Real-World study tests Once-Daily pill for ulcerative colitis in chinese adults
NCT ID NCT07705126
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This study looks at how the oral medication etrasimod works for Chinese adults with active ulcerative colitis (UC) in real-world settings. About 500 participants will take etrasimod as part of their routine care and be followed for at least 52 weeks. Researchers will track changes in UC symptoms, disease flares, treatment adjustments, and safety. The goal is to understand how etrasimod performs outside of controlled clinical trials.
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 medication taken once daily that reduces gut inflammation
- What this could lead to
- If successful, this study could show that etrasimod is effective and safe for Chinese adults with active ulcerative colitis in everyday clinical practice, potentially expanding treatment options.
- What could go wrong
- This is an observational registry, not a controlled trial, so results may be influenced by patient differences and real-world variability. It also focuses only on Chinese adults, so findings may not apply to other populations.
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.
- Participants
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About 500 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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Jun 2028
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.
Who is studied
This study will enroll approximately 500 Chinese adults (aged ≥ 18 years) with a documented diagnosis of active ulcerative colitis (UC) who are receiving or about to start etrasimod as part of their routine clinical care. Participants will be recruited from approximately 80 hospitals across China, including tertiary referral centers and regional hospitals. Eligible participants must have active UC defined as an endoscopic subscore ≥ 2, OR a stool frequency subscore ≥ 1, OR a rectal bleeding subscore ≥ 1, with any disease extent (Montreal classification E1, E2, or E3). Participants may be either etrasimod-naïve (starting treatment at enrollment) or etrasimod-experienced (receiving etrasimod for up to 6 months at enrollment). Individuals with contraindications to etrasimod, or those who have previously received ≥ 3 biologics or ≥ 2 biologics plus 1 JAK inhibitor, will be excluded. The study population reflects the real-world UC patient population seeking care at participating gastroenter
- Ages
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18 years and older
- 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: 1. Age ≥ 18 years at baseline, of any sex. 2. Have a documented diagnosis of active ulcerative colitis (UC) and be judged by the treating physician as likely to benefit from etrasimod therapy. Active UC is defined as an endoscopic subscore ≥ 2, OR a stool frequency subscore (SFS) ≥ 1, OR a rectal bleeding subscore (RBS) ≥ 1. Any disease extent (Montreal classification E1, E2, or E3) is eligible. Participants must provide an endoscopy (including sigmoidoscopy) report obtained within 12 months prior to enrollment. 3. Have been receiving etrasimod for no more than 6 months at the time of enrollment. 4. Voluntarily sign a written informed consent form and have the ability to understand and complete study-related questionnaires and visit procedures. Exclusion Criteria: 1. Have any contraindication to etrasimod use as per the approved prescribing information. 2. Have received prior treatment with ≥ 3 biologic therapies (including infliximab, adalimumab, vedolizumab, guselkumab, risankizumab, and mirikizumab), OR ≥ 2 biologic therapies plus 1 JAK inhibitor (including upadacitinib and tofacitinib). 3. Have any condition that, in the investigator's judgment, may compromise data quality or threaten participant safety. The reason for exclusion must be documented.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Tangdu Hospital
Xi’an, Shanxi, China
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