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

Eligibility: for people ages 16-80 (full criteria)
Location: at UC Irvine UCSD
Dates: study started September 2019
completion around June 2029

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: September 2019
Completion Date: June 2029 (estimated)
Sponsor: Pfizer
ID: NCT03950232
Phase: Phase 3 research study
Study Type: Interventional
Participants: About 778 people participating
Last Updated: December 2024