Plain-English translation of NCT03345849 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 a medication called in people with moderate to severe Crohn's disease who had not responded adequately to standard treatments or could not tolerate them. The study involved two phases: first, participants received either the medication or a placebo for 12 weeks to see if symptoms improved, and then those who did not improve initially had the option to continue with the medication for another 12 weeks. Researchers measured whether this treatment could reduce bowel symptoms like diarrhea and abdominal pain.
Crohn's disease can be severe and disabling, and some patients do not respond well to existing treatments or cannot tolerate them due to side effects. This trial was designed to see whether this new medication could offer a helpful option for people in this difficult situation.
Participants took a daily pill (either the test medication or placebo) for 12 weeks while tracking symptoms like stool frequency and abdominal pain. During this time, they visited the clinic for check-ups and testing. If symptoms did not improve after 12 weeks, participants could enroll in a second phase to continue receiving treatment for another 12 weeks. Those whose symptoms did improve were eligible to join a separate longer-term maintenance study.
AI-generated summary from trial data · Oct 12, 2026 · Not medical advice
United States