Testing a new intravenous treatment for moderate to severe ulcerative colitis

Plain-English translation of NCT06588855 on ClinicalTrials.gov ↗ · Source last updated August 2026 · Translation generated August 2026 · 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.

What is this trial?

This trial is testing a new medication called to see if it can help people with moderate to severe ulcerative colitis (a disease that causes inflammation and ulcers in the colon). The medication is given as an intravenous infusion followed by injections under the skin. Half of the participants will receive the new treatment, and half will receive a placebo (a dummy treatment with no active medicine) to see which works better.

Many people with ulcerative colitis don't respond well enough to current treatments or develop side effects that make them hard to use. This trial is testing whether this new medication could offer a better option for people whose disease is not controlled by existing therapies.

Do you qualify?

You likely qualify if…

you have been diagnosed with ulcerative colitis that is moderately to severely active
you weigh at least 40 kilograms (about 88 pounds)
you have not responded well to, lost response to, or had side effects from at least one standard or advanced ulcerative colitis treatment
you are up to date with colorectal cancer screening according to your doctor's recommendations
you are able and willing to use effective birth control if you can become pregnant

You likely don't qualify if…

you have severe complications of ulcerative colitis like fulminant colitis or toxic megacolon
you have Crohn's disease, microscopic colitis, or other types of colitis besides ulcerative colitis
you have had past or current dysplasia, adenomas, or cancer in your colon that were not completely removed
you have a current or suspected infection such as C. difficile, CMV, HIV, hepatitis B or C, or active or inadequately treated tuberculosis
you are pregnant, breastfeeding, or planning to become pregnant during the study

What participation looks like

If you join this trial, you will receive either the new medication or a placebo through an intravenous infusion, followed by injections under the skin. You will be randomly assigned to one of these two groups, and neither you nor your doctor will know which treatment you're receiving (this is called being 'blinded'). Throughout the study, you will have regular visits with the research team to check how you're doing, have blood tests, and discuss any side effects or changes in your symptoms.

AI-generated summary from trial data · Aug 11, 2026 · Not medical advice

Trial locations(200 sites)

United States

Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan, Dothan, Alabama

Mayo Clinic Hospital, Scottsdale, Arizona

Arizona Digestive Health, P.C (ADH), Sun City, Arizona

Om Research LLC, Apple Valley, California

Valley View Internal Medicine, Garden Grove, California