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 Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab
PHASE: IV DESCRIPTIVE: Randomized, interventional, open label multicenter trial POPULATION: Moderate to severe ulcerative colitis STUDY TREATMENTS: Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26) and could be optimized up to 80mg EOW (or 40 EW according to patient and/or investigator preference) for two months and then could be optimized up to 80mg EOW (or 40 EW according to patient and/or investigator preference) and azathioprine (2.0/2.5 mg/kg/ day) or methotrexate (25 mg EW) until V3 (W 38). OBJECTIVES: To assess the impact of a treat to target treatment follow up by e-Monitoring and fecal calprotectin dosing at home associated to an appropriate patient education versus standard treatment follow up at W48 in patients requiring a treatment with adalimumab (Humira®).
A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis
Probiotics are live microorganisms that provide health benefits when consumed in sufficient amounts. Traditional probiotics, mainly from the Lactobacillus and Bifidobacterium genera, originate from fermented foods or the human gut and are widely used in supplements. Although considered safe and easy to produce, they are not specifically designed to treat diseases, and no official health claims have been approved by EFSA. Advances in microbiome research have led to the discovery of Next-Generation Probiotics (NGPs), which are newly identified gut microbes associated with health and offer promising therapeutic potential despite lacking a long history of safe use.