Recruiting

Testing a new oral medication for moderate to severe ulcerative colitis

Plain-English translation of NCT07196748 on ClinicalTrials.gov ↗ · Source last updated May 2026 · Translation generated June 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 oral medication taken by mouth, to see if it can help people with moderate to severe ulcerative colitis—a condition where the colon becomes inflamed and develops small sores. The study will measure whether this medication reduces symptoms and allows the colon to heal better than a placebo (a pill with no active ingredient). Researchers will also carefully track how safe and well-tolerated the medication is.

Many people with ulcerative colitis don't get enough relief from current treatments, or they cannot tolerate them well. This medication works in a new way, and this trial aims to find out if it offers a better option for patients whose symptoms remain moderate to severe despite existing therapies.

Do you qualify?

You likely qualify if…

you have been diagnosed with ulcerative colitis for at least 12 weeks and have both endoscopy and tissue biopsy evidence of the disease
your ulcerative colitis is moderately to severely active at the time you enter the study
you have either not responded well to standard treatments or could not tolerate them, or you have not responded well to advanced biologic or oral therapies
you weigh at least 40 kilograms (88 pounds) if you are an adolescent participant
you are not pregnant and agree to pregnancy testing throughout the study if you are a woman who can become pregnant

You likely don't qualify if…

you have severe, life-threatening complications of ulcerative colitis such as fulminant colitis or toxic megacolon
you have had major bowel surgery in the past 6 months or other major abdominal surgery in the past 3 months
you have a colostomy or ileostomy (a surgically created opening in your abdomen)
you have a history of fistulas (abnormal tunnels between parts of your bowel or between your bowel and skin)
you have had so much of your colon removed that it would be impossible to properly assess your response to treatment

What participation looks like

You will take the medication or placebo by mouth once daily for 12 weeks during the first phase of the study. During this time, you'll have clinic visits and an endoscopy to see how well the treatment is working. If you respond well, you'll move into a second phase lasting 40 weeks where you'll continue taking the medication daily and have follow-up visits to monitor your progress and any side effects. In total, the study will last approximately one year, with regular visits to check on your health and bowel inflammation.

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

Trial locations(385 sites)

United States

AZ Gastro Care, Chandler, Arizona

Research Solutions of Arizona, Litchfield Park, Arizona

Mayo Clinic, Scottsdale, Arizona

Clinnova Research, Anaheim, California

Southern California Research Center, Coronado, California