Phase 4 Crohn's Disease and Colitis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been diagnosed with ulcerative colitis (UC), confirmed through medical history, a camera examination of the bowel, and tissue samples taken during that procedure.
- Children and teenagers aged 5 to 17 years old at the time of screening, who weigh more than 13.6 kg (about 30 pounds).
- People whose UC is currently active at a mild or moderate level, based on a specific scoring system used by doctors (called the Mayo score) that measures symptoms like rectal bleeding, stool frequency, and bowel appearance on camera.
- People who are taking an oral or rectal 5-ASA medication (a common UC treatment) at a stable dose and formulation for at least 6 weeks before joining, and who are willing to keep that same dose throughout the study.
Who may not be able to join:
- People who have been diagnosed with Crohn's disease or a condition called indeterminate colitis.
- People whose UC affects only a very small area at the very end of the bowel (within the first 15 centimetres from the anal opening).
- People with severe UC, based on a high score on the doctor's rating scale.
- People whose UC is not currently in an active flare, based on the doctor's scoring system.
- People who have a current bowel infection confirmed by lab tests, or who have had a bowel infection within the past 30 days before screening.
- People who have had previous bowel surgery, with the exception of appendix removal or certain hernia repairs — and gallbladder removal may also be acceptable if it happened more than one year before screening (confirm with trial site).
- People who have a history of a serious complication called toxic megacolon, or who have had part of their bowel surgically removed.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Varsha Bhatt, Bausch Health Americas, Inc.
Phone: 9082428287
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
The primary efficacy endpoint is the proportion of subjects who achieve clinical remission at Day 56, defined as a total Mayo score of ≤ 1 with subscores of 0 for both rectal bleeding and stool frequency, and a subscore of ≤ 1 for endoscopy.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.