This study is in progress, not accepting new patients

An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

a study on Inflammatory Bowel Disease Ulcerative Colitis

Summary

Eligibility
for people ages 16-80 (full criteria)
Location
at UC Irvine UCSD
Dates
study started
completion around

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, 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 listed below or other qualified region-specific studies and meet the following additional criteria:
    1. 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
    2. 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

  • UCI Gavin Herbert Eye Institute
    Irvine California 92697 United States
  • UCI Gottschalk Medical Plaza
    Irvine California 92697 United States
  • UCSD Clinical and Translational Research Institute (Research Clinic)
    La Jolla California 92037 United States
  • UCSD Health System ( ENDO and PFT)
    La Jolla California 92037 United States
  • UCSD lnvestigational Drug Service Pharmacy (Pharmacy Only)
    La Jolla California 92037 United States
  • UCI Health Eye Care Services (Ophthalmoscopy and OCTs)
    Orange California 92868 United States
  • UCI Health H. H. Chao Comprehensive Digestive Disease Center
    Orange California 92868 United States
  • UCI Investigational Drug Services (IDSP - Pharmacy)
    Orange California 92868 United States
  • UCI Irvine Medical Center - Pulmonology Services - PFTs
    Orange California 92868 United States
  • Center for Clinical Research (CCR)
    Irvine California 92697 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT03950232
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 778 people participating
Last Updated