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An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Sponsor: Pfizer
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
Key Details
Gender
All
Age Range
16 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
896
Start Date
2019-09-05
Completion Date
2029-06-19
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
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
Locations (472)
Center for Digestive Health (Colonoscopy Location)
Dothan, Alabama, United States
Digestive Health Specialists (IP Address)
Dothan, Alabama, United States
Flowers Hospital (PFT Location)
Dothan, Alabama, United States
Pulmonary Associates (Secondary PFT Location)
Dothan, Alabama, United States
Gut P.C., dba Digestive Health Specialists of the Southeast (IP Address)
Dothan, Alabama, United States
Inland Pulmonary Specialists [PFT Only]
Lake Elsinore, California, United States
A V Pediatrics,Allergy and Family Medicine
Lancaster, California, United States
Advanced Endoscopy and Pain Center(Colonoscopy)
Lancaster, California, United States
Antelope Valley Eye Care(Ophthalmologist)
Lancaster, California, United States
Jatinder S.Pruthi,MD FACG CPI
Lancaster, California, United States
Om Research LLC
Lancaster, California, United States
Renaissance Imaging Center(Chest X-Ray only)
Lancaster, California, United States
United Surgery Center Murrieta [Endoscopy Only]
Murrieta, California, United States
United Medical Doctors
Murrieta, California, United States
Advanced Imaging (Chest X-Ray)
Palmdale, California, United States
California Eye Professionals [OCT Only]
Temecula, California, United States
United Surgery Center Temecula [Endoscopy Only]
Temecula, California, United States
Front Range Endoscopy Center
Colorado Springs, Colorado, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test)
Clearwater, Florida, United States
West Coast Endoscopy Center (Endoscopy Procedures)
Clearwater, Florida, United States
Northwood Vision- Optical Coherence Tomography (OCT)
Clearwater, Florida, United States
Northwood Vision-Optical Coherence Tomography-(OCT)
Clearwater, Florida, United States
Safety Harbor Surgery (Endoscopy Facility)
Clearwater, Florida, United States
Gastro Florida (Regulatory & Administrative Duties)
Clearwater, Florida, United States
Gastro Florida-(Regulatory & Administrative Duties)
Clearwater, Florida, United States
West Coast Endoscopy Center (Endoscopy Procedures)
Clearwater, Florida, United States
Dr Lee Shettle
Largo, Florida, United States
Florida Center for Gastroenterology
Largo, Florida, United States
Tampa Bay Regional Surgery Center
Largo, Florida, United States
NSB Research
New Smyrna Beach, Florida, United States
Tampa Bay Endoscopy Center (ENDO Only)
Tampa, Florida, United States
Tampa Bay Endoscopy Center
Tampa, Florida, United States
Lab - Processing / Storage
Tampa, Florida, United States
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, United States
Pulmonary and Sleep of Tampa Bay (PFT Only)
Tampa, Florida, United States
GCP Clinical Research,LLC
Tampa, Florida, United States
LoCicero Medical Group (PFT Procedure Only)
Tampa, Florida, United States
Lyracore Health Alliance (PFT Procedure only)
Tampa, Florida, United States
Newsome Eye Specialist (OCT Procedures Only)
Tampa, Florida, United States
USF Health Morsani Center For Advanced Healthcare
Tampa, Florida, United States
Guardian Angel Research Center, INC
Tampa, Florida, United States
Perez Eye Center (OCT only)
Tampa, Florida, United States
Florida Medical Clinic, LLC (Endoscopy)
Zephyrhills, Florida, United States
Florida Medical Clinic, LLC (OCT)
Zephyrhills, Florida, United States
Florida Medical Clinic, LLC (PFT)
Zephyrhills, Florida, United States
Florida Medical Clinic, LLC
Zephyrhills, Florida, United States
Wiregrass Ranch special procedure center ( Endoscopy)
Zephyrhills, Florida, United States
Emory Pulmonary Function Tedt Lab
Atlanta, Georgia, United States
Emory Pulmonary Group (PFT only)
Atlanta, Georgia, United States
Atlanta Gastroenterology Associates (Endoscopy Location)
Atlanta, Georgia, United States
Atlanta Gastroenterology Associates (endoscopy only)
Atlanta, Georgia, United States
Atlanta Gastroenterology Associates (Screening and Recruitment)
Atlanta, Georgia, United States
Atlanta Gastroenterology Associates(IP only)
Atlanta, Georgia, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Emory Saint Joseph Pulmonary Function Test Lab
Atlanta, Georgia, United States
Thomas Eye Group (OCT only)
Sandy Springs, Georgia, United States
Illinois Gastroenterology Group dba GI Alliance (Patients seen; IP Delivered)
Gurnee, Illinois, United States
Medical Eye Services LTD (Ophthalmoscopy with OCT)
Gurnee, Illinois, United States
North Shore Endoscopy Center (Endoscopy)
Lake Bluff, Illinois, United States
Libertyville Imaging Center (Diagnostic Imaging)
Libertyville, Illinois, United States
Eye Medical Center (OCT location)
Baton Rouge, Louisiana, United States
Baton Rouge LA Endoscopy
Baton Rouge, Louisiana, United States
Chevy Chase Pulmonary Associate (PFT Only)
Chevy Chase, Maryland, United States
Friendship Heights Endoscopy Center (Endoscopy Facility Only)
Chevy Chase, Maryland, United States
Retina Group Of Washington (OCT Only)
Chevy Chase, Maryland, United States
Barnes-Jewish West County Hospital (Additional Endoscopy Location)
Creve Coeur, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Durango Surgical Center
Las Vegas, Nevada, United States
Abrams Eye Institute (OCT)
Las Vegas, Nevada, United States
Lung Center of Nevada
Las Vegas, Nevada, United States
Duke Medical Plaza North Duke Street
Durham, North Carolina, United States
Duke Eye Center (OCT only)
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Brier Creek Medical Pavilion
Raleigh, North Carolina, United States
Geauga Sleep Center (PFT Only)
Chardon, Ohio, United States
UC Health Hoxworth (OCT only)
Cincinnati, Ohio, United States
UC Health Physicians Office
Cincinnati, Ohio, United States
University of Cincinnati Medical Center (PFT and Endoscopy location)
Cincinnati, Ohio, United States
UC Health (Pulmonary Function Testing)
Cincinnati, Ohio, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Ophthalmic Physicians Incorporated (OCT Only)
Mentor, Ohio, United States
The Endoscopy Center of Lake County
Mentor, Ohio, United States
Vitreo Retinal Consultants (OCT only)
Mentor, Ohio, United States
Lake Pulmonary Associates (PFT only)
Willoughby Hills, Ohio, United States
Retina Specialist of Ohio (OCT only)
Willoughby Hills, Ohio, United States
Digestive Disease Specialists, Inc. Endoscopy Lab
Oklahoma City, Oklahoma, United States
Pulmonary Physicians of Oklahoma
Oklahoma City, Oklahoma, United States
Retina Center of Oklahoma
Oklahoma City, Oklahoma, United States
Susquehanna Research Group
Camp Hill, Pennsylvania, United States
West Shore Endoscopy Center
Camp Hill, Pennsylvania, United States
Farrell Ophthalmology (OCT only)
Harrisburg, Pennsylvania, United States
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, United States
Harrisburg Eye Associates (OCT only)
Harrisburg, Pennsylvania, United States
Medical Arts Allergy,PC (PFT Only)
Harrisburg, Pennsylvania, United States
Pulmonary and Critical Care Medicine Associates (PFT only)
Lemoyne, Pennsylvania, United States
Cross Timbers Surgery Center(Proctosigmoidoscopy)
Arlington, Texas, United States