What the trial was testing
The ELEVATE UC 52 enrolled 787 patients with ulcerative colitis. The study was sponsored by Pfizer and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
27% reached clinical remission at one year — vs. 7% on placebo.
The Lancet · 2023 · NCT03996369
These findings — that of patients in clinical remission at 52 weeks on etrasimod vs. placebo — were published in the The Lancet and represent the headline result of the study.
Researchers tracked outcomes across 787 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with ulcerative colitis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Etrasimod (Velsipity) is FDA-approved for moderately to severely active ulcerative colitis in adults and available now. It is a once-daily pill — no injections or infusions. Heart-rhythm checks and a vaccination check are needed before starting. Ask your gastroenterologist whether it fits your treatment history.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open ulcerative colitis trials
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 in Patients With Moderate-to-severe Active Ulcerative Colitis
This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of SHR-1139 in patients with moderate to severe active ulcerative colitis. This study consists 2 treatment parts, the Induction treatment part and Maintenance treatment part. The periods of Induction treatment part and Maintenance treatment part are 12 weeks and 48 weeks separately.
Development and Validation of a New Paediatric Inflammatory Bowel Disease NUTrition Risk Score (PIBD-NUTS)
Children with inflammatory bowel disease (IBD) including both Crohn's disease (CD) and ulcerative colitis (UC) can be at high risk of developing malnutrition due to the nature of their condition. It is also believed that some children with IBD, in need of nutritional care, are not identified quickly by their healthcare professionals. This may negatively affect their nutrition, disease progression and general well-being. Hence, it has been proposed that nutritional screening tools or scores (NSTs) should be used to promptly identify children needing further dietetic review and input. Although there are a few NSTs for generic use in sick children at hospital admission, NSTs or scores to use for children with IBD are currently missing. In this study, we would like to test the performance of an existing tool that is routinely used for all sick children at hospital admission (The Paediatric Yorkhill Malnutrition Score or PYMS)(5) and test whether PYMS can detect children with IBD who are at risk of malnutrition. If PYMS doesn't work well, we will develop a specific tool for children with IBD (The Paediatric IBD Nutrition Score or PIBD-NUTS).