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:

• People aged 18 to 75 years old at the time of signing the consent form, of any gender
• People who have had confirmed signs of active ulcerative colitis (UC) for at least 3 months before screening, confirmed by a camera examination of the bowel during the screening period
• People whose UC is considered moderately to severely active at screening, based on specific scoring measures of bowel symptoms and bowel lining appearance assessed during the screening process (confirm with trial site for scoring details)
• People who have previously tried standard UC medications — such as amino-salicylates, corticosteroids, methotrexate, azathioprine, or 6-mercaptopurine — and had an inadequate response, lost response, or could not tolerate them, or who became dependent on steroids, and have never used advanced biologic or small molecule therapies for UC
• People who have previously tried at least one approved advanced therapy (such as a biologic or advanced small molecule medication) for UC and had an inadequate response, lost response, or could not tolerate it
• People willing and able to use appropriate contraception during the study, in line with local guidelines

Who may not be able to join:

• People with active Crohn's disease, indeterminate colitis, or microscopic colitis
• People whose stool samples test positive for certain bacterial infections or a toxin called Clostridium difficile
• People who have had a colostomy bag, an ileoanal pouch, or removal of part or all of the colon, or for whom such surgery is planned during the study
• People with serious ongoing complications of UC, such as fulminant (very severe sudden) disease, toxic megacolon, or precancerous changes in the bowel lining (except for a specific non-harmful growth type called adenoma)
• People with intestinal failure or a short bowel condition requiring nutrition delivered directly into a vein (Total Parenteral Nutrition)
• People with a history of recurring or recent serious infections within 4 weeks of screening, or infections requiring hospital admission or intravenous antibiotics within 30 days before the study start, or infections requiring oral antibiotics within 14 days before the study start (unless part of a tuberculosis treatment plan)
• People with a known or suspected significant problem with their immune system's ability to fight infections
• People who have had a solid organ transplant or had their spleen removed
• People with a history of moderate to severe heart failure, or a recent stroke
• People with a history of diseases affecting the protective coating of nerve fibres (demyelinating diseases, such as multiple sclerosis), or symptoms that suggest such a condition
• People with a history of cancer or lymphoma, other than certain fully treated, non-spreading skin cancers or a specific localised cervical condition (confirm with trial site)
• People with other inflammatory conditions such as lupus, rheumatoid arthritis, sarcoidosis, Behçet's disease, or similar conditions
• People with a history of HIV infection, or a positive HIV test at screening
• People with a history of a lung condition called Interstitial Lung Disease
• People who test positive for Hepatitis B surface antigen, Hepatitis B core antibody with confirmed active virus, or Hepatitis C antibody at screening
• People whose screening blood tests or other results show abnormal values that fall outside acceptable ranges (confirm with trial site for specifics)
• People with any other health condition that, in the treating doctor's judgement, would put them at risk by taking part in the trial

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