Phase 2 Crohn's Disease and Colitis Trial, Recruiting

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

Who might be able to join this trial:

• You are between 18 and 75 years old and have been diagnosed with Crohn's Disease for at least 6 months
• You have one or two perianal fistulas (abnormal tunnels near the anus) with one or two openings that are actively draining
• You have tried at least one medical treatment in the past year (such as antibiotics, immune-suppressing drugs, or biologic injections) that did not work well enough
• You either tried surgery (including a seton drain placed at least 2 weeks before screening), are not a candidate for surgery, or do not wish to have surgery for your fistula
• Your current Crohn's Disease medications have been at a stable dose for at least 2 months before starting the trial
• If you take antibiotics for Crohn's Disease, your dose has been stable for at least 2 weeks before starting the trial
• If you take oral steroids, your dose is no more than 20 mg per day of prednisone (or equivalent) and has been stable for at least 4 weeks before starting
• You are able to have a pelvic MRI scan, and the scan results meet specific requirements reviewed by a specialist radiologist (confirm with trial site)
• Your MRI scan shows the fistula meets specific size, location, and tissue characteristics as assessed by a central radiologist (confirm with trial site)

Who may not be able to join:

• You did not provide written consent to participate
• You are pregnant, breastfeeding, or are a woman who could become pregnant without a confirmed negative pregnancy test
• You are unwilling to use an acceptable form of contraception during the study
• You have an active abscess or infection near the anus at the time of screening or at the start of the trial
• You have had a significant health condition within the past 6 months that the study doctor feels could put you at risk
• You have a confirmed diagnosis of HIV, Hepatitis B, or Hepatitis C
• You have a history of cancer, including melanoma, within the past year (minor non-melanoma skin cancers may be an exception)
• You have a history of colorectal (bowel) cancer within the past 2 years
• You have a bleeding or clotting disorder, or you currently take blood-thinning medication
• You have a fistula connecting the rectum or anus to the vagina
• You have had your rectum surgically removed, or you have an internal pouch (ileal anal pouch)
• You have severe inflammation of the rectum, based on a specific scoring system (confirm with trial site)
• You are unable to safely have an MRI scan (for example, due to certain metal implants, body weight limits, or severe claustrophobia)
• Your blood test results at screening fall outside acceptable ranges, including abnormal white blood cell count, low hemoglobin (signs of anaemia), low platelets, abnormal liver or kidney values, abnormal clotting levels, or a blood sugar marker above a certain level (confirm with trial site for specific values)
• You have taken part in another clinical trial or used an experimental treatment within 30 days before starting this trial
• Your MRI scan shows the fistula does not meet the required location or structural criteria as assessed by a central radiologist (confirm with trial site)
• Your MRI scan scores do not meet the minimum thresholds required for the study's imaging criteria (confirm with trial site)

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