Recruiting

Testing different medication combinations for severe ulcerative colitis flare-ups

Plain-English translation of NCT05867329 on ClinicalTrials.gov ↗ · Source last updated April 2025 · Translation generated June 2026 · How we translate trials

Phase 4 — The treatment has already been approved. Researchers are tracking how it works in a large number of people over time.

What is this trial?

This trial is testing different ways to treat acute severe ulcerative colitis—a serious flare-up of the disease that requires hospitalization. The study will compare several treatment strategies, including the use of medications like Methylprednisolone, Upadacitinib, and Cyclosporine, given alone or in combination. The goal is to figure out which treatment approach works best for different patients and whether starting with one medication and switching to another if needed is more effective than other options.

Currently, there is no clear agreement among doctors about the best way to treat severe ulcerative colitis flare-ups in hospitalized patients. This trial will help doctors learn which treatment combinations work fastest and most reliably, so they can personalize care and help more patients avoid surgery or serious complications.

Do you qualify?

You likely qualify if…

you are between 18 and 75 years old
you have been diagnosed with ulcerative colitis confirmed by endoscopy and biopsy
you are currently hospitalized and about to start intravenous corticosteroid treatment for a severe flare-up
you have had a severe flare-up with at least 4 bloody bowel movements per day plus fever, rapid heartbeat, low blood count, or other signs of inflammation
you have previously received at least one dose of a TNF inhibitor biologic medication (such as adalimumab, infliximab, certolizumab, or golimumab)

You likely don't qualify if…

you have been diagnosed with a different type of colitis, such as Crohn's disease, microscopic colitis, or infectious colitis
you have already received intravenous corticosteroids for 72 hours or longer before enrollment
you are pregnant or planning to become pregnant during the study period
you are unable to take oral medications or follow the study treatment plan and schedule

What participation looks like

You will be randomly assigned to one of several treatment groups while hospitalized for your severe flare-up. Depending on which group you are in, you may receive intravenous medications, oral pills, or a combination of both. If your initial treatment does not improve your symptoms within a certain timeframe, you may be switched to a rescue medication as part of the study plan. You will complete daily surveys about your bowel movements and symptoms, have regular blood tests, and attend follow-up visits over a three-month period.

AI-generated summary from trial data · Jun 2, 2026 · Not medical advice

Trial locations(1 site)

United States

University of Michigan, Ann Arbor, Michigan