A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
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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