Phase 4 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 given written consent to participate before any screening takes place.
• People who have been diagnosed with Crohn's disease, confirmed through imaging, endoscopy, and/or tissue examination.
• People aged 18 to 80 years.
• People who have had a specific bowel surgery (removal of part of the large and small intestine, joined back together) between 3 and 40 days before the screening visit — or, if a temporary stoma bag was part of that surgery, the original surgery may have been up to eight months earlier, provided the bowel was reconnected between 3 and 40 days before screening.
• People considered at higher risk of the Crohn's disease returning after surgery, due to at least one of the following: the surgery was needed because the disease had spread through the bowel wall; a similar surgery was performed within the past ten years; two or more similar surgeries have been performed previously; current active smoking; or biological medication for Crohn's disease was used within three months before this surgery.
• People whose surgery removed all visibly affected bowel segments (certain small bowel repairs not involving the join are allowed).
• People who have previously tried steroids and/or immune-suppressing treatment for at least three months each, or who were unable to tolerate or had a medical reason not to use those treatments.
• People who are able and willing to start and continue biological therapy at the time determined by the study.

Who may not be able to join:

• People whose Crohn's disease did not respond to — or stopped responding to — all five of the following biological therapies: adalimumab, infliximab, ustekinumab, vedolizumab, and risankizumab.
• People with any condition that the trial doctor believes could put them at risk or affect their ability to follow the study requirements.
• People who have had, or are currently receiving, treatments that the trial doctor believes could affect their safety or the reliability of the trial results.
• People currently taking part in another clinical trial involving an experimental medicine or device.
• People starting biological therapy as part of another clinical trial or special access program.
• People who do not understand Dutch, French, German, or English.
• People diagnosed with ulcerative colitis or a form of inflammatory bowel disease that could not be clearly classified.
• People whose bowel was reconnected using a different surgical arrangement than the specific type required by this trial (confirm with trial site).
• People with currently active perianal disease (disease around the anal area).
• People with a narrowing of the large bowel.
• People who currently have a stoma bag in place.
• People who experienced serious infection or other post-surgical complications requiring antibiotics for more than ten days after their bowel surgery or reconnection.
• People at risk of, or with, short bowel syndrome (a condition where too little bowel remains to absorb nutrients properly).
• People whose qualifying surgery was performed solely because of pre-cancer or cancer changes, without active inflammation being present.
• People with certain abnormal blood test results, including liver function abnormalities, a low white blood cell count, low neutrophil count, or low platelet count (confirm specific values with trial site).
• People with severe kidney, lung, or heart disease.
• People currently misusing alcohol or other substances.

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