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 (inclusive)
• You have been diagnosed with ulcerative colitis (UC) with confirmed symptoms for at least 3 months before the screening visit
• Your UC is considered moderately to severely active, based on specific scores measured during a scope procedure (confirm with trial site)
• You have previously tried at least one standard UC treatment (such as certain anti-inflammatory drugs, steroids, or immune-suppressing medicines) and it did not work well enough, stopped working, or you could not tolerate it — OR you have tried at least one more advanced UC treatment (such as a biologic injection or a newer tablet-based therapy) with the same result
• You are willing and able to use an appropriate method of contraception during the study, as required by local rules

Who may not be able to join:

• You have been diagnosed with Crohn's disease, indeterminate colitis, ischemic colitis, or microscopic colitis (a different type of bowel inflammation)
• You currently have serious UC complications such as fulminant colitis or toxic megacolon, or another condition that might require bowel surgery during the study
• You have previously had your colon surgically removed (colectomy), have a stoma bag, or have had an ileoanal pouch procedure, or this surgery is planned during the study
• Your stool sample tests positive for parasites, harmful bacteria, or a specific bacterial toxin called Clostridium difficile
• You have active tuberculosis (TB), a history of TB that was not fully treated, or an untreated latent (inactive) TB infection
• You tested positive for Hepatitis B or Hepatitis C at your screening visit
• You have any other ongoing, long-term, or recurring infection, including recurring shingles or herpes
• You have a known history of HIV, or you test positive for HIV at your screening visit
• You have had an active cancer or a blood/lymph system cancer in the past 5 years, or it has come back within that time
• You have a history of abnormal pre-cancerous changes in your digestive tract (other than low-grade changes that were fully removed), or you currently have abnormal bowel lining changes or polyps that were not removed during your scope procedure
• You have had extensive UC for 8 or more years, or UC limited to the left side of your colon for more than 10 years, and you have not had a colonoscopy within the past year to check for any abnormal or cancerous changes — and if that colonoscopy finds abnormal changes, you would not be eligible
• You are pregnant, breastfeeding, or planning to become pregnant during the study or within 3 months after your last dose of the study drug
• You have had an infection recently that needed treatment with antibiotics or anti-infective medicines given through a drip (IV) within the last 30 days, or by mouth or injection within the last 14 days
• You currently need or are receiving nutrition through a tube or drip (IV feeding)
• You have taken certain immune-suppressing medicines (such as cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide) within the last 30 days before screening
• You have had a fecal (stool) transplant within the last 30 days before screening
• You have ever been treated with the medicines natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
• You received steroid treatment through a drip (IV) within 14 days before or during the screening period
• Your blood tests or other screening results show results outside the accepted normal range (confirm with trial site)

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