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

NCT03950232 · tracked via the Priya Life Science India tracker

Sponsor

Pfizer

Phase

Phase 3

Started

2019-09-05

Last updated

2026-07-09

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

Etrasimod

Etrasimod: Etrasimod 2 mg tablet by mouth, once daily up to approximately 8 years or until marketing authorization is obtained in the participant's country, whichever comes first

Study 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 \[NCT04607837\]).

Eligibility

Sex

ALL

Min age

16 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Number and Severity of Safety Measures — Up to approximately 8 years
Safety as assessed by the evaluation of adverse events

Trial sites (470)

Facility	City	Region
Center for Digestive Health (Colonoscopy Location)	Dothan	Alabama
Digestive Health Specialists (IP Address)	Dothan	Alabama
Flowers Hospital (PFT Location)	Dothan	Alabama
Pulmonary Associates (Secondary PFT Location)	Dothan	Alabama
Gut P.C., dba Digestive Health Specialists of the Southeast (IP Address)	Dothan	Alabama
Inland Pulmonary Specialists [PFT Only]	Lake Elsinore	California
A V Pediatrics,Allergy and Family Medicine	Lancaster	California
Advanced Endoscopy and Pain Center(Colonoscopy)	Lancaster	California
Antelope Valley Eye Care(Ophthalmologist)	Lancaster	California
Jatinder S.Pruthi,MD FACG CPI	Lancaster	California
Om Research LLC	Lancaster	California
Renaissance Imaging Center(Chest X-Ray only)	Lancaster	California
United Surgery Center Murrieta [Endoscopy Only]	Murrieta	California
United Medical Doctors	Murrieta	California
Advanced Imaging (Chest X-Ray)	Palmdale	California
California Eye Professionals [OCT Only]	Temecula	California
United Surgery Center Temecula [Endoscopy Only]	Temecula	California
Front Range Endoscopy Center	Colorado Springs	Colorado
Peak Gastroenterology Associates	Colorado Springs	Colorado
Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test)	Clearwater	Florida
West Coast Endoscopy Center (Endoscopy Procedures)	Clearwater	Florida
Northwood Vision- Optical Coherence Tomography (OCT)	Clearwater	Florida
Northwood Vision-Optical Coherence Tomography-(OCT)	Clearwater	Florida
Safety Harbor Surgery (Endoscopy Facility)	Clearwater	Florida
Gastro Florida (Regulatory & Administrative Duties)	Clearwater	Florida
Gastro Florida-(Regulatory & Administrative Duties)	Clearwater	Florida
West Coast Endoscopy Center (Endoscopy Procedures)	Clearwater	Florida
Dr Lee Shettle	Largo	Florida
Florida Center for Gastroenterology	Largo	Florida
Tampa Bay Regional Surgery Center	Largo	Florida
NSB Research	New Smyrna Beach	Florida
Tampa Bay Endoscopy Center (ENDO Only)	Tampa	Florida
Tampa Bay Endoscopy Center	Tampa	Florida
Lab - Processing / Storage	Tampa	Florida
USF Health South Tampa Center for Advanced Healthcare	Tampa	Florida
Pulmonary and Sleep of Tampa Bay (PFT Only)	Tampa	Florida
GCP Clinical Research,LLC	Tampa	Florida
LoCicero Medical Group (PFT Procedure Only)	Tampa	Florida
Lyracore Health Alliance (PFT Procedure only)	Tampa	Florida
Newsome Eye Specialist (OCT Procedures Only)	Tampa	Florida

+ 430 more sites — see the full list on the official registry below.

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Other trials for the same condition

A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Ulcerative Colitis on Advanced Therapies Recruiting

LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis: Recruiting

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC) Recruiting

ABTECT - Maintenance Active, not recruiting

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03950232 on ClinicalTrials.gov ↗ ← All trials in India