Comaprison of Efficacy and Safety Between Etrasimod vs Mesalazine in Chinese Adults With Active UC

Etrasimod, Head-to-head, Mesalazine, Ulcerative Colitis (UC)

Etrasimod, Active UC, Mesalazine

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.

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