A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

Crohn's Disease Clinical Trial

— CULTIVATE  

Official title:

A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04173273
• Other study ID #: APD334-202
• Secondary ID: C5041006
• Status: Recruiting
• Phase: Phase 3
• Start date: January 6, 2020
• Est. completion date: August 8, 2029

Study information

• Verified date: June 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

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

Description:

This study includes 5 substudies:

Substudy A - Phase 2: A Phase 2, randomized, double-blind, substudy to assess the safety, tolerability, and efficacy of oral etrasimod therapy in participants with moderate to severe CD that supports the selection of an induction and maintenance dose(s) for Phase 3.

Substudy 1 - Phase 2: A Phase 2b randomized, double-blind, placebo-controlled, dose-ranging induction substudy to evaluate etrasimod as induction therapy and select an induction and maintenance dose(s) for continued evaluation in Phase 3.

Substudy 2 - Induction: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as induction therapy.

Substudy 3 - Maintenance: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as maintenance therapy. Participants from Substudy 1 and Substudy 2 will be enrolled in Substudy 3.

Substudy 4 - Long-Term Extension: A long-term extension substudy for participants who complete at least 52 weeks of treatment. Participants from Substudy 3 and Substudy A are planned to be enrolled in Substudy 4.

Other known NCT identifiers

• NCT05033340

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1175
• Est. completion date: August 8, 2029
• Est. primary completion date: July 16, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Eligibility criteria applicable to all substudies:

Inclusion Criteria:

• Men or women 18 to 80 years of age,

• Ability to provide written informed consent or assent and to be compliant with the schedule of protocol assessments

• Diagnosed with Crohn's disease (CD) = 3 months

• Have moderately to severely active CD at Screening

• Demonstrated inadequate response (ie, primary non-response), loss of response to, or intolerance to = 1 of the following therapies for the treatment of CD:

1. Oral corticosteroids (eg, prednisone or its equivalent, budesonide)

2. Immunosuppressants (eg, azathioprine [AZA], 6 mercaptopurine [6-MP], or methotrexate [MTX])

3. Tumor necrosis factor alpha (TNFa) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars)

4. Integrin receptor antagonist (eg, vedolizumab)

5. Interleukin -12/-23 antagonist (eg, ustekinumab)

• Females of childbearing potential must be nonpregnant

• Females of childbearing potential and males must use contraception

Exclusion Criteria:

• History of inadequate response (ie, primary non-response) to agents from = 2 classes of biologics marketed for the treatment of CD (ie, TNFa antagonists, interleukin 12/ 23 antagonist, and integrin receptor antagonist).

• Have ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, toxic megacolon, or active infectious colitis or test positive for Clostridioides difficile toxin at Screening.

• Have functional or post-operative short-bowel syndrome or any associated complications that may require surgery or interfere with efficacy assessments

• Had surgical treatment for intra abdominal abscesses = 8 weeks prior to randomization or surgical treatment for perianal abscesses = 4 weeks prior to randomization.

• Had intestinal resection = 24 weeks prior to randomization or other intra abdominal surgeries = 12 weeks prior to randomization.

• Have an ileostomy or a colostomy.

Inclusion Criteria for Substudy 3:

• Participants who entered the Extended Induction Period of Substudy 1 and Substudy 2 must have completed the Extended Induction -Week 6 Visit

Inclusion Criteria for Substudy 4:

• Participant must have completed the Week 52 Visit of Substudy 3 or the Week 66 Visit of Substudy A

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Etrasimod
Dose A taken by mouth, once daily.
• Etrasimod
Dose B taken by mouth, once daily.
• Placebo
Etrasimod matching placebo tablet taken by mouth, once daily.

Locations

Country	Name	City	State
Argentina	Centro Oftalmologico Dr. Carlos H.Lerner(OCT)	Ciudad Autonoma de Bs. As
Argentina	Centro de Educacion Medica e Investigacion Clinica (CEMIC)	Ciudad Autonoma de Bs. As.
Argentina	Clinica Adventista Belgrano	Ciudad Autonoma de Bs. As.
Argentina	Instituto Medico Elsa Perez (I.M.E.P.) (Local Lab)	Ciudadela	Prov. DE Buenos Aires
Argentina	Instituto Medico Elsa Perez (I.M.E.P.) (Pharmacy)	Ciudadela	Prov. DE Buenos Aires
Argentina	Instituto Medico Elsa Perez(I.M.E.P)	Ciudadela	Prov. DE Buenos Aires
Argentina	Estudio de La Vision (OCT, Ophthalmoscopy)	Hurlingham	Prov. DE Buenos Aires
Argentina	Clinica Santa Lucia (Optical Coherence Tomography, OCT)	La Plata	Buenos Aires
Argentina	Hospital Italiano de La Plata	La Plata	Buenos Aires
Argentina	CEN ASMA (Pulmonary Function Test, PFT)	Mar del Plata	Prov. DE Buenos Aires
Argentina	Centro de Investigaciones Medicas Mar del Plata	Mar del Plata	Prov. DE Buenos Aires
Argentina	Clinica Privada de Ojos Santa Lucia Mar del Plata (OCT, Ophthalmoscopy)	Mar del Plata	Prov. DE Buenos Aires
Argentina	Clinica Pueyrredon (Endoscopy)	Mar del Plata	Prov. DE Buenos Aires
Argentina	Consultorios extemos de Sanatorio Parque (PFT with DLCO, Pulmonar Functional Test with DLCO)	Rosario	Santa FE
Argentina	Gastroenterologia Rosario (Endoscopy)	Rosario	Santa FE
Argentina	Instituto Medico de la Fundacion Estudios Clinicos	Rosario	Santa FE
Argentina	Microcirugia Ocular SA (OCT, Ophthalmoscopy)	Rosario	Santa FE
Argentina	Sport Lab(PFT-DLCO)	San Isidro	Buenos Aires
Argentina	Centro de Investigaciones Medicas Tucuman	San Miguel de Tucuman	Tucuman
Australia	MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons	Bellfield	Victoria
Australia	Royal Brisbane & Women's Hospital	Brisbane	Queensland
Australia	The Northern Hospital	Epping	Victoria
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Macquarie Respiratory Services	Macquarie University	New South Wales
Australia	Macquarie University Hospital	Macquarie University	New South Wales
Australia	Macquarie University Hospital Clinical Trials	Macquarie University	New South Wales
Australia	Macquarie University Hospital Pharmacy	Macquarie University	New South Wales
Australia	MQ Health Ophthalmology	Macquarie University	New South Wales
Australia	Footscray Hospital	Melbourne	Victoria
Australia	Vision Eye Institute	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Lions Eye Institute Limited	Nedlands	Western Australia
Australia	Coral Sea Clinical Research Institute	North Mackay	Queensland
Australia	The trustee for The RTS Unit Trust trading as Respiratory Testing Services	O'Connor	Western Australia
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Australia	Heidelberg Eye Clinic	Rosanna	Victoria
Austria	LKH Universitats-Klinikum Graz	Graz
Austria	Medical University Innsbruck, Internal Medicine ?	Innsbruck
Austria	AKH Wien- Universitatsklinik fiir Innere Medizin III	Vienna
Austria	Univ.-Professor Dr. Mehrdad Baghestanian	Vienna
Austria	AKH Wien- Universitatsklinik fur Innere Medizin III	Wien
Belarus	Institution "Gomel Regional Clinical Hospital"	Gomel
Belarus	Health care Institution "10th City Clinical Hospital"	Minsk
Belarus	Health Care Institution "Mogilev Hospital #1"	Mogilev
Belarus	Health Care Institution "Vitebsk Regional Clinical Hospital"	Vitebsk
Belarus	Healthcare Institution "Vitebsk Regional Clinical Specialized Center"	Vitebsk
Belgium	AZ Maria-Middelares	Gent
Belgium	AZ Sint-Lucas	Gent	Oost-vlaanderen
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Universitaire Ziekenhuizen Leuven	Leuven
Belgium	University Hospital Leuven	Leuven	Vlaams-brabant
Belgium	Campus Brugsesteenweg	Roeselare
Belgium	Campus Rumbeke	Roeselare
Belgium	Campus Rembert Torhout	Torhout
Belgium	Centre Hospitalier Universitaire UCL Namur - Site Godinne	Yvoir
Bosnia and Herzegovina	University Clinical Hospital Mostar	Mostar
Bosnia and Herzegovina	University Clinical Centre Sarajevo	Sarajevo
Bulgaria	"DCC Alexandrovska", EOOD	Sofia
Bulgaria	,,University multiprofile hospital for active treatment and emergency medicine N.I. Pirogov" EAD	Sofia
Bulgaria	UMHAT "Tsaritsa Yoanna-ISUL" EAD	Sofia
Canada	Centre for Innovative Medicine - Research Institute of the McGill University Health Centre(Pulmonary	Montreal	Quebec
Canada	Eye Health MD (Ophthalmology)	Montreal	Quebec
Canada	McGill University Health Centre - Montreal General Hospital (Electrocardiogram Clinic)	Montreal	Quebec
Canada	McGill University Health Centre - Montreal General Hospital (Endoscopy Clinic)	Montreal	Quebec
Canada	McGill University Health Centre - Montreal General Hospital (Pharmacy)	Montreal	Quebec
Canada	McGill University Health Centre - Montreal General Hospital (Radiology)	Montreal	Quebec
Canada	McGill University Health Centre - Montreal General Hospital (Research Site)	Montreal	Quebec
Chile	Biomedica Reaserch Group	Santiago
Chile	CeCim Biocinetic	Santiago	Region Metropolitana
Chile	Centro de Investigaciones Clinicas de la Universidad Catolica	Santiago	RM
Chile	Clinica Las Condes	Santiago
Chile	Clinica Universidad de los Andes	Santiago	Region Metropolitana
Chile	M y F Estudios Clinicos - MIRES	Santiago
Chile	Clinica Alemana de Valdivia	Valdivia	Los Rios
Chile	Clinical Research Chile SpA	Valdivia	Los Rios
Chile	Centro de Investigaciones Clinicas	Vina del Mar
Colombia	IPS Fundacion Cardiomet CEQUIN	Armenia	Quindio
Colombia	Clinica de la Costa Ltda.	Barranquilla	Atlantico
Colombia	Clinica de la Mujer S.A.S	Bogota	Distrito Capital
Colombia	Centro de lnvestigaciones Clinicas S.A.S	Cali	Valle DEL Cauca
Croatia	General Hospital "Dr.Tomislav Bardek" Koprivnica	Koprivnica
Croatia	Clinical Hospital Centre Osijek	Osijek
Croatia	General Hospital Zadar	Zadar
Croatia	University Hospital Center Zagreb	Zagreb
Czechia	Asclepiades • interna a gastroenterologie s. r. o.	Havirov
Czechia	FOX Alcrgomcdical s.r.o.	Havirov
Czechia	MUDr. Jaroslava Skalova	Horazdovice
Czechia	Hepato-Gastroenterologie HK, s.r.o.	Hradec Kralove
Czechia	VISUS, spol s.r.o.	Hradec Kralove
Czechia	GASTRO JeKa, s.r.o.	Klatovy
Czechia	Klatovska nemocnice a.s.	Klatovy
Czechia	CTCenter MaVe. s. r. o.	Olomouc
Czechia	MUDr. Pavlina Kazinotova s.r.o.	Olomouc
Czechia	Ocni ordinace Olomouc	Olomouc
Czechia	PreventaMed s.r.o.	Olomouc
Czechia	Ocni ambulance - MUDr. Petra Tylova	Ostrava - Hrabuvka
Czechia	Axon Clinical, s.r.o	Praha 5
Czechia	ISCARE a.s.	Praha 9
Czechia	Nemocnice Slany	Slany
Czechia	Poliklinika Slany, spol. s.r.o.	Slany
Denmark	Aalborg University Hospital, Department of Medical Gastroenterology, Medicinerhuset	Aalborg
Denmark	Hvidovre University Hospital	Hvidovre
Denmark	Hvidovre University Hospital	Hvidovre
Denmark	Hvidovre University Hospital	Hvidovre	Hovedstaden
Egypt	Alexandria Clinical Research Center , Faculty of Medicine , Alexandria University	Alexandria
Egypt	Ain Shams University Hospital	Cairo
Egypt	Air Force Specialized Hospital(AFSH)	Cairo
Egypt	Cairo University , Kasr Al Aini Hospital	Cairo
Egypt	National Hepatology and Tropical Medicine Research Institute	Cairo
Egypt	Egyptian Liver Research Institute and Hospital ( ELRIAH)	Dakahlia
Egypt	Theodor Bilharz Research Institute Research Ethics Committee	Giza
Egypt	National Liver Institute	Menofeya
France	CHU Amiens Picardie	Amiens Cedex 1
France	CHU BESANCON, Centre d'Investigation Clinique	Besancon
France	CHU de Clermont Ferrand - Hopital Estaing	Clermont-Ferrand
France	CHU Gabriel Montpied	Clermont-Ferrand
France	Laboratoire de Biologie medicale Site de Flers	Flers
France	CHU Grenoble Alpes - Hopital Michallon	Grenoble Cedex 9
France	Endoscopy: CHU Grenoble Alpes- Hopital Michallon	Grenoble Cedex 9
France	CHD Vendee, Unite de Recherche Clinique	La Roche sur Yon, Cedex 9
France	CHU de Lille - Hopital Claude Huriez	Lille, Cedex
France	Optical Coherence Tomography and Ophthalmology CHU de Lille Hopital Roger Salengro	Lille, Cedex
France	Pulmonary Function Test CHU Lille, Institut Coeur Poumon	Lille, Cedex
France	CHU Saint-Eloi	Montpellier Cedex 5
France	Hopital Saint-Eloi - Pole Digestif - Hgea Recherche Clinique - Rdc	Montpellier Cedex 5
France	CHU de Nice, Hopital 1'Archet 2	Nice, Cedex 3
France	Hopital Maison Blanche, CHU DE REIMS	Reims
France	Hopital Robert Debre CHU DE REIMS	Reims
France	Hopital Robert Debre	Reims, Cedex
France	Optical Coherence Tomography and Ophthalmology	Saint Priest en Jarez
France	Pulmonary Function Test	Saint Priest en Jarez
France	CHU Saint Etienne - Hopital Nord	Saint-Etienne, Cedex 1
France	Hopital Purpan PPR pole cephalique	Toulouse
France	Hopital Rangueil	Toulouse, Cedex 9
France	Chru Nancy Brabois	Vandoeuvre Les Nancy
Georgia	JSC Infectious Diseases, AIDS and Clinical Immunology Research Center	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	LTD Medical Center "CITO"	Tbilisi
Georgia	Malkhaz Katsiashvili Multiprofile Emergency Medicine Center, LTD	Tbilisi
Germany	Universitaetsklinikum Augsburg	Augsburg
Germany	OCT/Ophtalmoscopy address: Hochkreuz Augenklinik + Laserzentrum	Bonn
Germany	Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling	Bonn
Germany	Staedtisches Klinikum Brandenburg	Brandenburg an der Havel
Germany	Florence-Nightingale-Krankenhaus-Diakonie Kaiserswerther	Dusseldorf
Germany	Prof. Dr. med. Dr. med. Habil. Jens Buhren, FEBO	Frankfurt
Germany	Agaplesion Markus Krankenhaus	Frankfurt am Main
Germany	HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen	Hamburg
Germany	OCT/Ophtalmoscopy address: Universitaetsklinikum Jena	Jena
Germany	PFT address: Universitaetsklinikum Jena	Jena
Germany	Universitaetsklinikum Jena	Jena
Germany	Gastroenterologie Opernstraße	Kassel	Hassen
Germany	OCT/Ophtalmoscopy address: Augenarztpraxis Dr. Karola Hassan	Kassel
Germany	PFT address: Praxis fur Pneumologie und Allergologie	Kassel
Germany	Nordblick Augenklinik	Kiel
Germany	Universitatsklinikum Schleswig-Holstein- Campus Kiel	Kiel
Germany	OCT/Ophtalmoscopy address: Augenarzte Krefeld, Dr. med. Christopher Kallen, Behnisch Haus	Krefeld
Germany	Universitaetsklinikum Leipzig AoeR	Leipzig
Germany	Johanna Etienne Krankenhaus	Neuss
Germany	Medius Klinik Nuertingen	Nuertingen
Germany	Dr. Irina Hasewinkel	Nurtingen
Germany	Dr. med Mayer AUGENPRAXISKLINIK IM ALLEE-CENTER REMSCHEID	Remscheid
Germany	Magen-Darm-Zentrum Remscheid	Remscheid
Greece	University General Hospital of Alexandroupoli	Alexandroupoli
Greece	Anticancer-Oncology Hospital of Athens "Agios Savvas"	Athens
Greece	General Hospital of Athens "Evangelismos"	Athens
Greece	General Hospital of Athens of Chest Diseases "Sotiria	Athens
Greece	"Agia Eirini" General Hospital of Corfu	Corfu
Greece	Univerisity General Hospital of Heraklion	Heraklion	Crete
Hungary	Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia	Bekescsaba
Hungary	Chest X-ray: XIII. keruleti Egeszsegugyi Szolgalat Kozhasznu Nonprofit Kft.	Budapest
Hungary	Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft. (abbreviated name: Clinexpert Kft.)	Budapest
Hungary	Ophthalmology procedures: Magyar Honvedseg Egeszsegugyi Kozpont	Budapest
Hungary	Ophthalmology, OCT: Medicover Zrt.	Budapest
Hungary	Pannonia Maganorvosi Centrum	Budapest
Hungary	Pulmonary procedures: Vasutegeszsegugyi Nonprofit Kozhasznu K ft.	Budapest
Hungary	Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika	Budapest
Hungary	Vasutegeszsegugyi Nonprofit Kozhasznu Kft.	Budapest
Hungary	Debreceni Egyetem	Debrecen
Hungary	Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont	Debrecen
Hungary	Bugat Pal Korhaz, Gasztroenterologia	Gyongyos	Heves
Hungary	Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia	Gyula	Bekes
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont	Szeged
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont	Szeged	Csongrad
Hungary	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Szekesfehervar
Hungary	DLCO and ophthalmology tests: Szent Borbala Korhaz	Tatabanya	Komarom-esztergom
Hungary	Szent Borbala Korhaz	Tatabanya	Komarom-esztergom
India	Fortis Memorial Research Institute	Gurugram	Haryana
India	Fortis Memorial Research Institute	Gurugram, Haryana
India	S. R. Kalla Memorial Gastro & General Hospital	Jaipur	Rajasthan
India	Aster Medcity, Aster DM Healthcare Ltd.	Kochi	Kerala
India	Aster Medcity, Aster DM Healthcare Ltd.	Kochi
India	Midas Multispeciality Hospital Pvt. Ltd	Nagpur	Maharashtra
India	Surat Institute of Digestive Sciences	Surat	Gujarat
Ireland	Portinucula Hospital	Galway
Israel	HaEmek Medical Center	Afula
Israel	Edith Wolfson Medical Center	Holon
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Galilee Medical Center	Nahariya
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Ziv Medical Center	Safed
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	I.R.C.C.S. Saverio De Bellis	Castellana Grotte	Bari
Italy	OCT/ PFT/ Endoscopy address: I.R.C.C.S. Saverio De Bellis	Castellana Grotte	Bari
Italy	Azienda Ospedaliera Ospedale Cannizzaro	Catania
Italy	Azienda Ospedaliera Ospedale Cannizzaro	Catania
Italy	A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente	Catanzaro
Italy	A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente Campus Universitario "Salvatore Venuta"	Catanzaro
Italy	CAMPUS GERMANETO Magazzino farmaci e dispositivi medici, uffici	Catanzaro
Italy	ASST Rhodense - Pneumology Unit	Garbagnate Milanese	Milan
Italy	ASST Rhodense, U.O.C. Gastroenterologia ed Endoscopia Digestiva	Milano	Milan
Italy	Ospedale San Raffaele	Milano	MI
Italy	OCT/ PFT/ Endoscopy address: IRCCS Ospedale Sacro Cuore Don Calabria	Negrar Di Valpolicella	Verona
Italy	Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche	Pavia
Italy	ASST Rhodense - Ophthalmology Unit	Rho	Milan
Italy	Azienda Ospedaliero-Universitaria Sant' Andrea UOC Malattie dell'apparato digerente	Rome
Italy	Endoscopy address: Azienda Ospedaliero-Universitaria Sant' Andrea UOD Endoscopia Digestiva	Rome
Italy	OCT address: Azienda Ospedaliero-Universitaria Sant' Andrea UOD Oculistica	Rome
Italy	PFT address: Azienda Ospedaliero-Universitaria Sant' Andrea UOC Pneumologia	Rome
Italy	IRCCS Humanitas Research Hospital	Rozzano	Milano
Italy	Istituto Clinico Humanitas	Rozzano	Lombardia
Italy	IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo	Foggia
Italy	OCT/ PFT/ Endoscopy address: IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo	Foggia
Italy	CRC - Centro Ricerche Cliniche di Verona	Verona
Italy	IRCCS Ospedale Sacro Cuore Don Calabria	Verona
Italy	OCT/PFT/Endoscopy address: CRC - Cenro Ricerche Cliniche di Verona	Verona
Italy	OCT/PFT/Endoscopy address: Ospedale San Bortolo di Vicenza	Vicenza
Italy	Ospedale San Bortolo di Vicenza	Vicenza
Japan	Fukuoka University Hospital	Fukuoka-shi	Fukuoka
Japan	Gifu University Hospital	Gifu-shi	Gifu
Japan	Jiaikai Idzuro Imamura Hospital	Kagoshima-shi	Kagoshima
Japan	Kagoshima Kouseiren Hospital	Kagoshima-shi	Kagoshima
Japan	Sameshima Eye Clinic	Kagoshima-shi	Kagoshima
Japan	Sameshima Hospital	Kagoshima-shi	Kagoshima
Japan	Kokikai Tsujinaka Hospital Kashiwanoha	Kashiwa-shi	Chiba
Japan	Hospital of the university of occupational and environmental health	Kitakyushu-shi	Fukuoka
Japan	Hospital of the university of occupational and environmental health	Kitakyushu-shi	Fukuoka
Japan	Hospital of the university of occupational and environmental health	Kitakyusyu	Fukuoka
Japan	Kitakyushu Municipal Medical Center	Kitakyusyu-shi	Fukuoka
Japan	Japanese Red Cross Kumamoto Hospital	Kumamoto-shi	Kumamoto
Japan	Ishii Eye Clinic	Nagareyama-shi	Chiba
Japan	Daido Clinic	Nagoya-shi	Aichi
Japan	Kojunkai Daido Hospital	Nagoya-shi	Aichi
Japan	JCHO Osaka Hospital	Osaka
Japan	Osaka Hospital IRB	Osaka
Japan	Saga University Hospital	Saga-shi	Saga
Japan	Japan Community Health care Organization Tokyo Yamate Medical Center	Shinjuku-ku	Tokyo
Japan	Matsumoto Eye Clinic	Toride-shi	Ibaraki
Japan	Tsuchiura Kyodo General Hospital	Tsuchiura-shi	Ibaraki
Korea, Republic of	Endoscopy room of Korea University Ansan Hospital	Ansan-si	Gyeonggi-do
Korea, Republic of	Korea University Ansan Hospital	Ansan-si	Gyeonggi-do
Korea, Republic of	OCT room of Korea University Ansan Hospital	Ansan-si	Gyeonggi-do
Korea, Republic of	PFT room of Korea University Ansan Hospital	Ansan-si	Gyeonggi-do
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Endoscopy room of Dong-A University Hospital	Busan
Korea, Republic of	OCT room of Dong-A University Hospital	Busan
Korea, Republic of	PFT room of Dong-A University Hospital	Busan
Korea, Republic of	Endoscopy Facility in kyungpook National University Hospital	Daegu
Korea, Republic of	Keimyung University Dongsan 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 Hospital	Daegu
Korea, Republic of	PFT Facility in Kyungpook National University Hospital	Daegu
Korea, Republic of	The Catholic University of Korea, Daejeon St. Mary's Hospital	Daejeon
Korea, Republic of	DongGuk University ilsan Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Gachon university Gil Medical Center	Incheon
Korea, Republic of	CHA University Bundang CHA Hospital	Seongnam-si
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Kyunghee University Medical Center	Seoul
Korea, Republic of	The Catholic University of South Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon-si	Gyeonggi-do
Lebanon	Hotel Dieu de France Hospital	Beirut
Lebanon	Rafik Hariri University Hospital	Beirut
Lebanon	Saint George University Hospital Medical Center	Beirut
Lebanon	Hammoud Hospital University Medical Center	Saida
Lebanon	Nini Hospital s.a:l	Tripoli
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius
Malaysia	Hospital Tengku Ampuan Rahimah Klang	Klang	Selangor
Malaysia	Hospital Universiti Sains Malaysia	Kota Bharu	Kelantan
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Hospital Shah Alam	Shah Alam	Selangor
Mexico	Cirugia y Gastro de Veracruz S.A. de C.V. (Progastro)	Boca del Rio	Veracruz
Mexico	Sanatorio Palmore A.C.	Chihuahua
Mexico	Scientia Investigacion Clinica S.C.	Chihuahua
Mexico	Servicios Hospitalarios de México, S.A. de C.V.	Chihuahua
Mexico	Vista Lasser de Chihuahua S.C.	Chihuahua
Mexico	Centro de Investigacion Medico Biologica Y Terapia Avanzada S.C.	Guadalajara	Jalisco
Mexico	Comercializadora Winco S.A. de C.V.	Guadalajara	Jalisco
Mexico	Global Glaucoma Institute	Guadalajara	Jalisco
Mexico	Video Endoscopia Americas	Guadalajara	Jalisco
Mexico	Consultorio Medico CEEDI	Irapuato	Guanajuato
Mexico	Hospital de Cirugia y Cardiologia los Angeles S.A. de C.V.	Irapuato	Guanajuato
Mexico	Oftalmolaser Irapuato, S.C.	Irapuato	Guanajuato
Mexico	Invesclinic Mx	Lrapuato	Guanajuato
Mexico	Endo Laser Microquirurgico S.A de C.V..	Monterrey	Nuevo LEON
Mexico	Servicios Medicos y de lnvestigacion Clinica Inspirepharma S de RI de CV	Monterrey	Nuevo LEON
Mexico	DENUSA S.A.P.I de C.V.(Medwell Center)	San Pedro Garza Garcia	Nuevo LEON
Mexico	Alberto Collado Solorzano (Clinica Vision)	Veracruz
Mexico	FAICIC S. de R.L. de C.V.	Veracruz
Mexico	Gabinete de Diagnostico COVADONGA	Veracruz
Moldova, Republic of	"Sf. Arhanghel Mihail" Municipal Clinical Hospital, Department of Gastroenterology	Chisinau
Moldova, Republic of	PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Colorectal Surgery	Chisinau
Moldova, Republic of	PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Gastroenterology	Chisinau
Moldova, Republic of	PMSI Republican Clinical Hospital "Timofei Mosneaga", Outpatient Department	Chisinau
Netherlands	Academic Medical Centre	Amsterdam
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Leids Universitair Medisch Centrum	Leiden
Netherlands	Leids Universitair Medisch Centrum	Leiden	Zuid-holland
Netherlands	Radboud UMC	Nijmegen
Netherlands	Radboud UMC	Nijmegen	THE Netherlands
Netherlands	UMC Utrecht	Utrecht
Norway	Sykehuset Innlandet HF Gjøvik	Gjoevik	Innlandet
Norway	Sykehuset Innlandet HF Gjøvik	Gjøvik	Oppland
Norway	Akershus University Hospital Department of Gastroenterology	Lorenskog
Philippines	The Medical City Clark	Mabalacat City	Pampanga
Philippines	Makati Medical Center	Makati City	Metro Mnaila
Philippines	University of the Philippines - Philippine General Hospital	Manila City	Metro Manila
Philippines	The Medical City	Pasig City	Metro Manila
Poland	Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)	Bystra
Poland	Centrum Medyczne Pratia	Czestochowa
Poland	Centrum Medyczne PZU Zdrowie Sw. Lukasz (Ophthalmoscopy, OCT, Endoscopy)	Czestochowa
Poland	Poliklinika Dabrowska PRINN (PFT, Endoscopy)	Dabrowa Gomicza
Poland	Centrum Okulistyczne Sudety, Gabinet Dzierzoniow (OCT, Ophtalmoscopy)	Dzierzoniow
Poland	Karkonoskie Centrum Badan Medycznych - Lexmedica	Jelenia Gora
Poland	Specjalistyczne Gabinety Lekarskie LANDA	Karkow
Poland	Clinical Medical Research sp. z o.o. (OCT. ophthalmoscopy)	Katowice
Poland	Centre De La Vision Centrum Okulistyczne(OCT, Ophthalmoscopy)	Krakow
Poland	Centrum Medyczne EVITA(Endoscopy)	Krakow
Poland	Medicina (Endoscopy)	Krakow
Poland	Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.	Ksawerow
Poland	(Centrum Medyczne Ksiezy Mlyn (OCT and Ophthalmoscopy)	Lodz
Poland	AMICARE Sp. z o.o. sp.k	Lodz
Poland	Centra Medyczne Medyceusz (DLCO)	Lodz
Poland	Centrum Medyczne "Ksiezy Mlyn" (OCT, Ophtalmoscopy)	Lodz
Poland	IP Clinic Sp. z o.o.	Lodz
Poland	Poradni NOWA (OCT, Ophtalmoscopy)	Lodz
Poland	Salve Health Care Sp. o.o., (PFT and Endoscopy)	Lodz
Poland	Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatolog i im. M. Kopernika w Lodzi	Lodz
Poland	Instytut Medycyny Wsi im. Witolda Chodzki (DLCO)	Lublin
Poland	Allmedica Badania Kliniczne Sp. z o.o. Sp. k.	Nowy Targ, Woj. Malopolskie
Poland	Medicome Sp. Z O.O	Oswiecim
Poland	Przychodnia Okulistyczna "Oculus" Barbara Cybulska (OCT, Ophtalmoscopy)	Piotrkow Trybunalski
Poland	Samodzielny Szpital Wojewodzki im. Mikolaja Kopernika (Endoscopy)	Piotrkow Trybunalski.
Poland	Trialmed CRS	Piotrokow Trybunalski
Poland	Centrum Medyczne Grunwald	Poznan
Poland	Centrum Medyczne Grunwald	Poznan	Wielkopolskie
Poland	NSZOZ Termedica	Poznan	Wielkopolskie
Poland	NSZOZ Termedica (Endoscopy)	Poznan
Poland	OCU Service Mikolaj Meller Sp.j.(OCT, Ophtalmoscopy)	Poznan
Poland	Ocuservice (OCT, ophtalmoscopy)	Poznan
Poland	Solurmed Centrum Medyczne	Poznan
Poland	Szpital Sw. Wojciecha (Endoscopy)	Poznan
Poland	Centrum Medyczne Medyk	Rzeszow
Poland	Gabinety Lekarskie Sensor (OCT and Ophthalmoscopy)	Rzeszow
Poland	Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie (Ophthalmpscopy)	Rzeszow
Poland	Korczowski Bartosz Gabinet Lekarski	Rzeszow
Poland	Podkarpackie Centrum Chorob Plue w Rzeszowie (DLCO)	Rzeszow
Poland	Kiepury Clinic Malgorzata Jarnot Specjalistyczna Praktyka Ginekologiczno	Sosnowiec
Poland	Strzegomskie Centrum Medyczno - Diagnostyczne Sp. z o.o. (Endoscopy)	Strzegom
Poland	Strzegomskie Centrum Medyczno - Diagnostyczne Sp. z o.o. (Endoscopy)	Strzegom
Poland	Centrum Medyczne EZ-MEDICA (OCT, Ophtalmoscopy)	Swidnica
Poland	DC-MED	Swidnica
Poland	Szpital "Latawiec" -Poradnia Gruzlicy i Chorob Pluc (PFT)	Swidnica
Poland	Szpital "Latawiec" -Poradnia Gruzlicy i Chorob Pluc (PFT)	Swidnica
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie	Warszawa
Poland	Centrum Okulistyczne JASKRA (OCT, Ophthalmoscopy)	Warszawa
Poland	Centrum Zdrowia MDM	Warszawa
Poland	Centrum Zdrowia MDM (OCT,opthalmoscopy)	Warszawa
Poland	Endoterapia PFG (Endoscopy)	Warszawa
Poland	Instytut Gruzlicy i Chorob Pluc(DLCO)	Warszawa
Poland	Instytut Oka (OCT, Ophtalmoscopy)	Warszawa
Poland	Specjalistyczne Gabinety Lekarskie Body Clinic	Warszawa
Poland	Wojskowy lnstytut Medyczny (PFT)	Warszawa
Poland	Centrum Badan Klinicznych Piotr Napora Lekarze Spoka Partnerska	Wroclaw
Poland	Dobrostan (Pft)	Wroclaw
Poland	EuroMediCare Szpital Specjalistyczny z Przychodnia (Endoscopy)	Wroclaw
Poland	EuroMediCare Szpital Specjalistyczny z Przychodniit (Endoscopy)	Wroclaw
Poland	Klinika SAL VITA Centrum Gastroenterologii	Wroclaw
Poland	Osrodek okulistyczny ,,Okolek" (OCT, Ophthalmoscopy)	Wroclaw
Poland	Planetmed sp. z.o.o.	Wroclaw
Poland	SPECTRUM - Osrodek Okulistyki Klinicznej (OCT, Ophthalmoscopy)	Wroclaw
Poland	ETG Zamosc	Zamosc
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Medlux. Jerzy Pukaluk, (Endoscopy)	Zamosc
Poland	Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II (Endoscopy)	Zamosc
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Joloko (OCT, Ophthalmoscopy)	Zomosc
Portugal	Hospital da Luz	Lisboa
Puerto Rico	Ahmed Morales, MD Private Office	Coto Laurel
Puerto Rico	Instituto de Endoscopia	Coto Laurel
Puerto Rico	Nelson R. Medina-Moreno, MD Private Office	Coto Laurel
Puerto Rico	Retina Consultants of Puerto Rico	Hato Rey
Puerto Rico	Caribbean Pulmonary Medical Society	Ponce
Puerto Rico	Luis A. Serrano Torres, MD Private Office	Ponce
Puerto Rico	Nelson R. Medina-Moreno, MD Private Office	Ponce
Puerto Rico	Ponce Medical School Foundation, Inc. CAIMED Center	Ponce
Puerto Rico	Therapeutic and Interventional Damas Endoscopy Center	Ponce
Romania	Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie	Bucuresti
Romania	lnstitutul Clinic Fundeni, Sectia Medicina lnterna 2	Bucuresti
Romania	S.C Medlife S.A., Departamentul Gastroenterologie	Bucuresti
Romania	S.C Policlinica CCBR S.R.L., Specialitatea Medicina lnterna	Bucuresti	Sector 3
Romania	S.C. Delta Health Care S.R.L., Specialitatea Gastroenterologie	Bucuresti
Romania	S.C. Euroclinic Hospital S.A., Specialitatea Gastroenterologie	Bucuresti
Romania	S.C. Quantum Medical Center S.R.L., Specialitatea Gastroenterologie	Bucuresti
Romania	SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Cluj Napoca	Cluj-Napoca	Jud. Cluj
Romania	Centrul de Diagnostic si Tratament Affidea, Specialitatea Medicina Interna	Constanta	Jud.constanta
Romania	S.C Pelican Impex S.R.L, Sectia Gastroenterologie	Oradea	Bihor
Romania	S.C. Centrul Medical Unirea S.R.L., Specialitatea Gastroenterologie	Targu-Mures	JUD. Mures
Russian Federation	SAIH "Kemerovo Regional Clinical Hospital"	Kemerovo
Russian Federation	Gastrocenter	Novosibirsk
Russian Federation	Hospital #12	Novosibirsk
Russian Federation	Joint Stock Company Medical Center "AVICENNA"	Novosibirsk
Russian Federation	LLC "Novosibirskiy Gastrocentr''	Novosibirsk
Russian Federation	LLC "Siberian Center for Prevention and Treatment of Myopia Eye"	Novosibirsk
Russian Federation	LLC "SibNovoMed"	Novosibirsk
Russian Federation	BHI of Omsk region "Clinical oncology dispensary"	Omsk
Russian Federation	Clinicodiagnostic Center "Ultramed"	Omsk
Russian Federation	Medical center "Intervzglyad"	Omsk
Russian Federation	LLC "Polyclinic of ultrasonography 4D"	Pyatigorsk	Stavropol Region
Russian Federation	FSBI of Higher Education " North-Western Medical University n.a.I.I. Mechnikov '' of MoH RF	Saint Petersburg
Russian Federation	FSBI of Higher Education "North-Western Medical University n.a.I.I. Mechnikov'' of MoH RF	St. Petersburg
Russian Federation	Autonomous Noncommercial Medical Organization "Stavropol Regional Clinical	Stavropol
Serbia	Clinical Center " Dr Dragisa Misovic-Dedinje"	Belgrade
Serbia	Clinical Center Zvezdara	Belgrade
Serbia	Clinical Center Zvezdara	Belgrade
Serbia	General Hospital Euromedik	Belgrade
Serbia	General Hospital Euromedik.	Belgrade
Serbia	Special Hospital for Ophthalmology Milos Clinic	Belgrade
Serbia	Special Hospital for Ophthalmology "Hospital Laser Center Vid"	Kragujevac
Serbia	University Clinical Center Kragujevac	Kragujevac
Serbia	Special Hospital for eye diseases "Veselinovic "	Nis
Serbia	University Clinical Center Nis	Nis
Serbia	General Hospital Sremska Mitrovica	Sremska Mitrovica
Slovakia	Fakultna nemocnica s poliklinikou F.D.Roosevelta	Banska Bystrica
Slovakia	ALIAN. s.r.o .. Ambulancia vnutorneho lekarstva	Bardejov
Slovakia	ENDOMED, s.r.o. Gastroenterologicka ambulancia	Kosice
Slovakia	Opthalmology outpatient clinic, MUDr. Michal Popovec, s.r.o.	Lipany
Slovakia	Opthalmology outpatient clinic, MUDr. Michal Popovec, s.r.o.	Lipany
Slovakia	KM Management spol.s.r.o. Gastroenterologicke a hepatologicke centrum	Nitra
Slovakia	GASTRO I., s.r.o. Gastroenterologicka ambulancia	Presov
Slovakia	GASTRO LM s.r.o., Gastroenterologicka ambulancia	Presov
Slovakia	Pneumology: PULMO, s.r.o.	Presov
Slovakia	Pneumology: PULMO, s.r.o.	Presov
Slovakia	X-ray: FNsP J.A. Reimana Presov	Presov
South Africa	Dr K Rahman (OTC and Opthalmoscopy)	Benoni	Gauteng
South Africa	Lakeview Hospital radiology (Radiology)	Benoni	Gauteng
South Africa	Worthwhile Clinical Trials	Benoni	Gauteng
South Africa	Worthwhile Clinical trials (PFT)	Benoni	Gauteng
South Africa	Dr W Simmonds (Gastroenterology Department)	Bloemfontein	FREE State
South Africa	Dr Chris Stander (OCT)	Cape Town	Western CAPE
South Africa	Dr Eduan Deetlefs (Endoscopy)	Cape Town	Western CAPE
South Africa	Dr Peter Chapman (PFT + DLCO)	Cape Town	Western CAPE
South Africa	Morton & Partners Radiologists (Radiology)	Cape Town	Western CAPE
South Africa	Spoke Research Inc. Room 109	Cape Town	Western CAPE
South Africa	Dr E Meyer & Partners, Centurion Eye Hospital (OTC and Opthalmoscopy)	Centurion	Gauteng
South Africa	Dr Hannes Jansen van Rensburg (PFT + DLCO)	Centurion	Gauteng
South Africa	Dr Jorg Reichenberger (Endoscopy)	Centurion	Gauteng
South Africa	Drs Burger Radiologists Inc (X-ray/CT)	Centurion	Gauteng
South Africa	Johese Clinical Research, Unitas Hospital	Centurion	Gauteng
South Africa	WITS Clinical Research	Johannesberg	Gauteng
South Africa	WITS Clinical Research	Johannesburg	Gauteng
South Africa	Burger Radiology (Radiology)	Kempton Park	Gauteng
South Africa	Clinresco (PTY)Ltd (PFT)	Kempton Park	Gauteng
South Africa	Clinresco Centres (Pty) Ltd	Kempton Park	Gauteng
South Africa	Dr KJP Lubuya (OCT and Opthalmology)	Kempton Park	Gauteng
South Africa	Prof O Mwantembe (Endoscopy)	Kempton Park	Gauteng
South Africa	Emmed Research	Pretoria	Gauteng
South Africa	Emmed Research	Pretoria	Gauteng
South Africa	Dr K Rahman(OTC and Opthalmoscopy)	Springs	Gauteng
South Africa	Dr I Moola (Endoscopy)	Sunninghill	Gauteng
Spain	CEIm Hospital Universitario Fundacion Alcorcon	Alcorcon
Spain	CEIm Hospital Universitario Fundacion Alcorcon	Alcorcon, Madrid
Spain	Hospital Universitario de Gran Canaria Dr. Negrin	Las Palmas de Gran Canaria
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitari Parc Tauli	Sabadell	Barcelona
Spain	Hospital General de Tomelloso	Tomellso	Ciudad REAL
Spain	Hospital Marina Baixa	Villajoyosa (Alicante)	Espana
Switzerland	Augenpraxis Baden (OCT/Ophtalmoscopy)	Baden
Switzerland	Kantonsspital Baden, Gastroenterologie	Baden
Switzerland	Clarunis - Universitäres Bauchzentrum Basel	Basel
Switzerland	Inselspital Bern	Bern
Switzerland	OCT/Ophtalmoscopy: Berner Augenklinik am Lindenhofspital	Bern
Turkey	Gazi University Medical Faculty	Ankara
Turkey	Hacettepe University Medical Faculty	Ankara
Turkey	T.C. Saglik Bakanligi Ankara Sehir Hastanesi	Ankara
Turkey	Saglik Bilimleri Universitesi Antalya Egitim ve Arastirma Hastanesi	Antalya
Turkey	Uludag Universitesi Tip Fakultesi	Bursa
Turkey	Ege Universitesi Tip Fakultesi Hastanesi	Izmir
Turkey	Kocaeli Universitesi Tip Fakultesi Hastanesi	Kocaeli
Turkey	Mersin University Faculty of Medicine	Yenisehir,Mersin
Ukraine	RCI Chernivtsi Regional Clinical Hospital	Chernivtsi
Ukraine	Communal Institution I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital, Department of	Dnipro
Ukraine	Academician Ye.M.Neiko Chair of Internal Medicine #1, Clinical Immunology and Allergology	Ivano-Frankivsk
Ukraine	CNE Reg Clinical Hospital of Ivano-Frankivsk Reg Council, Dep of Gastroenterology	Ivano-Frankivsk
Ukraine	Communal Non-commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council	Kharkiv
Ukraine	Communal Non-commercial Enterprise Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv	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	Kharkiv
Ukraine	Med Center 'Ok!Clinic+' of Comp with limited liability "Int Inst of Clin Research", Unit of Gastro	Kyiv
Ukraine	Medical Center of Limited Liability Company Harmoniia Krasy	Kyiv
Ukraine	Private Enterprise "Clinic Medicom"	Kyiv
Ukraine	CE Volyn Reg Clinical Hospital ofVolyn Reg Council, Surgical (Endocrine and Abdominal Pathology)	Lutsk
Ukraine	CNE Lviv Clinical Emergency Hospital, Center of Therapy,Danylo Galytskyy Lviv National Medical	Lviv
Ukraine	ETHICS Commission of Municipal City Clinical Hospital of the Emergency Medical Care	Lviv
Ukraine	CNE Andrii Novak Transcarpathian Regional Clinical Hospital of Transcarpathian Reg Council, Departme	Uzhgorod
Ukraine	CNE Non-commercial Enterprise Vinnytsia City Clinical Hospital #1, Department of Gastroenterology,	Vinnytsia
Ukraine	CNE of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council, Reg	Vinnytsia
Ukraine	Medical Center of LLC Health Clinic, Medical Clinical Research Center, Unit of Gastroenterology,	Vinnytsia
Ukraine	Private Enterprise Diagnostic Center "Mediscan"	Vinnytsia
Ukraine	Scientific and Research Institute of Invalid Rehabilitation (Educational, Scientific and Treatment	Vinnytsia
United Kingdom	Central Middlesex Hospital	Harrow	Middlesex
United Kingdom	St James University Hospital	Leeds
United Kingdom	Royal Liverpool University Hospital	Liverpool
United Kingdom	Royal Liverpool University Hospital	Liverpool, Merseyside
United Kingdom	Central Middlesex Hospital	London
United Kingdom	Guys & St Thomas Hospital	London
United Kingdom	Quadram Institute Clinical Research Facility	Norwich
United Kingdom	Yeovil District Hospital	Yeovil	Somerset
United States	Om Research LLC	Apple Valley	California
United States	Victor Valley Advanced Imaging	Apple Valley	California
United States	GI Alliance	Arlington Heights	Illinois
United States	Northwest Endoscopy Center (Endoscopy)	Arlington Heights	Illinois
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Atlanta Gastroenterology Associates (endoscopy only)	Atlanta	Georgia
United States	Atlanta Gastroenterology Associates(IP only)	Atlanta	Georgia
United States	Digestive Healthcare of Georgia	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Peachtree Allergy and Asthma Clinic - Chest X-rays and PFTs	Atlanta	Georgia
United States	Ross Eyecare - Opthalmoscopy and OCT	Atlanta	Georgia
United States	Central Texas Clinical Research	Austin	Texas
United States	Dell Seton Medical Center at The University of Texas(DSMCUT) - (PFT procedure & Endoscopy procedure)	Austin	Texas
United States	Mitchel & Shannon Wong Eye Institute - (OCT procedure)	Austin	Texas
United States	The University of Texas at Austin Dell Medical School - UT Health Austin	Austin	Texas
United States	Ponce PFT & Medical Service, Inc	Aventura	Florida
United States	CaroMont Endoscopy Center	Belmont	North Carolina
United States	Diagnostic Medical X-Ray & Imaging	Boardman	Ohio
United States	Lee Eye Center	Boardman	Ohio
United States	Southwoods Imaging	Boardman	Ohio
United States	Xera Med Research	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	RecioMed Clinical Research Network, Inc	Boynton Beach	Florida
United States	Eye Care Family Vision Center	Bradenton	Florida
United States	Lungs Associates- Rampertaap M P	Bradenton	Florida
United States	Synergy Healthcare	Bradenton	Florida
United States	Total Gastroenterology	Bradenton	Florida
United States	West Florida Surgery Center(Endoscopy)	Bradenton	Florida
United States	Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD	Brandon	Florida
United States	GI Alliance	Cedar Park	Texas
United States	Geauga Sleep Center(PFT only)	Chardon	Ohio
United States	Carolinas Research Center	Charlotte	North Carolina
United States	Cornerstone Medical (Imaging & PFT)	Charlotte	North Carolina
United States	Greenman Eye Associates (OCT)	Charlotte	North Carolina
United States	Queen City Gastroenterology and Hepatology (Endoscopy)	Charlotte	North Carolina
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	Bay Area Chest Physicians, P.A. (Pulmonary Function Test)	Clearwater	Florida
United States	Bay Area Chest Physicians, P.A. (Pulmonary Function Test)	Clearwater	Florida
United States	Gastro Florida (Regulatory Administrative Duties)	Clearwater	Florida
United States	Northwood Vision (Optical Coherence Tomography)	Clearwater	Florida
United States	Northwood Vision (Optical Coherence Tomography)	Clearwater	Florida
United States	Safety Harbor Surgery (Endoscopy Procedures)	Clearwater	Florida
United States	West Coast Endoscopy Center (Endoscopy Procedures)	Clearwater	Florida
United States	3T Radiology LLC	Coconut Creek	Florida
United States	Colorado Springs Imaging (Ultrasound and MRE Location)	Colorado Springs	Colorado
United States	Colorado Springs Pulmonary Consultants, PC	Colorado Springs	Colorado
United States	Front Range Endoscopy Center	Colorado Springs	Colorado
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	The Wright Eye Center (OCT Facility)	Colorado Springs	Colorado
United States	Cascades Endoscopy Center	Columbia	Maryland
United States	Charter Radiology	Columbia	Maryland
United States	Gastro Center of Maryland, LLC	Columbia	Maryland
United States	Beraja Medical Institute (OCT)	Coral Gables	Florida
United States	Carlos Selema MD PA	Coral Gables	Florida
United States	Barnes-Jewish West County Hospital (Additional Endoscopy Location)	Creve Coeur	Missouri
United States	Houston Pulmonary Sleep and Allergy Associates (PFT)	Cypress	Texas
United States	Interlab Corp	Doral	Florida
United States	Center for Digestive Health (Endoscopy Location)	Dothan	Alabama
United States	Digestive Health Specialists	Dothan	Alabama
United States	Dothan Eyecare-Dr. Brent McKinley (OCT Location)	Dothan	Alabama
United States	Flowers Hospital (Imaging Location)	Dothan	Alabama
United States	Pulmonary Associates (PFT Location)	Dothan	Alabama
United States	Duke Eye Center (Opthalmoscopy/OCT)	Durham	North Carolina
United States	Duke Medical Plaza North Duke Street (recruitment and study activities)	Durham	North Carolina
United States	Duke University Medical Center (Ileocolonoscopy, PFT & DLCO)	Durham	North Carolina
United States	Euclid Endoscopy Center-El Cajon (Endoscopy procedure only)	El Cajon	California
United States	Harman Eye Center (OCT only)	Forest	Virginia
United States	San Antonio Military Medical Center, Department of Pathology	Fort Sam Houston	Texas
United States	San Antonio Military Medical Center, Department of Pathology	Fort Sam Houston	Texas
United States	GI Alliance	Fort Worth	Texas
United States	Allied Health Clinical Research Organization, LLC	Freehold	New Jersey
United States	Freehold Endoscopy Associates, LLC d/b/a Endoscopy Center of Monmouth County	Freehold	New Jersey
United States	Freehold Ophthalmology	Freehold	New Jersey
United States	Monmouth Ocean Pulmonary Medicine	Freehold	New Jersey
United States	Princeton Radiology	Freehold	New Jersey
United States	Caromont Regional Medical Center (PFT and DCLO only)	Gastonia	North Carolina
United States	Clinical Research of Gastonia	Gastonia	North Carolina
United States	Covenant Eye Care (OCT only)	Gastonia	North Carolina
United States	GI Alliance (PFT)	Gurnee	Illinois
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	Medical Eye Services LTD (Ophthalmoscopy with OCT)	Gurnee	Illinois
United States	Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only)	Hanover	Maryland
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Advanced Eye Center	Hialeah	Florida
United States	Advanced Eye Center	Hialeah	Florida
United States	Hollywood Research Center, INC	Hollywood	Florida
United States	Alkek Eye Center Jamail Specialty Care Center (OCT)	Houston	Texas
United States	Bay Area Endoscopy Center, LLC	Houston	Texas
United States	Baylor College of Medicine - Baylor St. Luke's Medical Center	Houston	Texas
United States	Baylor St. Luke's Medical Center	Houston	Texas
United States	Baylor St. Luke's Medical Center - McNair Campus	Houston	Texas
United States	Baylor St. Luke's Medical Center - McNair Campus (pharmacy)	Houston	Texas
United States	Baylor St. Luke's Medical Center Endoscopy - McNair Campus	Houston	Texas
United States	Digestive Health Associates	Houston	Texas
United States	Eye Specialists of Texas	Houston	Texas
United States	Houston Eye Associates (For Eye Examination)	Houston	Texas
United States	Mann Eye Institute	Houston	Texas
United States	Memorial Endoscopy Center (For Colonoscopy)	Houston	Texas
United States	Memorial Hermann Hospital	Houston	Texas
United States	Memorial Hermann Hospital (Endoscopy)	Houston	Texas
United States	Memorial Hermann Hospital (PFT)	Houston	Texas
United States	Memorial Hermann Hospital- TMC Investigational Drugs Services Pharmacy (Drug Storage)	Houston	Texas
United States	Memorial Hermann Memorial City Digestive Health Center (For Colonoscopy)	Houston	Texas
United States	Memorial Hermann Memorial City Medical Digestive Health Center	Houston	Texas
United States	Memorial Pulmonology(For PFT)	Houston	Texas
United States	Northside Gastroenterology Associates PA	Houston	Texas
United States	Pearland Surgery Center	Houston	Texas
United States	Robert Cizik Eye Clinic	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Cabell Huntington Hospital (Endoscopy Only)	Huntington	West Virginia
United States	Cabell Huntington Hospital Center for Lung Health (PFTs Only)	Huntington	West Virginia
United States	MARSHALL EYE SURGEONS - HUNTINGTON (OCT and OPTHALMOSCOPY ONLY)	Huntington	West Virginia
United States	University Physicians and Surgeons (DBA: Marshall Health)	Huntington	West Virginia
United States	Swedish Endoscopy Center - Issaquah	Issaquah	Washington
United States	A Terrell Williams, MD, PLLC (OCT)	Jackson	Mississippi
United States	Jackson Pulmonary Associates (PFT)	Jackson	Mississippi
United States	Southern Therapy and Advanced Research, LLC	Jackson	Mississippi
United States	St. Dominic Ambulatory Surgery Center (colonoscopy, Endoscopy)	Jackson	Mississippi
United States	Borland-Groover Clinic (Endoscopy Facility)	Jacksonville	Florida
United States	Cisca Pulmonary & Critical Care (PFT Facility)	Jacksonville	Florida
United States	Encore Borland-Groover Clinical Research	Jacksonville	Florida
United States	Nicolitz Eye Consultants (OCT Facility)	Jacksonville	Florida
United States	UF Health Imaging Center-Emerson (chest x-rays)	Jacksonville	Florida
United States	UF Health Jacksonville Respiratory Therapy (PFT and DLCO)	Jacksonville	Florida
United States	UF Health Jacksonville-Faculty Clinic (ileocolonoscopy and biopsy)	Jacksonville	Florida
United States	UF Health Laboratory Emerson (blood draws)	Jacksonville	Florida
United States	UF Health Opthalmology - Jacksonville (Ophthalmology with OCT)	Jacksonville	Florida
United States	UF Health Radiology-Jacksonville (chest x-rays)	Jacksonville	Florida
United States	Jupiter Outpatient Surgery Center	Jupiter	Florida
United States	IHS Health, LLC	Kissimmee	Florida
United States	Koman Family Outpatient Pavilion (ENDO)	La Jolla	California
United States	Perlman Medical Offices	La Jolla	California
United States	Shiley Eye Institute (OCT)	La Jolla	California
United States	UCSD Clinical and Translational Research Institute	La Jolla	California
United States	UCSD Health System (Endo/PFT/DLCO)	La Jolla	California
United States	UCSD lnvestigational Drug Service Pharmacy	La Jolla	California
United States	Dr. Raed Al-Naser -Sharp Grossmont outpatient (DLCO procedure only)	La Mesa	California
United States	Dr. Sally s. Lee in La Mesa (Ophthalmologist procedure only)	La Mesa	California
United States	North Shore Endoscopy Center (Endoscopy)	Lake Bluff	Illinois
United States	Inland Pulmonary Specialists [PFT Only]	Lake Elsinore	California
United States	Inland Pulmonary Specialists [PFT Only]	Lake Elsinore	California
United States	A V Pediatrics, Allergy and Family Medicine - PFT	Lancaster	California
United States	Advanced Endoscopy and Pain Center - Colonoscopy	Lancaster	California
United States	Advanced Imaging Center - Chest X-Ray	Lancaster	California
United States	Antelope Valley Eye Care - Ophthalmologist	Lancaster	California
United States	AV Pediatrics Allergy and Family Medicine	Lancaster	California
United States	Jatinder S. Pruthi, MD FACG CPI	Lancaster	California
United States	OM Research LLC	Lancaster	California
United States	Advanced Research Institute, Inc.	Largo	Florida
United States	Florida Center for Gastroenterology	Largo	Florida
United States	Lee Shettle Eye & Hearing (Ophthalmoscopy Only)	Largo	Florida
United States	Lung Center (Pulmonary Function Test only)	Laurel	Maryland
United States	Libertyville Imaging Center (Diagnostic Imaging)	Libertyville	Illinois
United States	United Medical Doctors	Los Alamitos	California
United States	United Medical Doctors Los Alamitos	Los Alamitos	California
United States	Advanced Vision Care (OCT)	Los Angeles	California
United States	Century City Endoscopy (Colonoscopy - Nicholas Karyotakis, MD)	Los Angeles	California
United States	Gastrointestinal Biosciences Clinical Trials,LLC	Los Angeles	California
United States	Sleep Medicine/Pulmonary Disease (PFT - Said Mostafavi, MD)	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	Ophthalmic Physicians Incorporated (OCT Only)	Mentor	Ohio
United States	The Endoscopy Center of Lake County	Mentor	Ohio
United States	Vitreo Retinal Consultants(OCT only)	Mentor	Ohio
United States	Anchor Medical Research, Llc	Miami	Florida
United States	Global Life Research Network	Miami	Florida
United States	Infinite Clinical Research	Miami	Florida
United States	Juan Barrio, MD (PFT when needed)	Miami	Florida
United States	La Salud Research Clinic Inc.	Miami	Florida
United States	Pulmonology Physicians of South Florida	Miami	Florida
United States	Reina Eye Care P.A.	Miami	Florida
United States	Research Associates of South Florida	Miami	Florida
United States	South Florida Center for Endoscopy and Digestive Disease, LLC	Miami	Florida
United States	The Endoscopy Center (Endoscopy Procedure)	Miami	Florida
United States	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	Digestive Health Specialists (Satellite Clinic Location)	Mobile	Alabama
United States	Premier Medical Group East (Opthalmology & Optometry Facility)	Mobile	Alabama
United States	Pulmonary Associates (Chest X-Ray & PFT Facility)	Mobile	Alabama
United States	Surgicare of Mobile (Endoscopy & Biopsy Facility)	Mobile	Alabama
United States	3T Imaging of Morton Grove (Diagnostic Imaging)	Morton Grove	Illinois
United States	Temecula Valley Imaging [CXR Only]	Murrieta	California
United States	Temecula Valley Imaging [CXR Only]	Murrieta	California
United States	United Medical Doctors	Murrieta	California
United States	United Medical Doctors	Murrieta	California
United States	United Surgery Center Murrieta [Endoscopy Only]	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 only	Naples	Florida
United States	Retina Consultants of Southwest Florida OCT only	Naples	Florida
United States	NYU Langone Eye Center (Ophthalmology)	New York	New York
United States	NYU Langone Health	New York	New York
United States	NYU Langone Health - Ambulatory Care Center	New York	New York
United States	NYU Langone Health, Investigational Pharmacy, Perlmutter Cancer Center	New York	New York
United States	NYU Langone Inflammatory Bowel Disease Center	New York	New York
United States	NYU Pulmonary and Critical Care Associates (Pulmonary)	New York	New York
United States	One Health Research Clinic Atlanta, LLC	Norcross	Georgia
United States	Norman Endoscopy Center	Norman	Oklahoma
United States	Physicians and Surgeons X-Ray	Norman	Oklahoma
United States	Central Sooner Research	Oklahoma City	Oklahoma
United States	Hightower Clinical	Oklahoma City	Oklahoma
United States	Johnston Opthalmology	Oklahoma City	Oklahoma
United States	Saint Anthony Endoscopy Center	Oklahoma City	Oklahoma
United States	SSM Health, Saint Anthony Hospital	Oklahoma City	Oklahoma
United States	Center for Digestive Endoscopy - Endoscopy Facility	Orlando	Florida
United States	Central Florida Retina	Orlando	Florida
United States	Orlando Health Heart Institute	Orlando	Florida
United States	Orlando Health Inc.	Orlando	Florida
United States	Orlando Health/Digestive Health Institute	Orlando	Florida
United States	Pediatric & Adult Research Center	Orlando	Florida
United States	IMIC Inc	Palmetto Bay	Florida
United States	IMIC Inc.	Palmetto Bay	Florida
United States	LinQ Research, LLC	Pearland	Texas
United States	Arizona Retina Institute/ Phoenix Retina Associates(OCT)	Peoria	Arizona
United States	SimonMed Imaging (Imaging)	Peoria	Arizona
United States	BRCR Medical Center Inc	Plantation	Florida
United States	Florida Institute of Health(PFT)	Plantation	Florida
United States	Advanced Medical Research Center	Port Orange	Florida
United States	Duke Health's Brier Creek Medical Pavilion (recruitment and study activities)	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	Advanced Research Institute Inc.(IP and PFT)	Saint Petersburg	Florida
United States	Bay Area Endoscopy and Surgery Center (Endoscopy only)	Saint Petersburg	Florida
United States	Pasadena Center for Asthma and Lung Disorders (PFT and DLCO Only)	Saint Petersburg	Florida
United States	St. Petersburg Endoscopy Center (Endoscopy Procedures)	Saint Petersburg	Florida
United States	Theia Clinical Research, LLC	Saint Petersburg	Florida
United States	ACRC Studies	San Diego	California
United States	Guthrie Medical Group, PC	Sayre	Pennsylvania
United States	Robert Packer Hospital	Sayre	Pennsylvania
United States	First Hill Endoscopy Center	Seattle	Washington
United States	Pacific Northwest Retina	Seattle	Washington
United States	Pulmonary Function Lab	Seattle	Washington
United States	Richard Bensinger, MD	Seattle	Washington
United States	Swedish Gastroenterology	Seattle	Washington
United States	Swedish Medical Center	Seattle	Washington
United States	Bardmoor GastroEnterology	Seminole	Florida
United States	Larkin Community Hospital (Endoscopy Procedure)	South Miami	Florida
United States	Sun City Endoscopy Center (Endoscopy)	Sun City	Arizona
United States	Absolute Surgical Specialist - Craig Amshel, MD	Sun City Center	Florida
United States	Eye Physicians of Florida,LLP (OCT)	Sunrise	Florida
United States	Broward P.E.T. Imaging Center	Tamarac	Florida
United States	Impression Imaging	Tamarac	Florida
United States	GCP Clinical Research,LLC	Tampa	Florida
United States	Lab - Processing/ Storage	Tampa	Florida
United States	LoCicero Medical Group	Tampa	Florida
United States	Newsome Eye Specialist (OCT Procedures Only)	Tampa	Florida
United States	South Tampa Surgery Center	Tampa	Florida
United States	Theia Clinical Research Centers - Tampa	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	California Eye Professionals [OCT Only]	Temecula	California
United States	United Surgery Center Temecula [Endoscopy Only]	Temecula	California
United States	United Surgery Center Temecula [Endoscopy Only]	Temecula	California
United States	Theia Clinical Research Centers - Tampa	Temple Terrace	Florida
United States	Christus Trinity Mother Frances Endoscopy Center (endoscopies only)	Tyler	Texas
United States	Heaton Eye Associates (OCT 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 (for PFT only)	Victoria	Texas
United States	Surgery Center (For endoscopy only)	Victoria	Texas
United States	Victoria Eye Center (For OCT only)	Victoria	Texas
United States	Victoria Gastroenterology	Victoria	Texas
United States	Physicians Surgery Center	Victorville	California
United States	Retina Consultants of Southern California	Victorville	California
United States	GI Alliance Webster	Webster	Texas
United States	Weston Outpatient Surgical Center (Endoscopy)	Weston	Florida
United States	Lake Pulmonary Associates (PFT only)	Willoughby	Ohio
United States	Retina Specialists of Ohio(OCT only)	Willoughby Hills	Ohio
United States	Florida Pulmonary Research lnstitute - Pulmonary Function Test/DLCO	Winter Park	Florida
United States	Pulmonary Rehabilitation Associates	Youngstown	Ohio
United States	The Surgical Hospital at Southwoods	Youngstown	Ohio

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,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Chile,  Colombia,  Croatia,  Czechia,  Denmark,  Egypt,  France,  Georgia,  Germany,  Greece,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Lebanon,  Lithuania,  Malaysia,  Mexico,  Moldova, Republic of,  Netherlands,  Norway,  Philippines,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants with Endoscopic Response [Substudy A]		Weeks 14 and 52
Primary	Proportion of Participants With Endoscopic Response [Substudy 1]		Week 14
Primary	Proportion of Participants With Endoscopic Response [Substudy 2]		Week 14
Primary	Proportion of Participants With Clinical Remission Crohn's Disease Activity Index (CDAI) [Substudy 2]		Week 14
Primary	Proportion of Participants With Clinical Remission CDAI [Substudy 3]		Week 52
Primary	Proportion of Participants With Endoscopic Response [Substudy 3]		Week 52
Secondary	Proportion of Participants With Clinical Remission CDAI [Substudy A]		Up to Week 66
Secondary	Change From Baseline in Simple Endoscopic Score in Crohn's Disease (SES-CD) Score [Substudy A]		Baseline to Week 66
Secondary	Change From Baseline in CDAI Score [Substudy A]		Baseline to Week 66
Secondary	Proportion of Participants With Clinical Remission CDAI [Substudy 1]		Week 14
Secondary	Proportion of Participants with Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 1]		Week 14
Secondary	Proportion of Participants With Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 2]		Week 14
Secondary	Proportion of Participants With Clinical Response CDAI [Substudy 2]		Week 14
Secondary	Proportion of Participants With Endoscopic Response and Clinical Remission CDAI [Substudy 2]		Week 14
Secondary	Proportion of Participants With Endoscopic Remission [Substudy 2]		Week 14
Secondary	Change from baseline in CD-PRO/SS [Substudy 2]		Week 14
Secondary	Proportion of Participants With Clinical Remission CDAI Among Participants In Clinical Remission CDAI at Substudy 3 Baseline [Substudy 3]		Week 52
Secondary	Proportion of Participants With Endoscopic Response Among Participants in Endoscopic Response at Substudy 3 Baseline [Substudy 3]		Week 52
Secondary	Proportion of Participants With Corticosteroid-Free Clinical Remission CDAI Among Participants Receiving Corticosteroids at Substudy 3 Baseline [Substudy 3]		Week 52
Secondary	Proportion of Participants With Endoscopic Remission [Substudy 3]		Week 52
Secondary	Proportion of Participants With Clinical Remission PRO2 [Substudy 3]		Week 52
Secondary	Proportion of Participants with Clinical Response or Endoscopic Response [Substudy 3]		Week 52
Secondary	Proportion of Participants With Clinical Remission CDAI by Visit up to the End Of Treatment [Substudy 4]		Up to Week 208
Secondary	Proportion of Participants With Clinical Remission PRO2 by Visit up to the End Of Treatment [Substudy 4]		Up to Week 208
Secondary	Number and Severity of Adverse Events	Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.	Up to approximately 70 weeks for Substudy A,approximately 24 weeks for Substudy 1 and 2; 42 weeks for Substudy 3; and 212 weeks for Substudy 4

External Links

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