Cure8 trial brief
New pediatric trials test whether etrasimod, an oral S1P receptor modulator, is safe and effective for adolescents with moderate-to-severe ulcerative colitis—a group with fewer dedicated study options than adults.
If successful, this could expand treatment choices for teens who need alternatives to current biologics or steroids.
Adolescents (12–17) with moderately to severely active ulcerative colitis, parents and caregivers considering trial enrollment, pediatric gastroenterologists, and researchers in pediatric IBD therapeutics.
This is a Phase 2 interventional clinical trial (NCT05287126) testing etrasimod in adolescents aged 12–17 with moderately to severely active ulcerative colitis. The study will evaluate safety, efficacy, and pharmacokinetics of once-daily oral etrasimod over a 52-week treatment period, with an optional long-term extension of up to 4 additional years.
Primary outcome listed is clinical remission by Modified Mayo Score at Week 52. Planned enrollment is 36 participants and the trial is recruiting at multiple U.S. pediatric sites. The record is a trial registration (ClinicalTrials.gov) describing the study design, eligibility criteria, interventions, and planned outcomes; it does not present results.
It permits participants to remain on some background UC therapies per the eligibility rules. The trial excludes patients with Crohn’s disease, indeterminate colitis, or fistulizing disease.
If you or a child are considering participation, this registry entry is useful for understanding who is eligible and what the trial will measure, but it is not a substitute for discussing risks and benefits with your clinician or the study team.
Who to contact and site details are provided on the ClinicalTrials.gov page for enrollment and informed consent questions.
This is a trial registration record describing planned methods and outcomes; it does not report efficacy or safety results. As with any trial, eligibility, site availability, and the protocol (including allowed background therapies) determine whether a specific patient can enroll. ClinicalTrials.gov is the source of the structured trial details.
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.
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...
This study will collect real-world data on how people with moderate-to-severe ulcerative colitis do after starting etrasimod, including symptom changes measured by patient questionnaires. That information can help...
This registry will provide real-world data on how etrasimod is used and performs in routine clinical practice in China, including patient characteristics, symptom trajectories, safety, and healthcare costs. Real-world...
