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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified March 2026 by Pfizer
Sponsor
Pfizer
Information Provided by (Responsible Party)
Pfizer
Clinicaltrials.gov Identifier
NCT03950232
Other Study ID Numbers:
APD334-303
First Submitted
May 12, 2019
First Posted
May 14, 2019
Last Update Posted
April 26, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Ulcerative Colitis
Drug: Etrasimod

Study Design

Study TypeInterventional
Actual Enrollment896 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Study Start DateSeptember 4, 2019
Actual Primary Completion Date3yrs 1mo from now
Actual Study Completion Date3yrs 1mo from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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

Outcome Measures

Primary Outcome Measures
  1. Number and Severity of Safety Measures
    Safety as assessed by the evaluation of adverse events
Secondary Outcome Measures
  1. Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores
  2. Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry
  3. Change From Baseline in the Total Mayo Score
    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.
  4. Change From Baseline in Partial Mayo Score
    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.
  5. Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores
  6. Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsPfizer
Locations
Center for Digestive Health (Colonoscopy Location) | Dothan Alabama, United States, 36301Digestive Health Specialists (IP Address) | Dothan Alabama, United States, 36301Pulmonary Associates (Secondary PFT Location) | Dothan Alabama, United States, 36301Gut P.C., dba Digestive Health Specialists of the Southeast (IP Address) | Dothan Alabama, United States, 36305Inland Pulmonary Specialists [PFT Only] | Lake Elsinore California, United States, 92532A V Pediatrics,Allergy and Family Medicine | Lancaster California, United States, 93534Advanced Endoscopy and Pain Center(Colonoscopy) | Lancaster California, United States, 93534Antelope Valley Eye Care(Ophthalmologist) | Lancaster California, United States, 93534Jatinder S.Pruthi,MD FACG CPI | Lancaster California, United States, 93534Om Research LLC | Lancaster California, United States, 93534Renaissance Imaging Center(Chest X-Ray only) | Lancaster California, United States, 93534United Surgery Center Murrieta [Endoscopy Only] | Murrieta California, United States, 92562United Medical Doctors | Murrieta California, United States, 92563Advanced Imaging (Chest X-Ray) | Palmdale California, United States, 93551California Eye Professionals [OCT Only] | Temecula California, United States, 92591United Surgery Center Temecula [Endoscopy Only] | Temecula California, United States, 92592Front Range Endoscopy Center | Colorado Springs Colorado, United States, 80903Peak Gastroenterology Associates | Colorado Springs Colorado, United States, 80920Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test) | Clearwater Florida, United States, 33756West Coast Endoscopy Center (Endoscopy Procedures) | Clearwater Florida, United States, 33756Northwood Vision-Optical Coherence Tomography-(OCT) | Clearwater Florida, United States, 33761Safety Harbor Surgery (Endoscopy Facility) | Clearwater Florida, United States, 33761Gastro Florida (Regulatory & Administrative Duties) | Clearwater Florida, United States, 33762Gastro Florida-(Regulatory & Administrative Duties) | Clearwater Florida, United States, 33762West Coast Endoscopy Center (Endoscopy Procedures) | Clearwater Florida, United States, 33765Dr Lee Shettle | Largo Florida, United States, 33771Florida Center for Gastroenterology | Largo Florida, United States, 33771Tampa Bay Regional Surgery Center | Largo Florida, United States, 33771NSB Research | New Smyrna Beach Florida, United States, 32168Tampa Bay Endoscopy Center (ENDO Only) | Tampa Florida, United States, 33603Tampa Bay Endoscopy Center | Tampa Florida, United States, 33603Lab - Processing / Storage | Tampa Florida, United States, 33606USF Health South Tampa Center for Advanced Healthcare | Tampa Florida, United States, 33606Pulmonary and Sleep of Tampa Bay (PFT Only) | Tampa Florida, United States, 33607GCP Clinical Research,LLC | Tampa Florida, United States, 33609LoCicero Medical Group (PFT Procedure Only) | Tampa Florida, United States, 33609Lyracore Health Alliance (PFT Procedure only) | Tampa Florida, United States, 33609Newsome Eye Specialist (OCT Procedures Only) | Tampa Florida, United States, 33609USF Health Morsani Center For Advanced Healthcare | Tampa Florida, United States, 33612Guardian Angel Research Center, INC | Tampa Florida, United States, 33614Perez Eye Center (OCT only) | Tampa Florida, United States, 33614Florida Medical Clinic, LLC (Endoscopy) | Zephyrhills Florida, United States, 33542Florida Medical Clinic, LLC (OCT) | Zephyrhills Florida, United States, 33542Florida Medical Clinic, LLC (PFT) | Zephyrhills Florida, United States, 33542Florida Medical Clinic, LLC | Zephyrhills Florida, United States, 33542Emory Pulmonary Function Tedt Lab | Atlanta Georgia, United States, 30322Emory Pulmonary Group (PFT only) | Atlanta Georgia, United States, 30324Atlanta Gastroenterology Associates (Endoscopy Location) | Atlanta Georgia, United States, 30342Atlanta Gastroenterology Associates (Screening and Recruitment) | Atlanta Georgia, United States, 30342Atlanta Gastroenterology Associates(IP only) | Atlanta Georgia, United States, 30342Atlanta Gastroenterology Associates | Atlanta Georgia, United States, 30342Emory Saint Joseph Pulmonary Function Test Lab | Atlanta Georgia, United States, 30342Thomas Eye Group (OCT only) | Sandy Springs Georgia, United States, 30328Illinois Gastroenterology Group dba GI Alliance (Patients seen; IP Delivered) | Gurnee Illinois, United States, 60031Medical Eye Services LTD (Ophthalmoscopy with OCT) | Gurnee Illinois, United States, 60031North Shore Endoscopy Center (Endoscopy) | Lake Bluff Illinois, United States, 60044Libertyville Imaging Center (Diagnostic Imaging) | Libertyville Illinois, United States, 60048Eye Medical Center (OCT location) | Baton Rouge Louisiana, United States, 70808Our Lady of the Lake (PFT location) | Baton Rouge Louisiana, United States, 70808Baton Rouge LA Endoscopy | Baton Rouge Louisiana, United States, 70809Chevy Chase Pulmonary Associate (PFT Only) | Chevy Chase Maryland, United States, 20815Friendship Heights Endoscopy Center (Endoscopy Facility Only) | Chevy Chase Maryland, United States, 20815Retina Group Of Washington (OCT Only) | Chevy Chase Maryland, United States, 20815Barnes-Jewish West County Hospital (Additional Endoscopy Location) | Creve Coeur Missouri, United States, 63141Washington University School of Medicine | St Louis Missouri, United States, 63108Barnes-Jewish Hospital | St Louis Missouri, United States, 63110Washington University School of Medicine | St Louis Missouri, United States, 63110Durango Surgical Center | Las Vegas Nevada, United States, 89113Abrams Eye Institute (OCT) | Las Vegas Nevada, United States, 89148Lung Center of Nevada | Las Vegas Nevada, United States, 89148Duke Medical Plaza North Duke Street | Durham North Carolina, United States, 27704Duke Eye Center (OCT only) | Durham North Carolina, United States, 27705Duke University Medical Center | Durham North Carolina, United States, 27710Investigational Drug Services (Pharmacy) | Durham North Carolina, United States, 27710Brier Creek Medical Pavilion | Raleigh North Carolina, United States, 27617Geauga Sleep Center (PFT Only) | Chardon Ohio, United States, 44024UC Health Hoxworth (OCT only) | Cincinnati Ohio, United States, 45219UC Health Physicians Office | Cincinnati Ohio, United States, 45219University of Cincinnati Medical Center (PFT and Endoscopy location) | Cincinnati Ohio, United States, 45219UC Health (Pulmonary Function Testing) | Cincinnati Ohio, United States, 45229Great Lakes Gastroenterology Research, LLC | Mentor Ohio, United States, 44060Ophthalmic Physicians Incorporated (OCT Only) | Mentor Ohio, United States, 44060The Endoscopy Center of Lake County | Mentor Ohio, United States, 44060Vitreo Retinal Consultants (OCT only) | Mentor Ohio, United States, 44060Lake Pulmonary Associates (PFT only) | Willoughby Hills Ohio, United States, 44094Retina Specialist of Ohio (OCT only) | Willoughby Hills Ohio, United States, 44094Digestive Disease Specialists, Inc. Endoscopy Lab | Oklahoma City Oklahoma, United States, 73112Pulmonary Physicians of Oklahoma | Oklahoma City Oklahoma, United States, 73112Retina Center of Oklahoma | Oklahoma City Oklahoma, United States, 73112Susquehanna Research Group | Camp Hill Pennsylvania, United States, 17011West Shore Endoscopy Center | Camp Hill Pennsylvania, United States, 17011Farrell Ophthalmology (OCT only) | Harrisburg Pennsylvania, United States, 17110Susquehanna Research Group, LLC | Harrisburg Pennsylvania, United States, 17110Harrisburg Eye Associates (OCT only) | Harrisburg Pennsylvania, United States, 17111Medical Arts Allergy,PC (PFT Only) | Harrisburg Pennsylvania, United States, 17111Pulmonary and Critical Care Medicine Associates (PFT only) | Lemoyne Pennsylvania, United States, 17043Cross Timbers Surgery Center(Proctosigmoidoscopy) | Arlington Texas, United States, 76012Envision Imaging(Chest X-Ray) | Arlington Texas, United States, 76012Texas Clinical Research Institute | Arlington Texas, United States, 76012Texas Pulmonary and Critical Care Associates(Pulmonary Function Test) | Arlington Texas, United States, 76012Texas Retina Associates(Ophthalmoscopy) | Arlington Texas, United States, 76012Inquest Clinical Research | Baytown Texas, United States, 77521Texas Retina Associates (OCT Location) | Grapevine Texas, United States, 76051Plaza Medical Center | Houston Texas, United States, 77004East Houston Physicians Group | Houston Texas, United States, 77029Baylor College of Medicine- Baylor Medical Center | Houston Texas, United States, 77030Cross Eye Center (Optical Coherence Tomography) | Houston Texas, United States, 77401Lonestar Endoscopy(Endoscopy Location) | Keller Texas, United States, 76248Christus Santa Rosa Physicians Ambulatory Surgery Center New Braunfels (Endoscopy) | New Braunfels Texas, United States, 78130Tyrus Schroeder (PFT) | New Braunfels Texas, United States, 78130Central Texas Eye Center (OCT) | San Marcos Texas, United States, 78666Christus Santa Rosa Physicians Ambulatory Surgery Center San Marcos (Endoscopy) | San Marcos Texas, United States, 78666Envision Imaging (Chest X-ray location) | Southlake Texas, United States, 76092Lonestar Endoscopy (Endoscopy Location) | Southlake Texas, United States, 76092Christus Trinity Mother Frances Endosopy Center ( endoscopies only) | Tyler Texas, United States, 75701Heaton Eye Associates (OCT only) | Tyler Texas, United States, 75701Touchstone Imaging Tyler (chest x-rays only) | Tyler Texas, United States, 75701Tyler Internal Medicine (PFT's only) | Tyler Texas, United States, 75701UT Health East Texas Physicians (pulmonary functions only) | Tyler Texas, United States, 75701Gastro Health & Nutrition | Victoria Texas, United States, 77904Harman Eye Center (OCT only) | Forest Virginia, United States, 24551Lynchburg Pulmonary Associates, Inc. (PFT only) | Lynchburg Virginia, United States, 24501Blue Ridge Medical Research | Lynchburg Virginia, United States, 24502Swedish Endoscopy Center - Issaquah | Issaquah Washington, United States, 98029Pacific Northwest Retina | Seattle Washington, United States, 98104Richard Bensinger, MD | Seattle Washington, United States, 98104Swedish Gastroenterology | Seattle Washington, United States, 98104Swedish Medical Center First Hill Endoscopy Center | Seattle Washington, United States, 98122Swedish Medical Center First Hill | Seattle Washington, United States, 98122Froedtert Memorial Lutheran Hospital | Milwaukee Wisconsin, United States, 53226Centro de lnvestigation C.I .C.E. 9 de Julio | San Miguel de Tucumán Tucumán Province, Argentina, 4000Liverpool Hospital | Liverpool New South Wales, Australia, 2170Sunshine Coast University Private Hospital | Birtinya Queensland, Australia, 4575Sullivan Nicolaides Pathology | Bowen Hills Queensland, Australia, 4006Buderim Eye Centre( OCT and Ophthalmoscopy Facility) | Buderim Queensland, Australia, 4556Coral Sea Clinical Research Institute Pty.Ltd | Mackay Queensland, Australia, 4740Dr Shiran DeSilva Respiratory Clinic | Mackay Queensland, Australia, 4740Mater Misericordiae Hospital | Mackay Queensland, Australia, 4740Queensland X-Ray | Mackay Queensland, Australia, 4740Vision Eye Institute Mackay | Mackay Queensland, Australia, 4740Coastal Digestive Helath Pty. Ltd | Maroochydore Queensland, Australia, 4558Dr Pranav Kumar (PFT Facility) | North Mackey Queensland, Australia, 4740Austin Health | Heidelberg Victoria, Australia, 3084The Alfred Hospital | Melbourne Victoria, Australia, 3004Sunshine Coast Respiratory and Sleep (PFT Facility) | Birtinya , Australia, 4575Queensland Medical Laboratory (QML) pathology, QML Buderim Laboratory - Healius Pathology Pty Ltd | Buderim , Australia, 4556Department of Internal Medicine III, Clinical Division of Gastroenterology and Hepatology | Vienna , Austria, 1090Foreign Medical and Pharmaceutical Unitary Enterprise "Medical Center" Novoe Zrenie" | Grodno , Belarus, 230023Health Care Institution "City Clinical Hospital #4 Grodno" | Grodno , Belarus, 230026Healthcare Institution "Grodno University Hospital" | Grodno , Belarus, 230030Institution "Gomel Regional Specialized Clinical Hospital" | Homyel , Belarus, 246027Institution "Gomel Regional Clinical Hospital | Homyel , Belarus, 246029Health care Institution "10th City Clinical Hospital" | Minsk , Belarus, 220096Educational Establishment "Vitebsk State Medical University" | Vitebsk , Belarus, 210009Health care Institution "Vitebsk Regional Clinical Hospital" | Vitebsk , Belarus, 210037Healthcare Institution: Vitebsk Regional Clinical Specialized Center | Vitebsk , Belarus, 210604Hospital AZ Sint-Lucas | Ghent , Belgium, 9000AZ Delta campus Brugsesteenweg | Roeselare , Belgium, 8800AZ Delta | Roeselare , Belgium, 8800"UMHAT "Kanev"" AD, Ruse | Rousse , Bulgaria, 7002Diagnostic-Consultative Center I - Sliven, EOOD | Sliven , Bulgaria, 8800Acibadem City Clinic Tokuda Hospital EAD | Sofia , Bulgaria, 1407Acibadem City clinic University Hospital EOOD | Sofia , Bulgaria, 1407"DCC Alexandrovska", EOOD | Sofia , Bulgaria, 1431UMHAT "Sv. Ivan Rilski" EAD' | Sofia , Bulgaria, 1431UMHAT "Tsaritsa Yoanna - ISUL" EAD | Sofia , Bulgaria, 1527"University multiprofile hospital for active treatment and emergency medicine N.I. Pirogov"EAD | Sofia , Bulgaria, 1606Diagnostic Consultation Center CONVEX EOOD | Sofia , Bulgaria, 1680Medical Centre MEDICA Plus OOD | Veliko Tarnovo , Bulgaria, 5000Mount Sinai Hospital | Toronto Ontario, Canada, M5G 1X5Clinical Research Chile | Valdivia Los Ríos Region, Chile, General Hospital Zadar | Zadar , Croatia, 23000University Hospital Center Zagreb | Zagreb , Croatia, 10000Fakultni nemocnice u svate Anny v Brne | Brno , Czechia, 656 91Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové , Czechia, 500 12GASTRO JeKa, s.r.o. | Klatovy , Czechia, 339 01PreventaMed s.r.o. | Olomouc , Czechia, 779 00Fakultni nemocnice Ostrava | Ostrava-Poruba , Czechia, 708 52Axon Clinical, s.r.o. | Prague , Czechia, 150 00Nemocnice Na Bulovce | Prague , Czechia, 180 81ISCARE a.s. | Prague , Czechia, 190 00Nemocnice Slany | Slaný , Czechia, 274 01Aalborg University Hospital, department of medical gastroenterology, | Aalborg , Denmark, 9000Herlev Hospital, Stomach, -Bowel and Liver disease, Clinic 1 | Herlev , Denmark, 2730Innomedica OÜ | Tallinn Harju, Estonia, 10117OCT: Eye Clinic Dr. Krista Turman | Tallinn , Estonia, 10120DLCO: East Tallinn Central Hospital | Tallinn , Estonia, 10138West Tallinn Central Hospital | Tallinn , Estonia, 10617Endoscopy: North Estonia Medical Centre Foundation | Tallinn , Estonia, 13149North Estonia Medical Centre Foundation | Tallinn , Estonia, 13419CHU Amiens Picardie | Amiens , France, 80054Endoscopy: CHU Amiens-Picardie | Amiens , France, 80054Pulmonary examination: CHU Amiens-Picardie | Amiens , France, 80054Tomography: CHU Amiens-Picardie | Amiens , France, 80054CHU Grenoble Alpes -Hopital Michallon | Grenoble , France, 38043Endoscopy: CHU Grenoble Alpes- Hopital Michallon | Grenoble , France, 38043Pulmonary examination: CHU Grenoble Alpes - Hopital Michallon | Grenoble , France, 38043Tomography: CHU Grenoble Alpes - Hopital Michallon | Grenoble , France, 38043CHU Montpellier Hopital Saint-Eloi | Montpellier , France, 34295Endoscopy: Hopital Saint-Eloi | Montpellier , France, 34295Pulmonary examination: Hopital Arnaud de Villeneuve | Montpellier , France, 34295CHU Hotel Dieu | Nantes , France, 44093CHU de Nice - Hopital de l'Archet 2 | Nice , France, 06202CHU de Toulouse-Hopital Rangueil | Toulouse , France, 31059Tomography: CHU RANGUEIL | Toulouse , France, 31059LLC Todua Clinic | Tbilisi , Georgia, 0112Israeli-Georgian Medical Research Clinic Helsicore, LTD | Tbilisi , Georgia, 0119LLC Todua Clinic | Tbilisi , Georgia, 0119LLC Vivamedi | Tbilisi , Georgia, 0131JSC Infectious Diseases, AIDS and Clinical Immunology Research Center | Tbilisi , Georgia, 0159LTD Institute of Clinical Cardiology | Tbilisi , Georgia, 0159Medical Center CITO LTD | Tbilisi , Georgia, 0159LTD Academician Nikoloz Kipshidze Central University Clinic | Tbilisi , Georgia, 0160LTD Aversi Clinic | Tbilisi , Georgia, 0160Malkhaz Katsiashvili Multiprofile Emergency Medicine Center, LTD | Tbilisi , Georgia, Charite Universitaetsmedizin Berlin - Campus Charite Mitte Medizinische Klinik m. S. Hepatologie | Berlin , Germany, 10117Dr. med Zacharias A. R.Sherif | Berlin , Germany, 14163Krankenhaus Waldfriede e.V., | Berlin , Germany, 14163Schwerpunktpraxis Bonn | Bonn-Duisdorf , Germany, 53123Johanna-Etienne-Krankenhaus | Neuss , Germany, 41462OCT address: AOZNeuss Dr. Kersten | Neuss , Germany, 41462Praxis Dr. Jorgensen | Remscheid , Germany, 42859Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia | Gyula Bekes County, Hungary, 5600Ophthalmology tests:Bekes Megyei Kozponti Korhaz, Pady Kalman Tagkorhaz, Szemeszeti Osztaly | Gyula Bekes County, Hungary, 5700Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Székesfehérvár Fejér, Hungary, 8000Clinfan Szolgaltato Kft. | Szekszárd Tolna County, Hungary, 7100Ophthalmology tests: Tolna Megyei Balassa Janos Korhaz | Szekszárd Tolna County, Hungary, 7100Endoscopy: Magyar Imre Korhaz | Ajka Veszprém megye, Hungary, 8400DRC Gyogyszervizsgalo Kozpont Kft. | Balatonfüred Veszprém megye, Hungary, 8230Pulmonary function tests, endoscopy: Deak Jeno Korhaz | Tapolca Veszprém megye, Hungary, 8300Pulmonary function tests: Vasutegeszsegugyi Nonprofit Kozhasznu Kft. | Budapest , Hungary, 1062Ophthalmology tests: Magyar Honvedseg Egeszsegugyi Kozpont | Budapest , Hungary, 1068Semmelweis Egyetem | Budapest , Hungary, 1088Pannonia Maganorvosi Centrum | Budapest , Hungary, 1136Gyöngyösi Bugát Pál Kórház | Gyöngyös , Hungary, 3200Ophthalmology tests: RETINASZERVIZ Kft. | Veszprém , Hungary, 8230Sids Hospital & Research Centre | Surat Gujarat, India, 395002Surat Institute of Digestive Sciences | Surat Gujarat, India, 395002Fortis Memorial Research Institute | Gurgaon Haryana, India, 122002Midas Multispeciality Hospital Pvt. Ltd | Nagpur Maharashtra, India, 440010Grant Medical Foundation Ruby Hall Clinic | Pune Maharashtra, India, 411001S.R.Kalla Memorial Gastro & General Hospital | Jaipur Rajasthan, India, 302001Post Graduate Department Of Medicine | Kanpur Uttar Pradesh, India, 208002Government Medical College & Super Speciality Hospital | Nagpur , India, 440009Bnai Zion Medical Center | Haifa , Israel, 3104802, POB 4940Shaare Zedek Medical Center | Jerusalem , Israel, 9103102Galilee Medical Center | Nahariya , Israel, 2210001Rabin Medical Center | Petah Tikva , Israel, 4941492The Chaim Sheba Medical Center | Ramat Gan , Israel, 5262000Kaplan Medical Center | Rehovot , Israel, 7661041I.R.C.C.S "Saverio De Bellis", Gastroenterologia II | Castellana Grotte BARI, Italy, 70013Spedali Civili di Brescia, U.O. Gastroenterologia | Brescia Lombardy, Italy, 25123IRCCS Ospedale San Raffaele, Oculistica | Milan Lombardy, Italy, 20132I.R.C.C.S Policlinico San Donato | San Donato Milanese Milano, Italy, 20097ASST Rhodense - U.O.C. di Gastroenterologia ed Endoscopia Digestiva | Rho Milan, Italy, 20017A.O.U. Policlinico di Modena | Modena Reggio Emilia, Italy, 41124Azienda Ospedaliero Universitaria Careggi, U.O. Gastroenterologia 2 (St.19) | Florence Tuscany, Italy, 50134Ospedale Sacro Cuore Don Calabria | Negrar(vr) VR, Italy, 37024Azienda Ospedalieria Ospedale Cannizzaro | Catania , Italy, 95100Azienda Ospedaliero Universitaria Mater Domini | Catanzaro , Italy, 88100IRCCS Ospedale San Raffaele UO di Gastroenterologia e Endoscopia Digestiva | Milan , Italy, 20132U.O.C. Gastroenterologia ed Endoscopia Digestiva | Roma , Italy, 00157Fondazione Policlinico Universitario Agostino Gemelli IRCCS -CEMAD -UOC di Medicina lnterna e Gastro | Roma , Italy, 00168Kojunkai Daido Clinic | Nagoya Aichi-ken, Japan, 457-8511Toyohashi Municipal Hospital | Toyohashi Aichi-ken, Japan, 441-8570Tsujinaka Hospital Kashiwanoha | Kashiwa-shi Chiba, Japan, 277-0871Ishii Eye Clinic | Nagareyama-shi Chiba, Japan, 270-0116Toho University Sakura Medical Center | Sakura Chiba, Japan, 285-8741Fukuoka University Hospital | Fukuoka Fukuoka, Japan, 814-0180Fukuoka Tokushukai Hospital | Kasuga Fukuoka, Japan, 816-0864Takimoto Eye Clinic(OCT) | Kasuga-shi Fukuoka, Japan, 816-0863Japan Community Health Care Organization Kyushu Hospital | Kitakyushu Fukuoka, Japan, 806-8501Koyanose Eye Clinic | Kitakyushu-shi Fukuoka, Japan, 807-1266Our Lady of the Snow St. Mary's Hospital | Kurume Fukuoka, Japan, 830-8543Fukuoka Shinmizumaki Hospital | Onga-gun Fukuoka, Japan, 807-0051Gifu University Hospital | Gifu Gifu, Japan, 501-1194SUBARU Health Insurance Society Ota Memorial Hospital | Ota-shi Gunma, Japan, 373-8585National Hospital Organization Fukuyama Medical Center | Fukuyama Hiroshima, Japan, 720-8520Nakayama EYE Clinic | Fukuyama-shi Hiroshima, Japan, 720-0822Hiroshima University Hospital | Hiroshima Hiroshima, Japan, 734-8551Asahikawa City Hospital | Asahikawa-shi Hokkaido, Japan, 070-8610Tokushukai Sapporo Tokushukai Hospital | Sapporo Hokkaido, Japan, 004-0041NHO Mito Medical Center | Higashiibaraki-gun Ibaraki, Japan, 311-3193Matsumoto Eye Clinic | Toride-shi Ibaraki, Japan, 302-0014NHO Kanazawa Medical Center | Kanazawa Ishikawa-ken, Japan, 920-8650Iwate Medical University Uchimaru Medical Center | Morioka Iwate, Japan, 020-8505Kagawa Prefectural Central Hospital | Takainatsu-shi Kagawa-ken, Japan, 760-8557Takamatsu Red Cross Hospital | Takamatsu Kagawa-ken, Japan, 760-0017JA- Kagoshima Koseiren Hospital (PET/DLCO) | Kagoshima Kagoshima-ken, Japan, 890-0062Jiaikai Idzuro Imamura Hospital | Kagoshima Kagoshima-ken, Japan, 892-0824Sameshima Eye Clinic (OCT) | Kagoshima Kagoshima-ken, Japan, 892-0825Sameshima Hospital | Kagoshima Kagoshima-ken, Japan, 892-0846Sagamihara Kyodo Hospital | Sagamihara Kanagawa, Japan, 252-5188Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital | Yokohama Kanagawa, Japan, 234-0054Japanese Red Cross Kumamoto Hospital | Kumamoto Kumamoto, Japan, 861-8520University Hospital Kyoto Prefectural University of Medicine | Kyoto Kyoto, Japan, 602-8566National Hospital Organization Kyoto Medical Center | Kyoto Kyoto, Japan, 612-8555Mie University Hospital | Tsu Mie-ken, Japan, 514-8507Hinaga Nishi Ophthalmology Clinic | Yokkaichi- Shi Mie-ken, Japan, 510-0891Mie Prefectural General Medical Center | Yokkaichi-shi Mie-ken, Japan, 510-8561JOHAS Tohoku Rosai Hospital | Sendai Miyagi, Japan, 981-8563Sendai City Hospital | Sendai Miyagi, Japan, 982-8502Nagaoka Red Cross Hospital | Nagaoka-shi Niigata, Japan, 940-2085Kansai Medical University Hospital | Hirakata-shi Osaka, Japan, 573-1191Japan Community Health care Organization Osaka Hospital | Osaka Osaka, Japan, 553-0003Hamamatsu University Hospital | Hamamatsu Shizuoka, Japan, 431-3192Matsuda Hospital | Hamamatsu Shizuoka, Japan, 432-8061Hamamatsu Medical Center | Hamamatsu Shizuoka, Japan, 432-8580St. Luke's International Hospital | Chuo-ku Tokyo, Japan, 104-8560Teikyo University Hospital | Itabashi-ku Tokyo, Japan, 173-8606Showa General Hospital | Kodaira-shi Tokyo, Japan, 187-8510Kitasato University Kitasato Institute Hospital | Minato-ku Tokyo, Japan, 108-8642JCHO Tokyo Yamate Medical Center | Shinjuku-ku Tokyo, Japan, 169-0073Wakayama Medical University Hospital | Wakayama Wakayama, Japan, 641-8510Yamanashi Prefectural Central Hospital | Kofu Yamanashi, Japan, 400-8506Fukushima Medical University Hospital | Fukushima , Japan, 960-1295NHO Osaka National Hospital | Osaka , Japan, 540-0006Saga University Hospital | Saga , Japan, 849-8501P. Stradins Clinical University Hospital, Gastroenterology, Hepatology and Nutrition Therapy Center | Riga , Latvia, LV-1002American University of Beirut Medical Center | Beirut , Lebanon, Consultancy Polyclinic of Republican Panevezys Hospital | Panevezys , Lithuania, LT-35144Republican Panevezys Hospital | Panevezys , Lithuania, LT-35144UAB "Northway", Medical and Surgical Centre | Vilnius , Lithuania, 08234UAB "Inlita", Santaros Clinical Trials Centre | Vilnius , Lithuania, 08406Vilnius University Hospital Santaros Klinikos | Vilnius , Lithuania, 08661Vilnius University Hospital Santaros Klinikos | Vilnius , Lithuania, LT-08661Centro de lnvestigacion Medico Biologica y Terapia Avanzada S.C. | Guadalajara Jalisco, Mexico, 44130Servicios Medicos y de lnvestigacion Clinica Inspirepharma S. de R.L. de C.V. | Monterrey Nuevo León, Mexico, 64660Scientia, Investigacion Clinica S.C. | Chihuahua City , Mexico, 31203Scientia Investigación Clínica S.C | Chihuahua City , Mexico, 31207Invesclinic MX | Irapuato , Mexico, 36520FAICIC S. de R.L. de C.V. | Veracruz , Mexico, 91900Servicios Medicos y de lnvestigacion Clinica Inspirepharma S. de R.L. de C.V. | Veracruz , Mexico, 91900IMSP Institutul de Ftiziopneumologie "Chiril Draganiuc" | Chisinau , Moldova, 2025IMSP Spitalul Clinic Republican "Timofei Mosneaga" | Chisinau , Moldova, 2025ISMP Spitalul Clinic Republican "Timofei Mosneaga", RTL SM | Chisinau , Moldova, 2025Spitalul Polivalent Novamed | Chisinau , Moldova, 2038NSZOZ Termedica - Centrum Badan Klinicznych | Poznan Greater Poland Voivodeship, Poland, 60-681Penta Hospitals Przychodnie | Wroclaw Other, Poland, 54-239Centrum Dentystyczno-Lekarskie PROMEDICA Joanna Markiewicz | Będzin , Poland, 42-500Centrum Medycyny Oddechowej, Mroz Spolka Jawna (PFT, DLCO) | Bialystok , Poland, 15-044Gastromed Kralisz, Romatowski, Stachurska sp.j. | Bialystok , Poland, 15-322LSSP Eskulap (OCT, Ophthalmoscopy) | Bialystok , Poland, 15-453Dobry Wzrok (OCT) | Gdansk , Poland, 80-402Poradnia Pulmonologiczna | Gdynia , Poland, 81-366Karkonoskie Centrum Badan Klinicznych - Lexmedica Spolka z ograniczona odpowiedzialnoscia | Jelenia Góra , Poland, 58-500PROMED Centrum Medyczne (OCT, ophthalmoscopy) | Jelenia Góra , Poland, 58-506IP Clinic Sp. z o.o. | Lodz , Poland, 90-752Allmedica Badania Kliniczne Sp. z o.o. Sp. k. | Nowy Targ , Poland, 34-400MEDICOME Sp. z o.o. | Oświęcim , Poland, 32-600Centrum Medyczne MEDYK | Rzeszów , Poland, 35-326ENDOSKOPIA Sp. z o.o. | Sopot , Poland, 81-756Kiepury Clinic Malgorzata Jarnot Specjalistyczna Praktyka Ginekologiczno | Sosonowiec , Poland, 41-209DC-MED Sp. z o.o. | Swidnica , Poland, 58-100Twoja Przychodnia-Szczecinskie Centrum Medyczne | Szczecin , Poland, 71-434Centrum Zdrowia MDM | Warsaw , Poland, 00-635Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji | Warsaw , Poland, 02-507Centrum Medyczne Oporow | Wroclaw , Poland, 52-416Amicare Sp. z o.o. Sp.k. | Lodz Łódź Voivodeship, Poland, 91-495Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE | Vila Nova de Gaia Porto District, Portugal, 4434-502Centro Hospitalar e Universitario de Coimbra, EPE | Coimbra , Portugal, 3000-075Hospital Senhora da Oliveira Guimaraes, E.P.E | Guimarães , Portugal, 4835-044Centro Hospitalar Universitario de Sao Joao, E.P.E | Porto , Portugal, 4200-319SC Pelican lmpex SRL | Oradea Bihor County, Romania, 410469Oculens Med S.R.L. | Cluj-Napoca Cluj, Romania, 400501Spitalul Clinic Judetean de Urgenta Cluj-Napoca | Cluj-Napoca JUD. CLUJ, Romania, 400006S.C. Euroclinic Hospital S.A. | Bucharest , Romania, 014461Spitalul de Oncologie Monza | Bucharest , Romania, 13823Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca | Cluj-Napoca , Romania, 400371LLC "Multidisciplinary Medical Clinic "Anturium" | Barnaul Altayskiy Kray, Russia, 656043LLC Medical Company "Hepatologist" | Samara Samara Oblast, Russia, 443063LLC "Polyclinic of ultrasonography 4D" | Pyatigorsk Stavropol Kray, Russia, 357500Irkutsk State Medical Academy of Postgraduate Education | Irkutsk , Russia, 664049Professional Education" of MoH of RF | Irkutsk , Russia, 664049LLC "Alliance Biomedical -Ural Group" | Izhevsk , Russia, 426061SAIH "Kemerovo Regional Clinical Hospital" | Kemerovo , Russia, 650066State Budgetary Healthcare Instit. of Nizhniy Novgorod region | Nizhny Novgorod , Russia, 603126LLC "SibNovoMed" | Novosibirsk , Russia, 630005LLC "Novosibirsk GastroCenter" | Novosibirsk , Russia, 630007State Budgetary Healthcare Institution of Novosibirsk region "City clinical hospital # 12" | Novosibirsk , Russia, 630084Medical center "AVITSENNA" | Novosibirsk , Russia, 63009Clinicodiagnostic center "Ultramcd" | Omsk , Russia, 644024State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko" | Penza , Russia, 440026Federal State Budgetary Ed. Inst. of Higher Education "North-Western Medical University n.a. I.I. | Saint Petersburg , Russia, 191015FSBEI of Higher Education "North-Western State Medical University n.a. I.I. Mechnikov" of MoH RF | Saint Petersburg , Russia, 191015Spb SBIH "City Mariinskaya Hospital" | Saint Petersburg , Russia, 194104LLC "Medi com" (SM-Clinic) | Saint Petersburg , Russia, 195279FSBEI of Higher Education "First Saint Petersburg State Medical University n.a. I.P. Pavlov" | Saint Petersburg , Russia, 197022LLC "Gastroenterological centre Expert" | Saint Petersburg , Russia, 197110St.Petersburg State Budgetary Healthcare Institution "City Hospital #40 of Kurortnyi region" | Saint Petersburg , Russia, 197706Private Educational Institution of Higher Education "Medical University "Reaviz", Multifield Clinic | Samara , Russia, 443001LLC Medical company "Hepatologist" | Samara , Russia, 443093Autonomous Noncommercial Medical Organizations "Stavropol Regional Clinical Diagnostic Centre'' | Stavropol , Russia, 355017Autonomous Noncommercial Medical Organizations " Stavropol Regional Clinical Diagnostic Centre '' | Stavropol , Russia, 355032City Polyclinic #9 | Stavropol , Russia, 355044State Healthcare Institution of Yaroslavl Region "Clinical Hospital No 2" | Yaroslavl , Russia, 150030Clinical Center " Dr Dragisa Misovic-Dedinje" | Belgrade , Serbia, 11000Clinical Center Zvezdara | Belgrade , Serbia, 11000General Hospital Sremska Mitrovica | Sremska Mitrovica , Serbia, 22000Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica, II. Interna klinika SZU | Banská Bystrica , Slovakia, 97517ALIAN, s.r.o. | Bardejov , Slovakia, 08501GASTROMART s.r.o., Gastroenterologicka ambulancia | Bardejov , Slovakia, 085013F, s.r.o., Oftalmologicka ambulancia | Košice , Slovakia, 04011OCULOSANUS, s.r.o., Oftalmologicka ambulancia | Levice , Slovakia, 934 01MUDr. Michal Popovec, s.r.o., Oftalmologicka ambulancia | Lipany , Slovakia, 053 04KM Management, spol. s r.o .. Gastroenterologicke a hepatologicke centrum | Nitra , Slovakia, 94901Fakultna nemocnica Nitra, Oftalmologicka ambulancia | Nitra , Slovakia, 950 01Fakultna nemocnica Nitra, Pneumologicka ambulancia | Nitra , Slovakia, 950 01Fakultna nemocnica Nitra | Nitra , Slovakia, 950 01GASTRO I., s.r.o. Gastroenterologicka ambulancia | Prešov , Slovakia, 080 01PULMO, s.r.o., Plucna ambulancia | Prešov , Slovakia, 080 01Accout Center, s.r.o., Gastroenterologicka ambulancia | Šahy , Slovakia, 936 01COR, s.r.o., Pneumologicko-ftizeologicka ambulancia | Šahy , Slovakia, 936 01PULMOX spol. s r.o., Pneumologicko-ftizeologicka ambulancia | Vranov nad Topľou , Slovakia, 093 01Johese Clinical Research: Midstream | Centurion Gauteng, South Africa, 0157Johese Clinical Research:Unitas | Centurion Gauteng, South Africa, 0157Unitas Hospital | Centurion Gauteng, South Africa, 0157Dr John Philip Wright | Cape Town Western Cape, South Africa, 7708Dr Fritz Potgieter, Midstream Medi Clinic | Centurion , South Africa, 1692Yonsei University Wonju Severance Christian Hospital | Wŏnju Gangwon-do, South Korea, 26426Endoscopy Facility in The Catholic University of Korea, St. Vincent's Hospital | Suwon Gyeonggi-do, South Korea, 16247OCT Facility in The Catholic University of Korea, St. Vincent's Hospital | Suwon Gyeonggi-do, South Korea, 16247PFT Facility in The Catholic University of Korea, St. Vincent's Hospital | Suwon Gyeonggi-do, South Korea, 16247The Catholic University of Korea, St. Vincent's Hospital | Suwon Gyeonggi-do, South Korea, 16427Dong-A University Hospital | Busan , South Korea, 49201Endoscopy Facility in Kyungpook National University Chilgok Hospital | Daegu , South Korea, 41404Kyungpook National University Chilgok Hospital | Daegu , South Korea, 41404OCT Facility in Kyungpook National University Chilgok Hospital | Daegu , South Korea, 41404PFT Facility in Kyungpook National University Chilgok Hospital | Daegu , South Korea, 41404Kyungpook National University Hospital | Daegu , South Korea, 41944HOSPITAL GENERAL UNIVERSITARIO de Alicante | Alicante Valencia, Spain, 03010Hospital Universitario la Paz | Madrid , Spain, 28046Siriraj Hospital, Mahidol University | Bangkoknoi Bangkok, Thailand, 10700Chulalongkorn University, King Chulalongkorn Memorial Hospital | Bangkok , Thailand, 10330Hacettepe University Medical Faculty | Ankara , Turkey (Türkiye), 06100Gazi University Medical Faculty | Ankara , Turkey (Türkiye), 06500Gazi University Medical Faculty | Ankara , Turkey (Türkiye), 06560Saglik Bilimleri Universitesi Antalya Egitim ve Arastirma Hastanesi | Antalya , Turkey (Türkiye), 07030Uludag University Medical Faculty | Bursa , Turkey (Türkiye), 16059Kocaeli University Medical Faculty | Kocaeli , Turkey (Türkiye), 41380Communal Institution I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital, Department of | Dnipro , Ukraine, 49005Communal Non-commercial Enterprise Regional Clinical Hospital of lvano-Frankivsk Regional Council, | Ivano-Frankivsk , Ukraine, 76000Municipal Health Care "Kharkiv City Hospital Ambulance and Emergency Medical care named alter prof. | Kharkiv , Ukraine, 61018Llc "Ldts-Skaymed" | Kharkiv , Ukraine, 61022LLC "EyeQClinic" | Kharkiv , Ukraine, 61024Communal Noncommercial Enterprise Prof. O.O.Shalimov City Clinical Hospital #2 of Kharkiv City | Kharkiv , Ukraine, 61037Llc Medical Center Oftalmika | Kharkiv , Ukraine, 61045Communal Noncommercial Enterprise City Clinical Hospital # 13 of Kharkiv City Council, | Kharkiv , Ukraine, 61124Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City | Kherson , Ukraine, 73000LLC "Diagnostic center" | Kherson , Ukraine, 73003Kyiv City Clinical Hosptial #1, Department of Clinical Research at the Special Fund | Kyiv , Ukraine, 02091Communal Noncommercial Enterprise Lviv Clinical Emergency Hospital, 1st Department of Therapy | Lviv , Ukraine, 79059Communal Institution Odesa Regional Clinical Hospital, Regional Center of Gastroenterology, | Odesa , Ukraine, 65025LLC GLB Clinik | Odesa , Ukraine, 65025Andrii Novak Transcarpathian Regional Clinical Hospital, Department of Gastroenterology | Uzhagorod , Ukraine, 88018Transcarpathian Center of Eye Microsurgery | Uzhhorod , Ukraine, 88017Medical Clinical Investigational Center of Med Center LLC Health Clinic, Unit of Gastroenterology, | Vinnytsia , Ukraine, 21009Communal Nonprofit Enterprise M.I.Pyrogov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional | Vinnytsia , Ukraine, 21018Scientific and Research Institute of Invalid Rehabilitation (Educational and Scientific Treatment | Vinnytsia , Ukraine, 21029Llc "Optimal M" | Vinnytsia , Ukraine, 21036Yeovil District Hospital NHS Foundation Trust | Yeovil Somerset, United Kingdom, BA21 4ATBarts Health NHS Trust - Whipps Cross University Hospital | London , United Kingdom, E11 1NRGuy's and St Thomas' NHS Foundation Trust | London , United Kingdom, SE1 9RT
Investigators
Study Director: Pfizer CT.gov Call Center, Pfizer