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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
2026-05-11
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 (211)
Center for Digestive Health (Colonoscopy Location)
Dothan, Alabama, United States
Flowers Hospital (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
Advanced Endoscopy and Pain Center(Colonoscopy)
Lancaster, California, United States
Antelope Valley Eye Care(Ophthalmologist)
Lancaster, California, United States
Renaissance Imaging Center(Chest X-Ray only)
Lancaster, California, United States
Advanced Imaging (Chest X-Ray)
Palmdale, California, United States
California Eye Professionals [OCT Only]
Temecula, California, 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
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
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, United States
LoCicero Medical Group (PFT Procedure Only)
Tampa, Florida, United States
Guardian Angel Research Center, INC
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
Emory Pulmonary Function Tedt Lab
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
Libertyville Imaging Center (Diagnostic Imaging)
Libertyville, Illinois, 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
Washington University School of Medicine
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Durango Surgical Center
Las Vegas, Nevada, 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
UC Health Hoxworth (OCT only)
Cincinnati, Ohio, United States
University of Cincinnati Medical Center (PFT and Endoscopy location)
Cincinnati, Ohio, United States
The Endoscopy Center of Lake County
Mentor, 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
Farrell Ophthalmology (OCT 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
Inquest Clinical Research
Baytown, Texas, United States
Cross Eye Center (Optical Coherence Tomography)
Houston, Texas, United States
Lonestar Endoscopy(Endoscopy Location)
Keller, Texas, United States
Central Texas Eye Center (OCT)
San Marcos, Texas, United States
Lonestar Endoscopy (Endoscopy Location)
Southlake, Texas, United States
Christus Trinity Mother Frances Endosopy Center ( endoscopies only)
Tyler, Texas, United States
Touchstone Imaging Tyler (chest x-rays only)
Tyler, Texas, United States
Richard Bensinger, MD
Seattle, Washington, United States
Swedish Gastroenterology
Seattle, Washington, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
Sullivan Nicolaides Pathology
Bowen Hills, Queensland, Australia
Buderim Eye Centre( OCT and Ophthalmoscopy Facility)
Buderim, Queensland, Australia
Coral Sea Clinical Research Institute Pty.Ltd
Mackay, Queensland, Australia
Dr Shiran DeSilva Respiratory Clinic
Mackay, Queensland, Australia
Queensland X-Ray
Mackay, Queensland, Australia
Austin Health
Heidelberg, Victoria, Australia
Queensland Medical Laboratory (QML) pathology, QML Buderim Laboratory - Healius Pathology Pty Ltd
Buderim, Australia
Department of Internal Medicine III, Clinical Division of Gastroenterology and Hepatology
Vienna, Austria
Institution "Gomel Regional Specialized Clinical Hospital"
Homyel, Belarus
Educational Establishment "Vitebsk State Medical University"
Vitebsk, Belarus
AZ Delta campus Brugsesteenweg
Roeselare, Belgium
AZ Delta
Roeselare, Belgium
UMHAT "Sv. Ivan Rilski" EAD'
Sofia, Bulgaria
"University multiprofile hospital for active treatment and emergency medicine N.I. Pirogov"EAD
Sofia, Bulgaria
Diagnostic Consultation Center CONVEX EOOD
Sofia, Bulgaria
Medical Centre MEDICA Plus OOD
Veliko Tarnovo, Bulgaria
Fakultni nemocnice u svate Anny v Brne
Brno, Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, Czechia
GASTRO JeKa, s.r.o.
Klatovy, Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba, Czechia
Axon Clinical, s.r.o.
Prague, Czechia
Nemocnice Slany
Slaný, Czechia
Innomedica OÜ
Tallinn, Harju, Estonia
OCT: Eye Clinic Dr. Krista Turman
Tallinn, Estonia
North Estonia Medical Centre Foundation
Tallinn, Estonia
CHU Amiens Picardie
Amiens, France
Pulmonary examination: CHU Amiens-Picardie
Amiens, France
Tomography: CHU Amiens-Picardie
Amiens, France
CHU Grenoble Alpes -Hopital Michallon
Grenoble, France
Tomography: CHU Grenoble Alpes - Hopital Michallon
Grenoble, France
CHU de Nice - Hopital de l'Archet 2
Nice, France
Tomography: CHU RANGUEIL
Toulouse, France
LLC Todua Clinic
Tbilisi, Georgia
LLC Todua Clinic
Tbilisi, Georgia
LLC Vivamedi
Tbilisi, Georgia
LTD Institute of Clinical Cardiology
Tbilisi, Georgia
Medical Center CITO LTD
Tbilisi, Georgia
Aversi Clinic, LTD
Tbilisi, Georgia
LTD Academician Nikoloz Kipshidze Central University Clinic
Tbilisi, Georgia
LTD Aversi Clinic
Tbilisi, Georgia
Charite Universitaetsmedizin Berlin - Campus Charite Mitte Medizinische Klinik m. S. Hepatologie
Berlin, Germany
Dr. med Zacharias A. R.Sherif
Berlin, Germany
Krankenhaus Waldfriede e.V.,
Berlin, Germany
Schwerpunktpraxis Bonn
Bonn-Duisdorf, Germany
OCT address: AOZNeuss Dr. Kersten
Neuss, Germany
Praxis Dr. Jorgensen
Remscheid, Germany
Ophthalmology tests:Bekes Megyei Kozponti Korhaz, Pady Kalman Tagkorhaz, Szemeszeti Osztaly
Gyula, Bekes County, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, Fejér, Hungary
Semmelweis Egyetem
Budapest, Hungary
Gyöngyösi Bugát Pál Kórház
Gyöngyös, Hungary
Tolna Varmegyei Balassa Janos Korhaz
Szekszárd, Hungary
Sids Hospital & Research Centre
Surat, Gujarat, India
Midas Multispeciality Hospital Pvt. Ltd
Nagpur, Maharashtra, India
S.R.Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India
Shaare Zedek Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
The Chaim Sheba Medical Center
Ramat Gan, Israel
I.R.C.C.S "Saverio De Bellis", Gastroenterologia II
Castellana Grotte, BARI, Italy
A.O.U. Policlinico di Modena
Modena, Reggio Emilia, Italy
Azienda Ospedaliero Universitaria Careggi, U.O. Gastroenterologia 2 (St.19)
Florence, Tuscany, Italy
Ospedale Sacro Cuore Don Calabria
Negrar(vr), VR, Italy
Azienda Ospedalieria Ospedale Cannizzaro
Catania, Italy
Azienda Ospedaliero Universitaria Mater Domini
Catanzaro, Italy
IRCCS Ospedale San Raffaele UO di Gastroenterologia e Endoscopia Digestiva
Milan, Italy
U.O.C. Gastroenterologia ed Endoscopia Digestiva
Roma, Italy
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, Japan
Ishii Eye Clinic
Nagareyama-shi, Chiba, Japan
Toho University Sakura Medical Center
Sakura, Chiba, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Fukuoka Tokushukai Hospital
Kasuga, Fukuoka, Japan
Our Lady of the Snow St. Mary's Hospital
Kurume, Fukuoka, Japan
Gifu University Hospital
Gifu, Gifu, Japan
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi, Gunma, Japan
Nakayama EYE Clinic
Fukuyama-shi, Hiroshima, Japan
Tokushukai Sapporo Tokushukai Hospital
Sapporo, Hokkaido, Japan
NHO Mito Medical Center
Higashiibaraki-gun, Ibaraki, Japan
Iwate Medical University Uchimaru Medical Center
Morioka, Iwate, Japan
Sameshima Hospital
Kagoshima, Kagoshima-ken, Japan
Sagamihara Kyodo Hospital
Sagamihara, Kanagawa, Japan
Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital
Yokohama, Kanagawa, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, Kyoto, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Mie Prefectural General Medical Center
Yokkaichi-shi, Mie-ken, Japan
Sendai City Hospital
Sendai, Miyagi, Japan
Nagaoka Red Cross Hospital
Nagaoka-shi, Niigata, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan
Japan Community Health care Organization Osaka Hospital
Osaka, Osaka, Japan
Showa General Hospital
Kodaira-shi, Tokyo, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan
Fukushima Medical University Hospital
Fukushima, Japan
Saga University Hospital
Saga, Japan
P. Stradins Clinical University Hospital, Gastroenterology, Hepatology and Nutrition Therapy Center
Riga, Latvia
American University of Beirut Medical Center
Beirut, Lebanon
Servicios Medicos y de lnvestigacion Clinica Inspirepharma S. de R.L. de C.V.
Monterrey, Nuevo León, Mexico
Scientia, Investigacion Clinica S.C.
Chihuahua City, Mexico
Scientia Investigación Clínica S.C
Chihuahua City, Mexico
Servicios Medicos y de lnvestigacion Clinica Inspirepharma S. de R.L. de C.V.
Veracruz, Mexico
IMSP Institutul de Ftiziopneumologie "Chiril Draganiuc"
Chisinau, Moldova
IMSP Spitalul Clinic Republican "Timofei Mosneaga"
Chisinau, Moldova
Centrum Dentystyczno-Lekarskie PROMEDICA Joanna Markiewicz
Będzin, Poland
Centrum Medycyny Oddechowej, Mroz Spolka Jawna (PFT, DLCO)
Bialystok, Poland
Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
Nowy Targ, Poland
Centrum Zdrowia MDM
Warsaw, Poland
Centrum Medyczne Oporow
Wroclaw, Poland
Amicare Sp. z o.o. Sp.k.
Lodz, Łódź Voivodeship, Poland
Hospital Senhora da Oliveira Guimaraes, E.P.E
Guimarães, Portugal
S.C. Euroclinic Hospital S.A.
Bucharest, Romania
LLC "Multidisciplinary Medical Clinic "Anturium"
Barnaul, Altayskiy Kray, Russia
LLC Medical Company "Hepatologist"
Samara, Samara Oblast, Russia
LLC "Polyclinic of ultrasonography 4D"
Pyatigorsk, Stavropol Kray, Russia
LLC "Alliance Biomedical -Ural Group"
Izhevsk, Russia
LLC "SibNovoMed"
Novosibirsk, Russia
Medical center "AVITSENNA"
Novosibirsk, Russia
Clinicodiagnostic center "Ultramcd"
Omsk, Russia
Federal State Budgetary Ed. Inst. of Higher Education "North-Western Medical University n.a. I.I.
Saint Petersburg, Russia
FSBEI of Higher Education "North-Western State Medical University n.a. I.I. Mechnikov" of MoH RF
Saint Petersburg, Russia
Spb SBIH "City Mariinskaya Hospital"
Saint Petersburg, Russia
LLC "Medi com" (SM-Clinic)
Saint Petersburg, Russia
FSBEI of Higher Education "First Saint Petersburg State Medical University n.a. I.P. Pavlov"
Saint Petersburg, Russia
LLC Medical company "Hepatologist"
Samara, Russia
Autonomous Noncommercial Medical Organizations "Stavropol Regional Clinical Diagnostic Centre''
Stavropol, Russia
Autonomous Noncommercial Medical Organizations " Stavropol Regional Clinical Diagnostic Centre ''
Stavropol, Russia
City Polyclinic #9
Stavropol, Russia
GASTROMART s.r.o., Gastroenterologicka ambulancia
Bardejov, Slovakia
OCULOSANUS, s.r.o., Oftalmologicka ambulancia
Levice, Slovakia
MUDr. Michal Popovec, s.r.o., Oftalmologicka ambulancia
Lipany, Slovakia
KM Management, spol. s r.o .. Gastroenterologicke a hepatologicke centrum
Nitra, Slovakia
PULMO, s.r.o., Plucna ambulancia
Prešov, Slovakia
Dr Fritz Potgieter, Midstream Medi Clinic
Centurion, South Africa
OCT Facility in The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Dong-A University Hospital
Busan, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
OCT Facility in Kyungpook National University Chilgok Hospital
Daegu, South Korea
Kyungpook National University Hospital
Daegu, South Korea
HOSPITAL GENERAL UNIVERSITARIO de Alicante
Alicante, Valencia, Spain
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye)
Saglik Bilimleri Universitesi Antalya Egitim ve Arastirma Hastanesi
Antalya, Turkey (Türkiye)
Communal Non-commercial Enterprise Regional Clinical Hospital of lvano-Frankivsk Regional Council,
Ivano-Frankivsk, Ukraine
Municipal Health Care "Kharkiv City Hospital Ambulance and Emergency Medical care named alter prof.
Kharkiv, Ukraine
Llc "Ldts-Skaymed"
Kharkiv, Ukraine
Communal Noncommercial Enterprise Prof. O.O.Shalimov City Clinical Hospital #2 of Kharkiv City
Kharkiv, Ukraine
Llc Medical Center Oftalmika
Kharkiv, Ukraine
Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City
Kherson, Ukraine
LLC "Diagnostic center"
Kherson, Ukraine
Kyiv City Clinical Hosptial #1, Department of Clinical Research at the Special Fund
Kyiv, Ukraine
LLC GLB Clinik
Odesa, Ukraine
Andrii Novak Transcarpathian Regional Clinical Hospital, Department of Gastroenterology
Uzhagorod, Ukraine
Scientific and Research Institute of Invalid Rehabilitation (Educational and Scientific Treatment
Vinnytsia, Ukraine
Llc "Optimal M"
Vinnytsia, Ukraine
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom