Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis (GLADIATOR UC)

January 23, 2024 updated by: Pfizer

A Randomized, Double Blind, Placebo Controlled, 52 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

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

Study Contact

Study Locations

    • New South Wales
      • Sydney, New South Wales, Australia, 2200
        • Bankstown-Lidcombe Hospital
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility )
      • Birtinya, Queensland, Australia, 4575
        • Sunshine Coast Radiology
      • Birtinya, Queensland, Australia, 4575
        • Sunshine Coast University Private Hospital
      • Buderim, Queensland, Australia, 4575
        • Buderim Eye Centre( OCT and Ophthalmoscopy Facility)
      • Mackay, Queensland, Australia, 4740
        • Coral Sea Clinical Research Institute Pty.Ltd
      • Maroochydore, Queensland, Australia, 4558
        • Coastal Digestive Helath Pty. Ltd
      • North Mackay, Queensland, Australia, 4740
        • Dr.Shiran DeSilva Respiratory Clinic (PFT)
      • North Mackay, Queensland, Australia, 4740
        • Mater Misericordiae Hospital ( Endoscopy)
      • North Mackay, Queensland, Australia, 4740
        • Queensland X-Ray
      • North Mackay, Queensland, Australia, 4740
        • Vision Eye Institute Mackay (OCT)
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Parkville, Victoria, Australia, 3050
        • Melbourne Health
      • Gomel, Belarus, 246029
        • Institution "Gomel Regional Clinical Hospital"
      • Gomel, Belarus, 246027
        • Institution "Gomel Regional Specialized Clinical Hospital"
      • Grodno, Belarus, 230023
        • Foreign Medical and Pharmaceutical Unitary Enterprise "Medical center "Novoe Zrenie"
      • Grodno, Belarus, 230026
        • Health Care Institution "Grodno City Clinical Hospital #4"
      • Vitebsk, Belarus, 210037
        • Vitebsk Regional Clinical Hospital
      • Vitebsk, Belarus, 210604
        • Health Care Institution "Vitebsk Regional Clinical Specialized Center"
      • Vitebsk, Belarus
        • Vitebsk Regional Clinical Specialized Center
      • Gent, Belgium, 9000
        • AZ Sint-Lucas
      • Roeselare, Belgium, 8800
        • AZ Delta
      • Ruse, Bulgaria, 7002
        • UMHAT ,,Kanev" AD
      • Sliven, Bulgaria, 8800
        • Diagnostic-Consultative Center I - Sliven, EOOD
      • Sofia, Bulgaria, 1527
        • UMHAT "Tsaritsa Yoanna-ISUL" EAD
      • Sofia, Bulgaria, 1680
        • Diagnostic Consultation Center CONVEX EOOD
      • Sofia, Bulgaria, 1431
        • DCC Alexandrovska, EOOD
      • Sofia, Bulgaria, 1407
        • Acibadem City clinic University Hospital EOOD
      • Sofia, Bulgaria, 1606
        • University multiprofile hospital for active treatment and emergency medicine N.l Pirogov EAD
      • Veliko Tarnovo, Bulgaria, 5000
        • Medical Centre MEDICA Plus OOD
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary, Heritage Medical Research Clinic
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary, Department of Medicine - Respirology (PFT Only)
      • Calgary, Alberta, Canada, T3E 7M8
        • University of Calgary, Department of Medicine - Opthalmology (OCT Only)
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre - University Hospital
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Hospital (OCT Procedure only)
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Center- Montreal General Hospital (Electrocardiogram Clinic)
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Center- Montreal General Hospital (Endoscopy clinic)
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Center- Montreal General Hospital (IP Address)
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Center- Montreal General Hospital (Research Site)
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital (MUHC-Radiology)
      • Montreal, Quebec, Canada, H4P 2S4
        • Eye Health MD (OCT)
      • Boskovice, Czechia, 680 01
        • Gastroenterologicka ambulance
      • Hradec Kralove, Czechia, 500 12
        • Hepato-gastroenterologie HK, s.r.o.
      • Hradec Kralove, Czechia, 500 12
        • VISUS, spol s.r.o.
      • Olomouc, Czechia, 779 00
        • PreventaMed s.r.o.
      • Olomouc, Czechia, 779 00
        • Gastroenterologicka ordinace MUDr. Pavla Skalova s.r.o., MUDr. Frantisek Sincl s.r.o.
      • Olomouc, Czechia, 779 00
        • MUDr. Pavlina Kazinotova, s.r.o.
      • Olomouc, Czechia, 779 00
        • Ocni ordinace Olomouc
      • Ostrava-Poruba, Czechia, 708 52
        • Fakultni nemocnice Ostrava
      • Praha 7, Czechia, 170 00
        • Ocni centrum Praha, a.s.
      • Praha 9, Czechia, 190 00
        • ISCARE a.s.
      • Praha 9, Czechia, 190 00
        • Prvni plicni ambulance. s.r.o.
      • Prerov, Czechia, 750 02
        • Gastroenterologicka ambulance MUDr. Marcela Vyslouzilova
      • Prostejov, Czechia, 796 01
        • Privatni gastroenterologicka ambulance s.r.o. MUDr. Zdenek Vlk
      • Slany, Czechia, 274 01
        • Nemocnice Slany
      • Slany, Czechia, 274 01
        • Poliklinika Slany, spol. s.r.o.
      • Clermont-Ferrand Cedex 1, France, 63000
        • Centre Hospitalier Universitaire de Clermont-Ferrand - Hopital Estaing
      • Grenoble, France, 38043
        • Centre Hospitalier Universitaire de Genoble Alpes - CHU Michallon
      • Nantes Cedex 1, France, 44093
        • Centre Hospitalier Universitaire de Nantes - Hotel-Dieu
      • Nice Cedex 3, France, 06202
        • Centre Hospitalier Universitaire de Nice - Hopital de l'Archet 2
      • Rennes Cedex 09, France, 35033
        • CHU Rennes - Hôpital Pontchaillou
      • Tbilisi, Georgia, 0160
        • LTD Aversi Clinic
      • Tbilisi, Georgia, 0112
        • Ltd Israeli-Georgian Medical Research Clinic Helsicore
      • Tbilisi, Georgia, 0159
        • LTD Institute of Clinical Cardiology
      • Tbilisi, Georgia, 0160
        • JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
      • Tbilisi, Georgia, 0112
        • LLC Academic Pridon Todua Medical Center - LLC Research Institute of Clinical Medicine
      • Tbilisi, Georgia, 0112
        • LLC Todua Clinic
      • Tbilisi, Georgia, 0131
        • LTD Vivamedi
      • Tbilisi, Georgia, 0159
        • Medical Center CITO LTD
      • Tbilisi, Georgia, 0160
        • LTD Academician Nikoloz Kipshidze Central University Clinic
      • Tbilisi, Georgia, 0172
        • LTD Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
      • Berlin, Germany, 10117
        • Charite - Universitatsmedizin Berlin, Campus Mitte (CCM)
      • Berlin, Germany, 12203
        • OCT Charite - Universitatsmedizin Berlin
      • Berlin, Germany, 13353
        • PFT Klinik fur Infektiologie & Pneumologie
      • Bonn, Germany, 53123
        • Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
      • Duesseldorf, Germany, 40489
        • Florence-Nightingale-Krankenhaus
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein, Campus Kiel
      • Kiel, Germany, 24105
        • OCT: nordBLICK Augenklinik Bellevue
      • Krefeld, Germany, 47798
        • OCT: Dr. med. Christopher Kallen
      • Neuss, Germany, 41462
        • Johanna Etienne Krankenhaus
      • Neuss, Germany, 41462
        • OCT: AOZ Neuss
      • Remscheid, Germany, 42859
        • Magen-Darm-Zentrum Remscheid
      • Remscheid, Germany, 42853
        • OCT: Augenpraxisklinik REMSCHEID
      • Budapest, Hungary, 1136
        • Pannonia Maganorvosi Centrum Kft.
      • Budapest, Hungary, 1025
        • Ophthalmology tests: Tosho Kft.
      • Budapest, Hungary, 1051
        • Mediszem Kft.
      • Budapest, Hungary, 1054
        • Endoexpert EgeszsegUgyi Szolgaltato Kft.
      • Budapest, Hungary, 1062
        • Magyar Honvedseg Egeszsegugyi Kozpont (Ophthalmology Tests)
      • Budapest, Hungary, 1062
        • Pulmonary function test: Vasutegeszsegugyi Nonprofit Kozhasznu Kft.
      • Budapest, Hungary, 1062
        • Vasutegeszsegugyi Nonprofit Kozhasznu Kft. (Pulmonary function)
      • Budapest, Hungary, 1062
        • Vasutegeszsegugyi Nonprofit Kozhasznu Kft.
      • Budapest, Hungary, 1068
        • Honvedkorhaz II. telephely
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Gasztroenterologia
      • Szeged, Hungary, 6725
        • Opthalmology tests: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont,Szemeszeti Klinika
      • Szeged, Hungary, 6725
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Belgyogyaszati Klinika
    • Heves
      • Gyongyos, Heves, Hungary, 3200
        • Bugat Pal Korhaz
    • Komarom-esztergom
      • Tatabanya, Komarom-esztergom, Hungary, 2800
        • DLCO and Ophthalmology tests: Szent Borbala Korhaz
    • Tolna
      • Szekszard, Tolna, Hungary, 7100
        • Clinfan Szolgaltato Kft.
      • Szekszard, Tolna, Hungary, 7100
        • Ophthalmology tests: Tolna Megyei Balassa Janos Korhaz
      • Holon, Israel, 5822012
        • Edith Wolfson Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Nahariya, Israel, 2210001
        • Galilee Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center
      • Rehovot, Israel, 761001
        • Kaplan Medical Center
    • Bari
      • Puglia, Bari, Italy, 70013
        • Azienda Ospedaliera Saverio De Bellis
    • Milan
      • Garbagnate Milanese, Milan, Italy, 20024
        • ASST Rhodense - Pneumology Unit
      • Milano, Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele, Unita di Gastroenterologia
      • Rho, Milan, Italy, 20017
        • ASST Rhodense - Ophthalmology Unit (For Ophthalmoscopy)
      • Rho, Milan, Italy, 20017
        • ASST Rhodense - Ophthalmology Unit
      • Rho, Milan, Italy, 20017
        • ASST Rhodense - U.O.C. di Gastroenterologia ed Endoscopia Digestiva
    • Rome
      • Roma, Rome, Italy, 00168
        • Fondazione Policlinico Agostino Gemelli IRCCS
    • Veneto
      • Vicenza, Veneto, Italy, 36100
        • Ospedale San Bortolo di Vicenza, Gastroenterologia
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of, 41404
        • Endoscopy Facility in Kyungpook National University Chilgok Hospital
      • Daegu, Korea, Republic of, 41404
        • OCT Facility in Kyungpook National University Chilgok Hospital
      • Daegu, Korea, Republic of, 41404
        • PFT Facility in Kyungpook National University Chilgok Hospital
      • Daegu, Korea, Republic of, 41944
        • Endoscopy Facility in Kyungpook National University Hospital
      • Daegu, Korea, Republic of, 41944
        • OCT Facility In kyungpook Natioanl University Hospital
      • Daegu, Korea, Republic of, 41944
        • PFT Facility in kyungpook Natioanl University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 03722
        • Endoscopy Facility in Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 03722
        • OCT(1) Facility in Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 03722
        • OCT(2) Facility in Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 03722
        • PFT(1) Facility Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 03722
        • PFT(2) Facility Severance Hospital, Yonsei University Health System
    • Gangwon-do
      • Wonju-si, Gangwon-do, Korea, Republic of, 26426
        • Yonsei University Wonju Severance Christian Hospital
      • Bystra, Poland, 43-360
        • Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)
      • Lodz, Poland, 93-513
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
      • Lodz, Poland, 90-338
        • Centrum Medyczne Ksiezy Mlyn sp. z o.o. (Ophtalmoscopy, OCT)
      • Lodz, Poland, 91-053
        • Centra Medyczne 'MEDYCEUSZ" (Chest X-Ray)
      • Lodz, Poland, 91-347
        • Wojewodzki Szpital Specjalistyczny im.dr. WI. Bieganskiego (endoscopy)
      • Oswiecim, Poland, 32-600
        • MEDICOME- Oswiecimskie Centrum Medyczne (OCT)
      • Poznan, Poland, 60-369
        • Centrum Medyczne Grunwald
      • Poznan, Poland, 10160-681
        • Centrum Medyczne Grunwald
      • Warsaw, Poland, 00-635
        • Centrum Zdrowia MDM
      • Warszawa, Poland, 00-635
        • Centrum Zdrowia MDM
      • Warszawa, Poland, 00-189
        • Centrum Zdrowia MDM
      • Wroclaw, Poland, 53-661
        • Endomed
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 52-416
        • Centrum Medyczne Oporow
      • Wroclaw, Dolnoslaskie, Poland, 53-162
        • OKOLEK
      • Wroclaw, Dolnoslaskie, Poland, 54-144
        • EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu
    • Lodzkie
      • Lodz, Lodzkie, Poland, 90-644
        • Amicare Sp. z o.o. Sp.k.
      • Lodz, Lodzkie, Poland, 90-752
        • IP Clinic Sp. z o.o.
      • Lodz, Lodzkie, Poland, 91-495
        • Amicare Sp. z o.o. Sp.k.
    • Malopolskie
      • Nowy Targ, Malopolskie, Poland, 34-400
        • Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
      • Oswiecim, Malopolskie, Poland, 32-600
        • Medicome sp. z o.o.
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 00-631
        • Centrum Zdrowia MDM
      • Warszawa, Mazowieckie, Poland, 01-138
        • lnstytut Gruzlicy i Chorob Pluc
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-369
        • Centrum Medyczne Grunwald
      • Poznan, Wielkopolskie, Poland, 60-538
        • Specjalistyczny Okulistyczny Niepubliczny Zaklad Opieki Zdrowotnej OCUSERVICE
      • Poznan, Wielkopolskie, Poland, 60-681
        • NSZOZ Termedica
      • Poznan, Wielkopolskie, Poland, 61-444
        • Szpital Sw. Wojciecha
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 70-233
        • Spoldzielnia Pracy Lekarzy Specjalistow Medicus (for OCT)
      • Szczecin, Zachodniopomorskie, Poland, 71-434
        • Twoja Przychodnia-Szczecinskie Centrum Medyczne
      • Szczecin, Zachodniopomorskie, Poland, 71-610
        • Przychodnia EVOMED Pracownia USG i RTG
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitario de Sao Joao, E.P.E
      • Nizhniy Novgorod, Russian Federation, 603126
        • SBHI of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko
      • Omsk, Russian Federation, 644013
        • BHI of Omsk Region "Clinical Oncology Dispensary"
      • Omsk, Russian Federation, 644024
        • Clinicodiagnostic Center "Ultramed"
      • Omsk, Russian Federation, 644070
        • Medical center "Intervzglyad"
      • Saint Petersburg, Russian Federation, 197022
        • FSBEI of Higher Education "I.P.Pavlov First Saint Petersburg State Medical University" of MoH of RF
      • Samara, Russian Federation, 443001
        • Private Institution, Educational Organization of Higher Education "Medical University "Reaviz"
      • Samara, Russian Federation, 443011
        • Private Institution, Educational Organization of Higher Education "Medical University "Reaviz",
      • Samara, Russian Federation, 443029
        • Clinical Hospital Russian Railways - Medicina
      • Samara, Russian Federation, 443045
        • Medical Company "Hepatolog" LLC
      • Samara, Russian Federation, 443063
        • Medical Company "Hepatolog" LLC
      • Samara, Russian Federation, 443093
        • Samara Diagnostic center
      • Samara, Russian Federation, 443125
        • Regional Medical center LLC (Branchevsky's clinic)
      • Smolensk, Russian Federation, 214014
        • Inter-branch scientific and technical complex "Eye microsurgery"
      • Smolensk, Russian Federation, 214020
        • Multidisciplinary Medical center "Clinic Park"
      • Smolensk, Russian Federation, 214031
        • "Uromed" LLC
      • St. Petersburg, Russian Federation, 191015
        • FSBEI of Higher Education "North-Western State Medical University n.a. I.I. Mechnikov" of MoH RF
      • Stavropol, Russian Federation, 355017
        • Autonomous Noncommercial Medical Organization "Stavropol Regional Clinical Advisory-Diagnostic
    • Stavropol Region
      • Pyatigorsk, Stavropol Region, Russian Federation, 357500
        • "Clinic Ultrasound 4D" LLC
      • Pyatigorsk, Stavropol Region, Russian Federation, 357500
        • "Platnaya poliklinika" LLC
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Dnipro, Ukraine, 49000
        • Limited Liability Company "Lookout "Medical Center"
      • Dnipro, Ukraine, 49005
        • Limited Liability Company "MDC EXPERT"
      • Dnipro, Ukraine, 49005
        • Municipal Enterprise <<Dnipro Reg Clinical Hosp named after M. I.I. Mechnikov>>
      • Ivano-Frankivsk, Ukraine, 76008
        • Clinical Diagnostical Center "Simedgroup"
      • Ivano-Frankivsk, Ukraine, 76008
        • CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council,Department of Gastroenterology
      • Kharkiv, Ukraine, 61022
        • Llc "Ldts-Skaymed"
      • Kharkiv, Ukraine, 61037
        • CNE Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv City Council, Department of Proctology
      • Kharkiv, Ukraine, 61045
        • Llc Medical Center Oftalmika
      • Kyiv, Ukraine, 02091
        • CNE Kyiv City Clinical Hospital #1 of Executive Body of Kyiv City Council (Kyiv City State
      • Uzhgorod, Ukraine, 88017
        • Transcarpathian Center of Eye Microsurgery
      • Uzhgorod, Ukraine, 88018
        • CNE Andrii Novak Transcarpathian Regional Clinical Hospital of
      • Vinnytsia, Ukraine, 21009
        • Medical Center of LLC Health Clinic, Med Clinical lnvestigational Center, Unit of Gastroenterology,
      • Vinnytsia, Ukraine, 21018
        • CNE "Vinnytsia Reg Clinical Hosp named after N.I.Pirogov Vinnytsia Regional Council", Reg Specialize
      • Vinnytsia, Ukraine, 21018
        • Podilskyi tsentr zoru
      • Vinnytsia, Ukraine, 21029
        • Scientific and Research Institute of lnvalid Rehabilitation (Educational and Scientific
      • Vinnytsya, Ukraine, 21032
        • Diagnostic Center "Mediscan"
      • Vinnytsya, Ukraine, 21036
        • Llc "Optimal M"
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Digestive Health Specialists
      • Dothan, Alabama, United States, 36301
        • Center for Digestive Health (Colonoscopy Location)
      • Dothan, Alabama, United States, 36301
        • Dothan Eyecare-Dr. Brent McKinley (OCT Location)
      • Dothan, Alabama, United States, 36301
        • Pulmonary Associates (Secondary PFT Location)
      • Dothan, Alabama, United States, 36305
        • Flowers Hospital (PFT Location)
    • 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 (Endoscopy)
    • California
      • El Cajon, California, United States, 92020
        • Euclid Endoscopy Center-El Cajon (Endoscopy procedure only)
      • Irvine, California, United States, 92697
        • Center for Clinical Research (CCR)
      • Irvine, California, United States, 92697
        • UCI Gavin Herbert Eye Institute
      • Irvine, California, United States, 92697
        • UCI Gottschalk Medical Plaza
      • La Jolla, California, United States, 92037
        • Koman Family Outpatient Pavilion (Endoscopy)
      • La Jolla, California, United States, 92037
        • Perlman Medical Offices (IBD Clinic)
      • La Jolla, California, United States, 92037
        • UCSD Clinical and Translational Research Institute (Research Clinic)
      • La Jolla, California, United States, 92037
        • UCSD Health System (PFT/Endoscopy)
      • La Jolla, California, United States, 92037
        • UCSD lnvestigational Drug Service Pharmacy
      • La Jolla, California, United States, 92093
        • Shiley Eye Institute (OCT)
      • La Mesa, California, United States, 91942
        • Dr. Raed Al-Naser -Sharp Grossmont outpatient (DLCO procedure only)
      • La Mesa, California, United States, 91942
        • Dr. Sally s. Lee in La Mesa (Ophthalmologist procedure only)
      • Lake Elsinore, California, United States, 92532
        • Inland Pulmonary Specialists [PFT Only]
      • Lancaster, California, United States, 93534
        • Om Research LLC
      • 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 (PFT, Physical Exam, ECG Review, Lab Review)
      • Lancaster, California, United States, 93534
        • Jatinder S. Pruthi, MD FACG CPI (Physical Exam, ECG Review, Lab Review)
      • Los Angeles, California, United States, 90067
        • Advanced Vision Care (OCT)
      • Los Angeles, California, United States, 90067
        • Gastrointestinal Biosciences Clinical Trials, LLC
      • Los Angeles, California, United States, 90036
        • Abraham M. lshaaya MD (X-Ray)
      • Los Angeles, California, United States, 90036
        • Entertainment Medical Group, Inc (Main Site, Subject Visits, IP Delivery/Storage, Regulatory,
      • Los Angeles, California, United States, 90067
        • Century City Endoscopy (Colonoscopy - Nicholas Karyotakis M.D. Endoscopist)
      • Murrieta, California, United States, 92563
        • United Medical Doctors
      • Murrieta, California, United States, 92562
        • United Surgery Center Murrieta [Endoscopy Only]
      • Orange, California, United States, 92697
        • CCR-ICTS Center for Innovative Patient Care
      • Orange, California, United States, 92868
        • UCI Health Eye Care Services (Ophthalmoscopy and OCTs)
      • Orange, California, United States, 92868
        • UCI Health H. H. Chao Comprehensive Digestive Disease Center
      • Orange, California, United States, 92868
        • UCI Investigational Drug Services (IDSP - Pharmacy)
      • Orange, California, United States, 92868
        • UCI Irvine Medical Center - Pulmonology Services - PFTs
      • San Diego, California, United States, 92119
        • ACRC Studies
      • Temecula, California, United States, 92591
        • California Eye Professionals [OCT Only]
      • Temecula, California, United States, 92592
        • United Surgery Center Temecula [Endoscopy Only]
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates
      • Colorado Springs, Colorado, United States, 80920
        • 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
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale School of Medicine
      • New Haven, Connecticut, United States, 06510
        • Yale Ophtalmology
      • New Haven, Connecticut, United States, 06519
        • Yale New Haven Hospital - Winchester Chest Clinic - PFT
      • North Haven, Connecticut, United States, 06473
        • Yale New Haven Hospital MEMC- Endoscopy
    • Florida
      • Brandon, Florida, United States, 33511
        • Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD
      • Clearwater, Florida, United States, 33756
        • Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test)
      • Clearwater, Florida, United States, 33756
        • GASTRO FLORIDA (ADMINISTRATIVE DUTIES etc. CRA visits)
      • Clearwater, Florida, United States, 33756
        • West Coast Endoscopy (Colonoscopy Procedures)
      • Clearwater, Florida, United States, 33756
        • West Coast Endoscopy Center (Endoscopy Procedures)
      • Clearwater, Florida, United States, 33756
        • West Coast Radiology (Chest X-ray)
      • Clearwater, Florida, United States, 33761
        • Northwood Vision- Optical Coherence Tomography (OCT)
      • Coral Gables, Florida, United States, 33134
        • Beraja Medical Institute (OCT)
      • Coral Gables, Florida, United States, 33134
        • Juan Barrio, MD (PFT when needed)
      • Fort Myers, Florida, United States, 33912
        • Retina Consultants of Southwest Florida, PA "OCT"
      • Miami, Florida, United States, 33156
        • Research Associates of South Florida
      • Miami, Florida, United States, 33134
        • The Endoscopy Center (Endoscopy Procedure)
      • Miami, Florida, United States, 33157
        • Kendall Endoscopy and Surgery Center (Endoscopy)
      • Miami, Florida, United States, 33176
        • Clarin Eye Care Center (OCT/Ophthalmoscopy)
      • Naples, Florida, United States, 34102
        • Gastroenterology Group Of Naples
      • Naples, Florida, United States, 34102
        • Bruce Roy, MD "PFT"
      • Naples, Florida, United States, 34102
        • Gulfshore Endoscopy Center
      • Naples, Florida, United States, 34102
        • Radiology Regional Center "Chest x-ray"
      • New Smyrna Beach, Florida, United States, 32168
        • NSB Research
      • Palmetto Bay, Florida, United States, 33157
        • IMIC Inc
      • Port Orange, Florida, United States, 32127
        • Advanced Medical Research Center
      • South Miami, Florida, United States, 33143
        • Larkin Community Hospital (Endoscopy Procedure)
      • Sun City Center, Florida, United States, 33573
        • Absolute Surgical Specialists - Craig Amshel, MD
      • Tampa, Florida, United States, 33069
        • SimonMed Imaging
      • Tampa, Florida, United States, 33603
        • Perez Eye Center(OCT & Ophthalmoscopy only)
      • Tampa, Florida, United States, 33603
        • Tampa Bay Endoscopy Center(Proctosigmoidoscopy & colonoscopy ONLY)
      • Tampa, Florida, United States, 33606
        • Lyracore Health Alliance, Tampa Bay Pulmonology (PFT only)
      • Tampa, Florida, United States, 33607
        • Pulmonary and Sleep of Tampa Bay(PFT with DLCO only)
      • Tampa, Florida, United States, 33609
        • GCP Clinical Research,LLC
      • Tampa, Florida, United States, 33609
        • LoCicero Medical Group (PFT Procedure Only)
      • Tampa, Florida, United States, 33609
        • NewsomEye (OCT only)
      • Tampa, Florida, United States, 33609
        • South Tampa Surgery Center
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, LLC
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, LLC (Endoscopy)
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, LLC (OCT)
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, LLC (PFT)
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Medical Eye Services LTD (Ophthalmoscopy with OCT)
      • Gurnee, Illinois, United States, 60031
        • GI Alliance (Patients Seen; IP Delivered)
      • Lake Bluff, Illinois, United States, 60044
        • North Shore Endoscopy Center (Endoscopy)
      • Libertyville, Illinois, United States, 60048
        • Libertyville Imaging Center (Diagnostic Imaging)
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Endoscopy Center (Endoscopy Facility Only)
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Pulmonary Associate (PFT Only)
      • Chevy Chase, Maryland, United States, 20815
        • Retina Group of Washington (Ophthalmoscopy and OCT Only)
      • 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)
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Barnes-Jewish West County Hospital (Additional Endoscopy Location)
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63110
        • Barnes-jewish Hospital
      • Saint Louis, Missouri, United States, 63108
        • Center for Outpatient Health
      • Saint Louis, Missouri, United States, 63110
        • Center for Advanced Medicine
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Advantage Diagnostics(X-Ray only)
      • Chardon, Ohio, United States, 44024
        • Geauga Sleep Center(PFT only)
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati College of Medicine
      • Cincinnati, Ohio, United States, 45219
        • UC Health Physicians Office
      • Cincinnati, Ohio, United States, 45229
        • UC Health (Pulmonary Function Testing)
      • Mentor, Ohio, United States, 44060
        • The Endoscopy Center of Lake County
      • Painesville, Ohio, United States, 44077
        • 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)
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • West Shore Endoscopy Center
      • Harrisburg, Pennsylvania, United States, 17109
        • Medical Arts Allergy,PC (PFT Only)
      • Harrisburg, Pennsylvania, United States, 17110
        • Farrel Opthalmology(OCT only)
      • Harrisburg, Pennsylvania, United States, 17110
        • Susquehanna Research Group
      • Harrisburg, Pennsylvania, United States, 17110
        • Pinnacle Health Imaging at Tristan (X-Ray only)
    • Texas
      • Edinburg, Texas, United States, 78539
        • Advanced Radiology Associates (x-Ray only)
      • Grapevine, Texas, United States, 76051
        • Texas Retina Associates (OCT Location)
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine- Baylor Medical Center
      • Houston, Texas, United States, 77030
        • Alkek Eye Center Jamail Specialtu Care Center (OCT)
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine-Baylor Medical Center (Chest X-ray location)
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine-Baylor Medical Center (IP Storage)
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine-Baylor Medical Center (Patients seen address, ECG location, PFT)
      • Houston, Texas, United States, 77030
        • Baylor St. Luke's Medical Center Endoscopy- Mc Nair Campus (Endoscopy Location)
      • Keller, Texas, United States, 76248
        • Lonestar Endoscopy
      • McAllen, Texas, United States, 78501
        • Buena Vista Optical ( OCT only)
      • McAllen, Texas, United States, 78503
        • Endoscopy Center at Med Point (Endoscopy only)
      • McAllen, Texas, United States, 78503
        • Valley Pulmonary Group (PFT only)
      • Southlake, Texas, United States, 76092
        • Envision Imaging
      • Southlake, Texas, United States, 76092
        • Lonestar Endoscopy
      • Southlake, Texas, United States, 76092
        • Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
      • Tyler, Texas, United States, 75701
        • Christus Trinity Mother Frances Endoscopy Center
      • Tyler, Texas, United States, 75701-8355
        • Heaton Eye Associates (OCT only)
      • Tyler, Texas, United States, 75701
        • Christus Trinity Mother Frances Endosopy Center ( endoscopies only)
      • Tyler, Texas, United States, 75701
        • Tyler Open MRI (chest x-ray only)
      • Tyler, Texas, United States, 75701
        • UT Health East Texas Physicians (pulmonary functions only)
      • Victoria, Texas, United States, 77904
        • Citizen Healthplex (PFT)
      • Victoria, Texas, United States, 77904
        • Gastro Health & Nutrition - Victoria
      • Victoria, Texas, United States, 77904
        • Surgery Center (Endoscopy)
      • Victoria, Texas, United States, 77904
        • Victoria Eye Center (OCT and Opthalmoscopy)
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • University of Utah Huntsman Cancer Hospital Endoscopy
      • Salt Lake City, Utah, United States, 84112
        • University of Utah Clinic and Endoscopy Suite - Sugarhouse
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospitals and Clinics (PFT)
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Moran Eye Center (Opthalmoscopy/OCT)
    • 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)
      • Lynchburg, Virginia, United States, 24502
        • Radiology Consultants of Lynchburg (X-ray only)
    • Washington
      • Bellevue, Washington, United States, 98004
        • Washington Gastroenterology
      • Bellevue, Washington, United States, 98004
        • Eastside Endoscopy Center
      • Bellevue, Washington, United States, 98004
        • Overlake Clinics- Pulmonary Medicine
      • Bellevue, Washington, United States, 98005
        • Northwest Vision (OCT only)
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
      • Seattle, Washington, United States, 98104
        • Swedish Gastroenterology
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center First Hill Endoscopy Center
    • 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

No

Description

Inclusion Criteria:

  • Diagnosed with Ulcerative Colitis (UC) ≥ 3 months prior to screening
  • Active UC confirmed by endoscopy
  • Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic score ≥ 2 and rectal bleeding score ≥ 1
  • Received a surveillance colonoscopy within 12 months before baseline

Exclusion Criteria:

  • Severe extensive colitis
  • Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
  • Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
  • Hospitalization for exacerbation of UC requiring intravenous steroids within 12 weeks prior to or after screening

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment
Experimental: Etrasimod 2 mg
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
Other Names:
  • APD334

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Participants Achieving Clinical Remission
Time Frame: Week 52
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Achieving Endoscopic Improvement
Time Frame: Week 52
Week 52
Proportion of Participants Achieving Symptomatic Remission
Time Frame: Week 52
Week 52
Proportion of Participants Achieving Clinical Remission
Time Frame: Week 12
Week 12
Proportion of Participants Achieving Mucosal Healing
Time Frame: Week 52
Week 52
Proportion of participants achieving clinical remission at both Weeks 12 and 52
Time Frame: Week 12 and Week 52
Week 12 and Week 52
Proportion of Participants achieving clinical remission at Week 52 and who had not been receiving corticosteroids for ≥ 12 weeks immediately prior to Week 52
Time Frame: Week 52
Week 52
Number and Severity of Adverse Events
Time Frame: Up to approximately 56 weeks (52-Week Treatment Period and 4-Week Follow-Up Period)
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Up to approximately 56 weeks (52-Week Treatment Period and 4-Week Follow-Up Period)

Collaborators and Investigators

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

Sponsor

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.

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)

April 12, 2021

Primary Completion (Estimated)

July 18, 2024

Study Completion (Estimated)

July 18, 2024

Study Registration Dates

First Submitted

October 23, 2020

First Submitted That Met QC Criteria

October 23, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • APD334-210
  • C5041011 (Other Identifier: Alias Study Number)
  • 2020-003507-34 (EudraCT Number)

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

No

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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