Plain-English translation of NCT05837897 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Crohn's Disease 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 study is testing a medication called vedolizumab to see if it can help people with moderate to severe Crohn's disease—a condition where the digestive system becomes inflamed and causes pain, diarrhea, and other uncomfortable symptoms. Vedolizumab is given as an infusion (through a vein) and works by helping calm the inflammation in the gut. The researchers want to know if this medication is safe and whether it actually helps people feel better.
Many people with Crohn's disease don't respond well enough to existing treatments, or they stop working over time. This trial exists to find out whether this medication can be a better option for patients whose symptoms aren't controlled by current therapies.
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You would participate for approximately 58 weeks total. First, you'd receive either the study medication or a placebo as three infusions over 14 weeks (at the start, 2 weeks later, and 6 weeks later). After that 14-week period, everyone continues to receive the real medication every 8 weeks for the remainder of the study, with the option to switch to more frequent dosing if needed. You'll have regular clinic visits, blood tests, and possibly another colonoscopy to monitor how you're doing.
AI-generated summary from trial data · Jun 20, 2026 · Not medical advice
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