterminate colitis or subject has a diagnosis of Crohn's disease or indeterminate colitis .
2. Subject with signs or symptoms of bowel obstruction.
3. Subject has short bowel syndrome.
4. Subject has a current functional colostomy or ileostomy.
5. Subject has had a surgical bowel resection within the past 6 months prior to screening or is planning any resection during the study period.
6. Subject is pregnant or a nursing mother.
7. Subject is sexually active and not using effective contraception as defined in the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03169894
Study Brief:
Protocol Section:
NCT03169894