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:

• You are between 18 and 75 years old
• You have been diagnosed with Crohn's disease (CD) for at least 3 months before the study begins
• Your Crohn's disease has been confirmed as moderate to severe, based on specific scoring systems measuring disease activity, bowel habits, and abdominal pain, checked through a camera examination of your gut (endoscopy)
• You have previously tried at least one standard or advanced treatment for Crohn's disease (such as steroids, antibiotics, immune-suppressing drugs, or biologic medicines), but it either didn't work well enough, stopped working, or you couldn't tolerate it
• You are currently on a stable dose of certain standard Crohn's disease medications before the screening period begins
• You are not pregnant or breastfeeding, and you agree to use appropriate contraception during the study, as required by local guidelines

Who may not be able to join:

• You have been diagnosed with ulcerative colitis, indeterminate colitis, or short bowel syndrome
• Your Crohn's disease only affects your stomach, upper small intestine, or the area around your back passage, without involving your colon or lower small intestine
• You currently have serious complications of Crohn's disease, such as fistulas, abscesses, significant narrowing of the bowel, severe or dangerous inflammation of the colon, or you have had bowel surgery within the last 3 months or more than 3 bowel surgeries in total
• A stool test has found an active infectious cause for your symptoms
• You have active tuberculosis (TB) or a history of TB that was not fully treated
• You tested positive for Hepatitis B or Hepatitis C at the screening visit
• You have any other ongoing, long-term, or repeatedly occurring infection, including repeated outbreaks of herpes zoster (shingles) or herpes simplex
• You have a known history of HIV, or tested positive for HIV at screening
• You have had an active cancer or blood/lymph system cancer, or it has come back, within the last 5 years
• You have a history of abnormal cell changes in the lining of your colon, or polyps that were not removed during your colonoscopy at screening
• You have recently needed treatment with intravenous (IV) antibiotics or anti-infective medicines within the last 30 days, or oral/injected anti-infectives within the last 14 days
• You are currently receiving or require feeding through a drip or tube feeding as your main source of nutrition
• You have taken certain immune-suppressing medications (such as cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide) within 30 days before screening
• You have had a faecal transplant procedure within 30 days before screening
• You have ever been treated with natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
• You have received steroid treatment through a drip (IV) within 14 days before or during screening
• You have used a therapeutic enema or suppository (not related to colonoscopy preparation) within 14 days before or during screening
• Your blood tests or other screening results show abnormal values (confirm with trial site)

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