CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 42 enrolled
Drug / intervention
Etrasimod +1 moredrug
Likely dose
Etrasimod 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04706793
NCT04706793Phase 3Completed
CompareCT.gov

A Phase 3, Double-Blind, Placebo-Controlled, 40-Week Extension Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Pfizer·interventional·Posted Jan 13, 2021·Updated Oct 16, 2023

In Brief

A Phase 3 clinical trial evaluating Etrasimod and Placebo for Ulcerative Colitis. Completed, enrolled 42 participants across 38 sites.

Detailed Summary

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment in adult Japanese participants with moderately to severely active ulcerative colitis (UC). This study is an extension of study APD334-302 (NCT03996369). Participants will continue with the same blinded treatment assigned in Study APD334-302 for a total treatment duration of 52 weeks (12 weeks in Study APD334-302 plus 40 weeks in Study APD334-308).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesJapan
CollaboratorsArena is a wholly owned subsidiary of Pfizer

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJan 13, 2021
Enrollment StartDec 25, 2020
Primary CompletionAug 3, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.5 years ago

Interventions

Etrasimoddrug

Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks

Placebodrug

Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks