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

June 5, 2026 updated by: Pfizer

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

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.

Study Overview

Status

Terminated

Conditions

Crohn's Disease

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

379

Phase

Phase 2
Phase 3

Contacts and Locations

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

Study Locations

Argentina
- Prov. de Buenos Aires
  - Ciudadela, Prov. de Buenos Aires, Argentina, 1702
    - Instituto Medico Elsa Perez(I.M.E.P)
  - Ciudadela, Prov. de Buenos Aires, Argentina, B1702GIK
    - Instituto Medico Elsa Perez (I.M.E.P.) (Local Lab)
  - Ciudadela, Prov. de Buenos Aires, Argentina, B1702GIK
    - Instituto Medico Elsa Perez (I.M.E.P.) (Pharmacy)
  - Hurlingham, Prov. de Buenos Aires, Argentina, B1686NCI
    - Estudio de La Vision (OCT, Ophthalmoscopy)
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, S2000DEJ
    - Instituto Médico de la Fundación Estudios Clínicos
  - Rosario, Santa Fe Province, Argentina, S2000AUC
    - Gastroenterologia Rosario (Endoscopy)
  - Rosario, Santa Fe Province, Argentina, S2000CTC
    - Microcirugia Ocular SA (OCT, Ophthalmoscopy)
  - Rosario, Santa Fe Province, Argentina, S2000KZD
    - Consultorios extemos de Sanatorio Parque (PFT with DLCO, Pulmonar Functional Test with DLCO)
- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
    - Centro de Investigaciones Medicas Tucuman
Australia
- New South Wales
  - Macquarie University, New South Wales, Australia, 2109
    - Macquarie University Hospital
  - Macquarie University, New South Wales, Australia, 2109
    - Macquarie University Hospital Pharmacy
  - Macquarie University, New South Wales, Australia, 2109
    - Macquarie Respiratory Services
  - Macquarie University, New South Wales, Australia, 2109
    - Macquarie University Hospital Clinical Trials
  - Macquarie University, New South Wales, Australia, 2109
    - MQ Health Ophthalmology
- Queensland
  - Brisbane, Queensland, Australia, 4029
    - Royal Brisbane & Women's Hospital
  - North Mackay, Queensland, Australia, 4740
    - Coral Sea Clinical Research Institute
- Victoria
  - Bellfield, Victoria, Australia, 3081
    - MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons
  - Epping, Victoria, Australia, 3076
    - The Northern Hospital
  - Heidelberg, Victoria, Australia, 3084
    - Austin Hospital
  - Melbourne, Victoria, Australia, 3011
    - Vision Eye Institute
  - Melbourne, Victoria, Australia, 3011
    - Footscray Hospital
  - Parkville, Victoria, Australia, 3050
    - The Royal Melbourne Hospital
  - Rosanna, Victoria, Australia, 3084
    - Heidelberg Eye Clinic
- Western Australia
  - Murdoch, Western Australia, Australia, 6150
    - Fiona Stanley Hospital
  - Nedlands, Western Australia, Australia, 6009
    - Lions Eye Institute Limited
  - O'Connor, Western Australia, Australia, 6163
    - The trustee for The RTS Unit Trust trading as Respiratory Testing Services
Austria
- - Graz, Austria, 8036
    - LKH Universitats-Klinikum Graz
  - Innsbruck, Austria, A-6020
    - Medical University Innsbruck, Internal Medicine Ⅰ
  - Vienna, Austria, 1090
    - AKH Wien- Universitatsklinik fiir Innere Medizin III
  - Vienna, Austria, 1090
    - Univ.-Professor Dr. Mehrdad Baghestanian
  - Vienna, Austria, 1090
    - AKH Wien- Universitatsklinik fur Innere Medizin III
Belarus
- - Homyel, Belarus, 246029
    - Institution "Gomel Regional Clinical Hospital"
  - Minsk, Belarus, 220096
    - Health care Institution "10th City Clinical Hospital"
  - Mogilev, Belarus, 212018
    - Health Care Institution "Mogilev Hospital #1"
  - Vitebsk, Belarus, 210037
    - Health Care Institution "Vitebsk Regional Clinical Hospital"
  - Vitebsk, Belarus, 210604
    - Healthcare Institution "Vitebsk Regional Clinical Specialized Center"
Belgium
- - Ghent, Belgium, 9000
    - Universitair Ziekenhuis Gent
  - Ghent, Belgium, 9000
    - AZ Maria-Middelares
  - Leuven, Belgium, 3000
    - Universitaire Ziekenhuizen Leuven
  - Roeselare, Belgium, 8800
    - Campus Brugsesteenweg
  - Roeselare, Belgium, 8800
    - Campus Rumbeke
  - Torhout, Belgium, 8820
    - Campus Rembert Torhout
  - Yvoir, Belgium, 5530
    - Centre Hospitalier Universitaire UCL Namur - Site Godinne
Bulgaria
- - Sofia, Bulgaria, 1527
    - UMHAT "Tsaritsa Yoanna-ISUL" EAD
  - Sofia, Bulgaria, 1431
    - "DCC Alexandrovska", EOOD
  - Sofia, Bulgaria, 1606
    - ,,University multiprofile hospital for active treatment and emergency medicine N.I. Pirogov" EAD
Canada
- Quebec
  - Montreal, Quebec, Canada, H3G 1A4
    - McGill University Health Centre - Montreal General Hospital (Electrocardiogram Clinic)
  - Montreal, Quebec, Canada, H3G 1A4
    - McGill University Health Centre - Montreal General Hospital (Endoscopy Clinic)
  - Montreal, Quebec, Canada, H3G 1A4
    - McGill University Health Centre - Montreal General Hospital (Pharmacy)
  - Montreal, Quebec, Canada, H3G 1A4
    - McGill University Health Centre - Montreal General Hospital (Radiology)
  - Montreal, Quebec, Canada, H3G 1A4
    - McGill University Health Centre - Montreal General Hospital (Research Site)
  - Montreal, Quebec, Canada, H4A 3J1
    - Centre for Innovative Medicine - Research Institute of the McGill University Health Centre(Pulmonary
  - Montreal, Quebec, Canada, H4P 2S4
    - Eye Health MD (Ophthalmology)
Chile
- RM
  - Santiago, RM, Chile, 8330034
    - Centro de Investigaciones Clinicas de la Universidad Catolica
- Santiago Metropolitan
  - Santiago, Santiago Metropolitan, Chile, 7620157
    - Clinica Universidad de Los Andes
  - Santiago, Santiago Metropolitan, Chile, 8330336
    - CeCim Biocinetic
Colombia
- Quindío Department
  - Armenia, Quindío Department, Colombia, 630004
    - IPS Fundacion Cardiomet CEQUIN
- Valle del Cauca Department
  - Cali, Valle del Cauca Department, Colombia, 760035
    - Centro de lnvestigaciones Clinicas S.A.S
Croatia
- - Zagreb, Croatia, 10000
    - University Hospital Center Zagreb
Czechia
- - Horažďovice, Czechia, 341 01
    - MUDr. Jaroslava Skalova
  - Hradec Králové, Czechia, 500 12
    - Hepato-Gastroenterologie HK, s.r.o.
  - Hradec Králové, Czechia, 500 12
    - VISUS, spol s.r.o.
  - Klatovy, Czechia, 339 01
    - GASTRO JeKa, s.r.o.
  - Klatovy, Czechia, 339 01
    - Klatovska nemocnice a.s.
  - Olomouc, Czechia, 779 00
    - PreventaMed s.r.o.
  - Olomouc, Czechia, 779 00
    - Ocni ordinace Olomouc
  - Olomouc, Czechia, 779 00
    - MUDr. Pavlina Kazinotova s.r.o.
Denmark
- - Aalborg, Denmark, 9000
    - Aalborg University Hospital, Department of Medical Gastroenterology, Medicinerhuset
  - Hvidovre, Denmark, 2650
    - Hvidovre University Hospital
Egypt
- - Alexandria, Egypt, 21131
    - Alexandria Clinical Research Center , Faculty of Medicine , Alexandria University
  - Cairo, Egypt
    - National Hepatology and Tropical Medicine Research Institute
  - Cairo, Egypt, 11556
    - Ain Shams University hospital
  - Cairo, Egypt
    - Air Force Specialized Hospital(AFSH)
  - Cairo, Egypt
    - Cairo University , Kasr Al Aini Hospital
  - Dakahlia, Egypt
    - Egyptian Liver Research Institute and Hospital ( ELRIAH)
  - Giza, Egypt
    - Theodor Bilharz Research Institute Research Ethics Committee
  - Menofeya, Egypt, 32511
    - National liver institute
France
- - Amiens, France, 80054
    - CHU Amiens Picardie
  - Clermont-Ferrand, France, 63000
    - Chu Gabriel Montpied
  - Clermont-Ferrand, France, 63000
    - CHU De Clermont Ferrand - Hopital Estaing
  - Grenoble, France, 38043
    - CHU Grenoble Alpes - Hopital Michallon
  - Grenoble, France, 38043
    - Endoscopy: CHU Grenoble Alpes- Hopital Michallon
  - La Roche-sur-Yon, France, 85925
    - CHD Vendee, Unite de Recherche Clinique
  - Lille, France, 59037
    - CHU de Lille - Hopital Claude Huriez
  - Lille, France, 59037
    - Optical Coherence Tomography and Ophthalmology CHU de Lille Hopital Roger Salengro
  - Lille, France, 59037
    - Pulmonary Function Test CHU Lille, Institut Coeur Poumon
  - Montpellier, France, 34295
    - CHU Saint-Eloi
  - Montpellier, France, 34295
    - Hopital Saint-Eloi - Pole Digestif - Hgea Recherche Clinique - Rdc
  - Nice, France, 06202
    - CHU de Nice, Hopital 1'Archet 2
  - Reims, France, 51100
    - Hopital Maison Blanche, CHU DE REIMS
  - Reims, France, 51092
    - Hopital Robert Debre
  - Reims, France, 51100
    - Hopital Robert Debre CHU DE REIMS
  - Saint-Etienne, France, 42055
    - CHU Saint Etienne - Hôpital Nord
  - Saint-Priest-en-Jarez, France, 42270
    - Optical Coherence Tomography and Ophthalmology
  - Saint-Priest-en-Jarez, France, 42270
    - Pulmonary Function Test
  - Toulouse, France, 31059
    - Hopital Rangueil
  - Toulouse, France, 31300
    - Hopital Purpan PPR pole cephalique
  - Vandœuvre-lès-Nancy, France, 54511
    - CHRU Nancy Brabois
Georgia
- - Tbilisi, Georgia, 0160
    - LTD Aversi Clinic
  - Tbilisi, Georgia, 0159
    - LTD Institute of Clinical Cardiology
  - Tbilisi, Georgia, 0160
    - JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
  - Tbilisi, Georgia, 0160
    - LTD Academician Nikoloz Kipshidze Central University Clinic
  - Tbilisi, Georgia, 0172
    - Malkhaz Katsiashvili Multiprofile Emergency Medicine Center, LTD
  - Tbilisi, Georgia, 0179
    - LTD Medical Center "CITO"
Germany
- - Augsburg, Germany, 86156
    - Universitaetsklinikum Augsburg
  - Brandenburg an der Havel, Germany, 14770
    - Staedtisches Klinikum Brandenburg
  - Frankfurt, Germany, 60431
    - Prof. Dr. med. Dr. med. Habil. Jens Buhren, FEBO
  - Frankfurt am Main, Germany, 60431
    - Agaplesion Markus Krankenhaus
  - Hamburg, Germany, 20251
    - HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
  - Jena, Germany, 07747
    - Universitaetsklinikum Jena
  - Jena, Germany, 07747
    - OCT/Ophtalmoscopy address: Universitaetsklinikum Jena
  - Jena, Germany, 07747
    - PFT address: Universitaetsklinikum Jena
  - Kassel, Germany, 34121
    - PFT address: Praxis fur Pneumologie und Allergologie
  - Kassel, Germany, 34177
    - OCT/Ophtalmoscopy address: Augenarztpraxis Dr. Karola Hassan
  - Kiel, Germany, 24105
    - Nordblick Augenklinik
  - Kiel, Germany, 24105
    - Universitatsklinikum Schleswig-Holstein- Campus Kiel
  - Nürtingen, Germany, 72622
    - Dr. Irina Hasewinkel
  - Nürtingen, Germany, 72622
    - Medius Klinik Nuertingen
- Hassen
  - Kassel, Hassen, Germany, 34117
    - Gastroenterologie Opernstraβe
Greece
- - Alexandroupoli, Greece, 681 00
    - University General Hospital of Alexandroupoli
  - Athens, Greece, 10676
    - General Hospital of Athens "Evangelismos"
- Crete
  - Heraklion, Crete, Greece, 71500
    - Univerisity General Hospital of Heraklion
Hungary
- - Budapest, Hungary, 1136
    - Pannonia Maganorvosi Centrum
  - Budapest, Hungary, 1033
    - Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft. (abbreviated name: Clinexpert Kft.)
  - Budapest, Hungary, 1062
    - Ophthalmology procedures: Magyar Honvedseg Egeszsegugyi Kozpont
  - Budapest, Hungary, 1062
    - Pulmonary procedures: Vasutegeszsegugyi Nonprofit Kozhasznu K ft.
  - Budapest, Hungary, 1134
    - Ophthalmology, OCT: Medicover Zrt.
  - Budapest, Hungary, 1139
    - Chest X-ray: XIII. keruleti Egeszsegugyi Szolgalat Kozhasznu Nonprofit Kft.
  - Békéscsaba, Hungary, 5600
    - Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia
- Heves County
  - Gyöngyös, Heves County, Hungary, 3200
    - Bugat Pal Korhaz, Gasztroenterologia
- Komárom-Esztergom
  - Tatabánya, Komárom-Esztergom, Hungary, 2800
    - Szent Borbala Korhaz
  - Tatabánya, Komárom-Esztergom, Hungary, 2800
    - DLCO and ophthalmology tests: Szent Borbala Korhaz
India
- - Kochi, India, 682027
    - Aster Medcity, Aster DM Healthcare Ltd.
- Gujarat
  - Surat, Gujarat, India, 395002
    - Surat Institute of Digestive Sciences
- Haryana
  - Gurugram, Haryana, India, 122002
    - Fortis Memorial Research Institute
- Maharashtra
  - Nagpur, Maharashtra, India, 440010
    - Midas Multispeciality Hospital Pvt. Ltd
- Rajasthan
  - Jaipur, Rajasthan, India, 302001
    - S. R. Kalla Memorial Gastro & General Hospital
Israel
- - Afula, Israel, 1834111
    - Haemek Medical Center
  - Jerusalem, Israel, 9103102
    - Shaare Zedek Medical Center
  - Ramat Gan, Israel, 5262000
    - Chaim Sheba Medical Center
  - Tel Aviv, Israel, 6423906
    - Tel Aviv Sourasky Medical Center
Italy
- - Catania, Italy, 829-95126
    - Azienda Ospedaliera Ospedale Cannizzaro
  - Catanzaro, Italy, 88100
    - A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente Campus Universitario "Salvatore Venuta"
  - Catanzaro, Italy, 88100
    - A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente
  - Catanzaro, Italy, 88100
    - CAMPUS GERMANETO Magazzino farmaci e dispositivi medici, uffici
  - Pavia, Italy, 27100
    - Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche
  - Rome, Italy, 00189
    - PFT address: Azienda Ospedaliero-Universitaria Sant' Andrea UOC Pneumologia
  - Verona, Italy, 37024
    - IRCCS Ospedale Sacro Cuore Don Calabria
  - Verona, Italy, 37134
    - OCT/PFT/Endoscopy address: CRC - Cenro Ricerche Cliniche di Verona
- Foggia
  - San Giovanni Rotondo, Foggia, Italy, 71013
    - IRCCS Ospedale Casa Sollievo della Sofferenza
  - San Giovanni Rotondo, Foggia, Italy, 71013
    - OCT/ PFT/ Endoscopy address: IRCCS Ospedale Casa Sollievo della Sofferenza
- MI
  - Milan, MI, Italy, 20132
    - Ospedale San Raffaele
- Milan
  - Garbagnate Milanese, Milan, Italy, 20024
    - ASST Rhodense - Pneumology Unit
  - Milan, Milan, Italy, 20017 Rho
    - ASST Rhodense, U.O.C. Gastroenterologia ed Endoscopia Digestiva
  - Rho, Milan, Italy, 20017
    - ASST Rhodense - Ophthalmology Unit
- Milano
  - Rozzano, Milano, Italy, 20089
    - IRCCS Humanitas Research Hospital
- Verona
  - Negrar, Verona, Italy, 37024
    - OCT/ PFT/ Endoscopy address: IRCCS Ospedale Sacro Cuore Don Calabria
Japan
- Chiba
  - Kashiwa-shi, Chiba, Japan, 277-0871
    - Kokikai Tsujinaka Hospital Kashiwanoha
  - Nagareyama-shi, Chiba, Japan, 270-0116
    - Ishii Eye Clinic
- Fukuoka
  - Kitakyushu-shi, Fukuoka, Japan, 807-8555
    - Hospital of the University of Occupational and Environmental Health
  - Kitakyusyu-shi, Fukuoka, Japan, 802-8561
    - Kitakyushu Municipal Medical Center
- Ibaraki
  - Toride-shi, Ibaraki, Japan, 302-0014
    - Matsumoto Eye Clinic
- Kagoshima-ken
  - Kagoshima, Kagoshima-ken, Japan, 892-0846
    - Sameshima Hospital
  - Kagoshima, Kagoshima-ken, Japan, 892-0824
    - Jiaikai Idzuro Imamura Hospital
  - Kagoshima, Kagoshima-ken, Japan, 890-0062
    - Kagoshima Kouseiren Hospital
  - Kagoshima, Kagoshima-ken, Japan, 892-0825
    - Sameshima Eye Clinic
- Kumamoto
  - Kumamoto, Kumamoto, Japan, 861-8520
    - Japanese Red Cross Kumamoto Hospital
- Saga-ken
  - Saga, Saga-ken, Japan, 849-8501
    - Saga University Hospital
- Tokyo
  - Shinjuku-ku, Tokyo, Japan, 169-0073
    - Japan Community Health care Organization Tokyo Yamate Medical Center
Lebanon
- - Beirut, Lebanon, 166830
    - Hotel Dieu de France Hospital
  - Beirut, Lebanon, 1100 2807
    - Saint George University Hospital Medical Center
  - Beirut, Lebanon, 113-6044
    - Rafik Hariri University Hospital
  - Saida, Lebanon
    - Hammoud Hospital University Medical Center
  - Tripoli, Lebanon
    - Nini Hospital s.a:l
Lithuania
- - Vilnius, Lithuania, LT-08661
    - Vilnius University Hospital Santaros Klinikos
Malaysia
- - Kuala Lumpur, Malaysia, 59100
    - University Malaya Medical Centre
Mexico
- - Chihuahua City, Mexico, 31203
    - Scientia Investigacion Clinica S.C.
  - Chihuahua City, Mexico, 31020
    - Sanatorio Palmore A.C.
  - Chihuahua City, Mexico, 31203
    - Vista Lasser de Chihuahua S.C.
  - Chihuahua City, Mexico, 31283
    - Servicios Hospitalarios de México, S.A. de C.V.
  - Veracruz, Mexico, 91900
    - FAICIC S. de R.L. de C.V.
  - Veracruz, Mexico, 91910
    - Gabinete de Diagnostico COVADONGA
  - Veracruz, Mexico, 91918
    - Alberto Collado Solorzano (Clinica Vision)
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44130
    - Centro de Investigacion Medico Biologica Y Terapia Avanzada S.C.
  - Guadalajara, Jalisco, Mexico, 44600
    - Global Glaucoma Institute
  - Guadalajara, Jalisco, Mexico, 44600
    - Video Endoscopia Americas
  - Guadalajara, Jalisco, Mexico, 44670
    - Comercializadora Winco S.A. de C.V.
- Veracruz
  - Boca del Rio, Veracruz, Mexico, 94299
    - Cirugia y Gastro de Veracruz S.A. de C.V. (Progastro)
Moldova
- - Chisinau, Moldova, 2005
    - "Sf. Arhanghel Mihail" Municipal Clinical Hospital, Department of Gastroenterology
  - Chisinau, Moldova, MD2025
    - PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Colorectal Surgery
  - Chisinau, Moldova, MD2025
    - PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Gastroenterology
  - Chisinau, Moldova, MD2025
    - PMSI Republican Clinical Hospital "Timofei Mosneaga", Outpatient Department
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Academic Medical Centre
  - Utrecht, Netherlands, 3584 CX
    - UMC Utrecht
Poland
- - Bystra, Poland, 43-360
    - Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)
  - Karkow, Poland, 31-156
    - Specjalistyczne Gabinety Lekarskie LANDA
  - Krakow, Poland, 30-033
    - Centre De La Vision Centrum Okulistyczne(OCT, Ophthalmoscopy)
  - Krakow, Poland, 30-307
    - Medicina (Endoscopy)
  - Krakow, Poland, 31-153
    - Centrum Medyczne EVITA(Endoscopy)
  - Lodz, Poland, 90-752
    - IP Clinic Sp. z o.o.
  - Lodz, Poland, 90-338
    - Centrum Medyczne "Ksiezy Mlyn" (OCT, Ophtalmoscopy)
  - Lodz, Poland, 93-513
    - Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatolog i im. M. Kopernika w Lodzi
  - Lodz, Poland, 90-338
    - (Centrum Medyczne Ksiezy Mlyn (OCT and Ophthalmoscopy)
  - Lodz, Poland, 90-644
    - AMICARE Sp. z o.o. sp.k
  - Lodz, Poland, 91-053
    - Centra Medyczne Medyceusz (DLCO)
  - Lodz, Poland, 92-551
    - Salve Health Care Sp. o.o., (PFT and Endoscopy)
  - Nowy Targ, Poland, 34-400
    - Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
  - Oświęcim, Poland, 32-600
    - Medicome Sp. Z O.O
  - Piotrkow Trybunalski, Poland, 97-300
    - Przychodnia Okulistyczna "Oculus" Barbara Cybulska (OCT, Ophtalmoscopy)
  - Piotrkow Trybunalski, Poland, 97-300
    - Samodzielny Szpital Wojewodzki im. Mikolaja Kopernika (Endoscopy)
  - Piotrokow Trybunalski, Poland, 97-300
    - Trialmed CRS
  - Poznan, Poland, 60-529
    - Solurmed Centrum Medyczne
  - Poznan, Poland, 60-538
    - OCU Service Mikolaj Meller Sp.j.(OCT, Ophtalmoscopy)
  - Rzeszów, Poland, 35-326
    - Centrum Medyczne Medyk
  - Rzeszów, Poland, 35-055
    - Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie (Ophthalmpscopy)
  - Rzeszów, Poland, 35-241
    - Podkarpackie Centrum Chorob Plue w Rzeszowie (DLCO)
  - Strzegom, Poland, 58-150
    - Strzegomskie Centrum Medyczno - Diagnostyczne Sp. z o.o. (Endoscopy)
  - Swidnica, Poland, 58-100
    - DC-MED
  - Swidnica, Poland, 58-100
    - Centrum Medyczne EZ-MEDICA (OCT, Ophtalmoscopy)
  - Swidnica, Poland, 58-100
    - Szpital "Latawiec" -Poradnia Gruzlicy i Chorob Pluc (PFT)
  - Warsaw, Poland, 00-635
    - Centrum Zdrowia MDM
  - Warsaw, Poland, 00-631
    - Centrum Zdrowia MDM (OCT,opthalmoscopy)
  - Warsaw, Poland, 01-138
    - Instytut Gruzlicy i Chorob Pluc(DLCO)
  - Warsaw, Poland, 02-653
    - Endoterapia PFG (Endoscopy)
  - Warsaw, Poland, 02-653
    - Instytut Oka (OCT, Ophtalmoscopy)
  - Warsaw, Poland, 03-712
    - Specjalistyczne Gabinety Lekarskie Body Clinic
  - Warsaw, Poland, 03-731
    - Centrum Okulistyczne JASKRA (OCT, Ophthalmoscopy)
  - Warsaw, Poland, 04-141
    - Wojskowy lnstytut Medyczny (PFT)
  - Wroclaw, Poland, 60-681
    - EuroMediCare Szpital Specjalistyczny z Przychodniit (Endoscopy)
- Greater Poland Voivodeship
  - Poznan, Greater Poland Voivodeship, Poland, 60-681
    - NSZOZ Termedica
Romania
- - Bucharest, Romania, 012015
    - SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie
  - Bucharest, Romania, 022328
    - Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie
- JUD. CLUJ
  - Cluj-Napoca, JUD. CLUJ, Romania, 400006
    - Spitalul Clinic Judetean de Urgenta Cluj Napoca
- Jud.constanta
  - Constanța, Jud.constanta, Romania, 900591
    - Centrul de Diagnostic si Tratament Affidea, Specialitatea Medicina Interna
Russia
- - Kemerovo, Russia, 650066
    - SAIH "Kemerovo Regional Clinical Hospital"
  - Novosibirsk, Russia, 630005
    - LLC "SibNovoMed"
  - Novosibirsk, Russia, 630007
    - Gastrocenter
  - Novosibirsk, Russia, 630007
    - LLC "Novosibirskiy Gastrocentr''
  - Novosibirsk, Russia, 630084
    - Hospital #12
  - Novosibirsk, Russia, 630091
    - LLC "Siberian Center for Prevention and Treatment of Myopia Eye"
  - Novosibirsk, Russia, 630099
    - Joint Stock Company Medical Center "AVICENNA"
  - Omsk, Russia, 644013
    - BHI of Omsk region "Clinical Oncology Dispensary"
  - Omsk, Russia, 644024
    - Clinicodiagnostic Center "Ultramed"
  - Omsk, Russia, 644070
    - Medical center "Intervzglyad"
  - Saint Petersburg, Russia, 191015
    - FSBI of Higher Education " North-Western Medical University n.a.I.I. Mechnikov '' of MoH RF
  - Saint Petersburg, Russia, 195067
    - FSBI of Higher Education "North-Western Medical University n.a.I.I. Mechnikov'' of MoH RF
  - Stavropol, Russia, 355017
    - Autonomous Noncommercial Medical Organization "Stavropol Regional Clinical
- Stavropol Kray
  - Pyatigorsk, Stavropol Kray, Russia, 357502
    - LLC "Polyclinic of ultrasonography 4D"
Serbia
- - Belgrade, Serbia, 11000
    - Clinical Center Zvezdara
Slovakia
- - Banská Bystrica, Slovakia, 975 17
    - Fakultna nemocnica s poliklinikou F.D.Roosevelta
  - Bardejov, Slovakia, 08501
    - ALIAN. s.r.o .. Ambulancia vnutorneho lekarstva
  - Košice, Slovakia, 040 13
    - ENDOMED, s.r.o. Gastroenterologicka ambulancia
  - Lipany, Slovakia, 082 71
    - Opthalmology outpatient clinic, MUDr. Michal Popovec, s.r.o.
  - Nitra, Slovakia, 949 01
    - KM Management spol.s.r.o. Gastroenterologicke a hepatologicke centrum
  - Prešov, Slovakia, 080 01
    - GASTRO LM s.r.o., Gastroenterologicka ambulancia
  - Prešov, Slovakia, 080 01
    - Pneumology: PULMO, s.r.o.
South Africa
- Free State
  - Bloemfontein, Free State, South Africa, 9301
    - Dr W Simmonds (Gastroenterology Department)
- Gauteng
  - Benoni, Gauteng, South Africa, 1501
    - Worthwhile Clinical Trials
  - Benoni, Gauteng, South Africa, 1500
    - Dr K Rahman (OTC and Opthalmoscopy)
  - Benoni, Gauteng, South Africa, 1500
    - Lakeview Hospital radiology (Radiology)
  - Benoni, Gauteng, South Africa, 1500
    - Worthwhile Clinical trials (PFT)
  - Centurion, Gauteng, South Africa, 0157
    - Dr E Meyer & Partners, Centurion Eye Hospital (OTC and Opthalmoscopy)
  - Centurion, Gauteng, South Africa, 0157
    - Dr Jorg Reichenberger (Endoscopy)
  - Centurion, Gauteng, South Africa, 0157
    - Drs Burger Radiologists Inc (X-ray/CT)
  - Centurion, Gauteng, South Africa, 0157
    - Johese Clinical Research, Unitas Hospital
  - Johannesburg, Gauteng, South Africa, 2193
    - Wits Clinical Research
  - Kempton Park, Gauteng, South Africa, 1619
    - Clinresco Centres (Pty) Ltd
  - Kempton Park, Gauteng, South Africa, 1619
    - Burger Radiology (Radiology)
  - Kempton Park, Gauteng, South Africa, 1619
    - Dr KJP Lubuya (OCT and Opthalmology)
  - Kempton Park, Gauteng, South Africa, 1619
    - Prof O Mwantembe (Endoscopy)
  - Pretoria, Gauteng, South Africa, 0002
    - Emmed Research
  - Springs, Gauteng, South Africa, 1559
    - Dr K Rahman(OTC and Opthalmoscopy)
  - Sunninghill, Gauteng, South Africa, 2196
    - Dr I Moola (Endoscopy)
- Western Cape
  - Cape Town, Western Cape, South Africa, 7405
    - Dr Peter Chapman (PFT + DLCO)
  - Cape Town, Western Cape, South Africa, 7441
    - Dr Chris Stander (OCT)
  - Cape Town, Western Cape, South Africa, 7441
    - Morton & Partners Radiologists (Radiology)
  - Cape Town, Western Cape, South Africa, 7441
    - Spoke Research Inc. Room 109
South Korea
- - Daegu, South Korea, 41404
    - Kyungpook National University Chilgok Hospital
  - Daegu, South Korea, 41944
    - Kyungpook National University Hospital
  - Daegu, South Korea, 41944
    - Endoscopy Facility in kyungpook National University Hospital
  - Daegu, South Korea, 41944
    - OCT Facility In kyungpook National University Hospital
  - Daegu, South Korea, 41944
    - PFT Facility in Kyungpook National University Hospital
  - Daejeon, South Korea, 34943
    - The Catholic University of Korea, Daejeon St. Mary's Hospital
  - Incheon, South Korea, 21565
    - Gachon University Gil Medical Center
  - Seongnam-si, South Korea, 13496
    - CHA University Bundang CHA Hospital
  - Seoul, South Korea, 06273
    - Gangnam Severance Hospital, Yonsei University Health System
  - Seoul, South Korea, 06973
    - Chung-Ang University Hospital
  - Seoul, South Korea, 02447
    - Kyunghee University Medical Center
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, South Korea, 10326
    - Dongguk University Ilsan Hospital
Spain
- - Las Palmas de Gran Canaria, Spain, 35010
    - Hospital Universitario de Gran Canaria Dr. Negrin
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz
- Ciudad REAL
  - Tomellso, Ciudad REAL, Spain, 13700
    - Hospital General de Tomelloso
Switzerland
- - Bern, Switzerland, 3010
    - Inselspital Bern
  - Bern, Switzerland, 3012
    - OCT/Ophtalmoscopy: Berner Augenklinik am Lindenhofspital
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06500
    - Gazi University Medical Faculty
  - Ankara, Turkey (Türkiye), 06100
    - Hacettepe University Medical Faculty
  - Ankara, Turkey (Türkiye), 06800
    - T.C. Saglik Bakanligi Ankara Sehir Hastanesi
  - Antalya, Turkey (Türkiye), 07100
    - Saglik Bilimleri Universitesi Antalya Egitim ve Arastirma Hastanesi
  - Izmir, Turkey (Türkiye), 35100
    - Ege Universitesi Tip Fakultesi Hastanesi
  - Kocaeli, Turkey (Türkiye), 41380
    - Kocaeli University Research and Training Hospital
  - Yenişehir, Turkey (Türkiye), 33343
    - Mersin University Faculty of Medicine
Ukraine
- - Kharkiv, Ukraine, 61124
    - Communal Non-commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council
  - Kharkiv, Ukraine, 61024
    - LLC "EyeQClinic"
  - Kharkiv, Ukraine, 61022
    - Llc "Ldts Skaymed'
  - Kharkiv, Ukraine, 61037
    - Communal Non-commercial Enterprise Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv
  - Kharkiv, Ukraine, 61045
    - Llc "Medical Center Oftalmika"
  - Kharkiv, Ukraine, 61103
    - Municipal Health Care "Kharkiv City Hospital Ambulance and Emergency Medical care
  - Kyiv, Ukraine, 01135
    - Medical Center of Limited Liability Company Harmoniia Krasy
  - Kyiv, Ukraine, 02091
    - Med Center 'Ok!Clinic+' of Comp with limited liability "Int Inst of Clin Research", Unit of Gastro
  - Kyiv, Ukraine, 04210
    - Private Enterprise "Clinic Medicom"
  - Lutsk, Ukraine, 43005
    - CE Volyn Reg Clinical Hospital ofVolyn Reg Council, Surgical (Endocrine and Abdominal Pathology)
  - Vinnytsia, Ukraine, 21000
    - Private Enterprise Diagnostic Center "Mediscan"
  - Vinnytsia, Ukraine, 21009
    - Medical Center of LLC Health Clinic, Medical Clinical Research Center, Unit of Gastroenterology,
  - Vinnytsia, Ukraine, 21018
    - CNE of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council, Reg
  - Vinnytsia, Ukraine, 21029
    - Scientific and Research Institute of Invalid Rehabilitation (Educational, Scientific and Treatment
United Kingdom
- - Liverpool, United Kingdom, L7 8XP
    - Royal Liverpool University Hospital
  - London, United Kingdom, SE1 9RT
    - Guys & St Thomas Hospital
  - Norwich, United Kingdom, NR4 7UQ
    - Quadram Institute Clinical Research Facility
United States
- Alabama
  - Dothan, Alabama, United States, 36301
    - Digestive Health Specialists
  - Dothan, Alabama, United States, 36301
    - Dothan Eyecare-Dr. Brent McKinley (OCT Location)
  - Dothan, Alabama, United States, 36301
    - Center for Digestive Health (Endoscopy Location)
  - Dothan, Alabama, United States, 36301
    - Pulmonary Associates (PFT Location)
  - Dothan, Alabama, United States, 36305
    - Flowers Hospital (Imaging Location)
  - Mobile, Alabama, United States, 36608
    - Digestive Health Specialists (Satellite Clinic Location)
  - Mobile, Alabama, United States, 36608
    - Premier Medical Group East (Opthalmology & Optometry Facility)
  - Mobile, Alabama, United States, 36608
    - Pulmonary Associates (Chest X-Ray & PFT Facility)
  - Mobile, Alabama, United States, 36608
    - Surgicare of Mobile (Endoscopy & Biopsy Facility)
- Arizona
  - Peoria, Arizona, United States, 85381
    - Arizona Retina Institute/ Phoenix Retina Associates(OCT)
  - Peoria, Arizona, United States, 85381
    - SimonMed Imaging (Imaging)
  - Sun City, Arizona, United States, 85351
    - Sun City Endoscopy Center (Endoscopy)
- California
  - Apple Valley, California, United States, 92307
    - Om Research LLC
  - Apple Valley, California, United States, 92307
    - Victor Valley Advanced Imaging
  - La Jolla, California, United States, 92037
    - UCSD lnvestigational Drug Service Pharmacy
  - La Jolla, California, United States, 92093
    - Shiley Eye Institute (OCT)
  - La Jolla, California, United States, 92037
    - Koman Family Outpatient Pavilion (ENDO)
  - La Jolla, California, United States, 92037
    - Perlman Medical Offices
  - La Jolla, California, United States, 92037
    - UCSD Clinical and Translational Research Institute
  - La Jolla, California, United States, 92037
    - UCSD Health System (Endo/PFT/DLCO)
  - Lancaster, California, United States, 93534
    - Om Research LLC
  - Lancaster, California, United States, 93534
    - A V Pediatrics, Allergy and Family Medicine - PFT
  - Lancaster, California, United States, 93534
    - Advanced Endoscopy and Pain Center - Colonoscopy
  - Lancaster, California, United States, 93534
    - Advanced Imaging Center - Chest X-Ray
  - Lancaster, California, United States, 93534
    - Antelope Valley Eye Care - Ophthalmologist
  - Lancaster, California, United States, 93534
    - AV Pediatrics Allergy and Family Medicine
  - Lancaster, California, United States, 93534
    - Jatinder S. Pruthi, MD FACG CPI
  - Murrieta, California, United States, 92563
    - United Medical Doctors
  - Victorville, California, United States, 92392
    - Retina Consultants of Southern California
  - Victorville, California, United States, 92395
    - Physicians Surgery Center
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Peak Gastroenterology Associates
  - Colorado Springs, Colorado, United States, 80903
    - Front Range Endoscopy Center
  - Colorado Springs, Colorado, United States, 80909
    - Colorado Springs Pulmonary Consultants, PC
  - Colorado Springs, Colorado, United States, 80909
    - The Wright Eye Center (OCT Facility)
  - Colorado Springs, Colorado, United States, 80919
    - Colorado Springs Imaging (Ultrasound and MRE Location)
- Florida
  - Boca Raton, Florida, United States, 33487
    - Xera Med Research
  - Boynton Beach, Florida, United States, 33472
    - RecioMed Clinical Research Network, Inc
  - Brandon, Florida, United States, 33511
    - Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD
  - Clearwater, Florida, United States, 33756
    - West Coast Endoscopy Center (Endoscopy Procedures)
  - Clearwater, Florida, United States, 33756
    - Bay Area Chest Physicians, P.A. (Pulmonary Function Test)
  - Clearwater, Florida, United States, 33761
    - Northwood Vision (Optical Coherence Tomography)
  - Clearwater, Florida, United States, 33761
    - Safety Harbor Surgery (Endoscopy Procedures)
  - Clearwater, Florida, United States, 33762
    - Gastro Florida (Regulatory Administrative Duties)
  - Coral Gables, Florida, United States, 33134
    - Beraja Medical Institute (OCT)
  - Hialeah, Florida, United States, 33012
    - Advanced Eye Center
  - Jacksonville, Florida, United States, 32256
    - Encore Borland-Groover Clinical Research
  - Jacksonville, Florida, United States, 32207
    - UF Health Imaging Center-Emerson (chest x-rays)
  - Jacksonville, Florida, United States, 32207
    - UF Health Laboratory Emerson (blood draws)
  - Jacksonville, Florida, United States, 32209
    - UF Health Jacksonville Respiratory Therapy (PFT and DLCO)
  - Jacksonville, Florida, United States, 32209
    - UF Health Jacksonville-Faculty Clinic (ileocolonoscopy and biopsy)
  - Jacksonville, Florida, United States, 32209
    - UF Health Opthalmology - Jacksonville (Ophthalmology with OCT)
  - Jacksonville, Florida, United States, 32209
    - UF Health Radiology-Jacksonville (chest x-rays)
  - Jacksonville, Florida, United States, 32216
    - Cisca Pulmonary & Critical Care (PFT Facility)
  - Jacksonville, Florida, United States, 32216
    - Nicolitz Eye Consultants (OCT Facility)
  - Jacksonville, Florida, United States, 32256
    - Borland-Groover Clinic (Endoscopy Facility)
  - Jupiter, Florida, United States, 33458
    - Jupiter Outpatient Surgery Center
  - Kissimmee, Florida, United States, 34741
    - IHS Health, LLC
  - Largo, Florida, United States, 33773
    - Lee Shettle Eye & Hearing (Ophthalmoscopy Only)
  - Miami, Florida, United States, 33133
    - Infinite Clinical Research
  - Miami, Florida, United States, 33156
    - Research Associates of South Florida
  - Miami, Florida, United States, 33176
    - Anchor Medical Research, LLC
  - Miami, Florida, United States, 33134
    - The Endoscopy Center (Endoscopy Procedure)
  - Miami, Florida, United States, 33173
    - Juan Barrio, MD (PFT when needed)
  - Miami, Florida, United States, 33133
    - Pulmonology Physicians of South Florida
  - Miami, Florida, United States, 33133
    - Reina Eye Care P.A.
  - Miami, Florida, United States, 33155
    - La Salud Research Clinic Inc.
  - Miami, Florida, United States, 33156
    - South Florida Center for Endoscopy and Digestive Disease, LLC
  - Naples, Florida, United States, 34102
    - Gastroenterology Group of Naples
  - Naples, Florida, United States, 34102
    - Gulfshore Endoscopy Center
  - Naples, Florida, United States, 34103
    - Retina Consultants of Southwest Florida OCT only
  - Naples, Florida, United States, 34109
    - Lisette Delgado Sanchez, MD PFT only
  - Orlando, Florida, United States, 32825
    - Pediatric & Adult Research Center
  - Palmetto Bay, Florida, United States, 33157
    - IMIC Inc.
  - Palmetto Bay, Florida, United States, 33157
    - IMIC Inc
  - Port Orange, Florida, United States, 32127
    - Advanced Medical Research Center
  - Seminole, Florida, United States, 33777
    - Bardmoor GastroEnterology
  - South Miami, Florida, United States, 33143
    - Larkin Community Hospital (Endoscopy Procedure)
  - St. Petersburg, Florida, United States, 33705
    - St. Petersburg Endoscopy Center (Endoscopy Procedures)
  - St. Petersburg, Florida, United States, 33707
    - Pasadena Center for Asthma and Lung Disorders (PFT and DLCO Only)
  - St. Petersburg, Florida, United States, 33709
    - Bay Area Endoscopy and Surgery Center (Endoscopy only)
  - St. Petersburg, Florida, United States, 33709
    - Theia Clinical Research, LLC
  - St. Petersburg, Florida, United States, 33710
    - Advanced Research Institute Inc.(IP and PFT)
  - Sun City Center, Florida, United States, 33573
    - Absolute Surgical Specialist - Craig Amshel, MD
  - Tampa, Florida, United States, 33612
    - Usf Health Morsani Center For Advanced Healthcare
  - Tampa, Florida, United States, 33606
    - USF Health South Tampa Center for Advanced Healthcare
  - Tampa, Florida, United States, 33609
    - GCP Clinical Research,LLC
  - Tampa, Florida, United States, 33609
    - South Tampa Surgery Center
  - Tampa, Florida, United States, 33609
    - Newsome Eye Specialist (OCT Procedures Only)
  - Tampa, Florida, United States, 33606
    - Lab - Processing/ Storage
  - Tampa, Florida, United States, 33609
    - LoCicero Medical Group
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Atlanta Gastroenterology Associates
  - Atlanta, Georgia, United States, 30309
    - Digestive Healthcare of Georgia
  - Atlanta, Georgia, United States, 30324
    - Ross Eyecare - Opthalmoscopy and OCT
  - Atlanta, Georgia, United States, 30342
    - Atlanta Gastroenterology Associates (endoscopy only)
  - Atlanta, Georgia, United States, 30342
    - Atlanta Gastroenterology Associates(IP only)
  - Atlanta, Georgia, United States, 30309
    - Peachtree Allergy and Asthma Clinic - Chest X-rays and PFTs
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - GI Alliance
  - Arlington Heights, Illinois, United States, 60005
    - Northwest Endoscopy Center (Endoscopy)
  - Gurnee, Illinois, United States, 60031
    - GI Alliance (PFT)
  - Gurnee, Illinois, United States, 60031
    - Illinois Gastroenterology Group-Gurnee (Patients Seen; IP Delivered)
  - Gurnee, Illinois, United States, 60031
    - Medical Eye Services LTD (Ophthalmoscopy with OCT)
  - Lake Bluff, Illinois, United States, 60044
    - North Shore Endoscopy Center (Endoscopy)
  - Libertyville, Illinois, United States, 60048
    - Libertyville Imaging Center (Diagnostic Imaging)
  - Morton Grove, Illinois, United States, 60053
    - 3T Imaging of Morton Grove (Diagnostic Imaging)
- Maryland
  - Columbia, Maryland, United States, 21045
    - Cascades Endoscopy Center
  - Columbia, Maryland, United States, 21044
    - Charter Radiology
  - Columbia, Maryland, United States, 21045
    - Gastro Center of Maryland, LLC
  - Hanover, Maryland, United States, 21076
    - Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only)
  - Laurel, Maryland, United States, 20707
    - Lung Center (Pulmonary Function Test only)
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - Southern Therapy and Advanced Research, LLC
  - Jackson, Mississippi, United States, 39216
    - A Terrell Williams, MD, PLLC (OCT)
  - Jackson, Mississippi, United States, 39216
    - Jackson Pulmonary Associates (PFT)
  - Jackson, Mississippi, United States, 39216
    - St. Dominic Ambulatory Surgery Center (colonoscopy, Endoscopy)
- Missouri
  - Creve Coeur, Missouri, United States, 63141
    - Barnes-Jewish West County Hospital (Additional Endoscopy Location)
  - St Louis, Missouri, United States, 63110
    - Barnes-Jewish Hospital
  - St Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - St Louis, Missouri, United States, 63108
    - Washington University School of Medicine
- New Jersey
  - Freehold, New Jersey, United States, 07728
    - Allied Health Clinical Research Organization, LLC
  - Freehold, New Jersey, United States, 07728
    - Freehold Endoscopy Associates, LLC d/b/a Endoscopy Center of Monmouth County
  - Freehold, New Jersey, United States, 07728
    - Freehold Ophthalmology
  - Freehold, New Jersey, United States, 07728
    - Monmouth Ocean Pulmonary Medicine
  - Freehold, New Jersey, United States, 07728
    - Princeton Radiology
- New York
  - New York, New York, United States, 10016
    - NYU Langone Health
  - New York, New York, United States, 10016
    - NYU Langone Inflammatory Bowel Disease Center
  - New York, New York, United States, 10016
    - NYU Langone Eye Center (Ophthalmology)
  - New York, New York, United States, 10016
    - NYU Langone Health - Ambulatory Care Center
  - New York, New York, United States, 10016
    - NYU Langone Health, Investigational Pharmacy, Perlmutter Cancer Center
  - New York, New York, United States, 10016
    - NYU Pulmonary and Critical Care Associates (Pulmonary)
- North Carolina
  - Charlotte, North Carolina, United States, 28215
    - Carolinas Research Center
  - Charlotte, North Carolina, United States, 28204
    - Queen City Gastroenterology and Hepatology (Endoscopy)
  - Charlotte, North Carolina, United States, 28211
    - Greenman Eye Associates (OCT)
  - Charlotte, North Carolina, United States, 28273
    - Cornerstone Medical (Imaging & PFT)
- Ohio
  - Chardon, Ohio, United States, 44024
    - Geauga Sleep Center(PFT only)
  - Cincinnati, Ohio, United States, 45219
    - UC Health Physicians Office
  - Cincinnati, Ohio, United States, 45229
    - UC Health (Pulmonary Function Testing)
  - Cincinnati, Ohio, United States, 45219
    - UC Health Hoxworth (OCT only)
  - Cincinnati, Ohio, United States, 45219
    - University of Cincinnati Medical Center (PFT and Endoscopy location)
  - Mentor, Ohio, United States, 44060
    - Great Lakes Gastroenterology Research, LLC
  - Mentor, Ohio, United States, 44060
    - The Endoscopy Center of Lake County
  - Mentor, Ohio, United States, 44060
    - Ophthalmic Physicians Incorporated (OCT Only)
  - Mentor, Ohio, United States, 44060
    - Vitreo Retinal Consultants(OCT only)
  - Willoughby, Ohio, United States, 44094
    - Lake Pulmonary Associates (PFT only)
  - Willoughby Hills, Ohio, United States, 44094
    - Retina Specialists of Ohio(OCT only)
- Oklahoma
  - Norman, Oklahoma, United States, 73071
    - Norman Endoscopy Center
  - Norman, Oklahoma, United States, 73071
    - Physicians and Surgeons X-Ray
  - Oklahoma City, Oklahoma, United States, 73118
    - Central Sooner Research
  - Oklahoma City, Oklahoma, United States, 73102
    - Hightower Clinical
  - Oklahoma City, Oklahoma, United States, 73102
    - Saint Anthony Endoscopy Center
  - Oklahoma City, Oklahoma, United States, 73102
    - SSM Health, Saint Anthony Hospital
  - Oklahoma City, Oklahoma, United States, 73120
    - Johnston Opthalmology
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Penn State Milton S. Hershey Medical Center
- Texas
  - Austin, Texas, United States, 78705
    - Central Texas Clinical Research
  - Cypress, Texas, United States, 77429
    - Houston Pulmonary Sleep and Allergy Associates (PFT)
  - Houston, Texas, United States, 77030
    - The University of Texas Health Science Center at Houston
  - Houston, Texas, United States, 77030
    - Baylor St. Luke's Medical Center
  - Houston, Texas, United States, 77047
    - Pearland Surgery Center
  - Houston, Texas, United States, 77030
    - Alkek Eye Center Jamail Specialty Care Center (OCT)
  - Houston, Texas, United States, 77024
    - Houston Eye Associates (For Eye Examination)
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine - Baylor St. Luke's Medical Center
  - Houston, Texas, United States, 77030
    - Baylor St. Luke's Medical Center - McNair Campus (pharmacy)
  - Houston, Texas, United States, 77030
    - Baylor St. Luke's Medical Center - McNair Campus
  - Houston, Texas, United States, 77030
    - Baylor St. Luke's Medical Center Endoscopy - McNair Campus
  - Houston, Texas, United States, 77030
    - Mann Eye Institute
  - Houston, Texas, United States, 77030
    - Memorial Hermann Hospital- TMC Investigational Drugs Services Pharmacy (Drug Storage)
  - Houston, Texas, United States, 77034
    - Bay Area Endoscopy Center, LLC
  - Houston, Texas, United States, 77055
    - Memorial Endoscopy Center (For Colonoscopy)
  - Houston, Texas, United States, 77065
    - Eye Specialists of Texas
  - Houston, Texas, United States, 77065
    - Northside Gastroenterology Associates PA
  - Houston, Texas, United States, 77079
    - Memorial Pulmonology(For PFT)
  - Houston, Texas, United States, 77204
    - Digestive Health Associates
  - Houston, Texas, United States, 77204
    - Memorial Hermann Memorial City Digestive Health Center (For Colonoscopy)
  - Pearland, Texas, United States, 77584
    - LinQ Research, LLC
  - Tyler, Texas, United States, 75701
    - Tyler Research Institute, LLC
  - Tyler, Texas, United States, 75701
    - UT Health East Texas Physicians (pulmonary functions only)
  - Tyler, Texas, United States, 75701
    - Christus Trinity Mother Frances Endoscopy Center (endoscopies only)
  - Tyler, Texas, United States, 75701
    - Heaton Eye Associates (OCT only)
  - Victoria, Texas, United States, 77904
    - Victoria Gastroenterology
  - Victoria, Texas, United States, 77904
    - Citizens Healthplex (for PFT only)
  - Victoria, Texas, United States, 77904
    - Surgery Center (For endoscopy only)
  - Victoria, Texas, United States, 77904
    - Victoria Eye Center (For OCT only)
  - Webster, Texas, United States, 77598
    - GI Alliance Webster
- Virginia
  - Forest, Virginia, United States, 24551
    - Harman Eye Center (OCT only)
  - Lynchburg, Virginia, United States, 24502
    - Blue Ridge Medical Research
  - Lynchburg, Virginia, United States, 24501
    - Lynchburg Pulmonary Associates, Inc. (PFT only)
- Washington
  - Issaquah, Washington, United States, 98029
    - Swedish Endoscopy Center - Issaquah
  - Seattle, Washington, United States, 98122
    - Swedish Medical Center
  - Seattle, Washington, United States, 98104
    - Swedish Gastroenterology
  - Seattle, Washington, United States, 98104
    - Pacific Northwest Retina
  - Seattle, Washington, United States, 98104
    - Richard Bensinger, MD
  - Seattle, Washington, United States, 98122
    - First Hill Endoscopy Center
  - Seattle, Washington, United States, 98122
    - Pulmonary Function Lab
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Froedtert Memorial Lutheran Hospital

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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 (TNFα) 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, TNFα 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

Study Plan

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

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Etrasimod matching placebo tablet taken by mouth, once daily.
Experimental: Etrasimod Dose A	Drug: Etrasimod Dose A taken by mouth, once daily. Other Names: APD334 Drug: Etrasimod Dose B taken by mouth, once daily. Other Names: APD334
Experimental: Etrasimod Dose B	Drug: Etrasimod Dose A taken by mouth, once daily. Other Names: APD334 Drug: Etrasimod Dose B taken by mouth, once daily. Other Names: APD334

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA Time Frame: Week 14 of SSA	Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from study baseline in SES-CD. SES-CD consisted of a composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 bowel segments: ileum; right; transverse; left colon and rectum. Size of ulcers score: 0= none, 1= aphthous ulcers, 2= large ulcers and 3= very large ulcers. Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30% and 3= >30%. Affected surface score: 0= unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%. Presence of narrowing score: 0= none, 1= single, can be passed, 2= multiple, can be passed, 3= cannot be passed. Total SES-CD= sum of each component score for all 5 bowel segments and ranged from 0 (no disease) to 60 (severe disease), higher score indicated more severe disease.	Week 14 of SSA
Percentage of Participants With Endoscopic Response by SES-CD at Week 14: SS1 Time Frame: Week 14 of SS1	Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from study baseline in SES-CD. SES-CD consisted of composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 bowel segments: ileum; right; transverse; left colon and rectum. Size of ulcers score: 0= none, 1= aphthous ulcers, 2= large ulcers and 3= very large ulcers. Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30% and 3= >30%. Affected surface score: 0= unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%. Presence of narrowing score: 0= none, 1= single, can be passed, 2= multiple can be passed, 3= cannot be passed. Total SES CD= sum of each component score for all 5 bowel segments and ranged from 0 (no disease)-60 (severe disease), higher score indicated more severe disease. Multiple imputation (MI) method used; percentage calculated based on average response rate from MI datasets.	Week 14 of SS1
Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Responder Cohort Time Frame: Week 52 of study	Clinical remission was considered as CDAI score <150. CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); hematocrit (HCT): 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.	Week 52 of study
Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Non-Responder Cohort Time Frame: Week 52 of study	Clinical remission was considered as CDAI score <150. CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT: 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.	Week 52 of study
Percentage of Participants With Endoscopic Response by SES-CD at Week 52: SS3 Responder Cohort Time Frame: Week 52 of study	Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from parent study (SS1) baseline in SES-CD. SES-CD consisted of composite score based on size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right; transverse; left colon; rectum. Size of ulcers score: 0=none, 1=aphthous ulcers,2=large ulcers,3=very large ulcers. Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30%, 3= >30%. Affected surface score: 0= unaffected segment, 1= <50%,2= 50%-75%,3= >75%. Presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed,3=cannot be passed. Total SES CD=sum of each domain score for all 5 bowel segments and ranged from 0 (no disease) to 60 (severe disease), higher score= more severe disease.	Week 52 of study
Percentage of Participants With Endoscopic Response by SES-CD at Week 52: SS3 Non-Responder Cohort Time Frame: Week 52 of study	Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from parent study (SS1) baseline in SES-CD. SES-CD consisted of composite score based on size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right, transverse; left colon; rectum. Size of ulcers score: 0=none, 1=aphthous ulcers,2=large ulcers,3=very large ulcers. Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30%, 3= >30%. Affected surface score: 0= unaffected segment, 1= <50%,2= 50%-75%,3= >75%. Presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed,3=cannot be passed. Total SES CD=sum of each domain score for all 5 bowel segments and ranged from 0 (no disease) to 60 (severe disease), higher score= more severe disease.	Week 52 of study

Secondary Outcome Measures

Collaborators and Investigators

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

Sponsor

Pfizer

Collaborators

Arena is a wholly owned subsidiary of Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

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

General Publications

Dubinsky MC, Wu J, McDonnell A, Lazin K, Goetsch M, Branquinho D, Modesto I, Armuzzi A. Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program. J Crohns Colitis. 2025 May 8;19(5):jjae173. doi: 10.1093/ecco-jcc/jjae173.

Helpful Links

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

Study record dates

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

Study Major Dates

Study Start (Actual)

January 6, 2020

Primary Completion (Actual)

April 23, 2025

Study Completion (Actual)

June 9, 2025

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

APD334-202
C5041006 (Other Identifier: Alias Study Number)
2024-513569-38-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Crohn's Disease

Clinical Trials on Etrasimod

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