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

Ulcerative Colitis Clinical Trial

— ELEVATE UC OLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03950232
• Other study ID #: APD334-303
• Secondary ID: C5041012
• Status: Recruiting
• Phase: Phase 3
• Start date: September 5, 2019
• Est. completion date: July 21, 2026

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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]).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 912
• Est. completion date: July 21, 2026
• Est. primary completion date: July 21, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Argentina	Centro de lnvestigation C.I .C.E. 9 de Julio	San Miguel de Tucuman	Tucumán
Argentina	Centro Oftalmologico Lischinsky (Optical Coherence Tomography, Ophtalmoscopy)	San Miguel de Tucuman	Tucuman
Argentina	Instituto de Patologias Respitatorias (Pulmonary Function Test)	San Miguel de Tucuman	Tucuman
Argentina	Sanatorio 9 de Julio S.A. (Endoscopy)	San Miguel de Tucuman	Tucuman
Argentina	Sanatorio 9 de Julio S.A. (Exam Rooms)	San Miguel de Tucuman	Tucuman
Australia	Queensland Respiratory Services	Birtinya	Queensland
Australia	Sunshine Coast University Private Hospital	Birtinya	Queensland
Australia	Dr Mark De Wet	Buderim	Queensland
Australia	Austin Health	Heidelberg	Victoria
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Coral Sea Clinical Research Institute Pty.Ltd	Mackay	Queensland
Australia	Dr Shiran DeSilva Respiratory Clinic	Mackay	Queensland
Australia	Mackay Discount Drug Store	Mackay	Queensland
Australia	Mater Misericordiae Hospital	Mackay	Queensland
Australia	Queensland X-Ray	Mackay	Queensland
Australia	Vision Eye Institute Mackay	Mackay	Queensland
Australia	Coastal Digestive Helath Pty. Ltd	Maroochydore	Queensland
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Australia	Bankstown-Lidcombe Hospital	Sydney	New South Wales
Austria	Department of Internal Medicine III, Clinical Division of Gastroenterology and Hepatology	Vienna
Belarus	Institution "Gomel Regional Clinical Hospital	Gomel
Belarus	Institution "Gomel Regional Specialized Clinical Hospital"	Gomel
Belarus	Foreign Medical and Pharmaceutical Unitary Enterprise "Medical Center" Novoe Zrenie"	Grodno
Belarus	Health Care Institution "City Clinical Hospital #4 Grodno"	Grodno
Belarus	Healthcare Institution "Grodno University Hospital"	Grodno
Belarus	Health care Institution "10th City Clinical Hospital"	Minsk
Belarus	Educational Establishment "Vitebsk State Medical University"	Vitebsk
Belarus	Health care Institution "Vitebsk Regional Clinical Hospital"	Vitebsk
Belarus	Health Care Institution "Vitebsk Regional Clinical Hospital"	Vitebsk
Belarus	Healthcare Institution: Vitebsk Regional Clinical Specialized Center	Vitebsk
Belgium	Hospital AZ Sint-Lucas	Ghent
Belgium	AZ Delta	Roeselare
Belgium	AZ Delta campus Brugsesteenweg	Roeselare
Bulgaria	"UMHAT "Kanev"" AD, Ruse	Ruse
Bulgaria	Diagnostic-Consultative Center I - Sliven, EOOD	Sliven
Bulgaria	"DCC Alexandrovska", EOOD	Sofia
Bulgaria	"University multiprofile hospital for active treatment and emergency medicine N.I. Pirogov"EAD	Sofia
Bulgaria	Acibadem City Clinic Tokuda Hospital EAD	Sofia
Bulgaria	Acibadem City clinic University Hospital EOOD	Sofia
Bulgaria	Diagnostic Consultation Center CONVEX EOOD	Sofia
Bulgaria	UMHAT "Sv. Ivan Rilski" EAD'	Sofia
Bulgaria	UMHAT "Tsaritsa Yoanna - ISUL" EAD	Sofia
Bulgaria	Medical Centre MEDICA Plus OOD	Veliko Tarnovo
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario
Chile	Clinical Research Chile	Valdivia	Los Rios
Croatia	General Hospital Zadar	Zadar
Croatia	University Hospital Center Zagreb	Zagreb
Czechia	Gastroenterologicka ambulance, Nemocnice Boskovice	Boskovice
Czechia	Fakultni nemocnice u svate Anny v Brne	Brno
Czechia	MUDr. Jaroslava Skalova	Horazdovice
Czechia	Hepato-Gastroenterologie HK, s.r.o.	Hradec Kralove
Czechia	VISUS, spol.s.r.o.(OCT/ophtalmoscopy)	Hradec Kralove
Czechia	Gastro Jeka,s.r.o	Klatovy
Czechia	Klatovska nemocnice, a.s.	Klatovy
Czechia	Amulance alergologie a klinicke imunologie - MUDr. Pavlina Kazinotova, s.r.o.	Olomouc
Czechia	Endoskopicke pracoviste, Interni oddeleni	Olomouc
Czechia	Gastroenterologicka ordinace, MUDr. Pavla Skalova s.r.o., MUDr. Frantisek Sincl s.r.o.	Olomouc
Czechia	Gastroenterologie, MUDr. David Pridal	Olomouc
Czechia	Ocni ordinace Olomouc (OCT/ophtalmoscopy)	Olomouc
Czechia	PreventaMed s.r.o.	Olomouc
Czechia	Fakultni nemocnice Ostrava	Ostrava-Poruba
Czechia	Axon Clinical, s.r.o.	Praha 5
Czechia	Ocni centrum Praha,a.s.(OCT/ophtalmoscopy)	Praha 7
Czechia	Nemocnice Na Bulovce	Praha 8
Czechia	ISCARE a.s.	Praha 9
Czechia	Prvni plicni ambulance,s.r.o (PFT/DLCO)	Praha 9
Czechia	Gastroenterologicka ambulance, MUDr. Marcela Vyslouzilova	Prerov
Czechia	Gastroenterologicka ambulance, MUDr. Marcela Vyslouzilova	Prerov
Czechia	Gastroenterologie, MUDr. Michal Konecny, Ph.D., s.r.o.	Prerov
Czechia	Privatni gastroenterologicka ambulance s.r.o., MUDr. Zdenek Vlk	Prostejov
Czechia	Nemocnice Slany	Slany
Czechia	GASTRO-NELL s.r.o., MUDr. Vladimir Vaculin	Vsetin
Denmark	Aalborg University Hospital, department of medical gastroenterology,	Aalborg
Denmark	Herlev Hospital, Stomach, -Bowel and Liver disease, Clinic 1	Herlev
Estonia	DLCO: East Tallinn Central Hospital	Tallinn
Estonia	Endoscopy: North Estonia Medical Centre Foundation	Tallinn
Estonia	North Estonia Medical Centre Foundation	Tallinn
Estonia	OCT: Eye Clinic Dr. Krista Turman	Tallinn
Estonia	OU Innomedica	Tallinn
Estonia	West Tallinn Central Hospital	Tallinn
France	CHU Amiens Picardie	AMIENS Cedex 1
France	Endoscopy: CHU Amiens-Picardie	AMIENS Cedex 1
France	Pulmonary examination: CHU Amiens-Picardie	AMIENS Cedex 1
France	Tomography: CHU Amiens-Picardie	AMIENS Cedex 1
France	CHU Clermont Ferrand - Hopital Gabriel Montpied	Clermont-Ferrand
France	CHU Grenoble Alpes -Hopital Michallon	Grenoble cedex 9
France	Endoscopy: CHU Grenoble Alpes- Hopital Michallon	Grenoble Cedex 9
France	Pulmonary examination: CHU Grenoble Alpes - Hopital Michallon	Grenoble Cedex 9
France	Tomography: CHU Grenoble Alpes - Hopital Michallon	Grenoble Cedex 9
France	CHU de Lille - Hopital Claude Huriez	Lille
France	CHU de Lille - Hopital Claude Huriez	Lille Cedex
France	CHU Montpellier Hopital Saint-Eloi	Montpellier cedex 5
France	Endoscopy: Hopital Saint-Eloi	Montpellier cedex 5
France	Pulmonary examination: Hopital Arnaud de Villeneuve	Montpellier cedex 5
France	Tomography: Hopital Gui de Chauliac	Montpellier cedex 5
France	CHU Hotel Dieu	Nantes
France	Endoscopy: CHU Hotel Dieu	Nantes
France	Pulmonary examination: CHU Hotel Dieu	Nantes
France	Tomography: CHU Hotel Dieu	Nantes
France	CHU de Nice - Hopital de l'Archet 2	NICE cedex 03
France	Endoscopy: CHU de Nice - Hopital de I'Archet 2	NICE cedex 03
France	Pulmonary examination: CHU de Nice - Hopital de I'Archet 2	NICE cedex 03
France	Tomography: CHU de Nice - Hopital de I'Archet 2	NICE cedex 03
France	CHU RENNES - Hopital Pontchaillou	Rennes Cedex 09
France	Endoscopy: CHU RANGUEIL	Toulouse Cedex
France	Pulmonary examination: CHU RANGUEIL	Toulouse Cedex
France	Tomography: CHU RANGUEIL	Toulouse Cedex
France	CHU de Toulouse-Hopital Rangueil	Toulouse Cedex 09
Georgia	Aversi Clinic, LTD	Tbilisi
Georgia	Israeli-Georgian Medical Research Clinic Helsicore, LTD	Tbilisi
Georgia	JSC Infectious Diseases, AIDS and Clinical Immunology Research Center	Tbilisi
Georgia	LLC Todua Clinic	Tbilisi
Georgia	LLC Vivamedi	Tbilisi
Georgia	LTD Academician Nikoloz Kipshidze Central University Clinic	Tbilisi
Georgia	LTD Aversi Clinic	Tbilisi
Georgia	LTD Institute of Clinical Cardiology	Tbilisi
Georgia	Malkhaz Katsiashvili Multiprofile Emergency Medicine Center, LTD	Tbilisi
Georgia	Medical Center CITO LTD	Tbilisi
Germany	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. Studienambulanz lnnere Medizin	Berlin
Germany	Schwerpunktpraxis Bonn	Bonn-Duisdorf
Germany	Florence-Nightingale-Krankenhaus	Dusseldorf
Germany	Universitaetsklinikum Schleswig-Holstein	Kiel
Germany	Johanna-Etienne-Krankenhaus	Neuss
Germany	OCT address: AOZNeuss Dr. Kersten	Neuss
Germany	Praxis Dr. Jorgensen	Remscheid
Hungary	Endoscopy: Magyar Imre Korhaz	Ajka	Veszprem
Hungary	DRC Gyogyszervizsgalo Kozpont Kft.	Balatonfured	Veszprem
Hungary	Ophthalmology tests: Budapest Retina lntezet	Budapest
Hungary	Ophthalmology tests: Magyar Honvedseg Egeszsegugyi Kozpont	Budapest
Hungary	Pannonia Maganorvosi Centrum	Budapest
Hungary	Pulmonary function tests: Vasutegeszsegugyi Nonprofit Kozhasznu Kft.	Budapest
Hungary	Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika	Budapest
Hungary	Debreceni Egyetem, Belgyogyaszati Klinika, Gasztroenterologiai Osztaly	Debrecen	Hajdu-bihar
Hungary	Bugat Pal Korhaz	Gyongyos	Heves
Hungary	"Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia"	Gyula	Bekes
Hungary	Ophthalmology tests:Bekes Megyei Kozponti Korhaz, Pady Kalman Tagkorhaz, Szemeszeti Osztaly	Gyula	Bekes
Hungary	Ophthalmology tests:Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ,Szemészeti Kli	Szeged	Csongrad
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I .Belgyogyaszati Klinika	Szeged	Csongrad
Hungary	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Szekesfehervar	Fejer
Hungary	Clinfan Szolgaltato Kft.	Szekszard	Tolna
Hungary	Ophthalmology tests: Tolna Megyei Balassa Janos Korhaz	Szekszard	Tolna
Hungary	Pulmonary function tests, endoscopy: Deak Jeno Korhaz	Tapolca	Veszprem
Hungary	DLCO and Ophthalmology tests: Szent Borbala Korhaz	Tatabanya	Komarom-esztergom
Hungary	Ophthalmology tests: RETINASZERVIZ Kft.	Veszprem
India	Fortis Memorial Research Institute	Gurgaon	Haryana
India	S.R.Kalla Memorial Gastro & General Hospital	Jaipur	Rajasthan
India	Post Graduate Department Of Medicine	Kanpur	Uttar Pradesh
India	Government Medical College & Super Speciality Hospital	Nagpur
India	Midas Multispeciality Hospital Pvt. Ltd	Nagpur	Maharashtra
India	OCT- Drushti Eye clinic and squint centre	Nagpur	Maharashtra
India	PFT and Endoscopy- Midas Multispeciality Hospital Pvt. Ltd	Nagpur	Maharashtra
India	Grant Medical Foundation Ruby Hall Clinic	Pune	Maharashtra
India	Surat Institute of Digestive Sciences	Surat	Gujarat
Israel	Bnai Zion Medical Center	Haifa
Israel	Edith Wolfson Medical Center	Holon
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Galilee Medical Center	Naharya
Israel	Rabin Medical Center	Petah Tikva
Israel	The Chaim Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Rehovot
Italy	Spedali Civili di Brescia, U.O. Gastroenterologia	Brescia	Lombardia
Italy	I.R.C.C.S "Saverio De Bellis", Gastroenterologia II	Castellana Grotte	Bari
Italy	Azienda Ospedaliera Ospedale Cannizzaro	Catania
Italy	A.O. Mater Domini	Catanzaro	Calabria
Italy	Azienda Ospedaliero Universitaria Careggi, U.O. Gastroenterologia 2	Firenze	Toscana
Italy	Pneumology Unit - ASST Rhodense	Garbagnate Milanese	Other
Italy	IRCCS Ospedale San Raffaele UO di Gastroenterologia e Endoscopia Digestiva	Milan
Italy	IRCCS Ospedale San Raffaele, Oculistica	Milano	Lombardia
Italy	IRCCS Ospedale San Raffaele, Unita di Gastroenterologia	Milano	Milan
Italy	Ospedale San Raffaele	Milano	MI
Italy	A.O.U. Policlinico di Modena	Modena	Reggio Emilia
Italy	Ospedale Sacro Cuore Don Calabria	Negrar(vr)	VR
Italy	ASST Rhodense - U.O.C. di Gastroenterologia ed Endoscopia Digestiva	Rho	Milan
Italy	Policlinico Universitario Agostino Gemelli IRCCS -CEMAD -UOC di Medicina lnterna e Gastroenterologia	Roma	Lazio
Italy	U.O.C. Gastroenterologia ed Endoscopia Digestiva	Roma
Italy	I.R.C.C.S Policlinico San Donato	San Donato Milanese	Milano
Italy	Ospedale San Bortolo di Vicenza	Vicenza	Veneto
Japan	Asahikawa City Hospital	Asahikawa-shi	Hokkaido
Japan	Tokyo Medical And Dental University Hospital	Bunkyo-ku	Tokyo
Japan	St. Luke's International Hospital	Chuo-ku	Tokyo
Japan	Saiseikai Fukuoka General Hospital	Fukuoka
Japan	Fukuoka University Hospital	Fukuoka-shi	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	National Hospital Organization Fukuyama Medical Center	Fukuyama	Hiroshima
Japan	Gifu University Hospital	Gifu-shi	Gifu
Japan	Tokai University Hachioji Hospital	Hachioji	Tokyo
Japan	Hamamatsu University Hospital	Hamamatsu-shi	Shizuoka
Japan	Matsuda Hospital	Hamamatsu-shi	Shizuoka
Japan	NHO Mito Medical Center	Higashiibaraki-gun	Ibaraki
Japan	Kansai Medical University Hospital	Hirakata-city
Japan	Hirosaki University Hospital	Hirosaki-shi	Aomori KEN
Japan	NHO Hirosaki National Hospital	Hirosaki-shi	Aomori
Japan	Hiroshima University Hospital	Hiroshima-shi	Hiroshima
Japan	Hitachi Ltd. Hitachi General Hospital	Hitachi-shi	Ibaraki
Japan	Saitama Medical University Hospital	Iruma-gun	Saitama
Japan	Teikyo University Hospital	Itabashi-ku	Tokyo
Japan	Kagoshima University Hospital	Kagoshima
Japan	Clinical Pathology Laboratory (Diagnostick center)	Kagoshima-shi	Kagoshima
Japan	JA- Kagoshima Koseiren Hospital (PET/DLCO)	Kagoshima-shi	Kagoshima
Japan	Jiaikai Idzuro Imamura Hospital	Kagoshima-shi	Kagoshima
Japan	Kagoshima Kouseiren Hospital	Kagoshima-shi	Kagoshima
Japan	Sameshima Eye Clinic (OCT)	Kagoshima-shi	Kagoshima
Japan	Sameshima Hospital	Kagoshima-shi	Kagoshima
Japan	NHO Kanazawa Medical Center	Kanazawa-shi	Ishikawa
Japan	Tsujinaka Hospital Kashiwanoha	Kashiwa-shi	Chiba
Japan	Fukuoka Tokushukai Hospital Laboratory	Kasuga	Fukuoka
Japan	Takimoto Eye Clinic(OCT)	Kasuga-shi	Fukuoka
Japan	NHO Osaka Minami Medical Center	Kawachinagano	Osaka
Japan	Medical Corporation Tokushukai Kishiwada Tokushukai Hospital	Kishiwada-shi	Osaka
Japan	Japan Community Health Care Organization Kyushu Hospital	Kitakyushu	Fukuoka
Japan	Kitakyushu Municipal Medical Center	Kitakyushu-shi	Fukuoka
Japan	Showa General Hospital	Kodaira-shi	Tokyo
Japan	Yamanashi Prefectural Central Hospital	Kofu-shi	Yamanashi
Japan	Yuai Memorial Hospital	Koga-shi	Ibaraki
Japan	Japanese Red Cross Kumamoto Hospital	Kumamoto-shi	Kumamoto
Japan	Our Lady of the Snow St. Mary's Hospital	Kurume	Fukuoka
Japan	Kurume University Hospital	Kurume-shi	Fukuoka
Japan	Kokura Memorial Hospital	Kutakyushu-shi	Fukuoka
Japan	University Hospital Kyoto Prefectural University of Medicine	Kyoto
Japan	National Hospital Organization Kyoto Medical Center	Kyoto-shi	Kyoto
Japan	University Hospital Kyoto Prefectural University of Medicine	Kyoto-shi	Kyoto
Japan	Saiseikai Matsuyama Hospital	Matsuyama-shi	Ehime
Japan	Kitasato University Kitasato Institute Hospital	Minato-ku	Tokyo
Japan	Iwate Medical University Uchimaru Medical Center	Morioka-shi	Iwate
Japan	Aichi Medical University Hospital	Nagakute	Aichi
Japan	Nagaoka Red Cross Hospital	Nagaoka-shi	Niigata
Japan	Ishii Eye Clinic	Nagareyama-shi	Chiba
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	Kojunkai Daido Clinic	Nagoya-shi	Aichi-ken
Japan	Kojunkai Daido Hospital	Nagoya-shi	Aixhi-ken
Japan	Fukuoka Shinmizumaki Hospital	Onga-gun	Fukuoka
Japan	NHO Osaka National Hospital	Osaka
Japan	Osaka Metropolitan University Hospital	Osaka
Japan	Japan Community Health care Organization Osaka Hospital	Osaka-shi	Osaka
Japan	SUBARU Health Insurance Society Ota Memorial Hospital	Ota-shi	Gunma
Japan	Shiga University of Medical Science Hospital	Otsu	Shiga
Japan	Saga University Hospital	Saga-chi	Saga
Japan	Sagamihara Kyodo Hospital	Sagamihara	Kanagawa
Japan	Japan Community Health care Organization Saitama Medical Center	Saitama-shi	Saitama
Japan	Toho University Sakura Medical Center	Sakura	Chiba
Japan	Toho University Sakura Medical Center	Sakura	Chiba
Japan	Sapporo-Kosei General Hospital	Sapporo-shi	Hokkaido
Japan	Tokushukai Sapporo Tokushukai Hospital	Sapporo-shi	Hokkaido
Japan	JOHAS Tohoku Rosai Hospital	Sendai-shi	Miyagi
Japan	Sendai City Hospital	Sendai-shi	Miyagi
Japan	Tohoku University Hospital	Sendai-shi	Miyagi
Japan	JCHO Tokyo Yamate Medical Center	Shinjuku-ku	Tokyo
Japan	Kagawa Prefectural Central Hospital	Takainatsu-shi	Kagawa
Japan	Takamatsu Red Cross Hospital	Takamatsu-shi	Kagawa
Japan	Osaka Medical and Pharmaceutical University Hospital	Takatsuki-City	Osaka
Japan	Ehime University Hospital	Toon	Ehime
Japan	Matsumoto Eye Clinic	Toride-shi	Ibaraki
Japan	Fujita Health University Hospital	Toyoake-City	Aichi
Japan	Toyohashi Municipal Hospital	Toyohashi-shi	Aichi
Japan	Mie University Hospital	Tsu-shi	MIE
Japan	Tsuchiura Kyodo General Hospital	Tsuchiura-shi	Ibaraki
Japan	Wakayama Medical University Hospital	Wakayama-shi	Wakayama
Japan	Mie Prefectural General Medical Center	Yokkaichi-shi	MIE
Japan	National Hospital Organization Yokohama Medical Center	Yokohama	Kanagawa
Japan	Social Welfare Organization Imperial Gift Foundation,Inc.Saiseikai Yokohamashi Nanbu Hospital	Yokohama-shi	Kanagawa
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Endoscopy Facility in Dong-A University Hospital	Busan
Korea, Republic of	OCT Facility in Dong-A University Hospital	Busan
Korea, Republic of	PFT Facility in Dong-A University Hospital	Busan
Korea, Republic of	Endoscopy Facility in Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Endoscopy Facility in Kyungpook National University Hospital	Daegu
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	OCT Facility in Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	OCT Facility in Kyungpook National University Hospital	Daegu
Korea, Republic of	PFT Facility in Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	PFT Facility in Kyungpook National University Hospital	Daegu
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Endoscopy Facility in The Catholic University of Korea, St. Vincent's Hospital	Suwon-si	Gyeonggi-do
Korea, Republic of	OCT Facility in The Catholic University of Korea, St. Vincent's Hospital	Suwon-si	Gyeonggi-do
Korea, Republic of	PFT Facility in The Catholic University of Korea, St. Vincent's Hospital	Suwon-si	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Suwon-si	Gyeonggi-do
Korea, Republic of	Endoscopy Facility in Yonsei University Wonju Severance Christian Hospital	Wonju-si	Gangwon-du
Korea, Republic of	OCT Facility in Yonsei University Wonju Severance Christian Hospital	Wonju-si	Gangwon-du
Korea, Republic of	PFT Facility in Yonsei University Wonju Severance Christian Hospital	Wonju-si	Gangwon-do
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju-si	Gangwon-do
Latvia	P. Stradins Clinical University Hospital, Gastroenterology, Hepatology and Nutrition Therapy Center	Riga
Lebanon	American University of Beirut Medical Center	Beirut
Lithuania	Consultancy Polyclinic of Republican Panevezys Hospital	Panevezys
Lithuania	Republican Panevezys Hospital	Panevezys
Lithuania	UAB "Inlita", Santaros Clinical Trials Centre	Vilnius
Lithuania	UAB "Northway", Medical and Surgical Centre	Vilnius
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius
Mexico	Scientia, Investigacion Clinica S.C.	Chihuahua
Mexico	Centro de lnvestigacion Medico Biologica y Terapia Avanzada S.C.	Guadalajara	Jalisco
Mexico	Invesclinic MX	Irapuato	Guanajuato
Mexico	Servicios Medicos y de lnvestigacion Clinica Inspirepharma S. de R.L. de C.V.	Monterrey	Nuevo LEON
Mexico	FAICIC S. de R.L. de C.V.	Veracruz
Moldova, Republic of	IMSP Spitalul Clinic Republican "Timofei Mosneaga"	Chisinau
Moldova, Republic of	ISMP Spitalul Clinic Republican "Timofei Mosneaga", RTL SM	Chisinau
Poland	Centrum Dentystyczno-Lekarskie PROMEDICA Joanna Markiewicz	Bedzin
Poland	Centrum Medycyny Oddechowej, Mroz Spolka Jawna (PFT, DLCO)	Bialystok
Poland	Gastromed Kralisz, Romatowski, Stachurska sp.j.	Bialystok
Poland	LSSP Eskulap (OCT, Ophthalmoscopy)	Bialystok
Poland	Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)	Bystra
Poland	Poliklinika Dabrowska PRINN(PFT,colonoscopy)	Dabrowa Gomicza
Poland	Centrum Okulistyczne Sudety (OCT)	Dzierzoniow
Poland	Dobry Wzrok (OCT)	Gdansk
Poland	Poradnia Pulmonologiczna	Gdynia
Poland	Karkonoskie Centrum Badan Klinicznych - Lexmedica Spolka z ograniczona odpowiedzialnoscia	Jelenia Gora
Poland	PROMED Centrum Medyczne (OCT, ophthalmoscopy)	Jelenia Gora
Poland	Clinical Medical Research sp. z o.o. (OCT. ophthalmoscopy)	Katowice
Poland	Amicare Sp. z o.o. Sp.k.	Lodz
Poland	Centra Medyczne 'MEDYCEUSZ" (OCT, PFT, DLCO, Ophthalmoscopy)	Lodz
Poland	Centralny Szpital Kliniczny UM w Lodzi (PFT)	Lodz
Poland	IP Clinic Sp. z o.o.	Lodz
Poland	Salve Health Care Sp. z o.o (OCT, Endoscopy, Ophtalmoscopy)	Lodz
Poland	Wojewodzki Szpital Specjalistyczny im.dr. WI. Bieganskiego (endoscopy)	Lodz
Poland	Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi	Lodz
Poland	Allmedica Badania Kliniczne Sp. z o.o. Sp. k.	Nowy Targ
Poland	ALLMEDICA spolka z o.o (OCT/ophthalmoscopy)	Nowy Targ
Poland	MEDICOME Sp. z o.o.	Oswiecim
Poland	MEDICOME- Oswiecimskie Centrum Medyczne (OCT)	Oswiecim
Poland	Centrum Medyezne Grunwald	Poznan
Poland	Centrum Medyezne Grunwald	Poznan
Poland	NSZOZ Termedica	Poznan	Wielkopolskie
Poland	NSZOZ Termedica (colonoscopy)	Poznan
Poland	NSZOZ Termedica - Centrum Badan Klinicznych	Poznan	Wielkopolskie
Poland	Ocuservice (OCT, ophtalmoscopy)	Poznan
Poland	Szpital Sw. Wojciecha (colonoscopy)	Poznan
Poland	Szpital Sw. Wojciecha (Endoscopy)	Poznan
Poland	Wielkopolskie Centrum Pulmonologii i Torakochirurgii (PFT)	Poznan
Poland	Centrum Medyczne MEDYK	Rzeszow
Poland	Podkarpackie Centrum Chorob Pluc w Rzeszowie (DLCO)	Rzeszow
Poland	ENDOSKOPIA Sp. z o.o.	Sopot
Poland	Strzegomskie Centrum Medyczno - Diagnostyczne (Endoscopy)	Strzegom
Poland	DC-MED Sp. z o.o.	Swidnica
Poland	SP ZOZ w Swidnicy, Regionalny Szpital Specjalistyczny, Poradnia Gruzlicy i Chorob Pluc (Spirometry)	Swidnica
Poland	Spoldzielnia Pracy Lekarzy Medicus (OCT, ophtalmoscopy)	Szczecin
Poland	Twoja Przychodnia-Szczecinskie Centrum Medyczne	Szczecin
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie Klinika Chorob Wewnetrznych i Gastroenterologii	Warszawa
Poland	Centrum Zdrowia MDM	Warszawa
Poland	Centrum Zdrowia MDM	Warszawa
Poland	Centrum Zdrowia MDM (OCT,opthalmoscopy)	Warszawa
Poland	Instytut Gruzlicy i Chorob Pluc(DLCO)	Warszawa
Poland	Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych Administracji	Warszawa
Poland	Centrum Medyczne Oporow	Wroclaw
Poland	Dolnoslaskie Centrum Chorob Pluc We Wroclawiu	Wroclaw
Poland	Emc Instytut Medyczny Sa Przychodnia Przy Ul.Lowieckiej (Pft)	Wroclaw
Poland	Endomed	Wroclaw
Poland	EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu	Wroclaw
Poland	Osrodek Okulistyczny Okolek (Oct, Ophtalmoscopy)	Wroclaw
Poland	Perfect Vision (Oct)	Wroclaw
Poland	Szpital Specjalistyczny Chorob Pluc "Odrodzenie" im. Klary Jelskiej (DLCO, PFT)	Zakopane
Portugal	Centro Hospitalar e Universitario de Coimbra, E.P.E.	Coimbra
Portugal	Hospital Senhora da Oliveira Guimaraes, E.P.E	Guimaraes
Portugal	Centro Hospitalar Universitario de Sao Joao, E.P.E	Porto
Portugal	Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE	Vila Nova de Gaia
Portugal	Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE	Vila Nova de Gaia	Porto
Romania	Colentina Clinical Hospital	Bucharest	District 2
Romania	Monza Oncology Hospital. Gastroenterology Department	Bucharest	District 1
Romania	S.C. Euroclinic Hospital S.A.	Bucuresti	Sector 1
Romania	Spitalul Clinic Colentina	Bucuresti
Romania	Oculens Med S.R.L.	Cluj-Napoca	Cluj
Romania	Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca	Cluj-Napoca
Romania	Spitalul Clinic Judetean de Urgenta Cluj-Napoca	Cluj-Napoca
Romania	SC Pelican lmpex SRL	Oradea	Bihor
Russian Federation	LLC "Multidisciplinary Medical Clinic "Anturium"	Barnaul	Altayskiy Region
Russian Federation	Irkutsk State Medical Academy of Postgraduate Education	Irkutsk
Russian Federation	Professional Education" of MoH of RF	Irkutsk
Russian Federation	LLC "Alliance Biomedical -Ural Group"	Izhevsk
Russian Federation	SAIH "Kemerovo Regional Clinical Hospital"	Kemerovo
Russian Federation	State Budgetary Healthcare Instit. of Nizhniy Novgorod region	Nizhniy Novgorod
Russian Federation	LLC "Novosibirsk GastroCenter"	Novosibirsk
Russian Federation	LLC "SibNovoMed"	Novosibirsk
Russian Federation	Medical center "AVITSENNA"	Novosibirsk
Russian Federation	State Budgetary Healthcare Institution of Novosibirsk region "City clinical hospital # 12"	Novosibirsk
Russian Federation	Clinicodiagnostic center "Ultramcd"	Omsk
Russian Federation	State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"	Penza
Russian Federation	LLC "Polyclinic of ultrasonography 4D"	Pyatigorsk	Stavropol Region
Russian Federation	LLC "Medi com" (SM-Clinic)	Saint Petersburg
Russian Federation	Spb SBIH "City Mariinskaya Hospital"	Saint-Petersburg
Russian Federation	LLC Medical Company "Hepatologist"	Samara	Samara Region
Russian Federation	LLC Medical company "Hepatologist"	Samara
Russian Federation	Private Educational Institution of Higher Education "Medical University "Reaviz", Multifield Clinic	Samara
Russian Federation	LLC "Uromed"	Smolensk
Russian Federation	Federal state Budgetary Ed. Inst. of Higher Education "North-Western Medical University n.a.	St. Petersburg
Russian Federation	Federal State Budgetary Ed. Inst. of Higher Education "North-Western Medical University n.a. I.I.	St. Petersburg
Russian Federation	FSBEI of Higher Education "First Saint Petersburg State Medical University n.a. I.P. Pavlov"	St. Petersburg
Russian Federation	LLC "Gastroenterological centre Expert"	St. Petersburg
Russian Federation	St.Petersburg State Budgetary Healthcare Institution "City Hospital #40 of Kurortnyi region"	St.Petersburg
Russian Federation	Autonomous Noncommercial Medical Organizations " Stavropol Regional Clinical Diagnostic Centre ''	Stavropol
Russian Federation	Autonomous Noncommercial Medical Organizations "Stavropol Regional Clinical Diagnostic Centre''	Stavropol
Russian Federation	City Polyclinic #9	Stavropol
Russian Federation	State Healthcare Institution of Yaroslavl Region "Clinical Hospital No 2"	Yaroslavl
Serbia	Clinical Center " Dr Dragisa Misovic-Dedinje"	Belgrade
Serbia	Clinical Center Zvezdara	Belgrade
Serbia	General Hospital Sremska Mitrovica	Sremska Mitrovica
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica, II. Interna klinika SZU	Banska Bystrica
Slovakia	ALIAN. s.r.o .. Ambulancia vnutorneho lekarstva	Bardejov
Slovakia	DEJA. s.r.o .. Oftalmologicka ambulancia	Bardejov
Slovakia	3F, s.r.o., Oftalmologicka ambulancia	Kosice
Slovakia	OCULOSANUS, s.r.o., Oftalmologicka ambulancia	Levice
Slovakia	MUDr. Michal Popovec, s.r.o., Oftalmologicka ambulancia	Lipany
Slovakia	Fakultna nemocnica Nitra	Nitra
Slovakia	Fakultna nemocnica Nitra, Oftalmologicka ambulancia	Nitra
Slovakia	Fakultna nemocnica Nitra, Pneumologicka ambulancia	Nitra
Slovakia	KM Management, spol. s r.o .. Gastroenterologicke a hepatologicke centrum	Nitra
Slovakia	GASTRO I., s.r.o. Gastroenterologicka ambulancia	Presov
Slovakia	PULMO, s.r.o., Plucna ambulancia	Presov
Slovakia	Accout Center, s.r.o., Gastroenterologicka ambulancia	Sahy
Slovakia	COR, s.r.o., Pneumologicko-ftizeologicka ambulancia	Sahy
Slovakia	ENDOMED. s.r.o., Gastroenterologicka ambulancia	Vranov nad Toplou
Slovakia	PULMOX spol. s r.o., Pneumologicko-ftizeologicka ambulancia	Vranov nad Toplou
South Africa	Dr John Philip Wright	Cape Town	Western CAPE
South Africa	Dr Fritz Potgieter, Midstream Medi Clinic	Centurion
South Africa	Johese Clinical Research: Midstream	Centurion	Gauteng
South Africa	Johese Clinical Research:Unitas	Centurion	Gauteng
South Africa	Unitas Hospital	Centurion	Gauteng
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitario la Paz	Madrid
Thailand	Siriraj Hospital, Mahidol University	Bangkoknoi	Bangkok
Thailand	Chulalongkorn University, King Chulalongkorn Memorial Hospital	Pathumwan	Bangkok
Turkey	Gazi University Medical Faculty	Ankara
Turkey	Hacettepe University Medical Faculty	Ankara
Turkey	Saglik Bilimleri Universitesi Antalya Egitim ve Arastirma Hastanesi	Antalya
Turkey	Uludag University Medical Faculty	Bursa
Turkey	Kocaeli University Medical Faculty	Kocaeli
Ukraine	Communal Institution I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital, Department of	Dnipro
Ukraine	Clinical Diagnostical Center "Simedgroup"	Ivano-Frankivsk
Ukraine	Communal Non-commercial Enterprise Regional Clinical Hospital of lvano-Frankivsk Regional Council,	Ivano-Frankivsk
Ukraine	Regional Clin Hospital, Dep ofGastroenterology, State Higher Educational Institution Ivano-Frankivsk	Ivano-Frankivsk
Ukraine	Communal Noncommercial Enterprise City Clinical Hospital # 13 of Kharkiv City Council,	Kharkiv
Ukraine	Communal Noncommercial Enterprise Prof. O.O.Shalimov City Clinical Hospital #2 of Kharkiv City	Kharkiv
Ukraine	LLC "EyeQClinic"	Kharkiv
Ukraine	Llc "Ldts-Skaymed"	Kharkiv
Ukraine	Llc Medical Center Oftalmika	Kharkiv
Ukraine	Municipal Health Care "Kharkiv City Hospital Ambulance and Emergency Medical care named alter prof.	Kharkiv
Ukraine	Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City	Kherson
Ukraine	LLC "Diagnostic center"	Kherson
Ukraine	Kyiv City Clinical Hosptial #1, Department of Therappy #2	Kyiv
Ukraine	Communal Noncommercial Enterprise Lviv Clinical Emergency Hospital, 1st Department of Therapy	Lviv
Ukraine	Communal Institution Odesa Regional Clinical Hospital, Regional Center of Gastroenterology,	Odesa
Ukraine	LLC GLB Clinik	Odesa
Ukraine	Andrii Novak Transcarpathian Regional Clinical Hospital, Department of Gastroenterology	Uzhgorod
Ukraine	LLC "Transcarpathian Center Zoru"	Uzhgorod
Ukraine	Communal Nonprofit Enterprise M.I.Pyrogov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional	Vinnytsia
Ukraine	Medical Clinical Investigational Center of Med Center LLC Health Clinic, Unit of Gastroenterology,	Vinnytsia
Ukraine	National Medical University, Dep of Surgery, Vinnytsia M.I.Pyrogov National Medical University,	Vinnytsia
Ukraine	Scientific and Research Institute of Invalid Rehabilitation (Educational and Scientific Treatment	Vinnytsia
United Kingdom	Barts Health NHS Trust - Whipps Cross University Hospital	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Yeovil District Hospital NHS Foundation Trust	Yeovil	Somerset
United States	Cross Timbers Surgery Center(Proctosigmoidoscopy)	Arlington	Texas
United States	Envision Imaging(Chest X-Ray)	Arlington	Texas
United States	Texas Clinical Research Institute	Arlington	Texas
United States	Texas Pulmonary and Critical Care Associates(Pulmonary Function Test)	Arlington	Texas
United States	Texas Retina Associates(Ophthalmoscopy)	Arlington	Texas
United States	Atlanta Gastroenterology Associates (endoscopy only)	Atlanta	Georgia
United States	Atlanta Gastroenterology Associates(IP only)	Atlanta	Georgia
United States	Atlanta Pulmonary Group ( PFT only)	Atlanta	Georgia
United States	Pulmonary Critical Care of Atlanta (PFT)	Atlanta	Georgia
United States	Thomas Eye Group Corporate (OCT)	Atlanta	Georgia
United States	Baton Rouge LA Endoscopy	Baton Rouge	Louisiana
United States	Eye Medical Center (OCT location)	Baton Rouge	Louisiana
United States	Our Lady of the Lake (PFT location)	Baton Rouge	Louisiana
United States	Inquest Clinical Research	Baytown	Texas
United States	Retina Associates of Cleveland, Inc. (OCT only)	Beachwood	Ohio
United States	Brighton Surgical Center (endoscopy center - Nicholas Karyotakis - endoscopist)	Beverly Hills	California
United States	Great Lakes Medical Research, LLC	Camp Hill	Pennsylvania
United States	West Shore Endoscopy Center	Camp Hill	Pennsylvania
United States	Chevy Chase Endoscopy Center (Endoscopy Facility Only)	Chevy Chase	Maryland
United States	Chevy Chase Pulmonary Associate (PFT Only)	Chevy Chase	Maryland
United States	Retina Group Of Washington (OCT Only)	Chevy Chase	Maryland
United States	UC Health (Pulmonary Function Testing)	Cincinnati	Ohio
United States	UC Health Hoxworth (OCT only)	Cincinnati	Ohio
United States	UC Health Physicians Office	Cincinnati	Ohio
United States	University of Cincinnati Medical Center (PFT and Endoscopy location)	Cincinnati	Ohio
United States	University of Cincinnati Medical Center Department of Pharmacy Services	Cincinnati	Ohio
United States	Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test)	Clearwater	Florida
United States	Gastro Florida (Administrative & Regulatory Duties)	Clearwater	Florida
United States	Gastro Florida-(Regulatory & Administrative Duties)	Clearwater	Florida
United States	MACULA CENTER Dana M. Deupree, M.D., F.A.C.S (OCT)	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	West Coast Endoscopy Center (Endoscopy Facility)	Clearwater	Florida
United States	West Coast Endoscopy Center (Endoscopy Procedures)	Clearwater	Florida
United States	Front Range Endoscopy Center	Colorado Springs	Colorado
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Gastro Center of Maryland	Columbia	Maryland
United States	Beraja Medical Institute (OCT)	Coral Gables	Florida
United States	Barnes-Jewish West County Hospital (Additional Endoscopy Location)	Creve Coeur	Missouri
United States	Dallas Endoscopy Center (Endoscopy)	Dallas	Texas
United States	Center for Digestive Health (Colonoscopy Location)	Dothan	Alabama
United States	Digestive Health Specialists (IP Address)	Dothan	Alabama
United States	Dothan Eyecare-Dr. Brent McKinley (OCT Location)	Dothan	Alabama
United States	Flowers Hospital (PFT Location)	Dothan	Alabama
United States	Pulmonary Associates (Secondary PFT Location)	Dothan	Alabama
United States	Duke Eye Center (OCT only)	Durham	North Carolina
United States	Duke Medical Plaza North Duke Street	Durham	North Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	Investigational Drug Services (Pharmacy)	Durham	North Carolina
United States	Swedish Medical Center	Englewood	Colorado
United States	Harman Eye Center (OCT only)	Forest	Virginia
United States	GI Alliance	Fort Worth	Texas
United States	Illinois Gastroenterology Group-Gurnee (Patients Seen; IP Delivered)	Gurnee	Illinois
United States	Medical Eye Services LTD (Ophthalmoscopy with OCT)	Gurnee	Illinois
United States	Farrell Ophthalmology (OCT only)	Harrisburg	Pennsylvania
United States	Great Lakes Medical Research, LLC	Harrisburg	Pennsylvania
United States	Pulmonary and Critical Care Medicine Associates (PFT only)	Harrisburg	Pennsylvania
United States	Alkek Eye Center Jamail Specialty Care Center (OCT)	Houston	Texas
United States	Baylor College of Medicine- Baylor Medical Center	Houston	Texas
United States	Baylor College of Medicine-Baylor Medical Center ( IP Storage)	Houston	Texas
United States	Baylor College of Medicine-Baylor Medical Center (Chest X-ray location)	Houston	Texas
United States	Baylor St.Luke's Medical Center Endoscopy-Mc Nair Campus (Endoscopy Location)	Houston	Texas
United States	Cross Eye Center (Optical Coherence Tomography)	Houston	Texas
United States	East Houston Physicians Group	Houston	Texas
United States	Plaza Medical Center	Houston	Texas
United States	Center for Clinical Research (CCR)	Irvine	California
United States	UCI Gavin Herbert Eye Institute	Irvine	California
United States	UCI Gottschalk Medical Plaza	Irvine	California
United States	Lonestar Endoscopy(Endoscopy Location)	Keller	Texas
United States	Koman Family Outpatient Pavilion (ENDO)	La Jolla	California
United States	Perlman Medical Offices (IBD Clinic)	La Jolla	California
United States	Shiley Eye Institute (OCT)	La Jolla	California
United States	UCSD Clinical and Translational Research Institute (Research Clinic)	La Jolla	California
United States	UCSD Health System ( ENDO and PFT)	La Jolla	California
United States	UCSD lnvestigational Drug Service Pharmacy (Pharmacy Only)	La Jolla	California
United States	North Shore Endoscopy Center (Endoscopy)	Lake Bluff	Illinois
United States	Inland Pulmonary Specialists [PFT Only]	Lake Elsinore	California
United States	A V Pediatrics,Allergy and Family Medicine	Lancaster	California
United States	Advanced Endoscopy and Pain Center(Colonoscopy)	Lancaster	California
United States	Antelope Valley Eye Care(Ophthalmologist)	Lancaster	California
United States	Jatinder S.Pruthi,MD FACG CPI	Lancaster	California
United States	Om Research LLC	Lancaster	California
United States	Renaissance Imaging Center(Chest X-Ray only)	Lancaster	California
United States	Dr Lee Shettle	Largo	Florida
United States	Florida Center for Gastroenterology	Largo	Florida
United States	Tampa Bay Regional Surgery Center	Largo	Florida
United States	Abrams Eye Institute (OCT)	Las Vegas	Nevada
United States	Durango Surgical Center	Las Vegas	Nevada
United States	Lung Center of Nevada	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Libertyville Imaging Center (Diagnostic Imaging)	Libertyville	Illinois
United States	Advanced Vision Care (OCT)	Los Angeles	California
United States	Gastrointestinal Biosciences Clinical Trials, LLC	Los Angeles	California
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	Lynchburg Pulmonary Associates, Inc. (PFT only)	Lynchburg	Virginia
United States	Great Lakes Gastroenterology Research, LLC	Mentor	Ohio
United States	The Endoscopy Center of Lake County	Mentor	Ohio
United States	Clarineyecare	Miami	Florida
United States	Endoscopy Center (For Endoscopy procedure)	Miami	Florida
United States	Juan Barrio, MD (PFT)	Miami	Florida
United States	Kendall Endoscopy and Surgery Center	Miami	Florida
United States	Research Associates of South Florida, LLC(IP address)	Miami	Florida
United States	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	United Medical Doctors	Murrieta	California
United States	United Surgery Center Murrieta [Endoscopy Only]	Murrieta	California
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Gulfshore Endoscopy Center	Naples	Florida
United States	Lisette Delgado Sanchez, MD "PFT"	Naples	Florida
United States	Retina Consultants of Southwest Florida, PA "OCT"	Naples	Florida
United States	Christus Santa Rosa Physicians Ambulatory Surgery Center New Braunfels (Endoscopy)	New Braunfels	Texas
United States	Tyrus Schroeder (PFT)	New Braunfels	Texas
United States	Yale School of Medicine	New Haven	Connecticut
United States	NSB Research	New Smyrna Beach	Florida
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	CCR-ICTS Center for Innovative Patient Care	Orange	California
United States	UCI Health Eye Care Services (Ophthalmoscopy and OCTs)	Orange	California
United States	UCI Health H. H. Chao Comprehensive Digestive Disease Center	Orange	California
United States	UCI Investigational Drug Services (IDSP - Pharmacy)	Orange	California
United States	UCI Irvine Medical Center - Pulmonology Services - PFTs	Orange	California
United States	Advanced Imaging (Chest X-Ray)	Palmdale	California
United States	IMIC Inc .	Palmetto Bay	Florida
United States	IMIC Inc.	Palmetto Bay	Florida
United States	Advanced Medical Research Center	Port Orange	Florida
United States	Brier Creek Medical Pavilion	Raleigh	North Carolina
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University Of Utah School Of Medicine	Salt Lake City	Utah
United States	Central Texas Eye Center (OCT)	San Marcos	Texas
United States	Christus Santa Rosa Physicians Ambulatory Surgery Center San Marcos (Endoscopy)	San Marcos	Texas
United States	Thomas Eye Group (OCT only)	Sandy Springs	Georgia
United States	Swedish Medical Center	Seattle	Washington
United States	Larkin Community Hospital (For endoscopy procedure)	South Miami	Florida
United States	Lonestar Endoscopy (Endoscopy Location)	Southlake	Texas
United States	GI Alliance	Sun City	Arizona
United States	Absolute Surgical Specialists - Craig Amshel, MD	Sun City Center	Florida
United States	GCP Clinical Research,LLC	Tampa	Florida
United States	Guardian Angel Research Center, INC	Tampa	Florida
United States	Lab - Processing / Storage	Tampa	Florida
United States	LoCicero Medical Group (PFT Procedure Only)	Tampa	Florida
United States	Newsome Eye Specialist (OCT Procedures Only)	Tampa	Florida
United States	Perez Eye Center (OCT only)	Tampa	Florida
United States	Pulmonary and Sleep of Tampa Bay (PFT Only)	Tampa	Florida
United States	South Tampa Surgery Center	Tampa	Florida
United States	Tampa Bay Endoscopy Center (ENDO Only)	Tampa	Florida
United States	University of South Florida "Administrative Office"	Tampa	Florida
United States	USF Health Morsani Center For Advanced Healthcare	Tampa	Florida
United States	USF Health South Tampa Center for Advanced Healthcare	Tampa	Florida
United States	California Eye Professionals [OCT Only]	Temecula	California
United States	United Surgery Center Temecula [Endoscopy Only]	Temecula	California
United States	Christus Trinity Mother Frances Endosopy Center ( endoscopies only)	Tyler	Texas
United States	Heaton Eye Associates (OCT only)	Tyler	Texas
United States	Tyler Open MRI (x-ray only)	Tyler	Texas
United States	Tyler Research Institute, LLC	Tyler	Texas
United States	UT Health East Texas Physicians (pulmonary functions only)	Tyler	Texas
United States	Citizens Healthplex	Victoria	Texas
United States	Surgery Center	Victoria	Texas
United States	Victoria Eye Center	Victoria	Texas
United States	Victoria Gastroenterology	Victoria	Texas
United States	Lake Pulmonary Associates (PFT only)	Willoughby	Ohio
United States	Florida Medical Clinic, LLC	Zephyrhills	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

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Arena is a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Bulgaria,  Canada,  Chile,  Croatia,  Czechia,  Denmark,  Estonia,  France,  Georgia,  Germany,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lebanon,  Lithuania,  Mexico,  Moldova, Republic of,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With Histologic Improvement Assessed by the Geboes, Robarts, and Nancy Histopathology Scores		Week 52 and Week 104
Other	Percentage of Participants With Histologic Remission Assessed by the Geboes, Robarts, and Nancy Histopathology Scores		Week 52 and Week 104
Other	Time to Loss of Response Assessed by Mayo Component Sub-scores		Up to Week 260
Other	Proportion of Participants Achieving Improvement in Extraintestinal Manifestations (EIMs) in Participants With EIMs at Baseline		Baseline, Week 12, Week 52, Week 104, Week 156, Week 208, and Week 260
Primary	Number and Severity of Safety Measures	Safety as assessed by the evaluation of adverse events	Up to approximately 8 years
Secondary	Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores		Week 52 and Week 104
Secondary	Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry		Week 52 and Week 104
Secondary	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.	Baseline, Week 52, and Week 104
Secondary	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.	Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260
Secondary	Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores		Week 52 and Week 104
Secondary	Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores		Week 52 and Week 104

External Links

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