A Phase 2 Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Etrasimod in Children Ages 2 to Under 12 with Moderately to Severely Active Ulcerative Colitis

What this Trial Is About

This research aims to evaluate the safety, effectiveness, and how the body processes the medicine etrasimod in children aged 2 to under 12 years who have moderately to severely active ulcerative colitis, a chronic gut disease. The study is a phase 2, open-label, single-arm trial sponsored by Pfizer. Participants who complete the initial 52-week treatment have the option to continue in a long-term extension period lasting up to 4 additional years, for a total of 5 years of monitoring. Children in the study will take etrasimod by mouth once daily for up to 52 weeks. After this treatment period, those who qualify may enter the long-term extension phase to continue treatment and observation. There are no placebo or comparison groups in this study, allowing all participants to receive the study medicine. Throughout the study, participants will undergo evaluations measuring clinical remission based on the Modified Mayo Score at weeks 12 and 52, along with other assessments such as endoscopic improvement, symptomatic remission, and growth measurements. Researchers will monitor safety by tracking adverse events, laboratory tests, and vital signs from baseline through 28 days after treatment and up to week 260. Participants may also provide feedback on the taste of the medicine. Overall participation can last up to 5 years from enrollment.

A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis