NCT07470879

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

A Phase 2 Open-Label, Single Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in pediatrics participants (≥ 2 years up to \< 12 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment).

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Etrasimod	Once daily by mouth

Timeline

• Start date: 2026-03-31
• Primary completion: 2030-07-12
• Completion: 2034-06-21
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

3 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study