Phase 3 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 80 years old and have been diagnosed with ulcerative colitis (UC)
• You are able to understand and follow the study instructions
• You are willing to sign a consent form agreeing to take part
• You have had UC for at least 3 months before the screening visit, and have had at least one flare-up in the past 12 months
• Your UC diagnosis has been confirmed by a tissue sample (biopsy)
• Your UC is currently mild to moderate in severity, based on specific scoring measures used by doctors
• Your inflammation levels measured during a camera examination of your bowel meet certain thresholds (confirm with trial site)
• The area of your bowel affected by UC extends more than 15 cm from the end of the bowel
• Your blood or stool tests show raised inflammation markers during the screening period
• You have had a full bowel camera examination (colonoscopy) showing no signs of cancer, either during screening or within the past year
• You are either not currently taking oral 5-ASA medication (a common UC treatment), or you have been on a stable dose for more than 3 months before screening and meet specific dosing conditions (confirm with trial site)

Who may not be able to join:

• You have been diagnosed with Crohn's disease, microscopic colitis, ischaemic colitis, radiation colitis, or indeterminate colitis
• You have had an infection-related bowel condition or diverticulitis in the last 6 months
• You currently have or have previously had complex fistulas, abscesses in the abdomen, or bowel narrowing causing blockage symptoms
• Your UC is currently classed as severe (confirm with trial site)
• You have severe UC-related symptoms outside the bowel that require special treatment
• Your UC has not responded to, or has become dependent on, steroid treatments
• It is likely you will need to be admitted to hospital in the near future
• You have had previous bowel surgery, other than having your appendix removed
• Your stool tests show signs of a bowel infection, including C. difficile or cytomegalovirus, at screening
• You currently have or have previously had bowel cancer, high-grade pre-cancerous changes in the bowel, or other cancers (except certain fully removed skin cancers)
• Your blood test shows moderate to severe anaemia (low red blood cell levels) at screening
• Your kidneys are not working well enough, based on a blood test at screening
• You have a significant bleeding or clotting disorder
• You have had problems with alcohol or drug misuse in the last 2 years
• You have used rectal UC treatments (such as enemas or suppositories) within 2 weeks before your bowel camera examination (more than 3 single doses)
• You have taken steroid tablets or oral budesonide within 4 weeks before your bowel camera examination
• You have previously used immunosuppressant drugs, certain targeted therapies (such as JAK inhibitors), or biologic medications for UC
• You have taken antibiotics for UC or probiotic supplements within 6 weeks before your bowel camera examination
• You need intravenous (drip) treatments for your UC, other than iron infusions
• You are known to be allergic to any ingredient in the study medication or placebo tablets
• You have taken part in another clinical trial within the past 4 weeks, or taken an experimental medication within the past 8 weeks (or longer, depending on the medication)
• You are under legal guardianship or are detained under a court or government order
• You are in a dependent relationship with the doctor running the trial or the company sponsoring it
• You are pregnant or breastfeeding
• You are a woman who could become pregnant and are not using a highly effective form of contraception until at least 1 month after your last dose of the study medication
• You are a man whose partner could become pregnant and you are not willing to use a highly effective form of contraception until at least 1 month after your last dose of the study medication
• There are concerns that you may not be able to follow the trial procedures, for example due to a language barrier
• There is any other medical or personal reason that the trial doctor feels makes it unsuitable for you to take part

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