Summary

Eligibility
for people ages 16-80 (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).

Official Title

An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

Keywords

Ulcerative Colitis Etrasimod APD334 Colitis Colitis, Ulcerative Ulcer Etrasimod 2 mg

Eligibility

You can join if…

Open to people ages 16-80

  • Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies and meet the following additional criteria:
  • Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit
  • Participants previously enrolled in APD334-302 (NCT03996369) must have completed the Week 12 visit

You CAN'T join if...

  • If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
  • Experienced an adverse event that led to discontinuation from parent study

Locations

  • UC Irvine Center for Clinical Research (UCI-CCR) accepting new patients
    Orange California 92868 United States
  • Odyssey Clinical Research, LLC withdrawn
    Orange California 92866 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arena Pharmaceuticals
Links
Elevate UC Clinical Trial Website
ID
NCT03950232
Phase
Phase 3
Study Type
Interventional
Last Updated