Clinical Trial

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

Study acronym: ELEVATE UC OLE
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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 \[NCT04607837\]).
Protocol Amendment History 2 changes
notable Trial sites expanded: 211 -> 470 locations 2026-07-10
notable Trial sites reduced: 463 -> 211 locations 2026-05-12
Trial Details
NCT Number NCT03950232
Lead Sponsor Pfizer
Collaborators: Arena is a wholly owned subsidiary of Pfizer
Conditions Ulcerative Colitis
Enrollment 896 participants
Start Date 2019-09-05
Primary Completion 2029-06-19 (estimated)
Study Completion 2029-06-19 (estimated)
Updated on ClinicalTrials.gov 2026-07-09