Phase 2 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with ulcerative colitis (UC) for at least 3 months before the study starts, with both camera examination of the bowel and tissue sample results confirming that diagnosis.
• People whose UC is considered moderately to severely active, based on specific scoring measures confirmed by a specialist review of their bowel examination at screening.
• People who have had UC symptoms for more than 8 years must have had a full bowel camera examination (colonoscopy) within the past year, or within the timeframe recommended by local medical guidelines, to check for any growths or abnormal cells — this must be done before joining the trial.
• People who are up to date with recommended bowel cancer monitoring checks according to local medical guidelines.
• People who have not responded well to, stopped responding to, or could not tolerate at least one UC medication, which may include: steroids or immune-suppressing medications (outside the US); or advanced treatments such as certain biologic injections, biosimilar medicines, JAK inhibitor tablets (such as filgotinib, tofacitinib, or upadacitinib), or S1P receptor medicines (such as etrasimod or ozanimod) — note that mirikizumab does not count as a prior advanced treatment for this criterion (confirm with trial site for US-specific rules).

Who may not be able to join:

• People who have been diagnosed with Crohn's disease, a type of bowel disease that cannot be clearly classified (previously called indeterminate colitis), or a liver condition called primary sclerosing cholangitis.
• People who have had, or are expected to need, surgery to remove part of the bowel or any operation inside the abdomen.
• People who have signs of a serious bowel complication such as toxic megacolon, an abscess inside the abdomen, or a narrowing in the small bowel or colon that blocks or causes symptoms.
• People who have an adenomatous polyp (a type of growth) in a part of the bowel not affected by colitis that has not been fully removed — note that if such a polyp has been completely removed and shows only low-grade changes, this restriction may no longer apply (confirm with trial site).
• People who currently have or have recently had an active infection.

Important: Always verify eligibility with the trial site directly before applying.