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A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
Sponsor: Pfizer
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
Conditions
Interventions
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