An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis (ELEVATE UC OLE)

July 8, 2026 updated by: Pfizer

An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

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]).

Study Overview

Status

Active, not recruiting

Conditions

Ulcerative Colitis

Intervention / Treatment

Drug: Etrasimod

Study Type

Interventional

Enrollment (Actual)

896

Phase

Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    - Centro de lnvestigation C.I .C.E. 9 de Julio
Australia
- - Birtinya, Australia, 4575
    - Sunshine Coast Respiratory and Sleep (PFT Facility)
  - Buderim, Australia, 4556
    - Queensland Medical Laboratory (QML) pathology, QML Buderim Laboratory - Healius Pathology Pty Ltd
- New South Wales
  - Liverpool, New South Wales, Australia, 2170
    - Liverpool Hospital
- Queensland
  - Birtinya, Queensland, Australia, 4575
    - Sunshine Coast University Private Hospital
  - Bowen Hills, Queensland, Australia, 4006
    - Sullivan Nicolaides Pathology
  - Buderim, Queensland, Australia, 4556
    - Buderim Eye Centre( OCT and Ophthalmoscopy Facility)
  - Mackay, Queensland, Australia, 4740
    - Dr Shiran DeSilva Respiratory Clinic
  - Mackay, Queensland, Australia, 4740
    - Mater Misericordiae Hospital
  - Mackay, Queensland, Australia, 4740
    - Queensland X-Ray
  - Mackay, Queensland, Australia, 4740
    - Vision Eye Institute Mackay
  - Mackay, Queensland, Australia, 4740
    - Coral Sea Clinical Research Institute Pty.Ltd
  - Maroochydore, Queensland, Australia, 4558
    - Coastal Digestive Helath Pty. Ltd
  - North Mackey, Queensland, Australia, 4740
    - Dr Pranav Kumar (PFT Facility)
- Victoria
  - Heidelberg, Victoria, Australia, 3084
    - Austin Health
  - Melbourne, Victoria, Australia, 3004
    - The Alfred Hospital
Austria
- - Vienna, Austria, 1090
    - Department of Internal Medicine III, Clinical Division of Gastroenterology and Hepatology
Belarus
- - Grodno, Belarus, 230023
    - Foreign Medical and Pharmaceutical Unitary Enterprise "Medical Center" Novoe Zrenie"
  - Grodno, Belarus, 230026
    - Health Care Institution "City Clinical Hospital #4 Grodno"
  - Grodno, Belarus, 230030
    - Healthcare Institution "Grodno University Hospital"
  - Homyel, Belarus, 246027
    - Institution "Gomel Regional Specialized Clinical Hospital"
  - Homyel, Belarus, 246029
    - Institution "Gomel Regional Clinical Hospital
  - Minsk, Belarus, 220096
    - Health care Institution "10th City Clinical Hospital"
  - Vitebsk, Belarus, 210009
    - Educational Establishment "Vitebsk State Medical University"
  - Vitebsk, Belarus, 210037
    - Health Care Institution "Vitebsk Regional Clinical Hospital"
  - Vitebsk, Belarus, 210604
    - Healthcare Institution: Vitebsk Regional Clinical Specialized Center
Belgium
- - Ghent, Belgium, 9000
    - Hospital AZ Sint-Lucas
  - Roeselare, Belgium, 8800
    - AZ Delta
  - Roeselare, Belgium, 8800
    - AZ Delta campus Brugsesteenweg
Bulgaria
- - Rousse, Bulgaria, 7002
    - "UMHAT "Kanev"" AD, Ruse
  - Sliven, Bulgaria, 8800
    - Diagnostic-Consultative Center I - Sliven, EOOD
  - Sofia, Bulgaria, 1407
    - Acibadem City Clinic Tokuda Hospital EAD
  - Sofia, Bulgaria, 1680
    - Diagnostic Consultation Center CONVEX EOOD
  - Sofia, Bulgaria, 1407
    - Acibadem City clinic University Hospital EOOD
  - Sofia, Bulgaria, 1431
    - "DCC Alexandrovska", EOOD
  - Sofia, Bulgaria, 1431
    - UMHAT "Sv. Ivan Rilski" EAD'
  - Sofia, Bulgaria, 1527
    - UMHAT "Tsaritsa Yoanna - ISUL" EAD
  - Sofia, Bulgaria, 1606
    - "University multiprofile hospital for active treatment and emergency medicine N.I. Pirogov"EAD
  - Veliko Tarnovo, Bulgaria, 5000
    - Medical Centre MEDICA Plus OOD
Canada
- Ontario
  - Toronto, Ontario, Canada, M5G 1X5
    - Mount Sinai Hospital
Chile
- Los Ríos Region
  - Valdivia, Los Ríos Region, Chile
    - Clinical Research Chile
Croatia
- - Zadar, Croatia, 23000
    - General Hospital Zadar
  - Zagreb, Croatia, 10000
    - University Hospital Center Zagreb
Czechia
- - Brno, Czechia, 656 91
    - Fakultni nemocnice u svate Anny v Brne
  - Hradec Králové, Czechia, 500 12
    - Hepato-Gastroenterologie HK, s.r.o.
  - Klatovy, Czechia, 339 01
    - GASTRO JeKa, s.r.o.
  - Olomouc, Czechia, 779 00
    - PreventaMed s.r.o.
  - Ostrava-Poruba, Czechia, 708 52
    - Fakultni nemocnice Ostrava
  - Prague, Czechia, 150 00
    - Axon Clinical, s.r.o.
  - Prague, Czechia, 190 00
    - ISCARE a.s.
  - Prague, Czechia, 180 81
    - Nemocnice Na Bulovce
  - Slaný, Czechia, 274 01
    - Nemocnice Slany
Denmark
- - Aalborg, Denmark, 9000
    - Aalborg University Hospital, department of medical gastroenterology,
  - Herlev, Denmark, 2730
    - Herlev Hospital, Stomach, -Bowel and Liver disease, Clinic 1
Estonia
- - Tallinn, Estonia, 10617
    - West Tallinn Central Hospital
  - Tallinn, Estonia, 13419
    - North Estonia Medical Centre Foundation
  - Tallinn, Estonia, 10120
    - OCT: Eye Clinic Dr. Krista Turman
  - Tallinn, Estonia, 10138
    - DLCO: East Tallinn Central Hospital
  - Tallinn, Estonia, 13149
    - Endoscopy: North Estonia Medical Centre Foundation
- Harju
  - Tallinn, Harju, Estonia, 10117
    - Innomedica OÜ
France
- - Amiens, France, 80054
    - CHU Amiens Picardie
  - Amiens, France, 80054
    - Endoscopy: CHU Amiens-Picardie
  - Amiens, France, 80054
    - Pulmonary examination: CHU Amiens-Picardie
  - Amiens, France, 80054
    - Tomography: CHU Amiens-Picardie
  - Grenoble, France, 38043
    - CHU Grenoble Alpes -Hopital Michallon
  - Grenoble, France, 38043
    - Endoscopy: CHU Grenoble Alpes- Hopital Michallon
  - Grenoble, France, 38043
    - Pulmonary examination: CHU Grenoble Alpes - Hopital Michallon
  - Grenoble, France, 38043
    - Tomography: CHU Grenoble Alpes - Hopital Michallon
  - Montpellier, France, 34295
    - CHU Montpellier Hopital Saint-Eloi
  - Montpellier, France, 34295
    - Endoscopy: Hopital Saint-Eloi
  - Montpellier, France, 34295
    - Pulmonary examination: Hopital Arnaud de Villeneuve
  - Montpellier, France, 34295
    - Tomography: Hopital Gui de Chauliac
  - Nantes, France, 44093
    - CHU Hôtel Dieu
  - Nice, France, 06202
    - CHU de Nice - Hopital de l'Archet 2
  - Toulouse, France, 31059
    - CHU de Toulouse-Hopital Rangueil
  - Toulouse, France, 31059
    - Tomography: CHU RANGUEIL
  - Toulouse, France, 31059
    - Endoscopy: CHU RANGUEIL
  - Toulouse, France, 31059
    - Pulmonary examination: CHU RANGUEIL
Georgia
- - Tbilisi, Georgia, 0131
    - LLC Vivamedi
  - Tbilisi, Georgia, 0160
    - LTD Aversi Clinic
  - Tbilisi, Georgia, 0159
    - LTD Institute of Clinical Cardiology
  - Tbilisi, Georgia, 0112
    - Llc Todua Clinic
  - Tbilisi, Georgia, 0159
    - Medical Center CITO LTD
  - Tbilisi, Georgia, 0160
    - LTD Academician Nikoloz Kipshidze Central University Clinic
  - Tbilisi, Georgia, 0160
    - Aversi Clinic, LTD
  - Tbilisi, Georgia, 0119
    - Llc Todua Clinic
  - Tbilisi, Georgia
    - Malkhaz Katsiashvili Multiprofile Emergency Medicine Center, LTD
  - Tbilisi, Georgia, 0159
    - JSC T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center
  - Tbilisi, Georgia, 0119
    - Israeli-Georgian Medical Research Clinic Healthycore LLC
Germany
- - Berlin, Germany, 14163
    - Krankenhaus Waldfriede e.V.,
  - Berlin, Germany, 10117
    - Charite Universitaetsmedizin Berlin - Campus Charite Mitte Medizinische Klinik m. S. Hepatologie
  - Berlin, Germany, 14163
    - Dr. med Zacharias A. R.Sherif
  - Bonn-Duisdorf, Germany, 53123
    - Schwerpunktpraxis Bonn
  - Neuss, Germany, 41462
    - Johanna-Etienne-Krankenhaus
  - Neuss, Germany, 41462
    - OCT address: AOZNeuss Dr. Kersten
  - Remscheid, Germany, 42859
    - Praxis Dr. Jorgensen
Hungary
- - Budapest, Hungary, 1088
    - Semmelweis Egyetem
  - Budapest, Hungary, 1136
    - Pannonia Maganorvosi Centrum
  - Budapest, Hungary, 1062
    - Pulmonary function tests: Vasutegeszsegugyi Nonprofit Kozhasznu Kft.
  - Budapest, Hungary, 1068
    - Ophthalmology tests: Magyar Honvedseg Egeszsegugyi Kozpont
  - Gyöngyös, Hungary, 3200
    - Gyongyosi Bugat Pal Korhaz
  - Szekszárd, Hungary, 7100
    - Tolna Varmegyei Balassa Janos Korhaz
  - Veszprém, Hungary, 8230
    - Ophthalmology tests: RETINASZERVIZ Kft.
- Bekes County
  - Gyula, Bekes County, Hungary, 5700
    - Ophthalmology tests:Bekes Megyei Kozponti Korhaz, Pady Kalman Tagkorhaz, Szemeszeti Osztaly
  - Gyula, Bekes County, Hungary, 5600
    - Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia
- Fejér
  - Székesfehérvár, Fejér, Hungary, 8000
    - Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
- Tolna County
  - Szekszárd, Tolna County, Hungary, 7100
    - Clinfan Szolgaltato Kft.
- Veszprém megye
  - Ajka, Veszprém megye, Hungary, 8400
    - Endoscopy: Magyar Imre Korhaz
  - Balatonfüred, Veszprém megye, Hungary, 8230
    - DRC Gyogyszervizsgalo Kozpont Kft.
  - Tapolca, Veszprém megye, Hungary, 8300
    - Pulmonary function tests, endoscopy: Deak Jeno Korhaz
India
- - Nagpur, India, 440009
    - Government Medical College & Super Speciality Hospital
- Gujarat
  - Surat, Gujarat, India, 395002
    - Surat Institute of Digestive Sciences
  - Surat, Gujarat, India, 395002
    - Sids Hospital & Research Centre
- Haryana
  - Gurgaon, Haryana, India, 122002
    - Fortis Memorial Research Institute
- Maharashtra
  - Nagpur, Maharashtra, India, 440010
    - Midas Multispeciality Hospital Pvt. Ltd
  - Pune, Maharashtra, India, 411001
    - Grant Medical Foundation Ruby Hall Clinic
- Rajasthan
  - Jaipur, Rajasthan, India, 302001
    - S.R.Kalla Memorial Gastro & General Hospital
- Uttar Pradesh
  - Kanpur, Uttar Pradesh, India, 208002
    - Post Graduate Department Of Medicine
Israel
- - Haifa, Israel, 3104802, POB 4940
    - Bnai Zion Medical Center
  - Jerusalem, Israel, 9103102
    - Shaare Zedek Medical Center
  - Nahariya, Israel, 2210001
    - Galilee Medical Center
  - Petah Tikva, Israel, 4941492
    - Rabin Medical Center
  - Ramat Gan, Israel, 5262000
    - The Chaim Sheba Medical Center
  - Rehovot, Israel, 7661041
    - Kaplan Medical Center
Italy
- - Catania, Italy, 95100
    - Azienda Ospedalieria Ospedale Cannizzaro
  - Catanzaro, Italy, 88100
    - Azienda Ospedaliero Universitaria Mater Domini
  - Milan, Italy, 20132
    - IRCCS Ospedale San Raffaele UO di Gastroenterologia e Endoscopia Digestiva
  - Roma, Italy, 00157
    - U.O.C. Gastroenterologia ed Endoscopia Digestiva
  - Roma, Italy, 00168
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS -CEMAD -UOC di Medicina lnterna e Gastro
- BARI
  - Castellana Grotte, BARI, Italy, 70013
    - I.R.C.C.S "Saverio De Bellis", Gastroenterologia II
- Lombardy
  - Brescia, Lombardy, Italy, 25123
    - Spedali Civili di Brescia, U.O. Gastroenterologia
  - Milan, Lombardy, Italy, 20132
    - IRCCS Ospedale San Raffaele, Oculistica
- Milan
  - Rho, Milan, Italy, 20017
    - ASST Rhodense - U.O.C. di Gastroenterologia ed Endoscopia Digestiva
- Milano
  - San Donato Milanese, Milano, Italy, 20097
    - I.R.C.C.S Policlinico San Donato
- Reggio Emilia
  - Modena, Reggio Emilia, Italy, 41124
    - A.O.U. Policlinico di Modena
- Tuscany
  - Florence, Tuscany, Italy, 50134
    - Azienda Ospedaliero Universitaria Careggi, U.O. Gastroenterologia 2 (St.19)
- VR
  - Negrar(vr), VR, Italy, 37024
    - Ospedale Sacro Cuore Don Calabria
Japan
- - Fukushima, Japan, 960-1295
    - Fukushima Medical University Hospital
  - Osaka, Japan, 540-0006
    - NHO Osaka National Hospital
  - Saga, Japan, 849-8501
    - Saga University Hospital
- Aichi-ken
  - Nagoya, Aichi-ken, Japan, 457-8511
    - Kojunkai Daido Clinic
  - Toyohashi, Aichi-ken, Japan, 441-8570
    - Toyohashi Municipal Hospital
- Chiba
  - Kashiwa-shi, Chiba, Japan, 277-0871
    - Tsujinaka Hospital Kashiwanoha
  - Nagareyama-shi, Chiba, Japan, 270-0116
    - Ishii Eye Clinic
  - Sakura, Chiba, Japan, 285-8741
    - Toho University Sakura Medical Center
- Fukuoka
  - Fukuoka, Fukuoka, Japan, 814-0180
    - Fukuoka University Hospital
  - Kasuga, Fukuoka, Japan, 816-0864
    - Fukuoka Tokushukai Hospital
  - Kasuga-shi, Fukuoka, Japan, 816-0863
    - Takimoto Eye Clinic(OCT)
  - Kitakyushu, Fukuoka, Japan, 806-8501
    - Japan Community Health Care Organization Kyushu Hospital
  - Kitakyushu-shi, Fukuoka, Japan, 807-1266
    - Koyanose Eye Clinic
  - Kurume, Fukuoka, Japan, 830-8543
    - Our Lady of the Snow St. Mary's Hospital
  - Onga-gun, Fukuoka, Japan, 807-0051
    - Fukuoka Shinmizumaki Hospital
- Gifu
  - Gifu, Gifu, Japan, 501-1194
    - Gifu University Hospital
- Gunma
  - Ota-shi, Gunma, Japan, 373-8585
    - SUBARU Health Insurance Society Ota Memorial Hospital
- Hiroshima
  - Fukuyama, Hiroshima, Japan, 720-8520
    - National Hospital Organization Fukuyama Medical Center
  - Fukuyama-shi, Hiroshima, Japan, 720-0822
    - Nakayama EYE Clinic
  - Hiroshima, Hiroshima, Japan, 734-8551
    - Hiroshima University Hospital
- Hokkaido
  - Asahikawa-shi, Hokkaido, Japan, 070-8610
    - Asahikawa City Hospital
  - Sapporo, Hokkaido, Japan, 004-0041
    - Tokushukai Sapporo Tokushukai Hospital
- Ibaraki
  - Higashiibaraki-gun, Ibaraki, Japan, 311-3193
    - NHO Mito Medical Center
  - Toride-shi, Ibaraki, Japan, 302-0014
    - Matsumoto Eye Clinic
- Ishikawa-ken
  - Kanazawa, Ishikawa-ken, Japan, 920-8650
    - NHO Kanazawa Medical Center
- Iwate
  - Morioka, Iwate, Japan, 020-8505
    - Iwate Medical University Uchimaru Medical Center
- Kagawa-ken
  - Takainatsu-shi, Kagawa-ken, Japan, 760-8557
    - Kagawa Prefectural Central Hospital
  - Takamatsu, Kagawa-ken, Japan, 760-0017
    - Takamatsu Red Cross Hospital
- Kagoshima-ken
  - Kagoshima, Kagoshima-ken, Japan, 892-0846
    - Sameshima Hospital
  - Kagoshima, Kagoshima-ken, Japan, 890-0062
    - JA- Kagoshima Koseiren Hospital (PET/DLCO)
  - Kagoshima, Kagoshima-ken, Japan, 892-0824
    - Jiaikai Idzuro Imamura Hospital
  - Kagoshima, Kagoshima-ken, Japan, 892-0825
    - Sameshima Eye Clinic (OCT)
- Kanagawa
  - Sagamihara, Kanagawa, Japan, 252-5188
    - Sagamihara Kyodo Hospital
  - Yokohama, Kanagawa, Japan, 234-0054
    - Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital
- Kumamoto
  - Kumamoto, Kumamoto, Japan, 861-8520
    - Japanese Red Cross Kumamoto Hospital
- Kyoto
  - Kyoto, Kyoto, Japan, 602-8566
    - University Hospital Kyoto Prefectural University of Medicine
  - Kyoto, Kyoto, Japan, 612-8555
    - National Hospital Organization Kyoto Medical Center
- Mie-ken
  - Tsu, Mie-ken, Japan, 514-8507
    - Mie University Hospital
  - Yokkaichi- Shi, Mie-ken, Japan, 510-0891
    - Hinaga Nishi Ophthalmology Clinic
  - Yokkaichi-shi, Mie-ken, Japan, 510-8561
    - Mie Prefectural General Medical Center
- Miyagi
  - Sendai, Miyagi, Japan, 981-8563
    - JOHAS Tohoku Rosai Hospital
  - Sendai, Miyagi, Japan, 982-8502
    - Sendai City Hospital
- Niigata
  - Nagaoka-shi, Niigata, Japan, 940-2085
    - Nagaoka Red Cross Hospital
- Osaka
  - Hirakata-shi, Osaka, Japan, 573-1191
    - Kansai Medical University Hospital
  - Osaka, Osaka, Japan, 553-0003
    - Japan Community Health care Organization Osaka Hospital
- Shizuoka
  - Hamamatsu, Shizuoka, Japan, 431-3192
    - Hamamatsu University Hospital
  - Hamamatsu, Shizuoka, Japan, 432-8580
    - Hamamatsu Medical Center
  - Hamamatsu, Shizuoka, Japan, 432-8061
    - Matsuda Hospital
- Tokyo
  - Chuo-ku, Tokyo, Japan, 104-8560
    - St. Luke's International Hospital
  - Itabashi-ku, Tokyo, Japan, 173-8606
    - Teikyo University Hospital
  - Kodaira-shi, Tokyo, Japan, 187-8510
    - Showa General Hospital
  - Minato-ku, Tokyo, Japan, 108-8642
    - Kitasato University Kitasato Institute Hospital
  - Shinjuku-ku, Tokyo, Japan, 169-0073
    - JCHO Tokyo Yamate Medical Center
- Wakayama
  - Wakayama, Wakayama, Japan, 641-8510
    - Wakayama Medical University Hospital
- Yamanashi
  - Kofu, Yamanashi, Japan, 400-8506
    - Yamanashi Prefectural Central Hospital
Latvia
- - Riga, Latvia, LV-1002
    - P. Stradins Clinical University Hospital, Gastroenterology, Hepatology and Nutrition Therapy Center
Lebanon
- - Beirut, Lebanon
    - American University of Beirut Medical Center
Lithuania
- - Panevezys, Lithuania, LT-35144
    - Consultancy Polyclinic of Republican Panevezys Hospital
  - Panevezys, Lithuania, LT-35144
    - Republican Panevezys Hospital
  - Vilnius, Lithuania, LT-08661
    - Vilnius University Hospital Santaros Klinikos
  - Vilnius, Lithuania, 08661
    - Vilnius University Hospital Santaros Klinikos
  - Vilnius, Lithuania, 08234
    - UAB "Northway", Medical and Surgical Centre
  - Vilnius, Lithuania, 08406
    - UAB "Inlita", Santaros Clinical Trials Centre
Mexico
- - Chihuahua City, Mexico, 31203
    - Scientia, Investigacion Clinica S.C.
  - Chihuahua City, Mexico, 31207
    - Scientia Investigación Clínica S.C
  - Irapuato, Mexico, 36520
    - Invesclinic MX
  - Veracruz, Mexico, 91900
    - FAICIC S. de R.L. de C.V.
  - Veracruz, Mexico, 91900
    - Servicios Medicos y de lnvestigacion Clinica Inspirepharma S. de R.L. de C.V.
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44130
    - Centro de lnvestigacion Medico Biologica y Terapia Avanzada S.C.
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64660
    - Servicios Medicos y de lnvestigacion Clinica Inspirepharma S. de R.L. de C.V.
Moldova
- - Chisinau, Moldova, 2025
    - IMSP Institutul de Ftiziopneumologie "Chiril Draganiuc"
  - Chisinau, Moldova, 2025
    - IMSP Spitalul Clinic Republican "Timofei Mosneaga"
  - Chisinau, Moldova, 2038
    - Spitalul Polivalent Novamed
Poland
- - Bialystok, Poland, 15-044
    - Centrum Medycyny Oddechowej, Mroz Spolka Jawna (PFT, DLCO)
  - Bialystok, Poland, 15-322
    - Gastromed Kralisz, Romatowski, Stachurska sp.j.
  - Bialystok, Poland, 15-453
    - LSSP Eskulap (OCT, Ophthalmoscopy)
  - Będzin, Poland, 42-500
    - Centrum Dentystyczno-Lekarskie PROMEDICA Joanna Markiewicz
  - Gdansk, Poland, 80-402
    - Dobry Wzrok (OCT)
  - Gdynia, Poland, 81-366
    - Poradnia Pulmonologiczna
  - Jelenia Góra, Poland, 58-500
    - Karkonoskie Centrum Badan Klinicznych - Lexmedica Spolka z ograniczona odpowiedzialnoscia
  - Jelenia Góra, Poland, 58-506
    - PROMED Centrum Medyczne (OCT, ophthalmoscopy)
  - Lodz, Poland, 90-752
    - IP Clinic Sp. z o.o.
  - Nowy Targ, Poland, 34-400
    - Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
  - Oświęcim, Poland, 32-600
    - MEDICOME Sp. z o.o.
  - Rzeszów, Poland, 35-326
    - Centrum Medyczne Medyk
  - Sopot, Poland, 81-756
    - ENDOSKOPIA Sp. z o.o.
  - Sosonowiec, Poland, 41-209
    - Kiepury Clinic Malgorzata Jarnot Specjalistyczna Praktyka Ginekologiczno
  - Swidnica, Poland, 58-100
    - DC-MED Sp. z o.o.
  - Szczecin, Poland, 71-434
    - Twoja Przychodnia-Szczecinskie Centrum Medyczne
  - Warsaw, Poland, 00-635
    - Centrum Zdrowia MDM
  - Warsaw, Poland, 02-507
    - Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji
  - Wroclaw, Poland, 52-416
    - Centrum Medyczne Oporow
- Greater Poland Voivodeship
  - Poznan, Greater Poland Voivodeship, Poland, 60-681
    - NSZOZ Termedica - Centrum Badan Klinicznych
- Other
  - Wroclaw, Other, Poland, 54-239
    - Penta Hospitals Przychodnie
- Łódź Voivodeship
  - Lodz, Łódź Voivodeship, Poland, 91-495
    - Amicare Sp. z o.o. Sp.k.
Portugal
- - Coimbra, Portugal, 3004-561
    - Unidade Local de Saude de Coimbra, E.P.E
  - Guimarães, Portugal, 4835-044
    - Hospital Senhora da Oliveira Guimaraes, E.P.E
  - Porto, Portugal, 4200-319
    - Centro Hospitalar Universitario de Sao Joao, E.P.E
- Porto District
  - Vila Nova de Gaia, Porto District, Portugal, 4434-502
    - Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
Romania
- - Bucharest, Romania, 014461
    - S.C. Euroclinic Hospital S.A.
  - Bucharest, Romania, 13823
    - Spitalul de Oncologie Monza
  - Cluj-Napoca, Romania, 400371
    - Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca
- Bihor County
  - Oradea, Bihor County, Romania, 410469
    - SC Pelican lmpex SRL
- Cluj
  - Cluj-Napoca, Cluj, Romania, 400501
    - Oculens Med S.R.L.
- JUD. CLUJ
  - Cluj-Napoca, JUD. CLUJ, Romania, 400006
    - Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Russia
- - Irkutsk, Russia, 664049
    - Irkutsk State Medical Academy of Postgraduate Education
  - Irkutsk, Russia, 664049
    - Professional Education" of MoH of RF
  - Izhevsk, Russia, 426061
    - LLC "Alliance Biomedical -Ural Group"
  - Kemerovo, Russia, 650066
    - SAIH "Kemerovo Regional Clinical Hospital"
  - Nizhny Novgorod, Russia, 603126
    - State Budgetary Healthcare Instit. of Nizhniy Novgorod region
  - Novosibirsk, Russia, 630005
    - LLC "SibNovoMed"
  - Novosibirsk, Russia, 630007
    - LLC "Novosibirsk GastroCenter"
  - Novosibirsk, Russia, 630084
    - State Budgetary Healthcare Institution of Novosibirsk region "City clinical hospital # 12"
  - Novosibirsk, Russia, 63009
    - Medical center "AVITSENNA"
  - Omsk, Russia, 644024
    - Clinicodiagnostic center "Ultramcd"
  - Penza, Russia, 440026
    - State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"
  - Saint Petersburg, Russia, 191015
    - Federal State Budgetary Ed. Inst. of Higher Education "North-Western Medical University n.a. I.I.
  - Saint Petersburg, Russia, 191015
    - FSBEI of Higher Education "North-Western State Medical University n.a. I.I. Mechnikov" of MoH RF
  - Saint Petersburg, Russia, 194104
    - Spb SBIH "City Mariinskaya Hospital"
  - Saint Petersburg, Russia, 195279
    - LLC "Medi com" (SM-Clinic)
  - Saint Petersburg, Russia, 197022
    - FSBEI of Higher Education "First Saint Petersburg State Medical University n.a. I.P. Pavlov"
  - Saint Petersburg, Russia, 197110
    - LLC "Gastroenterological centre Expert"
  - Saint Petersburg, Russia, 197706
    - St.Petersburg State Budgetary Healthcare Institution "City Hospital #40 of Kurortnyi region"
  - Samara, Russia, 443001
    - Private Educational Institution of Higher Education "Medical University "Reaviz", Multifield Clinic
  - Samara, Russia, 443093
    - LLC Medical company "Hepatologist"
  - Stavropol, Russia, 355017
    - Autonomous Noncommercial Medical Organizations "Stavropol Regional Clinical Diagnostic Centre''
  - Stavropol, Russia, 355032
    - Autonomous Noncommercial Medical Organizations " Stavropol Regional Clinical Diagnostic Centre ''
  - Stavropol, Russia, 355044
    - City Polyclinic #9
  - Yaroslavl, Russia, 150030
    - State Healthcare Institution of Yaroslavl Region "Clinical Hospital No 2"
- Altayskiy Kray
  - Barnaul, Altayskiy Kray, Russia, 656043
    - LLC "Multidisciplinary Medical Clinic "Anturium"
- Samara Oblast
  - Samara, Samara Oblast, Russia, 443063
    - LLC Medical company "Hepatologist"
- Stavropol Kray
  - Pyatigorsk, Stavropol Kray, Russia, 357500
    - LLC "Polyclinic of ultrasonography 4D"
Serbia
- - Belgrade, Serbia, 11000
    - Clinical Center Zvezdara
  - Belgrade, Serbia, 11000
    - Clinical Center " Dr Dragisa Misovic-Dedinje"
  - Sremska Mitrovica, Serbia, 22000
    - General Hospital Sremska Mitrovica
Slovakia
- - Banská Bystrica, Slovakia, 97517
    - Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica, II. Interna klinika SZU
  - Bardejov, Slovakia, 08501
    - ALIAN, s.r.o.
  - Bardejov, Slovakia, 08501
    - GASTROMART s.r.o., Gastroenterologicka ambulancia
  - Košice, Slovakia, 04011
    - 3F, s.r.o., Oftalmologicka ambulancia
  - Levice, Slovakia, 934 01
    - OCULOSANUS, s.r.o., Oftalmologicka ambulancia
  - Lipany, Slovakia, 053 04
    - MUDr. Michal Popovec, s.r.o., Oftalmologicka ambulancia
  - Nitra, Slovakia, 950 01
    - Fakultná nemocnica Nitra
  - Nitra, Slovakia, 94901
    - KM Management, spol. s r.o .. Gastroenterologicke a hepatologicke centrum
  - Nitra, Slovakia, 950 01
    - Fakultna nemocnica Nitra, Oftalmologicka ambulancia
  - Nitra, Slovakia, 950 01
    - Fakultna nemocnica Nitra, Pneumologicka ambulancia
  - Prešov, Slovakia, 080 01
    - GASTRO I., s.r.o. Gastroenterologicka ambulancia
  - Prešov, Slovakia, 080 01
    - PULMO, s.r.o., Plucna ambulancia
  - Vranov nad Topľou, Slovakia, 093 01
    - PULMOX spol. s r.o., Pneumologicko-ftizeologicka ambulancia
  - Vranov nad Topľou, Slovakia, 093 01
    - ENDOMED. s.r.o., Gastroenterologicka ambulancia
  - Šahy, Slovakia, 936 01
    - Accout Center, s.r.o., Gastroenterologicka ambulancia
  - Šahy, Slovakia, 936 01
    - COR, s.r.o., Pneumologicko-ftizeologicka ambulancia
South Africa
- - Centurion, South Africa, 1692
    - Dr Fritz Potgieter, Midstream Medi Clinic
- Gauteng
  - Centurion, Gauteng, South Africa, 0157
    - Unitas Hospital
  - Centurion, Gauteng, South Africa, 0157
    - Johese Clinical Research:Unitas
  - Centurion, Gauteng, South Africa, 0157
    - Johese Clinical Research: Midstream
- Western Cape
  - Cape Town, Western Cape, South Africa, 7708
    - Dr John Philip Wright
South Korea
- - Busan, South Korea, 49201
    - Dong-A University Hospital
  - Daegu, South Korea, 41404
    - Kyungpook National University Chilgok Hospital
  - Daegu, South Korea, 41944
    - Kyungpook National University Hospital
  - Daegu, South Korea, 41404
    - Endoscopy Facility in Kyungpook National University Chilgok Hospital
  - Daegu, South Korea, 41404
    - OCT Facility in Kyungpook National University Chilgok Hospital
  - Daegu, South Korea, 41404
    - PFT Facility in Kyungpook National University Chilgok Hospital
- Gangwon-do
  - Wŏnju, Gangwon-do, South Korea, 26426
    - Yonsei University Wonju Severance Christian Hospital
- Gyeonggi-do
  - Suwon, Gyeonggi-do, South Korea, 16247
    - Endoscopy Facility in The Catholic University of Korea, St. Vincent's Hospital
  - Suwon, Gyeonggi-do, South Korea, 16247
    - OCT Facility in The Catholic University of Korea, St. Vincent's Hospital
  - Suwon, Gyeonggi-do, South Korea, 16247
    - PFT Facility in The Catholic University of Korea, St. Vincent's Hospital
  - Suwon, Gyeonggi-do, South Korea, 16427
    - The Catholic University Of Korea, St. Vincent's Hospital
Spain
- - Madrid, Spain, 28046
    - Hospital Universitario La Paz
- Valencia
  - Alicante, Valencia, Spain, 03010
    - Hospital General Universitario de Alicante
Thailand
- - Bangkok, Thailand, 10330
    - Chulalongkorn University, King Chulalongkorn Memorial Hospital
- Bangkok
  - Bangkoknoi, Bangkok, Thailand, 10700
    - Siriraj Hospital, Mahidol University
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06500
    - Gazi University Medical Faculty
  - Ankara, Turkey (Türkiye), 06100
    - Hacettepe University Medical Faculty
  - Ankara, Turkey (Türkiye), 06560
    - Gazi University Medical Faculty
  - Antalya, Turkey (Türkiye), 07030
    - Saglik Bilimleri Universitesi Antalya Egitim ve Arastirma Hastanesi
  - Bursa, Turkey (Türkiye), 16059
    - Uludag University Medical Faculty
  - Kocaeli, Turkey (Türkiye), 41380
    - Kocaeli University Medical Faculty
Ukraine
- - Dnipro, Ukraine, 49005
    - Communal Institution I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital, Department of
  - Ivano-Frankivsk, Ukraine, 76000
    - Clinical Diagnostical Center "Simedgroup"
  - Ivano-Frankivsk, Ukraine, 76000
    - Communal Non-commercial Enterprise Regional Clinical Hospital of lvano-Frankivsk Regional Council,
  - Kharkiv, Ukraine, 61022
    - Llc "Ldts-Skaymed"
  - Kharkiv, Ukraine, 61045
    - Llc Medical Center Oftalmika
  - Kharkiv, Ukraine, 61018
    - Municipal Health Care "Kharkiv City Hospital Ambulance and Emergency Medical care named alter prof.
  - Kharkiv, Ukraine, 61024
    - LLC "EyeQClinic"
  - Kharkiv, Ukraine, 61037
    - Communal Noncommercial Enterprise Prof. O.O.Shalimov City Clinical Hospital #2 of Kharkiv City
  - Kharkiv, Ukraine, 61124
    - Communal Noncommercial Enterprise City Clinical Hospital # 13 of Kharkiv City Council,
  - Kherson, Ukraine, 73000
    - Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City
  - Kherson, Ukraine, 73003
    - LLC "Diagnostic center"
  - Kyiv, Ukraine, 02091
    - Kyiv City Clinical Hosptial #1, Department of Clinical Research at the Special Fund
  - Lviv, Ukraine, 79059
    - Communal Noncommercial Enterprise Lviv Clinical Emergency Hospital, 1st Department of Therapy
  - Odesa, Ukraine, 65025
    - Communal Institution Odesa Regional Clinical Hospital, Regional Center of Gastroenterology,
  - Odesa, Ukraine, 65025
    - LLC GLB Clinik
  - Uzhagorod, Ukraine, 88018
    - Andrii Novak Transcarpathian Regional Clinical Hospital, Department of Gastroenterology
  - Uzhhorod, Ukraine, 88017
    - Transcarpathian Center of Eye Microsurgery
  - Vinnytsia, Ukraine, 21009
    - Medical Clinical Investigational Center of Med Center LLC Health Clinic, Unit of Gastroenterology,
  - Vinnytsia, Ukraine, 21018
    - Communal Nonprofit Enterprise M.I.Pyrogov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional
  - Vinnytsia, Ukraine, 21029
    - Scientific and Research Institute of Invalid Rehabilitation (Educational and Scientific Treatment
  - Vinnytsia, Ukraine, 21036
    - Llc "Optimal M"
United Kingdom
- - London, United Kingdom, SE1 9RT
    - Guy's and St Thomas' NHS Foundation Trust
  - London, United Kingdom, E11 1NR
    - Barts Health NHS Trust - Whipps Cross University Hospital
- Somerset
  - Yeovil, Somerset, United Kingdom, BA21 4AT
    - Yeovil District Hospital NHS Foundation Trust
United States
- Alabama
  - Dothan, Alabama, United States, 36301
    - Center for Digestive Health (Colonoscopy Location)
  - Dothan, Alabama, United States, 36301
    - Pulmonary Associates (Secondary PFT Location)
  - Dothan, Alabama, United States, 36301
    - Digestive Health Specialists (IP Address)
  - Dothan, Alabama, United States, 36305
    - Gut P.C., dba Digestive Health Specialists of the Southeast (IP Address)
  - Dothan, Alabama, United States, 36301
    - Flowers Hospital (PFT Location)
- California
  - Lake Elsinore, California, United States, 92532
    - Inland Pulmonary Specialists [PFT Only]
  - Lancaster, California, United States, 93534
    - Om Research LLC
  - Lancaster, California, United States, 93534
    - A V Pediatrics,Allergy and Family Medicine
  - Lancaster, California, United States, 93534
    - Advanced Endoscopy and Pain Center(Colonoscopy)
  - Lancaster, California, United States, 93534
    - Antelope Valley Eye Care(Ophthalmologist)
  - Lancaster, California, United States, 93534
    - Jatinder S.Pruthi,MD FACG CPI
  - Lancaster, California, United States, 93534
    - Renaissance Imaging Center(Chest X-Ray only)
  - Murrieta, California, United States, 92563
    - United Medical Doctors
  - Murrieta, California, United States, 92562
    - United Surgery Center Murrieta [Endoscopy Only]
  - Palmdale, California, United States, 93551
    - Advanced Imaging (Chest X-Ray)
  - Temecula, California, United States, 92591
    - California Eye Professionals [OCT Only]
  - Temecula, California, United States, 92592
    - United Surgery Center Temecula [Endoscopy Only]
- Colorado
  - Colorado Springs, Colorado, United States, 80920
    - Peak Gastroenterology Associates
  - Colorado Springs, Colorado, United States, 80903
    - Front Range Endoscopy Center
- Florida
  - Clearwater, Florida, United States, 33762
    - Gastro Florida (Regulatory & Administrative Duties)
  - Clearwater, Florida, United States, 33756
    - Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test)
  - Clearwater, Florida, United States, 33756
    - West Coast Endoscopy Center (Endoscopy Procedures)
  - Clearwater, Florida, United States, 33761
    - Northwood Vision- Optical Coherence Tomography (OCT)
  - Clearwater, Florida, United States, 33761
    - Northwood Vision-Optical Coherence Tomography-(OCT)
  - Clearwater, Florida, United States, 33761
    - Safety Harbor Surgery (Endoscopy Facility)
  - Clearwater, Florida, United States, 33762
    - Gastro Florida-(Regulatory & Administrative Duties)
  - Clearwater, Florida, United States, 33765
    - West Coast Endoscopy Center (Endoscopy Procedures)
  - Largo, Florida, United States, 33771
    - Dr Lee Shettle
  - Largo, Florida, United States, 33771
    - Florida Center for Gastroenterology
  - Largo, Florida, United States, 33771
    - Tampa Bay Regional Surgery Center
  - New Smyrna Beach, Florida, United States, 32168
    - NSB Research
  - Tampa, Florida, United States, 33612
    - Usf Health Morsani Center For Advanced Healthcare
  - Tampa, Florida, United States, 33606
    - USF Health South Tampa Center for Advanced Healthcare
  - Tampa, Florida, United States, 33603
    - Tampa Bay Endoscopy Center
  - Tampa, Florida, United States, 33614
    - Guardian Angel Research Center, INC
  - Tampa, Florida, United States, 33609
    - GCP Clinical Research,LLC
  - Tampa, Florida, United States, 33609
    - LoCicero Medical Group (PFT Procedure Only)
  - Tampa, Florida, United States, 33603
    - Tampa Bay Endoscopy Center (ENDO Only)
  - Tampa, Florida, United States, 33606
    - Lab - Processing / Storage
  - Tampa, Florida, United States, 33607
    - Pulmonary and Sleep of Tampa Bay (PFT Only)
  - Tampa, Florida, United States, 33609
    - Newsome Eye Specialist (OCT Procedures Only)
  - Tampa, Florida, United States, 33614
    - Perez Eye Center (OCT only)
  - Tampa, Florida, United States, 33609
    - Lyracore Health Alliance (PFT Procedure only)
  - Zephyrhills, Florida, United States, 33542
    - Florida Medical Clinic, LLC
  - Zephyrhills, Florida, United States, 33542
    - Florida Medical Clinic, LLC (Endoscopy)
  - Zephyrhills, Florida, United States, 33542
    - Florida Medical Clinic, LLC (OCT)
  - Zephyrhills, Florida, United States, 33542
    - Florida Medical Clinic, LLC (PFT)
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Atlanta Gastroenterology Associates
  - Atlanta, Georgia, United States, 30342
    - Atlanta Gastroenterology Associates (endoscopy only)
  - Atlanta, Georgia, United States, 30342
    - Atlanta Gastroenterology Associates(IP only)
  - Atlanta, Georgia, United States, 30322
    - Emory Pulmonary Function Tedt Lab
  - Atlanta, Georgia, United States, 30324
    - Emory Pulmonary Group (PFT only)
  - Atlanta, Georgia, United States, 30342
    - Atlanta Gastroenterology Associates (Endoscopy Location)
  - Atlanta, Georgia, United States, 30342
    - Atlanta Gastroenterology Associates (Screening and Recruitment)
  - Atlanta, Georgia, United States, 30342
    - Emory Saint Joseph Pulmonary Function Test Lab
  - Sandy Springs, Georgia, United States, 30328
    - Thomas Eye Group (OCT only)
- Illinois
  - Gurnee, Illinois, United States, 60031
    - Medical Eye Services LTD (Ophthalmoscopy with OCT)
  - Gurnee, Illinois, United States, 60031
    - Illinois Gastroenterology Group dba GI Alliance (Patients seen; IP Delivered)
  - Lake Bluff, Illinois, United States, 60044
    - North Shore Endoscopy Center (Endoscopy)
  - Libertyville, Illinois, United States, 60048
    - Libertyville Imaging Center (Diagnostic Imaging)
- Louisiana
  - Baton Rouge, Louisiana, United States, 70808
    - Eye Medical Center (OCT location)
  - Baton Rouge, Louisiana, United States, 70809
    - Baton Rouge LA Endoscopy
- Maryland
  - Chevy Chase, Maryland, United States, 20815
    - Chevy Chase Pulmonary Associate (PFT Only)
  - Chevy Chase, Maryland, United States, 20815
    - Retina Group Of Washington (OCT Only)
  - Chevy Chase, Maryland, United States, 20815
    - Friendship Heights Endoscopy Center (Endoscopy Facility Only)
- Missouri
  - Creve Coeur, Missouri, United States, 63141
    - Barnes-Jewish West County Hospital (Additional Endoscopy Location)
  - St Louis, Missouri, United States, 63110
    - Barnes-Jewish Hospital
  - St Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - St Louis, Missouri, United States, 63108
    - Washington University School of Medicine
- Nevada
  - Las Vegas, Nevada, United States, 89113
    - Durango Surgical Center
  - Las Vegas, Nevada, United States, 89148
    - Abrams Eye Institute (OCT)
  - Las Vegas, Nevada, United States, 89148
    - Lung Center of Nevada
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Durham, North Carolina, United States, 27704
    - Duke Medical Plaza North Duke Street
  - Durham, North Carolina, United States, 27710
    - Investigational Drug Services (Pharmacy)
  - Durham, North Carolina, United States, 27705
    - Duke Eye Center (OCT only)
  - Raleigh, North Carolina, United States, 27617
    - Brier Creek Medical Pavilion
- Ohio
  - Chardon, Ohio, United States, 44024
    - Geauga Sleep Center (PFT Only)
  - Cincinnati, Ohio, United States, 45219
    - UC Health Physicians Office
  - Cincinnati, Ohio, United States, 45229
    - UC Health (Pulmonary Function Testing)
  - Cincinnati, Ohio, United States, 45219
    - UC Health Hoxworth (OCT only)
  - Cincinnati, Ohio, United States, 45219
    - University of Cincinnati Medical Center (PFT and Endoscopy location)
  - Mentor, Ohio, United States, 44060
    - Great Lakes Gastroenterology Research, LLC
  - Mentor, Ohio, United States, 44060
    - The Endoscopy Center of Lake County
  - Mentor, Ohio, United States, 44060
    - Ophthalmic Physicians Incorporated (OCT Only)
  - Mentor, Ohio, United States, 44060
    - Vitreo Retinal Consultants (OCT only)
  - Willoughby Hills, Ohio, United States, 44094
    - Lake Pulmonary Associates (PFT only)
  - Willoughby Hills, Ohio, United States, 44094
    - Retina Specialist of Ohio (OCT only)
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Digestive Disease Specialists, Inc. Endoscopy Lab
  - Oklahoma City, Oklahoma, United States, 73112
    - Pulmonary Physicians of Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Retina Center of Oklahoma
- Pennsylvania
  - Camp Hill, Pennsylvania, United States, 17011
    - West Shore Endoscopy Center
  - Camp Hill, Pennsylvania, United States, 17011
    - Susquehanna Research Group
  - Harrisburg, Pennsylvania, United States, 17110
    - Susquehanna Research Group, LLC
  - Harrisburg, Pennsylvania, United States, 17111
    - Harrisburg Eye Associates (OCT only)
  - Harrisburg, Pennsylvania, United States, 17110
    - Farrell Ophthalmology (OCT only)
  - Harrisburg, Pennsylvania, United States, 17111
    - Medical Arts Allergy,PC (PFT Only)
  - Lemoyne, Pennsylvania, United States, 17043
    - Pulmonary and Critical Care Medicine Associates (PFT only)
- Texas
  - Arlington, Texas, United States, 76012
    - Texas Clinical Research Institute
  - Arlington, Texas, United States, 76012
    - Cross Timbers Surgery Center(Proctosigmoidoscopy)
  - Arlington, Texas, United States, 76012
    - Envision Imaging(Chest X-Ray)
  - Arlington, Texas, United States, 76012
    - Texas Pulmonary and Critical Care Associates(Pulmonary Function Test)
  - Arlington, Texas, United States, 76012
    - Texas Retina Associates(Ophthalmoscopy)
  - Baytown, Texas, United States, 77521
    - Inquest Clinical Research
  - Grapevine, Texas, United States, 76051
    - Texas Retina Associates (OCT Location)
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine- Baylor Medical Center
  - Houston, Texas, United States, 77004
    - Plaza Medical Center
  - Houston, Texas, United States, 77029
    - East Houston Physicians Group
  - Houston, Texas, United States, 77401
    - Cross Eye Center (Optical Coherence Tomography)
  - Keller, Texas, United States, 76248
    - Lonestar Endoscopy(Endoscopy Location)
  - New Braunfels, Texas, United States, 78130
    - Tyrus Schroeder (PFT)
  - New Braunfels, Texas, United States, 78130
    - Christus Santa Rosa Physicians Ambulatory Surgery Center New Braunfels (Endoscopy)
  - San Marcos, Texas, United States, 78666
    - Central Texas Eye Center (OCT)
  - San Marcos, Texas, United States, 78666
    - Christus Santa Rosa Physicians Ambulatory Surgery Center San Marcos (Endoscopy)
  - Southlake, Texas, United States, 76092
    - Lonestar Endoscopy (Endoscopy Location)
  - Southlake, Texas, United States, 76092
    - Envision Imaging (Chest X-ray location)
  - Tyler, Texas, United States, 75701
    - Christus Trinity Mother Frances Endosopy Center ( endoscopies only)
  - Tyler, Texas, United States, 75701
    - UT Health East Texas Physicians (pulmonary functions only)
  - Tyler, Texas, United States, 75701
    - Heaton Eye Associates (OCT only)
  - Tyler, Texas, United States, 75701
    - Touchstone Imaging Tyler (chest x-rays only)
  - Tyler, Texas, United States, 75701
    - Tyler Internal Medicine (PFT's only)
  - Victoria, Texas, United States, 77904
    - Gastro Health & Nutrition
- Virginia
  - Forest, Virginia, United States, 24551
    - Harman Eye Center (OCT only)
  - Lynchburg, Virginia, United States, 24502
    - Blue Ridge Medical Research
  - Lynchburg, Virginia, United States, 24501
    - Lynchburg Pulmonary Associates, Inc. (PFT only)
- Washington
  - Issaquah, Washington, United States, 98029
    - Swedish Endoscopy Center - Issaquah
  - Seattle, Washington, United States, 98122
    - Swedish Medical Center First Hill
  - Seattle, Washington, United States, 98104
    - Swedish Gastroenterology
  - Seattle, Washington, United States, 98122
    - Swedish Medical Center First Hill Endoscopy Center
  - Seattle, Washington, United States, 98104
    - Pacific Northwest Retina
  - Seattle, Washington, United States, 98104
    - Richard Bensinger, MD
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Froedtert Memorial Lutheran Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Etrasimod 2 mg	Drug: 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 Other Names: APD334

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Severity of Safety Measures Time Frame: Up to approximately 8 years	Safety as assessed by the evaluation of adverse events	Up to approximately 8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores Time Frame: Week 52 and Week 104		Week 52 and Week 104
Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry Time Frame: Week 52 and Week 104		Week 52 and Week 104
Change From Baseline in the Total Mayo Score Time Frame: Baseline, Week 52, and Week 104	The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 components (endoscopic score, rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.	Baseline, Week 52, and Week 104
Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores Time Frame: Week 52 and Week 104		Week 52 and Week 104
Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores Time Frame: Week 52 and Week 104		Week 52 and Week 104
Change From Baseline in Partial Mayo Score Time Frame: Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260	The partial Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 non-invasive components (rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.	Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260

Other Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Histologic Improvement Assessed by the Geboes, Robarts, and Nancy Histopathology Scores Time Frame: Week 52 and Week 104	Week 52 and Week 104
Percentage of Participants With Histologic Remission Assessed by the Geboes, Robarts, and Nancy Histopathology Scores Time Frame: Week 52 and Week 104	Week 52 and Week 104
Time to Loss of Response Assessed by Mayo Component Sub-scores Time Frame: Up to Week 260	Up to Week 260
Proportion of Participants Achieving Improvement in Extraintestinal Manifestations (EIMs) in Participants With EIMs at Baseline Time Frame: Baseline, Week 12, Week 52, Week 104, Week 156, Week 208, and Week 260	Baseline, Week 12, Week 52, Week 104, Week 156, Week 208, and Week 260

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Arena is a wholly owned subsidiary of Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Vermeire S, Rubin DT, Peyrin-Biroulet L, Dubinsky MC, Regueiro M, Irving PM, Goetsch M, Lazin K, Gu G, Wu J, Modesto I, McDonnell A, Guo X, Green J, Dalam AB, Yarur AJ. Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis. BMJ Open Gastroenterol. 2025 Jan 8;12(1):e001516. doi: 10.1136/bmjgast-2024-001516.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2019

Primary Completion (Estimated)

June 19, 2029

Study Completion (Estimated)

June 19, 2029

Study Registration Dates

First Submitted

May 13, 2019

First Submitted That Met QC Criteria

May 13, 2019

First Posted (Actual)

May 15, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

APD334-303
C5041012 (Other Identifier: Alias Study Number)
2024-515156-21-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Expanded Access

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

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Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Ulcerative Colitis

Clinical Trials on Etrasimod

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