Plain-English translation of NCT06405087 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 the long-term safety of vedolizumab, an injectable medication designed to treat moderate to severe ulcerative colitis or Crohn's disease in children and teenagers. The study follows young people who already tried the medication in an earlier trial and are doing well on it. Researchers want to make sure this treatment remains safe and effective when used for a longer period.
While earlier studies showed that this medication can help children with these bowel diseases, doctors and researchers need to understand how safe it is over months and years of use. This trial will gather that important safety information to help this treatment become available for young patients.
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You will continue receiving the same injectable medication dose you were on at the end of the earlier trial, either every 2 or 4 weeks depending on your weight. You'll receive the injection as either an auto-injector pen or a prefilled syringe with a safety needle device. The study lasts up to 2 years, with regular clinic visits to check how you're doing and monitor for any side effects.
AI-generated summary from trial data · Jun 23, 2026 · Not medical advice
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