Recruiting

Testing a new oral medication for moderate to severe ulcerative colitis

Plain-English translation of NCT07415044 on ClinicalTrials.gov ↗ · Source last updated September 2026 · Translation generated September 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing a new medication called to see if it can help adults with moderate to severe ulcerative colitis feel better. You would take this medication by mouth, and researchers will compare how well it works compared to a placebo (a pill with no active medicine) over nearly two years.

Many people with ulcerative colitis don't respond well enough to existing treatments, or they stop working over time. This trial is looking for a new option to help these patients control their symptoms and reduce inflammation in the colon.

Do you qualify?

You likely qualify if…

you have been diagnosed with ulcerative colitis for at least 3 months, confirmed by a doctor looking inside your colon
you have moderate to severe ulcerative colitis that is currently active, meaning you are having significant symptoms
you have not responded well to, or cannot tolerate, at least one standard ulcerative colitis treatment (like steroids or biologic medications)
you have had a colonoscopy or scope test within the last year (or as recommended by your doctor's guidelines)
you are willing to use birth control during the trial if you can become pregnant

You likely don't qualify if…

you have Crohn's disease or other forms of inflammatory bowel disease
you have had colon removal surgery or need surgery on your intestines
you have severe complications like toxic megacolon, abscesses, or blockages in your colon
you have a history of cancer in your digestive tract or cancer diagnosed within the past 5 years
you have a weakened immune system from birth or a genetic condition causing ulcerative colitis-like inflammation

What participation looks like

You would take the medication by mouth at home, either the new treatment or a placebo, and visit the study center regularly for check-ups and tests over about two years. The study includes two different doses of the medication so researchers can learn which works best and is safest. Throughout the trial, doctors will monitor your symptoms, check your colon health, and watch for any side effects.

AI-generated summary from trial data · Sep 16, 2026 · Not medical advice

Trial locations(258 sites)

United States

Valleywise Health Medical Center, Phoenix, Arizona

One of a Kind Clinical Research Center, Scottsdale, Arizona

Clinnova Research, Anaheim, California

GMC Clinical Research, Folsom, California

Om Research LLC, Temple City, California