Open-Label Study of Etrasimod Treatment for Adolescents Aged 12 to 17 with Moderate to Severe Ulcerative Colitis

What this Trial Is About

Researchers are evaluating etrasimod for treating adolescents aged 12 to under 18 years with moderately to severely active ulcerative colitis. This Phase 2 study aims to determine the safety, effectiveness, and how the drug is processed in the body over a 52-week treatment period. Participants who complete this treatment may continue in a long-term extension for up to 4 additional years, totaling 5 years after enrollment. Participants will take etrasimod tablets or granules by mouth once daily for up to 52 weeks. After this period, those who complete the treatment can join an optional long-term extension phase lasting up to 4 years. The study does not include a placebo group and involves a single treatment arm. During the study, participants will be monitored through regular assessments including clinical remission measured by the Modified Mayo Score at week 52. Blood samples will be taken at various times to measure drug levels. Other outcomes include endoscopic improvement, symptomatic remission, and safety evaluations through adverse event tracking. The total participation could last up to 5 years for those continuing in the extension phase.

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis