Recruiting

Testing a new oral medication for moderate to severe ulcerative colitis

Plain-English translation of NCT07083193 on ClinicalTrials.gov ↗ · Source last updated July 2025 · Translation generated June 2026 · How we translate trials

Read our Ulcerative Colitis research guide →

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This trial is testing a new oral medication called to see if it can help people with moderate to severe ulcerative colitis — a chronic inflammatory bowel condition. The study will measure how safe the medication is, how well it works, and how your body processes it. About 24 people will participate, and the trial will last up to 17 weeks total.

Ulcerative colitis can be very difficult to manage, and many patients don't respond well to current treatments or experience side effects. This medication aims to offer a new option for people whose symptoms aren't well controlled, particularly those with moderate to severe disease.

Do you qualify?

You likely qualify if…

you have been diagnosed with ulcerative colitis for at least 3 months, confirmed by endoscopy and biopsy during screening
you have moderate to severe active ulcerative colitis with specific symptoms including increased stool frequency, rectal bleeding, and visible inflammation on endoscopy
your disease extends at least 15 centimeters from the anal opening, as confirmed by screening endoscopy
you are currently taking stable doses of 5-ASA or low-dose oral corticosteroids (prednisone 20 mg or less, or equivalent) and can keep them stable throughout the study
you have either never taken biologic drugs before, or you stopped taking them at least 5 half-lives before enrolling

You likely don't qualify if…

you have been diagnosed with Crohn's disease, indeterminate colitis, or other intestinal diseases
you have previously failed treatment with two or more advanced therapies (like biologic drugs or JAK inhibitors) that your doctor deemed ineffective
you have received intravenous or rectal steroids, or topical 5-ASA medication within 2 weeks before enrollment, or systemic small-molecule drugs within 4 weeks
you have had a Clostridium difficile infection or other intestinal infection within 30 days before screening, or test positive for these infections before enrollment

What participation looks like

If you enroll, you'll first go through a 4-week screening period where doctors confirm your diagnosis and check your overall health. Then you'll take the medication twice daily (Dose 1 group) or once daily (Dose 2 group) for 12 weeks. During treatment, you'll have visits to check how you're responding and monitor for any side effects. Finally, you'll return for a 1-week safety follow-up after the medication period ends. The entire study lasts about 17 weeks.

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

Trial locations(1 site)

China

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