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 (a type of bowel inflammation) that extends beyond the lower part of the colon, with the diagnosis confirmed at least 3 months before enrolling in the study and verified by a camera examination of the bowel.
• People whose ulcerative colitis is currently moderately to severely active, based on a specific scoring system that measures symptoms including blood in the stool and findings seen during a bowel camera examination.
• People whose condition has not responded well enough to previous treatments — this includes people who did not improve with steroid medications, people whose symptoms returned when steroids were reduced or stopped, people who did not improve with certain immune-suppressing tablets, people who did not respond to or lost response to certain advanced medications (such as TNF inhibitors, anti-integrin drugs, certain injected biologics, JAK inhibitors, or S1P receptor modulators), or people who had to stop one of these treatments due to side effects or intolerance.
• People who have been on a stable, unchanged dose of any current bowel medications for at least 2 weeks (for steroids and 5-ASA medicines) or at least 4 weeks (for immune-suppressing tablets such as azathioprine or 6-mercaptopurine) before enrolling.

Who may not be able to join:

• People who have, or have previously had, Crohn's disease, unspecified colitis, colitis caused by reduced blood flow, radiation-related colitis, microscopic colitis, or complicated diverticular disease.
• People with a history of a liver condition called primary sclerosing cholangitis.
• People who have previously had a very severe or dangerous flare of colitis, a severely widened colon, a bowel blockage, or a hole in the bowel wall (unless caused by injury or appendicitis).
• People who have had any abnormal pre-cancerous cell changes found anywhere in the digestive tract.
• People who currently have or require a stoma (a surgically created opening in the abdomen) or an artificial bowel connection.
• People who have already tried and not responded to three or more different classes of advanced biologic or targeted medications, or four or more individual advanced medications regardless of type.
• People who have recently used certain medications within specified timeframes before enrolling, including: JAK inhibitors within the past 2 weeks; TNF inhibitors within the past 8 weeks; S1P receptor modulators within the past 10 weeks; anti-integrin or IL-12/23 inhibitor medications within the past 12 weeks; higher-dose oral steroids, rectal steroids, or injected steroids within specified recent timeframes; rectal 5-ASA medicines within the past 2 weeks; certain other immune-suppressing medicines (such as tacrolimus, cyclosporine, or similar drugs) within the past 4 weeks; regular use of anti-inflammatory pain medicines (such as ibuprofen, used 3 or more times per week for 6 or more weeks) within the past 2 weeks; or any other experimental drug from another clinical trial within the past 8 weeks or within 5 times the drug's clearance period, whichever is longer.

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