Cure8 trial brief
A pediatric Phase 2 trial testing etrasimod could expand treatment options for children with moderately to severely active ulcerative colitis if later shown safe and effective. Families of affected children and their clinicians may want to know about enrollment opportunities and trial design.
Parents-caregivers; pediatric-patients; clinicians; researchers
This is a Phase 2 interventional clinical trial (recruiting) testing etrasimod, an oral S1P receptor modulator, for moderately to severely active ulcerative colitis in children aged 2 to <12 years.
The study plans to enroll about 24 pediatric participants who will receive once-daily oral etrasimod for up to 52 weeks, with an optional long-term extension of up to 4 additional years. The registered primary outcome is the number and percent of participants achieving clinical remission at Week 52 using a Modified Mayo Score.
The record lists inclusion and exclusion criteria, key sites (NYU Langone locations), and standard safety, efficacy, and pharmacokinetic assessments for a pediatric UC trial. It permits certain background UC therapies per the protocol and excludes diagnoses consistent with Crohn’s disease or other colitis types.
If you are a parent or clinician considering trial participation, the registry record gives the basic design, eligibility windows (ages 2–11), and outcome timing but does not present results — it describes a planned study. Contact the study sites or sponsor for up-to-date enrollment details, full protocol, and safety monitoring information.
This entry is a ClinicalTrials.gov trial record (Phase 2, interventional, recruiting) and does not contain results. Enrollment is small and the primary endpoint is remission at Week 52 using a Modified Mayo Score.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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