A Phase 4 interventional study of Etrasimod and mesalazine in Etrasimod, Mesalazine and Ulcerative Colitis (UC), sponsored by Sir Run Run Shaw Hospital. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Sir Run Run Shaw Hospital · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
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.
Drug: Etrasimod
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.
Drug: mesalazine
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.
Also known as: Velsipity, ADP334
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.
Also known as: 5-ASA
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.
Time frame: week 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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: 1. C-reactive protein (CRP) within the normal range (≤ upper limit of normal \[ULN\] per the central/local laboratory), and 2. 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.
Time frame: 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: 1. a reduction in BWT of ≥2 mm from baseline, OR 2. 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.
Time frame: 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: 1. 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 2. 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.
Time frame: 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: 1. 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 2. 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.
Time frame: 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.
Time frame: 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.
Time frame: week 12 and week 24
No study locations are listed for this record.
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Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
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Sir Run Run Shaw Hospital