Plain-English translation of NCT03464136 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 trial tested and compared two biologic medications — ustekinumab and adalimumab — to see which one was safer and more effective at helping people with moderate to severe Crohn's disease feel better. Both medications work by calming down the immune system's attack on the digestive tract. The study followed participants for one year to measure how well each treatment worked.
Crohn's disease can be very difficult to control with older treatments alone, and doctors needed to know which of these newer biologic medications would work best for patients who had never tried biologic therapy before.
Participants were randomly assigned to receive either ustekinumab or adalimumab and visited the clinic over 76 weeks total. The first dose was given as an intravenous infusion at Week 0, followed by injections you could give yourself at home every 2 weeks or every 8 weeks depending on which medication you received. During the year of treatment, participants had blood tests, scans, and scope exams to measure how well the medication was working and to check for any side effects.
AI-generated summary from trial data · Sep 1, 2026 · Not medical advice
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