Phase 3 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:

• People who have been diagnosed with Crohn's disease (CD) at least 3 months before the screening visit, confirmed by examination of the bowel and tissue samples.
• People whose Crohn's disease is considered moderately to severely active, based on specific symptom scores and results from a bowel camera examination (colonoscopy) done during screening.
• People whose Crohn's disease affects the small intestine (ileum) and/or the large intestine (colon), at minimum.
• People with long-standing inflammation of the large intestine (more than 8 years of extensive involvement, or more than 12 years of limited involvement) who have had a surveillance colonoscopy within the past 12 months, or who are able to have one during screening.
• People who have a family history of bowel cancer, a personal history of increased bowel cancer risk, are over 50 years old, or have other known risk factors, and who are up to date with bowel cancer surveillance (which may be done during screening).
• People whose Crohn's disease has not responded well enough to, has stopped responding to, or who have not been able to tolerate at least one of the following treatments: corticosteroids, immunomodulators (medicines that affect the immune system), or TNF-alpha antagonists (a type of anti-inflammatory biological medicine).

Who may not be able to join:

• People who have a pocket of infection (abscess) in the abdomen at the time of the first screening visit.
• People who have had a large portion or all of the large intestine surgically removed.
• People who have had more than 3 surgeries to remove sections of the small intestine, or who have been diagnosed with short bowel syndrome.
• People who have been fed through a tube, special formula diet, or directly into a vein within 21 days before the first dose of the study medicine.
• People who have a stoma (ileostomy or colostomy), a known fixed blockage in the intestine, or a narrowing of the small intestine with a build-up of fluid or waste above it.
• People who have used certain non-biological medicines (such as cyclosporine or thalidomide) for their Crohn's disease, or taken part in another study using a non-biological treatment, within 30 days before joining the trial.
• People who have used traditional Chinese medicines within 30 days before joining the trial.
• People who have previously been treated with certain medicines that target the gut immune system, including natalizumab, efalizumab, etrolizumab, abrilumab, MAdCAM-1 antagonists, or rituximab.
• People who have previously been treated with vedolizumab.
• People who have used rectal (topical) treatments such as 5-ASA suppositories or enemas, steroid enemas, or traditional Chinese medicines for Crohn's disease within 2 weeks before the first dose of the study medicine.
• People who currently need, or are expected to need, bowel surgery during the study period.
• People who have adenomatous polyps (a type of bowel growth) that have not been removed.
• People who have a history or current evidence of abnormal cell changes (dysplasia) in the lining of the large intestine.
• People who have signs of an active infection during the screening period.
• People who have been treated for a gut infection caused by Clostridioides difficile or another intestinal bug within 28 days before the first dose of the study medicine.
• People who have a chronic (long-term) hepatitis B or hepatitis C infection.
• People who have active or latent (dormant) tuberculosis (TB).
• People who have a known immune system deficiency, whether inherited or acquired, such as a common variable immunodeficiency, HIV infection, or who have had an organ transplant.
• People who have received a live vaccine within 30 days before screening.
• People who have had a significant active infection (such as pneumonia, a kidney infection, or COVID-19) within 30 days before or during screening, or who still have ongoing symptoms related to a previous COVID-19 infection.
• People who have had surgery requiring general anaesthesia within 30 days before joining the trial, or who plan to have major surgery during the study.
• People who have a history of cancer, with some exceptions: certain treated skin cancers that have not spread, and certain treated cervical or skin cancers that have not returned for a specified period of time (confirm with trial site for details on exceptions).
• People who have a history of a major neurological condition, such as stroke, multiple sclerosis, a brain tumour, or a degenerative brain disease.

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