Plain-English translation of NCT06660693 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 whether upadacitinib, a newer oral medication, works as well as infliximab (the current standard treatment) for patients hospitalized with severe ulcerative colitis that hasn't improved after three days of steroid therapy. The study will compare giving the medication first to see if it helps, and if it doesn't, switching to the standard treatment. Researchers hope this approach might be easier for patients and just as effective.
Right now, infliximab is the go-to rescue treatment for severe ulcerative colitis that doesn't respond to steroids, but it requires IV infusions and has some drawbacks. Early evidence suggests this medication could work just as well but with the convenience of taking a daily pill instead, and without some of the complications seen with the current standard therapy.
You likely qualify if…
You likely don't qualify if…
If you qualify and enroll, you'll be randomly assigned to receive either the new oral medication (taken once daily by mouth for at least five days) or the standard IV infliximab treatment while you're in the hospital. Researchers will monitor how well the treatment works and watch for any side effects. If you receive the new medication and it doesn't help after the initial period, you may then receive the standard treatment. You'll need to follow study procedures for safety monitoring as outlined in the medication instructions.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
Canada
Phase
Large-scale testing
Sponsor
McMaster University
Collaborators
AbbVie
Enrollment target
~134 participants
Started
April 2025
Primary completion
May 2027
Age range
18 Years – 64 Years
Last updated on clinicaltrials.gov in June 2025.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Neeraj Narula
McMaster University
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.