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Ulcerative Colitis (UC)E-Heal ChinaNCT07705126

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

An observational study of Ulcerative Colitis (UC), run by Tang-Du Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis (UC)
What is being tested?
Etrasimod
Type of treatment
Pill or oral medicine
How many people
500 participants
Where
1 siteChina
Study dates
15 Jul 2026to 30 Jun 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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

Who may be able to join

  • Age ≥ 18 years at baseline, of any sex.
  • 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.
  • Have been receiving etrasimod for no more than 6 months at the time of enrollment.
  • Voluntarily sign a written informed consent form and have the ability to understand and complete study-related questionnaires and visit procedures.

Who cannot join

  • Have any contraindication to etrasimod use as per the approved prescribing information.
  • 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).
  • Have any condition that, in the investigator's judgment, may compromise data quality or threaten participant safety. The reason for exclusion must be documented.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xin Wang, Doctor contact

+86 13571826689

tangduxiaohua@163.com

China1 site
  • Tangdu Hospital

    Xi’an, Shanxi

    Xin Wang, +8613571826689, tangduxiaohua@163.com

Other trials in China

About this study

Official title: Etrasimod for the Treatment of Active UC in Chinese Adults: A National Multicenter Prospective Registry Study (E-HEAL CHINA)

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.

Read more

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.

Read the detailed description

Ulcerative colitis (UC) is a chronic inflammatory condition of the large intestine that causes symptoms such as bloody stools, frequent diarrhea, abdominal cramps, and an urgent need to move the bowels. These symptoms often come and go over time, and the unpredictable nature of the disease can severely disrupt daily activities, work, and emotional well-being. While several treatments are available, many patients do not achieve lasting remission or may experience side effects. Etrasimod is a once-daily oral medication that works by modulating immune cell activity in the gut to reduce inflammation. Although clinical trials have shown that etrasimod is effective and generally safe for treating active UC, data from routine clinical practice-where patients have a wider range of health conditions, treatment histories, and lifestyle factors-are still limited, especially in the Chinese population.

To address this gap, this study is designed as a prospective, multicenter, observational registry. It is not a clinical trial, meaning that no study medication is assigned or provided by the research team. All enrolled participants are already prescribed etrasimod by their own doctors as part of their standard medical care. The study will be conducted at approximately 80 hospitals across China and aims to enroll about 500 adults aged 18 years or older who have active UC and have been receiving etrasimod for no more than 6 months at the time of enrollment. Participants will be followed for at least 52 weeks (12 months). Those who have previously used three or more biological therapies, or two biological therapies plus one JAK inhibitor, are not eligible to join.

The study includes two participant groups. The first group consists of patients who are starting etrasimod for the first time at enrollment. The second group includes patients who have already been taking etrasimod for up to 6 months before joining, for whom past medical data will be collected retrospectively. All participants will attend routine clinic visits at baseline (enrollment), Week 2, Week 12, Week 24, and Week 52. These visits align with normal clinical care, and the study does not require any additional tests beyond what doctors would typically order for managing UC.

At each study visit, data will be collected from medical records and patient-completed questionnaires. Information collected includes participants' age, sex, disease duration, disease extent and severity, previous treatments, and any other health conditions. The study will track changes in UC symptoms-such as stool frequency and rectal bleeding-as well as disease flare-ups, adjustments in treatment, and the development of new health issues. Participants will be asked to complete validated questionnaires, including the Inflammatory Bowel Disease Questionnaire (IBDQ), which measures quality of life, and the 8-item Morisky Medication Adherence Scale (MMAS-8), which assesses how well participants follow their prescribed treatment plan. The study will also collect information on healthcare costs, including medication expenses, hospitalization fees, and indirect costs such as transportation and lost work time.

In terms of clinical outcomes, the study will describe disease activity using the partial Mayo score, which evaluates stool frequency and bleeding. For those who undergo routine endoscopy as part of their care, the study will record endoscopic findings and, when available, tissue biopsy results to assess mucosal healing. Blood and stool tests, including C-reactive protein (CRP) and fecal calprotectin (FCP), will also be collected if performed in routine practice. Safety is an important focus; the study will systematically document any adverse events or serious adverse events that occur during follow-up.

A planned interim analysis will be performed when approximately 40% of the target enrollment (about 200 participants) is reached, to assess data quality and recruitment progress. No efficacy comparisons or hypothesis testing will be conducted in this interim review. All final analyses will be descriptive in nature, summarizing participant characteristics, treatment patterns, clinical outcomes, patient-reported outcomes, and safety data over the 52-week period.

The findings from this registry are expected to provide valuable real-world evidence on the use of etrasimod in Chinese adults with active UC. This information will help clinicians better understand how the medication performs in everyday practice, support informed treatment decisions, and ultimately improve the management and quality of life for patients living with UC in China.

Being tested
Etrasimod
Keywords
Ulcerative colitis, Etrasimod
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtrasimodDrug

    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.

Study groups in NCT07705126
Study groupRoleWhat they receive
Etrasimod group including the naive and treated patients groupThis cohort includes Chinese adults with active ulcerative colitis who are receiving etrasimod as part of routine clinical care. The cohort is divided into two subgroups based on treatment status at enrollment: 1. Etrasimod-naïve subgroup - participants who start etrasimod at enrollment and are followed prospectively for 52 weeks; 2. Etrasimod-experienced subgroup - participants who have been receiving etrasimod for up to 6 months before enrollment, with baseline data collected retrospectively and subsequent follow-up data collected prospectively for 52 weeks. All participants are followed at baseline and at Weeks 2, 12, 24, and 52 through routine clinic visits, medical records, and patient-completed questionnaires. No study medication is assigned; treatment decisions are made solely by the treating physicians.
Receives: Drug: Etrasimod

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline Demographic and Clinical Characteristics of Chinese Adults with Active UC Receiving Etrasimod

    At enrollment (baseline), the following descriptive data are collected from medical records, electronic health systems, and patient interviews:

    Demographic information: age, sex, ethnicity, region of residence, marital status, occupation, education level, income level, health insurance type, smoking status, and alcohol use.

    UC disease characteristics: age at UC diagnosis, time from symptom onset to confirmed diagnosis, disease duration, disease extent (Montreal classification: E1/E2/E3), disease severity (modified Truelove and Witts classification: mild/moderate/severe), baseline disease activity (modified Mayo score, partial Mayo score including stool frequency subscore and rectal bleeding subscore), presence of extraintestinal manifestations (e.g., joint, skin, eye), and prior UC treatments including medications and surgeries.

    History of previous biologic or JAK inhibitor use.

    All data are collected at a single time point (enrollment) and are derived from existing clinical recor

    Measured: Enrollment (baseline)

  2. Disease Control Status in Chinese Adults with Active UC Receiving Etrasimod Over 52 Weeks

    Over the 52-week follow-up period, disease control is assessed descriptively through the following parameters collected from routine clinic visits, electronic medical records, and patient-completed questionnaires at baseline and at Weeks 2, 12, 24, and 52:

    Changes in UC-related clinical manifestations: improvements or worsening of stool frequency, rectal bleeding, and other UC symptoms, assessed using the partial Mayo score (stool frequency subscore and rectal bleeding subscore), recorded daily for 7 days before each visit.

    Disease flare (relapse) events: timing of each relapse, relapse frequency, disease activity at the time of relapse (assessed by partial Mayo score), and post-relapse disease management strategies (including medications added, changed, or discontinued).

    Concomitant therapy adjustments: for all UC-related concomitant medications, the generic drug name, treatment regimen, reason for treatment change or discontinuation, and any new treatments initiated are documente

    Measured: From enrollment (baseline) through the 52-week follow-up visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start15 Jul 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07705126
Sponsor's protocol ID
K202606-61
Acronym
E-Heal China
Status last verified
Jul 2026
First submitted
9 Jul 2026
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis (UC), run by Tang-Du Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xin Wang, Doctor (+86 13571826689, tangduxiaohua@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline Demographic and Clinical Characteristics of Chinese Adults with Active UC Receiving Etrasimod (time frame: Enrollment (baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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