UCNot yet recruiting
Comaprison of Efficacy and Safety Between Etrasimod vs Mesalazine in Chinese Adults With Active UC
Phase 4 · Testing Etrasimod and mesalazine · Sites not listed yet · Sir Run Run Shaw Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Etrasimod (a drug) and mesalazine (a drug) as a possible treatment. Condition(s) listed: Etrasimod, Mesalazine and Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 to 100
- Any sex
Some of the main requirements, copied from the record:
- 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…
- 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…
Plus 1 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 320 participants are expected to take part.
- Start date: 2026-07-31 (planned).
- Main results expected around 2027-06-30 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Percentage of participants achieving clinical remission (week 24)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Etrasimod; Mesalazine; Ulcerative Colitis (UC); Head-to-head |
| Lead sponsor | Sir Run Run Shaw Hospital |
| Collaborators | Everest Medicines |
| Enrollment | 320 (estimated) |
| Start date | 2026-07-31 |
| Primary completion (est.) | 2027-06-30 |
| First posted | 2026-08-24 |
| Last updated | 2026-08-24 |
| 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 |
Interventions
- Etrasimod (Drug)
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 … - mesalazine (Drug)
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 locatio…
Full eligibility criteria (from the record)
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.