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Clinical trial

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

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Last updated:17th Sep 2023
Status: RECRUITING
Identifier: NCT05287126
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis


ClinicalTrials.gov ID: NCT05287126

Sponsor: Pfizer
Information provided by: Pfizer (Responsible Party)
Last Update Posted: 2023-09-18

Brief 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 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), or until marketing authorization is obtained in the participant's country, whichever comes first.

OFFICIAL TITLE
An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Subjects With Moderately to Severely Active Ulcerative Colitis

INTERVENTION / TREATMENT
Drug: Etrasimod

Category Value
Study Start (Actual) 2022-12-16
Primary Completion (Estimated) 2025-11-25
Study Completion (Estimated) 2029-12-19
Enrollment (Estimated) 36
Study Type Interventional
Phase Phase 2
Other Study ID Numbers
APD334-207
C5041010 (Other Identifier) (OTHER: Alias Study Number)
2021-003627-15 (EudraCT Number)
2022-500345-25-00 (Registry Identifier) (REGISTRY: CTIS (EU))


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