Evaluating Etrasimod Treatment in Children Ages 2 to 11 with Moderate to Severe Ulcerative Colitis A Phase 2 Study on Safety and Effects of Etrasimod in Pediatric Ulcerative Colitis

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and how the body processes the drug etrasimod in children aged 2 to under 12 years with moderately to severely active ulcerative colitis. The study focuses on this pediatric population to better understand how etrasimod works for this gut condition. After completing the initial treatment phase, participants can join a long-term extension to continue monitoring for up to five years after enrollment. Participants receive etrasimod orally once daily for up to 52 weeks during the main treatment period. Those who complete this phase may enter the Long-Term Extension LTE period, which can last up to four additional years, allowing researchers to observe longer-term effects and safety. The study administers the medication as a single-group intervention without a placebo comparison. Throughout the study, children undergo regular assessments to track clinical remission using the Modified Mayo Score at 12 and 52 weeks, endoscopic improvements, symptom relief, and growth changes. Researchers also monitor safety through adverse event reports, laboratory tests, vital sign checks, and measure drug levels in the blood. The total participation may extend up to five years, including the treatment and extension phases, to gather comprehensive data on the drugs impact.

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