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 @ 10:03 PM
Ignite Modification Date:
2025-12-24 @ 10:03 PM
NCT ID:
NCT03482635
Eligibility Criteria:
Inclusion Criteria:
* 18 - 75 years, at date of signing informed consent, males or females
* Diagnosis of ulcerative colitis ≥ 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report
* Moderate to severe activity (total MCS 6 to 12 with a RBS ≥ 1 AND an SFS ≥ 1 AND mESS ≥ 2 within 7-28 days prior to first dose)
* Endoscopic activity extending proximal to the rectum (≥ 15 cm from anal verge)
* Well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of TNFɑ antagonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past (screening of both TNFɑ antagonists-AND-Vedolizumab failure patients will be capped once 48 randomized patients in Part 1 and 117 randomized patients in Part 2 meet this criterion; patients who have already been screened at the time of the cap will continue to be randomized into the study)
* Further inclusion criteria apply
Exclusion Criteria:
* Evidence of abdominal abscess at screening
* Evidence of fulminant colitis or toxic megacolon at screening
* Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
* Further exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03482635
Study Brief:
Protocol Section:
NCT03482635