Testing a new injection treatment for moderate-to-severe ulcerative colitis

Plain-English translation of NCT07232576 on ClinicalTrials.gov ↗ · Source last updated May 2026 · Translation generated June 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 study is testing a new medication called SHR-1139, given as an injection, to see if it can improve ulcerative colitis symptoms in adults whose condition is moderate to severe and hasn't improved with other treatments. Researchers will look at how well the medication works, how safe it is, and how your body processes it. The study lasts about one year total, split into an initial treatment phase (12 weeks) and a longer maintenance phase (48 weeks).

Many people with ulcerative colitis don't respond well enough to current standard treatments, and some develop side effects that force them to stop taking those medications. This trial is testing whether this new medication offers a better option for those patients.

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 90 days
your ulcerative colitis is moderate-to-severe and currently active
you have not responded well to, lost response to, or could not tolerate at least one standard treatment (like mesalamine, immunosuppressants, or corticosteroids), or you have previously tried biologic therapies
you have a healthy enough body weight (BMI of 18 or higher)
you are willing to use reliable contraception if you can become pregnant

You likely don't qualify if…

you have never been treated for ulcerative colitis before
you have Crohn's disease or another type of inflammatory bowel disease
you have had bowel surgery for ulcerative colitis or are likely to need surgery soon
you currently have a serious infection, have had shingles more than once, or have had a recent intestinal infection like C. difficile
you have a history of cancer or precancerous changes in your colon

What participation looks like

You would receive injections of the study medication and attend multiple clinic visits over 60 weeks (about 14 months). The first 12 weeks focus on whether the medication controls your symptoms, and the remaining 48 weeks test whether it keeps working long-term. You'll have blood tests, colonoscopies (camera examination of your colon), and symptom assessments to help doctors understand how well the treatment is working and monitor for any side effects.

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