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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT03524092
Eligibility Criteria:
Inclusion Criteria:
* Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
* Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
* If female, must meet the contraception requirements.
Exclusion Criteria:
* Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
* Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.
* Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
* Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).
* Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
* Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03524092
Study Brief:
Protocol Section:
NCT03524092