Trial | NCT04176588  Report issue

Title

A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Etrasimod for Induction and Maintenance Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    Etrasimod ...

  • Study Participants

    333
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.

Condition or disease: Ulcerative Colitis Intervention/treatment: Drug: Etrasimod Drug: Placebo Phase: Phase 3
Study Started
Sep 10
2019
Primary Completion
Oct 31
2022
Anticipated
Study Completion
Nov 30
2022
Anticipated
Last Update
Nov 27
2019

Drug Etrasimod

Drug:Etrasimod Tablet other name:APD334

Drug Placebo

Drug:placebo Tablet

Experimental: Etrasimod 2mg Experimental

2mg/tablet, administratered orally, once daily

Placebo Comparator: Placebo Placebo Comparator

matching tablet, administratered orally, once daily

Etrasimod 2mg (optional open-label extension period) Experimental

2mg/tablet, administratered orally, once daily

Criteria 

Inclusion Criteria:

A documented of diagnosis with UC at least 6 months prior to screening.
Have active UC extending proximal to the rectum confirmed on endoscopy (≥ 15 cm involved)

Exclusion Criteria:

Have severe extensive colitis
Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
Diagnosis of microscopic colitis, ischemic colitis, infection colitis or colonic mucosal dysplasia
No Results Posted