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NOT YET RECRUITING
NCT07470879
PHASE2

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-03-31

Completion Date

2034-06-21

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Etrasimod

Once daily by mouth

Locations (3)

Saitama Prefectural Children's Medical Center

Saitama-shi, Saitama, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Japanese Red Cross Kumamoto Hospital

Kumamoto, Japan