Plain-English translation of NCT04779320 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
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, a medication that works by calming the immune system, to see if it can help children and teenagers with moderate to severe Crohn's disease. Vedolizumab is already approved and used in adults in about 70 countries, but this study will determine if it is safe and effective for younger patients. The trial will enroll about 120 children whose disease has not responded well to standard treatments.
Many children with Crohn's disease don't respond adequately to the treatments currently available, such as steroids, immunomodulators, or other biologic drugs. This trial exists to provide a new treatment option for those children and to understand the right dose of this medication for different age and weight groups.
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You will first receive three intravenous infusions of the medication over six weeks to see if it helps control your Crohn's disease symptoms. If you respond well, you will then be randomly assigned to receive either a higher or lower dose of the medication every eight weeks for the next several months. Throughout the study, your doctor will monitor how you are doing and may adjust your dose if needed. The entire study lasts about 46 weeks, and you will need to visit the clinic regularly for infusions and check-ups.
AI-generated summary from trial data · Jun 5, 2026 · Not medical advice
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