Can a new pill outperform standard care for ulcerative colitis?
NCT ID NCT07782242
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This trial compares two oral medications for active ulcerative colitis, a chronic inflammatory bowel disease causing diarrhea, bleeding, and pain. About 320 Chinese adults will be randomly assigned to take either etrasimod, a newer drug that blocks immune cells from entering the gut, or mesalazine, the usual first-line treatment. The main question is whether more people achieve clinical remission—no rectal bleeding, near-normal stool frequency, and healed gut lining—after 24 weeks. The study also tracks symptom improvement, endoscopic healing, quality of life, and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Etrasimod, an oral drug that reduces gut inflammation by keeping immune cells out of the intestinal wall, compared with mesalazine, a standard first-line treatment.
- What this could lead to
- If etrasimod proves superior, it could offer a more effective oral option for Chinese patients with active ulcerative colitis who don't respond well to standard therapy.
- What could go wrong
- This is an open-label trial, so results may be biased. Etrasimod may not show a clear advantage over mesalazine, and it carries risks like infections or heart rhythm effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 320 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female, aged 18 years or above. * Patients diagnosed with active ulcerative colitis at multiple centers including Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (lead center), defined as having a modified Mayo Score (without physician's global assessment) ranging from 3 to 6 points. If ES = 1 point, RBS ≥ 1 point is required. Patients with proctitis are allowed to be enrolled, provided that the proctitis lesion extends more than 5 cm from the anal verge. * Treatment-naive patients at initial visit accounting for no more than 30% of the total sample size; Or patients who have previously received conventional pharmacological therapy (including mesalazine, corticosteroids and immunosuppressants) but have inadequate response, intolerance (excluding mesalazine), or non-standard treatment (including but not limited to insufficient dosage or duration of oral 5-ASA, corticosteroids or immunosuppressants, which shall be determined by the investigator based on individual patient conditions). The proportion of patients receiving combined glucocorticoid therapy at baseline shall not exceed 30% of the total sample size. * Voluntarily participate in this study and sign the informed consent form. Exclusion Criteria: * Subjects with contraindications to etrolimod or mesalazine. * Previously treated with etrasimod or other biologics and small-molecule drugs. * Patients are currently receiving full-dose conventional therapy yet still have active disease, including any one of the following: Treatment with mesalazine (≥3 g/day) for ≥8 weeks; Or continuous treatment with prednisone ≥40 mg/day or equivalent dose for ≥3 days (intravenous administration); Or continuous oral treatment with prednisone \>20 mg/day or equivalent dose for ≥2 weeks; or oral azathioprine (≥0.75 mg/kg/day), 6-mercaptopurine (≥0.5 mg/kg/day), methotrexate (≥15 mg/week) for ≥3 months. * Recent history of acute severe ulcerative colitis (ASUC), toxic megacolon, etc. * Patients with stomas or patients with UC scheduled for inpatient surgical intervention. * Pregnant and lactating women. * Vulnerable groups excluding the elderly and illiterate, including people with mental illnesses, individuals with cognitive impairment, critically ill patients, etc. * Other circumstances where researchers consider participation in this study inappropriate.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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