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:

• The child or young person weighs at least 10 kg at the time of screening and enrolment.
• The child or young person has been diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) at least 1 month before screening.
• The child or young person has moderately to severely active UC, measured using a specific scoring system based on a colonoscopy and symptom assessment (confirm with trial site for exact score details).
• The child or young person has moderately to severely active Crohn's disease, measured using specific activity and colonoscopy scoring tools (confirm with trial site for exact score details).
• Previous treatments have not worked, stopped working, or caused intolerable side effects — these treatments include steroids, immune-suppressing medicines (such as azathioprine, 6-mercaptopurine, or methotrexate), or TNF-blocking medicines (such as infliximab or adalimumab).
• For UC: the inflammation extends beyond just the lowest part of the bowel (the rectum).
• For UC of long duration (more than 8 years of widespread disease, or more than 12 years of left-sided disease), there must be a record of a clear surveillance colonoscopy within the past 12 months.
• Vaccinations are up to date according to the standard childhood vaccine schedule for that country.

Who may not be able to join:

• The child or young person has previously been treated with certain medicines that target the immune system's trafficking pathways, including natalizumab, efalizumab, etrolizumab, abrilumab, ontamalimab, or rituximab.
• The child or young person has previously received vedolizumab (the medicine being studied in this trial).
• There is a known allergy or sensitivity to vedolizumab or any of its ingredients.
• The child or young person has active brain or nervous system disease, any history or signs of a serious brain condition called progressive multifocal leukoencephalopathy (PML), or any other major neurological disorder.
• A live vaccine has been given within 30 days before the first dose of the study medicine.
• Surgery for UC or CD is currently needed or is expected to be needed during the trial.
• The child or young person has already had a large portion or all of their colon removed, or has a stoma bag, intestinal pouch, known fixed bowel narrowing, short bowel syndrome, or more than 3 small intestine surgeries.
• The current diagnosis is "indeterminate colitis" (where it is unclear whether the condition is UC or CD).
• There are signs suggesting a rare, very early-onset form of bowel disease caused by a single gene change.
• There is active or latent (hidden/inactive) tuberculosis (TB).
• Testing shows active hepatitis B infection (confirm with trial site for specific test details; people with evidence of immunity to hepatitis B may still be eligible).
• There is a known immune system deficiency, whether present from birth or developed later — for example, a common variable immune deficiency, HIV infection, or a history of organ transplantation.
• Stool tests at screening show the presence of parasites or harmful bacteria.
• Stool tests at screening show the presence of a bacteria called Clostridioides difficile (C. diff).

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