Recruiting

Testing a new oral medication for active ulcerative colitis

Plain-English translation of NCT07265570 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated July 2026 · How we translate trials

Read our Ulcerative Colitis research guide →

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 ISM5411 to see if it can help people with active ulcerative colitis. The medication works by protecting the lining of your intestines and reducing inflammation. Researchers believe this approach might be more effective than traditional anti-inflammatory treatments alone.

Ulcerative colitis can be difficult to control with current treatments, and patients often need better options. This medication is designed to work differently by strengthening your intestinal barrier and calming inflammation at the same time, which could help more people feel better.

Do you qualify?

You likely qualify if…

you are between 18 and 75 years old
you have been diagnosed with ulcerative colitis for at least 3 months
you are willing and able to give written informed consent
you are able to take tablets by mouth without problems absorbing medication
you are willing to use effective contraception from screening through 3 months after your last dose (if applicable)

You likely don't qualify if…

you have or may have Crohn's disease, ischemic colitis, or other types of inflammatory bowel disease
you have had intestinal surgery or are likely to need surgery during the study
you have had a recent intestinal infection (like C. difficile) in the past 30 days
you have a known allergy to the medication or its ingredients
you are currently unable to take medications by mouth or have severe malnutrition that affects medication absorption

What participation looks like

You will visit the clinic regularly over 12 weeks. You will be randomly assigned to either take the new medication or a placebo (an inactive pill that looks identical). Throughout the study, researchers will check your health with blood tests, colonoscopy, and other examinations to see if the medication is safe and if it helps reduce your ulcerative colitis symptoms.

AI-generated summary from trial data · Jul 1, 2026 · Not medical advice

Trial locations(28 sites)

China

Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality

The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality

Guangzhou First People's Hospital, Guangzhou, Guangdong

The First Affiliated Hospital,Sun Yat-sen University, Guangzhou, Guangdong

Huizhou First Hospital, Huizhou, Guangdong