EtrasimodPhase 4E-CompareNCT07782242
Comaprison of Efficacy and Safety Between Etrasimod vs Mesalazine in Chinese Adults With Active UC
A Phase 4 study testing Etrasimod and mesalazine in people with Etrasimod and Mesalazine, run by Sir Run Run Shaw Hospital.
Trial summary
Ulcerative colitis (UC) is a chronic, relapsing inflammatory disease of the colon that causes diarrhea, bleeding, and abdominal pain. Mesalazine (5-aminosalicylic acid) is the current standard first-line treatment for mild-to-moderate UC, but many patients do not respond well enough, and some experience side effects. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Etrasimod, Mesalazine, Ulcerative Colitis (UC)
- What is being tested?
- Etrasimod and mesalazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2026to 31 Dec 2027
- Phase
- Phase 4
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Etrasimod Versus Mesalazine in Chinese Adult Patients With Active Ulcerative Colitis: A Multicenter, Randomized, Open-Label, Superiority Trial
Ulcerative colitis (UC) is a chronic, relapsing inflammatory disease of the colon that causes diarrhea, bleeding, and abdominal pain. Mesalazine (5-aminosalicylic acid) is the current standard first-line treatment for mild-to-moderate UC, but many patients do not respond well enough, and some experience side effects. Etrasimod is an oral, selective sphingosine-1-phosphate (S1P) receptor modulator that helps reduce gut inflammation by keeping immune cells from moving into the intestinal wall. This study will test whether etrasimod works better than mesalazine in Chinese adults with active UC. The study plans to enroll about 320 patients from multiple hospitals across China. Eligible participants are adults aged 18 years or older with active UC, defined by a modified Mayo score of 3 to 6 (including specific endoscopic and bleeding criteria). Both newly diagnosed patients (within the past 4 weeks, with no prior UC treatment) and those who had an inadequate response, intolerance, or non-standard use of conventional therapies-but who have never taken biologics or other small-molecule drugs-may join. Patients will be randomly assigned in a 1:1 ratio to receive either etrasimod 2 mg once daily or mesalazine (starting at 4 g/day for 12 weeks, then at least 2 g/day based on response) for 24 weeks. Randomisation will balance important factors like steroid use and baseline endoscopic severity.
The primary research objective is whether more patients on etrasimod achieve clinical remission at week 24. Clinical remission means no rectal bleeding, normal or near-normal stool frequency, and an endoscopic score of 1 or less (without easy bleeding). The study will also measure other benefits, such as symptom improvement, endoscopic healing, normalisation of blood and stool inflammation markers, bowel ultrasound response, tissue healing, and quality of life using standard questionnaires. Safety will be carefully tracked by recording all adverse events during treatment and follow-up.
Read more
This is an open-label study (patients and clinical staff know which drug is given) to reflect real-world practice, but the clinical staff who read the colonoscopy results and tissue samples will not know the treatment assignment. An independent statistician will analyse the results. One interim analysis is planned to check for early evidence of benefit or futility. The study involves 24 weeks of treatment, with visits at baseline, week 6, week 12, and week 24, plus a 4-week safety follow-up.
Sample size calculation indicates that 320 participants (160 per group) will provide 90% power to detect a clinically important difference, accounting for a 30% dropout rate. The primary analysis will compare remission rates between groups, adjusting for the stratification factors. All findings will be published to share knowledge with the medical community and help guide future treatment decisions for UC patients in China.
Read the detailed description
Living with ulcerative colitis (UC) can be very difficult. This chronic gut condition causes repeated bouts of diarrhoea, rectal bleeding, abdominal pain, and extreme tiredness. It often strikes young adults in their 20s and 40s, and it can disrupt work, relationships, and daily life. Over time, persistent inflammation also raises the risk of colon cancer.
Currently, the standard first treatment for mild-to-moderate UC in China is mesalazine (5-ASA), an oral anti-inflammatory drug. While it helps many people, a large number of patients either do not respond well enough, relapse frequently, or cannot tolerate its side effects, such as kidney problems. Stronger drugs like biologics or JAK inhibitors are usually held back until after mesalazine fails. This step-up approach may delay effective disease control and allow gut damage to progress.
Etrasimod is a new type of oral pill that works differently. It gently steers certain immune cells away from the gut by blocking their exit from lymph nodes-like keeping "firefighters" away from the "fire" inside the colon. Because it is taken just once a day and does not require injections, it could be more convenient for long-term use. Global clinical trials have shown that etrasimod helps more patients achieve remission than a placebo, but no large study has directly compared it with mesalazine in Chinese adults.
This study aims to fill that gap. The study will recruit about 320 adults with active UC from multiple hospitals across China. Both individuals who are newly diagnosed (within the last month) and those who have used conventional drugs like mesalazine, steroids, or immune suppressors without enough improvement may join-as long as such individuals have never taken biologics or other small-molecule therapies. Participants will be randomly assigned to one of two groups: one group takes etrasimod 2 mg once daily, and the other takes mesalazine at standard doses. The treatment lasts for 24 weeks.
The core research question focuses on whether etrasimod leads to more patients achieving clinical remission-meaning no rectal bleeding, nearly normal bowel habits, and visible healing of the colon lining seen on a camera test (endoscopy)-compared with mesalazine at 24 weeks. The study will also evaluate many other real-world benefits, such as improvement in daily symptoms, deeper tissue healing (examined under a microscope), normalisation of blood and stool inflammation markers, and better scores on quality-of-life questionnaires that assess mood, work, and social activities. Since this is an open-label study, both patients and attending clinical staff will know which drug is being taken, but the clinical staff who review the endoscopic images and biopsy samples will not know the treatment assignments to ensure objective study results.
Safety is a top priority for the study. All participants will receive close monitoring for side effects, with regular blood tests, heart checks, and eye examinations conducted as needed. All unwanted events occurring during the 24-week treatment period and the subsequent 4-week follow-up period will be recorded. The study team may terminate the trial early if serious safety concerns arise.
By generating direct head-to-head evidence in a Chinese population, this research will support clinical staff and patients to make better-informed treatment choices. If etrasimod proves to be more effective and equally safe, it could offer a new, convenient, and early intervention treatment option that optimises UC management strategies in China-potentially enabling more patients to achieve early disease control and maintain long-term gut health.
Study participation is completely voluntary, and participant withdrawal may occur at any time without impact on routine medical care. All personal data collected during the study will be strictly confidential.
- Conditions
- Etrasimod, Mesalazine, Ulcerative Colitis (UC), Head-to-head
- Being tested
- Etrasimod, mesalazine
- Keywords
- Etrasimod, Active UC, Mesalazine
- 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
Also called Velsipity, ADP334
Etrasimod is an oral, once-daily, small-molecule selective S1P receptor modulator (targeting S1P₁,₄,₅) that traps lymphocytes in lymph nodes to reduce gut inflammation without broad immunosuppression. FDA-approved (VELSIPITY, Oct 2023), EMA-approved (2024), and NMPA-approved in China (Feb 2026, Velsipity) for moderately-to-severely active UC. Global Phase 3 trials (ELEVATE UC 12/52, n=741) showed etrasimod significantly outperformed placebo in clinical remission (25% vs 15% at Wk12, 32% vs 7% at Wk52), endoscopic normalisation, and steroid-free remission. The Asian ENLIGHT UC trial confirmed benefits in 320 Chinese patients. Safety data over 4 years show mostly mild-to-moderate AEs with low serious events. This head-to-head superiority trial against mesalazine addresses a key evidence gap in Chinese UC management, assessing whether earlier etrasimod improves outcomes over current standard care.
mesalazineDrug
Also called 5-ASA
Mesalazine (5-ASA) is the current first-line standard treatment for mild-to-moderate ulcerative colitis in China and worldwide. It works directly on the inflamed gut lining by reducing local inflammatory chemicals (prostaglandins and leukotrienes), with very little drug absorbed into the bloodstream - making it generally safe. It comes in oral tablets and rectal forms, depending on disease location.
Most people tolerate mesalazine well. Common, mild side effects include stomach upset, nausea, headache, or dizziness. Rare but serious risks include kidney inflammation (so regular blood tests are needed), pancreatitis, liver problems, and allergic reactions. Long-term use may also lower the risk of colon cancer in UC patients.
This trial compares mesalazine head-to-head against etrasimod to see if the newer drug offers better outcomes for Chinese adults with active UC.
| Study group | Role | What they receive |
|---|---|---|
| Etrasimod | Experimental | Participants receive etrasimod 2 mg film-coated tablets orally once daily for 24 weeks. Etrasimod is a selective S1P receptor modulator that traps lymphocytes in lymph nodes, reducing gut inflammation. Dose is fixed; no adjustments, but may be interrupted/discontinued for safety (e.g., liver enzyme elevation, bradycardia, infection). After 24 weeks, a 4-week safety follow-up occurs without study drug. Baseline steroids are allowed but must be tapered. Receives: Drug: Etrasimod |
| Mesalazine (5-ASA) | Active comparator | Participants receive mesalazine 0.5 g enteric-coated tablets orally. Induction: 4 g/day (8 tablets) for first 12 weeks; maintenance: ≥2 g/day (4 tablets) from weeks 13-24, adjusted by investigator based on response. Mesalazine acts topically on colonic mucosa. Dose reduction allowed in maintenance; may be interrupted/discontinued for intolerance (e.g., renal issues). 4-week safety follow-up after 24 weeks. Same steroid tapering applies. Receives: Drug: mesalazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving clinical remission
Proportion of participants achieving clinical remission at Week 24. Clinical remission is defined as meeting all three of the following criteria: (1) rectal bleeding score (RBS) = 0; (2) stool frequency score (SFS) = 0, or SFS = 1 with a decrease of ≥1 point from baseline; and (3) Mayo endoscopic score (ES) ≤ 1 (excluding mucosal friability). RBS and SFS are derived from the modified Mayo score and assessed via participant-reported daily diaries. Endoscopic score is obtained by colonoscopy (sigmoidoscopy), with central independent reading performed by readers blinded to treatment allocation. The assessment window is Week 24 ± 4 weeks. For missing data, non-responder imputation (NRI) is applied, meaning that participants with missing data or who discontinue early are counted as not having achieved remission.
Measured: week 24
Secondary outcomes (10)
Percentage of Participants Achieving Clinical Response
Clinical response is a composite endpoint assessed using the modified Mayo score (which consists of subscores including rectal bleeding). Response is defined as a binary outcome: a reduction from baseline in the total modified Mayo score of ≥2 points and ≥30%, in conjunction with either a reduction from baseline in the rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1 point. The proportion of participants meeting all of these criteria will be reported at each time point.
Measured: week 12 and week 24
Percentage of Participants Achieving Symptomatic Remission
Symptomatic remission is a composite endpoint assessed using the rectal bleeding subscore (RBS) and stool frequency subscore (SFS) of the modified Mayo score. It is defined as a binary outcome where participants must have an RBS of 0, and either (a) an SFS of 0, or (b) an SFS of 1 with a reduction of ≥1 point from baseline. Participants meeting these criteria at the specified visit will be classified as responders. The proportion of responders out of the total analyzed population will be reported at each time point.
Measured: week 12 and week 24
Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission is defined as a Mayo endoscopic subscore (MES) of ≤1, assessed on a scale of 0 to 3 (where 0 = normal mucosa, 1 = mild erythema/decreased vascular pattern, 2 = moderate erosions, 3 = severe ulceration). This is a binary outcome; participants with MES ≤1 at the specified visit are classified as responders. The proportion of responders out of the total analyzed population will be reported at each time point.
Measured: week 12 and week 24
Percentage of Participants Achieving Endoscopic Normalization
Endoscopic normalization is defined as a Mayo endoscopic subscore (MES) of exactly 0, assessed on a scale of 0 to 3 (where 0 = normal mucosa, 1 = mild erythema/decreased vascular pattern, 2 = moderate erosions, 3 = severe ulceration). This is a stricter binary outcome compared to endoscopic remission (MES ≤ 1); participants with an MES of 0 at the specified visit are classified as responders. The proportion of responders out of the total analyzed population will be reported at each time point.
Measured: week 12 and week 24
Percentage of Participants Achieving Normalization of Inflammatory Markers
Normalization of inflammatory markers is a composite endpoint defined as the simultaneous achievement of both of the following criteria at the specified visit:
- C-reactive protein (CRP) within the normal range (≤ upper limit of normal [ULN] per the central/local laboratory), and
- fecal calprotectin (FCP) reduced from baseline to a range of 100-250 μg/g. This is a binary outcome; participants meeting both criteria are classified as responders. The proportion of responders out of the total analyzed population will be reported at each time point. CRP and FCP values themselves are not reported as separate outcome measures in this endpoint; only the proportion achieving combined normalization is presented.
Measured: week 12 and week 24
Percentage of Participants Achieving Intestinal Ultrasound Response
Intestinal ultrasound response is a composite endpoint assessed using bowel wall thickness (BWT, measured in millimeters) and vascularity assessed via a validated color Doppler grading scale. It is defined as a binary outcome where participants are classified as responders if they meet either of the following criteria at the specified visit:
- a reduction in BWT of ≥2 mm from baseline, OR
- a reduction in BWT of ≥25% from baseline accompanied by a concurrent one-grade decrease in vascularity on the color Doppler signal scale.
The proportion of participants meeting these criteria out of the total analyzed population will be reported at each time point. Individual measured values of BWT and vascularity grade are not reported within this composite outcome; only the binary responder status is presented.
Measured: week 12 and week 24
Percentage of Participants Achieving Histologic and Endoscopic Improvement
Histologic and endoscopic improvement is a composite endpoint requiring simultaneous achievement of both of the following criteria at the specified visit:
- Mayo endoscopic subscore (MES) ≤ 1, assessed on a scale of 0 to 3 (0 = normal mucosa, 1 = mild erythema/decreased vascular pattern, 2 = moderate erosions, 3 = severe ulceration); and
- Geboes score ≤ 3.1, assessed on a scale of 0 to 5.4 (higher scores indicate more severe histologic disease activity).
This is a binary outcome; participants meeting both criteria are classified as responders. The proportion of responders out of the total analyzed population will be reported at each time point. Individual MES and Geboes scores are not reported within this composite outcome; only the binary responder status is presented.
Measured: week 12 and week 24
Percentage of Participants Achieving Mucosal Healing
Mucosal healing is a composite endpoint requiring simultaneous achievement of both of the following criteria at the specified visit:
- Mayo endoscopic subscore (MES) ≤ 1, assessed on a scale of 0 to 3 (0 = normal mucosa, 1 = mild erythema/decreased vascular pattern, 2 = moderate erosions, 3 = severe ulceration); and
- Geboes score < 2.0, assessed on a scale of 0 to 5.4 (higher scores indicate more severe histologic disease activity; a score < 2.0 represents normal or near-normal histology, which is a stricter criterion than ≤ 3.1).
This is a binary outcome; participants meeting both criteria are classified as responders. The proportion of responders out of the total analyzed population will be reported at each time point. Individual MES and Geboes scores are not reported within this composite outcome; only the binary responder status is presented.
Measured: week 12 and week 24
Percentage of Participants Achieving Histologic Remission
Histologic remission is a binary composite endpoint assessed using one of three validated histologic scoring systems (Robarts Histopathology Index [RHI], Nancy score, or Geboes score), which serve as alternative measurement methods for the same underlying construct of histologic disease activity. A participant is classified as a responder if they meet any one of the following predefined thresholds at the specified visit:
RHI ≤ 3, OR
Nancy score = 0, OR
Geboes score < 2.0. The specific index applied to each participant may vary based on site-specific standard practices or central reading availability. Importantly, this endpoint reports only the unified binary responder status (achieved remission / did not achieve remission) based on the applicable index for each participant; individual raw scores for RHI, Nancy, and Geboes are not reported separately within this outcome measure.
Measured: week 12 and week 24
Percentage of Participants Achieving Health-related Quality of Life
This is a composite binary endpoint requiring simultaneous achievement of both of the following at the specified visit: (1) IBDQ remission, defined as a total score of ≥170 on the 32-item IBDQ (range 32-224; higher = better), AND (2) a reduction from baseline in the partial Mayo score (pMMS, range 0-6; derived from daily diary SFS and RBS). The specific threshold for pMMS reduction will be predefined in the statistical analysis plan (e.g., ≥1-point or ≥2-point decrease). Participants meeting both criteria are classified as composite responders. Only the binary responder status is reported within this outcome; individual IBDQ and pMMS values are not reported separately here.
Measured: week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start31 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EtrasimodStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to receive either Etrasimod (2 mg once daily) or Mesalazine (standard doses: 4 g/day for 12 weeks, then at least 2 g/day) for 24 weeks. Randomization is stratified by two factors: baseline steroid use (yes/no) and baseline endoscopic score (ES ≤ 2 vs. ES = 3) to ensure balance between the two groups. Each participant remains in their assigned treatment arm for the entire 24-week treatment period and does not cross over to the other treatment.
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Everest Medicines
- Responsible party
- Principal investigator, Qian Cao, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782242
- Sponsor's protocol ID
- 2026-2585-01
- Acronym
- E-Compare
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share de-identified individual participant data (IPD) underlying published results, including demographics, baseline characteristics, efficacy outcomes (clinical remission, response, endoscopic/histologic endpoints), safety data (adverse events, labs), and quality-of-life measures. The study protocol and statistical analysis plan will also be provided. IPD will be shared with academic researchers who submit a methodologically sound proposal aligned with the study objectives. Proposals are reviewed by the Principal Investigator and steering committee. Data may be used for individual participant data meta-analysis or other scientifically valid secondary analyses. Interested researchers should submit a written proposal to the Principal Investigator. Approved applicants must sign a data access agreement covering: use only for approved purposes, no re-identification, secure storage, and appropriate acknowledgement.
Publications
Sandborn WJ, Vermeire S, Peyrin-Biroulet L, Dubinsky MC, Panes J, Yarur A, Ritter T, Baert F, Schreiber S, Sloan S, Cataldi F, Shan K, Rabbat CJ, Chiorean M, Wolf DC, Sands BE, D'Haens G, Danese S, Goetsch M, Feagan BG. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies. Lancet. 2023 Apr 8;401(10383):1159-1171. doi: 10.1016/S0140-6736(23)00061-2. Epub 2023 Mar 2.
PubMed 36871574Wu K, Zheng C, Cao Q, Ding Y, Gao X, Zhong J, Chiu CT, Zhang H, Wang X, Wang B, Liang J, Liu X, Zhou Y, Xu B, Kim TO, Shen X, Chen D, Chen W, Liu Y, Shen J, Liu F, Ding X, Zhan Q, Chou JW, Zeng S, Lin Y, Ying L, Chen X; ENLIGHT UC Study Group. Etrasimod as induction and maintenance treatment for patients with moderately to severely active ulcerative colitis in East Asia (ENLIGHT UC): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Lancet Gastroenterol Hepatol. 2025 Dec;10(12):1089-1103. doi: 10.1016/S2468-1253(25)00198-0. Epub 2025 Sep 30.
PubMed 41043449
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Etrasimod Versus Mesalazine in Chinese Adult Patients With Active Ulcerative Colitis: A Multicenter, Randomized, Open-Label, Superiority Trial
- ClinicalTrials.gov ID
- NCT07782242
- Acronym / sponsor ID
- E-Compare / 2026-2585-01
- Conditions
- Etrasimod, Mesalazine, Ulcerative Colitis (UC), Head-to-head
- Keywords
- Etrasimod, Active UC, Mesalazine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Collaborators
- Everest Medicines
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ulcerative colitis (UC) is a chronic, relapsing inflammatory disease of the colon that causes diarrhea, bleeding, and abdominal pain. Mesalazine (5-aminosalicylic acid) is the current standard first-line treatment for mild-to-moderate UC, but many patients do not respond well enough, and some experience side effects. Etrasimod is an oral, selective sphingosine-1-phosphate (S1P) receptor modulator that helps reduce gut inflammation by keeping immune cells from moving into the intestinal wall. This study will test whether etrasimod works better than mesalazine in Chinese adults with active UC. The study plans to enroll about 320 patients from multiple hospitals across China. Eligible participants are adults aged 18 years or older with active UC, defined by a modified Mayo score of 3 to 6 (including specific endoscopic and bleeding criteria). Both newly diagnosed patients (within the past 4 weeks, with no prior UC treatment) and those who had an inadequate response, intolerance, or non-standard use of conventional therapies-but who have never taken biologics or other small-molecule drugs-may join. Patients will be randomly assigned in a 1:1 ratio to receive either etrasimod 2 mg once daily or mesalazine (starting at 4 g/day for 12 weeks, then at least 2 g/day based on response) for 24 weeks. Randomisation will balance important factors like steroid use and baseline endoscopic severity.
The primary research objective is whether more patients on etrasimod achieve clinical remission at week 24. Clinical remission means no rectal bleeding, normal or near-normal stool frequency, and an endoscopic score of 1 or less (without easy bleeding). The study will also measure other benefits, such as symptom improvement, endoscopic healing, normalisation of blood and stool inflammation markers, bowel ultrasound response, tissue healing, and quality of life using standard questionnaires. Safety will be carefully tracked by recording all adverse events during treatment and follow-up.
This is an open-label study (patients and clinical staff know which drug is given) to reflect real-world practice, but the clinical staff who read the colonoscopy results and tissue samples will not know the treatment assignment. An independent statistician will analyse the results. One interim analysis is planned to check for early evidence of benefit or futility. The study involves 24 weeks of treatment, with visits at baseline, week 6, week 12, and week 24, plus a 4-week safety follow-up.
Sample size calculation indicates that 320 participants (160 per group) will provide 90% power to detect a clinically important difference, accounting for a 30% dropout rate. The primary analysis will compare remission rates between groups, adjusting for the stratification factors. All findings will be published to share knowledge with the medical community and help guide future treatment decisions for UC patients in China.
Detailed description
Living with ulcerative colitis (UC) can be very difficult. This chronic gut condition causes repeated bouts of diarrhoea, rectal bleeding, abdominal pain, and extreme tiredness. It often strikes young adults in their 20s and 40s, and it can disrupt work, relationships, and daily life. Over time, persistent inflammation also raises the risk of colon cancer.
Currently, the standard first treatment for mild-to-moderate UC in China is mesalazine (5-ASA), an oral anti-inflammatory drug. While it helps many people, a large number of patients either do not respond well enough, relapse frequently, or cannot tolerate its side effects, such as kidney problems. Stronger drugs like biologics or JAK inhibitors are usually held back until after mesalazine fails. This step-up approach may delay effective disease control and allow gut damage to progress.
Etrasimod is a new type of oral pill that works differently. It gently steers certain immune cells away from the gut by blocking their exit from lymph nodes-like keeping "firefighters" away from the "fire" inside the colon. Because it is taken just once a day and does not require injections, it could be more convenient for long-term use. Global clinical trials have shown that etrasimod helps more patients achieve remission than a placebo, but no large study has directly compared it with mesalazine in Chinese adults.
This study aims to fill that gap. The study will recruit about 320 adults with active UC from multiple hospitals across China. Both individuals who are newly diagnosed (within the last month) and those who have used conventional drugs like mesalazine, steroids, or immune suppressors without enough improvement may join-as long as such individuals have never taken biologics or other small-molecule therapies. Participants will be randomly assigned to one of two groups: one group takes etrasimod 2 mg once daily, and the other takes mesalazine at standard doses. The treatment lasts for 24 weeks.
The core research question focuses on whether etrasimod leads to more patients achieving clinical remission-meaning no rectal bleeding, nearly normal bowel habits, and visible healing of the colon lining seen on a camera test (endoscopy)-compared with mesalazine at 24 weeks. The study will also evaluate many other real-world benefits, such as improvement in daily symptoms, deeper tissue healing (examined under a microscope), normalisation of blood and stool inflammation markers, and better scores on quality-of-life questionnaires that assess mood, work, and social activities. Since this is an open-label study, both patients and attending clinical staff will know which drug is being taken, but the clinical staff who review the endoscopic images and biopsy samples will not know the treatment assignments to ensure objective study results.
Safety is a top priority for the study. All participants will receive close monitoring for side effects, with regular blood tests, heart checks, and eye examinations conducted as needed. All unwanted events occurring during the 24-week treatment period and the subsequent 4-week follow-up period will be recorded. The study team may terminate the trial early if serious safety concerns arise.
By generating direct head-to-head evidence in a Chinese population, this research will support clinical staff and patients to make better-informed treatment choices. If etrasimod proves to be more effective and equally safe, it could offer a new, convenient, and early intervention treatment option that optimises UC management strategies in China-potentially enabling more patients to achieve early disease control and maintain long-term gut health.
Study participation is completely voluntary, and participant withdrawal may occur at any time without impact on routine medical care. All personal data collected during the study will be strictly confidential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to receive either Etrasimod (2 mg once daily) or Mesalazine (standard doses: 4 g/day for 12 weeks, then at least 2 g/day) for 24 weeks. Randomization is stratified by two factors: baseline steroid use (yes/no) and baseline endoscopic score (ES ≤ 2 vs. ES = 3) to ensure balance between the two groups. Each participant remains in their assigned treatment arm for the entire 24-week treatment period and does not cross over to the other treatment.
| Arm | Type | Receives |
|---|---|---|
| Etrasimod | Experimental | Drug: EtrasimodParticipants receive etrasimod 2 mg film-coated tablets orally once daily for 24 weeks. Etrasimod is a selective S1P receptor modulator that traps lymphocytes in lymph nodes, reducing gut inflammation. Dose is fixed; no adjustments, but may be interrupted/discontinued for safety (e.g., liver enzyme elevation, bradycardia, infection). After 24 weeks, a 4-week safety follow-up occurs without study drug. Baseline steroids are allowed but must be tapered. |
| Mesalazine (5-ASA) | Active comparator | Drug: mesalazineParticipants receive mesalazine 0.5 g enteric-coated tablets orally. Induction: 4 g/day (8 tablets) for first 12 weeks; maintenance: ≥2 g/day (4 tablets) from weeks 13-24, adjusted by investigator based on response. Mesalazine acts topically on colonic mucosa. Dose reduction allowed in maintenance; may be interrupted/discontinued for intolerance (e.g., renal issues). 4-week safety follow-up after 24 weeks. Same steroid tapering applies. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtrasimodAlso: Velsipity, ADP334Etrasimod is an oral, once-daily, small-molecule selective S1P receptor modulator (targeting S1P₁,₄,₅) that traps lymphocytes in lymph nodes to reduce gut inflammation without broad immunosuppression. FDA-approved (VELSIPITY, Oct 2023), EMA-approved (2024), and NMPA-approved in China (Feb 2026, Velsipity) for moderately-to-severely active UC. Global Phase 3 trials (ELEVATE UC 12/52, n=741) showed etrasimod significantly outperformed placebo in clinical remission (25% vs 15% at Wk12, 32% vs 7% at Wk52), endoscopic normalisation, and steroid-free remission. The Asian ENLIGHT UC trial confirmed benefits in 320 Chinese patients. Safety data over 4 years show mostly mild-to-moderate AEs with low serious events. This head-to-head superiority trial against mesalazine addresses a key evidence gap in Chinese UC management, assessing whether earlier etrasimod improves outcomes over current standard care. | Drug | Etrasimod |
| mesalazineAlso: 5-ASAMesalazine (5-ASA) is the current first-line standard treatment for mild-to-moderate ulcerative colitis in China and worldwide. It works directly on the inflamed gut lining by reducing local inflammatory chemicals (prostaglandins and leukotrienes), with very little drug absorbed into the bloodstream - making it generally safe. It comes in oral tablets and rectal forms, depending on disease location. Most people tolerate mesalazine well. Common, mild side effects include stomach upset, nausea, headache, or dizziness. Rare but serious risks include kidney inflammation (so regular blood tests are needed), pancreatitis, liver problems, and allergic reactions. Long-term use may also lower the risk of colon cancer in UC patients. This trial compares mesalazine head-to-head against etrasimod to see if the newer drug offers better outcomes for Chinese adults with active UC. | Drug | Mesalazine (5-ASA) |
Primary outcome
Percentage of participants achieving clinical remission
Time frame: week 24
Proportion of participants achieving clinical remission at Week 24. Clinical remission is defined as meeting all three of the following criteria: (1) rectal bleeding score (RBS) = 0; (2) stool frequency score (SFS) = 0, or SFS = 1 with a decrease of ≥1 point from baseline; and (3) Mayo endoscopic score (ES) ≤ 1 (excluding mucosal friability). RBS and SFS are derived from the modified Mayo score and assessed via participant-reported daily diaries. Endoscopic score is obtained by colonoscopy (sigmoidoscopy), with central independent reading performed by readers blinded to treatment allocation. The assessment window is Week 24 ± 4 weeks. For missing data, non-responder imputation (NRI) is applied, meaning that participants with missing data or who discontinue early are counted as not having achieved remission.
10 secondary outcomes
Percentage of Participants Achieving Clinical Response
Time frame: week 12 and week 24
Percentage of Participants Achieving Symptomatic Remission
Time frame: week 12 and week 24
Percentage of Participants Achieving Endoscopic Remission
Time frame: week 12 and week 24
Percentage of Participants Achieving Endoscopic Normalization
Time frame: week 12 and week 24
Percentage of Participants Achieving Normalization of Inflammatory Markers
Time frame: week 12 and week 24
Percentage of Participants Achieving Intestinal Ultrasound Response
Time frame: week 12 and week 24
Percentage of Participants Achieving Histologic and Endoscopic Improvement
Time frame: week 12 and week 24
Percentage of Participants Achieving Mucosal Healing
Time frame: week 12 and week 24
Percentage of Participants Achieving Histologic Remission
Time frame: week 12 and week 24
Percentage of Participants Achieving Health-related Quality of Life
Time frame: week 12 and week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Results publication: PubMed 36871574Sandborn WJ, Vermeire S, Peyrin-Biroulet L, Dubinsky MC, Panes J, Yarur A, Ritter T, Baert F, Schreiber S, Sloan S, Cataldi F, Shan K, Rabbat CJ, Chiorean M, Wolf DC, Sands BE, D'Haens G, Danese S, Goetsch M, Feagan BG. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies. Lancet. 2023 Apr 8;401(10383):1159-1171. doi: 10.1016/S0140-6736(23)00061-2. Epub 2023 Mar 2.
- Results publication: PubMed 41043449Wu K, Zheng C, Cao Q, Ding Y, Gao X, Zhong J, Chiu CT, Zhang H, Wang X, Wang B, Liang J, Liu X, Zhou Y, Xu B, Kim TO, Shen X, Chen D, Chen W, Liu Y, Shen J, Liu F, Ding X, Zhan Q, Chou JW, Zeng S, Lin Y, Ying L, Chen X; ENLIGHT UC Study Group. Etrasimod as induction and maintenance treatment for patients with moderately to severely active ulcerative colitis in East Asia (ENLIGHT UC): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Lancet Gastroenterol Hepatol. 2025 Dec;10(12):1089-1103. doi: 10.1016/S2468-1253(25)00198-0. Epub 2025 Sep 30.
- Individual participant dataSharing planned: Yes. We plan to share de-identified individual participant data (IPD) underlying published results, including demographics, baseline characteristics, efficacy outcomes (clinical remission, response, endoscopic/histologic endpoints), safety data (adverse events, labs), and quality-of-life measures. The study protocol and statistical analysis plan will also be provided. IPD will be shared with academic researchers who submit a methodologically sound proposal aligned with the study objectives. Proposals are reviewed by the Principal Investigator and steering committee. Data may be used for individual participant data meta-analysis or other scientifically valid secondary analyses. Interested researchers should submit a written proposal to the Principal Investigator. Approved applicants must sign a data access agreement covering: use only for approved purposes, no re-identification, secure storage, and appropriate acknowledgement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etrasimod and mesalazine in people with Etrasimod and Mesalazine, run by Sir Run Run Shaw Hospital.
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 9 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 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Qian Cao, Doctor (+8613588706896, caoq@srrsh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants achieving clinical remission (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07782242, which also lists 2 linked publications.
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 24 Aug 2026.