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A National Multicenter Study of Etrasimod for the Treatment of Patients With Active UC

NCT07705126 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-07-15

No results posted yet for this study

Summary

Ulcerative colitis (UC) is a chronic inflammatory bowel disease that causes symptoms such as bloody diarrhea, abdominal pain, and frequent bowel movements. It can significantly affect patients' quality of life. Etrasimod is an oral medication taken once daily that has been shown in clinical trials to be effective for treating active UC. However, clinical trial results may not fully reflect how the drug works in real-world clinical practice, where patients have more diverse backgrounds and medical conditions.

This is a prospective, multicenter, observational registry study conducted at approximately 80 hospitals across China. The study will enroll about 500 Chinese adults with active UC who are receiving or about to start treatment with etrasimod. Participants will be followed for at least 52 weeks. The study does not assign any treatment-all participants receive etrasimod as part of their routine clinical care, and treatment decisions are made by their doctors.

The main goal of this study is to describe the characteristics of Chinese adults with active UC who are treated with etrasimod in real-world settings, including their age, sex, disease duration, disease activity, and prior treatments. The study will also track how UC symptoms change over time, how often disease flares occur, and how treatment is adjusted during follow-up. Additional goals include describing medication use patterns, changes in physician-assessed and patient-reported outcomes, treatment-related economic burden, and safety information including adverse events.

Data will be collected at baseline and at Weeks 2, 12, 24, and 52 through routine clinic visits, medical records, and patient questionnaires. The study will help provide a more complete understanding of how etrasimod performs in everyday clinical practice in China.

Conditions

  • Ulcerative Colitis (UC)

Interventions

DRUG

Etrasimod

Intervention Type: Drug Intervention Name: Etrasimod Description: Etrasimod 2 mg tablet, taken orally once daily (swallowed whole, not crushed or chewed). Participants receive etrasimod as part of routine clinical care. The recommended treatment duration in this registry is at least 52 weeks, but dosing adjustments and discontinuation are at the discretion of the treating physician. Etrasimod is a selective sphingosine-1-phosphate (S1P) receptor modulator (targeting S1PR1, S1PR4, and S1PR5) that reduces lymphocyte trafficking to the gut, thereby decreasing intestinal inflammation.

Sponsors & Collaborators

  • Shanghai Yicai Feiyang Public Welfare Foundation

    collaborator UNKNOWN

  • Tang-Du Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2027-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07705126 on ClinicalTrials.gov