Phase 3 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from the ISRCTN registry 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 diagnosed with Crohn's disease (CD) at least 12 weeks before the screening visit, confirmed by both a camera examination of the gut (endoscopy) and a tissue sample report (biopsy/histopathology).
• People whose Crohn's disease is moderately to severely active, based on a specific scoring system (CDAI), meaning their score falls between 220 and 450, and they also have frequent loose stools or significant abdominal pain on average each day.
• People whose Crohn's disease is also confirmed as moderately to severely active through a camera examination of the gut, meeting specific activity scores depending on which part of the bowel is affected.
• Women who could become pregnant must have a negative pregnancy blood test at screening and a negative pregnancy urine test at the start of the treatment period, and must agree to further pregnancy testing during the trial.
• People who have either not responded well enough to standard treatments, lost their response over time, or could not tolerate standard treatments — or who have previously tried or not responded to more advanced treatments (such as biologics or advanced oral medicines) for Crohn's disease.

Who may not be able to join:

• People who have complications from Crohn's disease — such as narrowing of the bowel, short gut syndrome, or other issues — that may require surgery during the trial or that could make it difficult to accurately measure how well the treatment is working.
• People who have a stoma or ostomy (a surgically created opening in the abdomen for waste removal).
• People who have had a portion of their large bowel (colon) removed in the 24 weeks before the start of the trial, or any other major surgery in the 12 weeks before the start of the trial.
• People who were found to have certain types of bowel growths (adenomatous polyps) during their screening colonoscopy, in areas not affected by Crohn's disease, that had not been removed before the start of the trial.

Note: People with active fistulas (abnormal tunnels connecting body parts) may still be considered eligible, provided surgery is not needed for them (confirm with trial site).

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