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 were assigned male at birth, or people who were assigned female at birth and are not currently pregnant or breastfeeding, and who are between 18 and 75 years old at the time of the screening visit.
• People who have had a confirmed diagnosis of ulcerative colitis (a type of inflammatory bowel disease affecting the large intestine) for at least 90 days before joining the trial, confirmed by camera examination of the bowel and tissue samples taken at any point in the past, and where the disease affects at least 15 cm of the bowel from the end of the digestive tract.
• People whose ulcerative colitis is considered moderately to severely active during screening, based on specific scoring of symptoms such as how often they go to the toilet, bleeding, and the appearance of the bowel lining during examination.
• People who have previously been treated with at least one approved advanced medication for ulcerative colitis, but where no more than three different types of advanced treatments have stopped working or never worked.
• People who may need a bowel cancer surveillance examination (colonoscopy) before joining, if this is recommended by guidelines in their region for people with ulcerative colitis.

Who may not be able to join:

• People who have been diagnosed with Crohn's disease, indeterminate colitis caused by a bowel infection, or certain other types of colitis (lymphocytic or collagenous colitis).
• People whose ulcerative colitis is limited only to the rectum (the last section of the bowel), as found during the screening bowel examination.
• People who are currently taking, or have previously taken, certain medications that are not permitted in this trial (confirm with trial site for the specific list of prohibited medications).
• People who have an active significant infection, or who have had any infection serious enough to require a hospital stay or treatment through a drip within the past 8 weeks, or any infection treated with antibiotic tablets or similar medication within the past 6 weeks.
• People who have a history of certain serious or rare infections known as opportunistic infections (infections that typically occur when the immune system is weakened).
• People who currently have a very severe or dangerous form of colitis, including acute severe colitis, fulminant colitis, or toxic megacolon.

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