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 (male or female)
• Your body weight is in a healthy range relative to your height (BMI of 18 or above)
• You have active Ulcerative Colitis with a moderate-to-severe level of disease activity, confirmed by a camera examination of your bowel (colonoscopy/endoscopy), including visible rectal bleeding
• You have been diagnosed with Ulcerative Colitis for at least 90 days before joining the trial
• Your current treatments have not worked well enough, have stopped working, or you could not tolerate them — this includes common medicines like 5-ASA, steroids, immunosuppressants, biologic treatments (such as infliximab or adalimumab), or JAK inhibitor medicines
• You are able to read, understand, and sign a consent form agreeing to take part in the study
• If you are a woman who could become pregnant, or a man whose partner could become pregnant, you must agree to use highly effective contraception during the trial and for 3 months after the last dose of the study medicine

Who may not be able to join:

• You have been diagnosed with indeterminate colitis, or your symptoms suggest you may have Crohn's Disease instead of Ulcerative Colitis
• Your Ulcerative Colitis only affects the very last part of your bowel (the bottom 15 cm or less)
• You have never received any treatment for your Ulcerative Colitis before
• You are showing signs of serious bowel complications such as severely reduced blood flow to the colon, severe flare-up (fulminant colitis), or dangerous bowel swelling (toxic megacolon)
• You have already had surgery for your Ulcerative Colitis, or it is likely you will need surgery during the study
• A bowel examination found signs of abnormal or pre-cancerous cell changes, or cancer in your digestive tract (except for a completely removed low-grade abnormality — confirm with trial site)
• You have a current bowel infection, or had a specific gut infection called C. difficile (or another intestinal infection) within the past 30 days, or tested positive for one at screening
• You have had a significant infection in the past month, more than one episode of shingles (herpes zoster), or a severe widespread case of shingles
• You have any ongoing infection that the doctor thinks could get worse if you join the trial
• You have needed antibiotic or antifungal treatment for an infection within the past 2 weeks
• You are currently taking certain medicines that could interfere with the trial, including cyclosporine, tacrolimus, mycophenolate, or JAK inhibitors (within the past 4 weeks), interferon therapy (within the past 8 weeks), or steroid infusions, rectal steroids, or rectal 5-ASA treatments (within the past 2 weeks)

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