Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-01 @ 9:38 PM
Study NCT ID:
NCT03950232
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2019-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT06025227
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
ELEVATE UC OLE
Brief 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 \[NCT04607837\]).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: