Plain-English translation of NCT06100289 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Ulcerative Colitis research guide →Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing vedolizumab in children and teenagers with ulcerative colitis or Crohn's disease. The study will first give participants intravenous infusions of the medication over 6 weeks, and then switch those who improve to self-injections given at home every 2 or 4 weeks (depending on body weight) for 5 months. Researchers want to make sure this injectable form works safely and effectively in young patients.
Many children with inflammatory bowel disease struggle to manage their condition with current treatments. This medication has helped adult patients, but doctors need to test whether the injectable version works well and is safe in children, and determine the best dosing schedule based on a child's weight.
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You would start with three intravenous infusions at a hospital or clinic (at the beginning, week 2, and week 6), with the dose adjusted for your body weight. At week 14, if you're improving, you would switch to self-injections at home either every 2 weeks or every 4 weeks (depending on your weight) for about 5 months. The entire study lasts about 8 months, with regular check-ins to monitor how you're doing and watch for any side effects.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
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