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A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
Who can join
Ages 12 to 17 · All sexes
Full eligibility criteria
Inclusion criteria: * Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active * Participants are permitted to be receiving a therapeutic dose of select UC therapies Exclusion criteria: * Severe extensive colitis * Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD * Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
About the study
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 adolescents (≥ 12 years up to \< 18 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).
What is being tested
- Etrasimod (drug)
Sponsor: Pfizer · Participants: 36 · Started: Dec 16, 2022
Contact the study team
- Pfizer CT.gov Call Center · Phone: 1-800-718-1021
Official record on ClinicalTrials.gov — NCT05287126
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.