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

July 1, 2025 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

Completed

Conditions

Ulcerative Colitis

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 Locations

Australia
- 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
Belarus
- - 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, 210604
    - Health Care Institution "Vitebsk Regional Clinical Specialized Center"
  - Vitebsk, Belarus
    - Vitebsk Regional Clinical Specialized Center
Belgium
- - Roeselare, Belgium, 8800
    - AZ Delta
Bulgaria
- - Ruse, Bulgaria, 7002
    - UMHAT ,,Kanev" AD
  - Sofia, Bulgaria, 1527
    - UMHAT "Tsaritsa Yoanna-ISUL" EAD
  - Sofia, Bulgaria, 1680
    - Diagnostic Consultation Center CONVEX EOOD
  - Sofia, Bulgaria, 1784
    - Acibadem City clinic University Hospital EOOD
  - Sofia, Bulgaria, 1407
    - Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD
  - 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
  - Sofia, Bulgaria, 1431
    - UMHAT "Aleksandrovska" EAD (Colonoscopy/Sigmoidoscopy Facility)
  - Sofia, Bulgaria, 1431
    - UMHAT Aleksandrovska EAD (X-Ray Facility)
  - Sofia, Bulgaria, 1527
    - UMHAT ''Tsaritsa Yoanna-lSUL" EAD (Colonoscopy/ Sigmoidoscopy Facility)
  - Sofia, Bulgaria, 1527
    - UMHAT Tsaritsa Yoanna - ISUL EAD (X-ray)
  - Veliko Tarnovo, Bulgaria, 5000
    - Medical Centre MEDICA Plus OOD
Czechia
- - 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, 77900
    - Gastroenterologie-interna, SPEA
  - Olomouc, Czechia, 77900
    - Vojenska nemocnice Olomouc
  - Ostrava-Poruba, Czechia, 708 52
    - Fakultni Nemocnice Ostrava
  - 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.
  - Vsetin, Czechia, 755 01
    - Gatronell s.r.o
France
- - Grenoble, France, 38043
    - Centre Hospitalier Universitaire de Genoble Alpes - CHU Michallon
  - Nantes Cedex 1, France, 44093
    - Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu
  - Nice Cedex 3, France, 06202
    - Centre Hospitalier Universitaire de Nice - Hopital de l'Archet 2
Georgia
- - 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
Germany
- - Bonn, Germany, 53123
    - Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
  - Duesseldorf, Germany, 40489
    - Florence-Nightingale-Krankenhaus
  - Kiel, Germany, 24105
    - Universitatsklinikum Schleswig-Holstein, Campus Kiel
  - Kiel, Germany, 24105
    - OCT: nordBLICK Augenklinik Bellevue
  - Krefeld, Germany, 47798
    - OCT: Dr. med. Christopher Kallen
  - Remscheid, Germany, 42859
    - Magen-Darm-Zentrum Remscheid
  - Remscheid, Germany, 42853
    - OCT: Augenpraxisklinik REMSCHEID
Hungary
- - Budapest, Hungary, 1136
    - Pannonia Maganorvosi Centrum Kft.
  - Budapest, Hungary, 1025
    - Ophthalmology tests: Tosho Kft.
  - Budapest, Hungary, 1051
    - Mediszem Kft.
  - Budapest, Hungary, 1062
    - Pulmonary function test: Vasutegeszsegugyi Nonprofit Kozhasznu Kft.
  - Budapest, Hungary, 1062
    - Vasutegeszsegugyi Nonprofit Kozhasznu Kft.
  - Budapest, Hungary, 1068
    - Honvedkorhaz II. telephely
  - Budapest, Hungary, 1088
    - Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
  - Budapest, Hungary, 1068
    - Magyar Honvedseg Egeszsegugyi Kozpont (Ophthalmology Tests)
- 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
Israel
- - 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
Italy
- Bari
  - Puglia, Bari, Italy, 70013
    - Azienda Ospedaliera Saverio De Bellis
- Milan
  - Milano, Milan, Italy, 20132
    - IRCCS Ospedale San Raffaele, Unita di Gastroenterologia
- Rome
  - Roma, Rome, Italy, 00168
    - Fondazione Policlinico Agostino Gemelli IRCCS
- Veneto
  - Vicenza, Veneto, Italy, 36100
    - Ospedale San Bortolo di Vicenza, Gastroenterologia
Korea, Republic of
- - Daegu, Korea, Republic of, 41944
    - Kyungpook National University 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, Gangwon-do, Korea, Republic of, 26426
    - WonJu Severance Christian Hospital
Poland
- - 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)
  - Warsaw, Poland, 00-635
    - 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, 01-138
    - lnstytut Gruzlicy i Chorob Pluc
- Wielkopolskie
  - Poznan, Wielkopolskie, Poland, 60-681
    - NSZOZ Termedica - Centrum Badan Klinicznych
- 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
Portugal
- - Porto, Portugal, 4200-319
    - Centro Hospitalar Universitario de Sao Joao, E.P.E
Russian Federation
- - 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
Spain
- - Madrid, Spain, 28046
    - Hospital Universitario La Paz
Ukraine
- - 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"
United States
- 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 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)
  - 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
- 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)
  - 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)
  - 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, 33603
    - Tampa Bay Endoscopy Center
  - 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
- 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)
- 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, 17111
    - Harrisburg Eye Associates (OCT only)
  - Harrisburg, Pennsylvania, United States, 17110
    - Susquehanna Research Group
  - Harrisburg, Pennsylvania, United States, 17110
    - Pinnacle Health Imaging at Tristan (X-Ray only)
  - Harrisburg, Pennsylvania, United States, 17102
    - Pulmonary and Critical Care Medicine Associates (PFT only)
  - Lemoyne, Pennsylvania, United States, 17043
    - Pulmonary and Critical Care Medicine Associates (PFT 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
    - 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)
  - Tyler, Texas, United States, 75701
    - Heaton Eye Associates (OCT 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)
- 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
  - Seattle, Washington, United States, 98122
    - Swedish Medical Center First Hill
  - Seattle, Washington, United States, 98104
    - Swedish Medical Center Investigational Drug Services Pharmacy
  - Seattle, Washington, United States, 98122
    - Swedish Medical Center First Hill Endoscopy Center
  - Seattle, Washington, United States, 98104
    - Pacific Northwest Retina
  - Seattle, Washington, United States, 98104
    - Richard Bensinger, MD

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

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment
Experimental: Etrasimod 2 mg	Drug: Etrasimod 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	Measure Description	Time Frame
Percentage of Participants Achieving Clinical Remission (CR) at Week 52 Using Modified Mayo Score (MMS) Time Frame: Week 52	MMS is used to assess disease activity in participants with UC and has following components: endoscopic score(ES),rectal bleeding(RB),stool frequency(SF).Each component score ranges from 0 to 3(0=normal,1=mild,2=moderate,3=severe); higher scores indicating more severe disease.ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy,scores ranged from 0(normal or inactive disease) to 3(severe disease [spontaneous bleeding, ulceration]).RB reported most severe amount of blood passed per rectum in 24-hour period,scores ranged from 0(no blood seen) to 3(blood alone passes).SF reported number of stools in 24-hour period relative to normal number of stools for that participant in same period,scores ranged from 0(normal number of stools) to 3(5 or more stools than normal).CR per FDA draft guidance defined as:SF=0 or 1 and no greater than baseline, RB=0,ES less than or equal to (<=)1(excluding friability).Percentage of participants achieving CR at Week 52 was evaluated.	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Clinical Remission at Week 12 Using MMS Time Frame: Week 12	MMS is used to assess disease activity in participants with UC and has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe); higher scores indicating more severe disease. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]). RB reported the most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes). SF reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal). CR per FDA draft guidance was defined as: SF=0 or =1 and no greater than baseline, RB=0, and ES <=1 (excluding friability). Percentage of participants achieving CR at Week 12 was evaluated in this endpoint.	Week 12
Percentage of Participants Achieving Endoscopic Improvement at Week 52 Time Frame: Week 52	Endoscopic improvement was defined as ES <=1 (excluding friability). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]), higher scores = more severity. Percentage of participants achieving endoscopic improvement at Week 52 was evaluated in this endpoint.	Week 52
Percentage of Participants Achieving Symptomatic Remission at Week 52 Time Frame: Week 52	Symptomatic remission was defined as SF =0 (or = 1 with a >= 1 point decrease from baseline) and RB =0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving symptomatic remission at Week 52 was evaluated in this endpoint.	Week 52
Percentage of Participants Achieving Complete Symptomatic Remission at Week 52 Time Frame: Week 52	Complete symptomatic remission was defined as participants with RB = 0 and SF = 0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving complete symptomatic remission at Week 52 was evaluated in this endpoint.	Week 52
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 52 Time Frame: Week 52	Histologic-endoscopic mucosal improvement was defined as ES <=1 (excluding friability) with Geboes score <2.0. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]), higher scores = more severity. The Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. Percentage of participants achieving mucosal improvement at Week 52 was evaluated in this endpoint.	Week 52
Percentage of Participants Achieving Clinical Remission at Both Weeks 12 and 52 [Combined] Using MMS Time Frame: Weeks 12 and 52 [Combined]	MMS is used to assess disease activity in participants with UC and has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0= normal, 1= mild, 2= moderate, 3= severe); higher scores = more severe disease. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease). RB: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes). SF reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal). Clinical remission per FDA draft guidance: SF =0 or =1 and no greater than baseline, RB =0, and ES <=1 (excluding friability). Percentage of participants who achieved clinical remission at both the time points Week 12 and Week 52 [Combined] are reported.	Weeks 12 and 52 [Combined]
Percentage of Participants With 12-Week Corticosteroid-Free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline Using MMS Time Frame: Week 52	MMS has following components:ES, RB and SF. Each component score ranges from 0 to 3(0=normal,1=mild,2=moderate,3=severe); higher scores indicating more severe disease. ES:worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0(normal or inactive disease)to 3(severe disease). RB:most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0(no blood seen)to 3(blood alone passes). SF:number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0(normal number of stools)to 3(5 or more stools than normal). CR per FDA draft guidance as: SF =0 or =1 and no greater than baseline, RB=0, and ES <=1(excluding friability). 12-week corticosteroid-free CR was defined as CR at Week 52 and corticosteroid-free for >=12 weeks immediately prior to Week 52. The baseline was balanced between treatment groups and representative of participants with mildly to moderately active UC.	Week 52
Percentage of Participants With 12-Week Corticosteroid-Free Clinical Remission at Week 52 Using MMS Time Frame: Week 52	MMS has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0=normal,1=mild,2=moderate,3=severe); higher scores indicating more severe disease. ES: worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0(normal or inactive disease) to 3 (severe disease). RB: most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0(no blood seen) to 3 (blood alone passes). SF: number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0(normal number of stools) to 3 (5 or more stools than normal). CR per FDA draft guidance as: SF =0 or =1 and no greater than baseline, RB=0, and ES <=1(excluding friability). 12-week corticosteroid-free CR was defined as CR at Week 52 and corticosteroid-free for >=12 weeks immediately prior to Week 52.	Week 52
Percentage of Participants Achieving 4-Week Corticosteroid-Free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline Using MMS Time Frame: Week 52	MMS has following components: ES, RB and SF; each ranged as 0=normal,1=mild,2=moderate,3=severe; total MMS score 0-9; higher scores=more severe disease. ES:worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0(normal or inactive disease)to 3(severe disease). RB:most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0(no blood seen) to 3(blood alone passes). SF:number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0(normal number of stools)to 3(5 or more stools than normal). CR per FDA draft guidance as: SF =0 or =1 and no greater than baseline, RB=0, and ES <=1(excluding friability). 4-week corticosteroid-free CR was defined as CR at Week 52 and corticosteroid-free for >=4 weeks immediately prior to Week 52. The baseline was balanced between treatment groups and representative of participants with mildly to moderately active UC.	Week 52
Percentage of Participants With 4-Week Corticosteroid-Free Clinical Remission at Week 52 Using MMS Time Frame: Week 52	MMS has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0=normal,1=mild,2=moderate,3=severe); where total score is sum of three components giving total MMS score as 0 to 9; higher scores indicating more severe disease. ES: worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0(normal or inactive disease) to 3 (severe disease). RB: most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0(no blood seen) to 3 (blood alone passes). SF: number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal). CR per FDA draft guidance as: SF =0 or =1 and no greater than baseline, RB=0, and ES <=1(excluding friability). 4-week corticosteroid-free CR was defined as CR at Week 52 and corticosteroid-free for >=4 weeks immediately prior to Week 52.	Week 52
Percentage of Participants Achieving Clinical Response at Week 12 Using MMS Time Frame: Week 12	Clinical response was defined as a >=2-point and >=30 percentage (%) decrease from baseline in MMS, and a >=1-point decrease from baseline in RB subscore or an absolute RB subscore <=1 and is as per FDA draft guidance. MMS was used to assess disease activity in participants with UC and has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0= normal, 1= mild, 2= moderate, 3= severe); where total score is sum of three components giving total MMS score as 0 to 9; higher scores indicating more severe disease. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]). Percentage of participants achieving clinical response at Week 12 was evaluated in this endpoint.	Week 12
Percentage of Participants Achieving Clinical Response at Week 52 Using MMS Time Frame: Week 52	Clinical response was defined as a >=2-point and >=30 % decrease from baseline in MMS, and a >=1-point decrease from baseline in RB subscore or an absolute RB subscore <=1 and is as per FDA draft guidance. MMS is used to assess disease activity in participants with UC and has following components: ES, RB and SF. Each component scores ranges from 0 to 3 (0= normal, 1= mild, 2= moderate, 3= severe); where total score is sum of three components giving total MMS score as 0 to 9; higher scores indicating more severe disease. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]). Percentage of participants achieving clinical response at Week 52 was evaluated in this endpoint.	Week 52
Percentage of Participants Achieving Endoscopic Improvement at Week 12 Time Frame: Week 12	Endoscopic improvement was defined as ES <=1 (excluding friability). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]), higher scores = more severity. Percentage of participants achieving endoscopic improvement at Week 12 was evaluated in this endpoint.	Week 12
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 12 Time Frame: Week 12	Histologic-endoscopic mucosal improvement was defined as ES <=1 (excluding friability) with Geboes score <2.0. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]), higher scores = more severity. The Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. Percentage of participants achieving mucosal improvement at Week 12 was evaluated in this endpoint.	Week 12
Percentage of Participants Achieving Symptomatic Remission at Week 12 Time Frame: Week 12	Symptomatic remission was defined as SF =0 (or = 1 with a >= 1 point decrease from baseline) and RB =0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving symptomatic remission at Week 12 was evaluated in this endpoint.	Week 12
Percentage of Participants Achieving Complete Symptomatic Remission at Week 12 Time Frame: Week 12	Complete symptomatic remission was defined as participants with RB = 0 and SF = 0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving complete symptomatic remission at Week 12 was evaluated in this endpoint.	Week 12
Percentage of Participants Achieving Change From Baseline in Both ES and RB or in Both ES and SF at Week 12 Time Frame: Baseline to Week 12	ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease [spontaneous bleeding, ulceration]), higher scores = more severity. RB: reported the most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. SF reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. Percentage of participants with reduction from baseline in both ES and RB or in both ES and SF at Week 12 was evaluated in this endpoint. The baseline primary analysis set was balanced between treatment groups and representative of participants with mildly to moderately active UC.	Baseline to Week 12
Percentage of Participants Achieving Histologic Response Based on the Geboes Grading System at Week 12 Time Frame: Week 12	Histologic response based on the Geboes grading system was defined as Geboes score <=3.1. The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. Percentage of participants achieving histologic response based on the Geboes grading system at week 12 was evaluated in this endpoint.	Week 12
Percentage of Participants Achieving Histologic Response Based on Robarts Histopathology Index (RHI) at Week 12 Time Frame: Week 12	RHI is an evaluative index, derived from the Geboes score, that is designed to be reproducible and responsive to clinically meaningful change in disease activity over time. Histologic response based on RHI was defined as decrease in RHI of >=7 points from baseline. Total RHI score ranges from 0 (no disease activity) to 33 (severe disease activity), higher score = more severity. Percentage of participants achieving histologic response based on RHI at Week 12 was evaluated in this endpoint.	Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs) Time Frame: From first dose of study treatment up to 4 weeks post last dose of study treatment (up to 56 Weeks)	An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and all non-SAEs.	From first dose of study treatment up to 4 weeks post last dose of study treatment (up to 56 Weeks)
Number of Participants With AEs Based on Severity Time Frame: From first dose of study treatment up to 4 weeks post last dose of study treatment (up to 56 Weeks)	An AE was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An AE was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity was classified using common terminology criteria for adverse events (CTCAE), version 5.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death related to AE. Only those categories in which at least 1 participant had data for any reporting group were reported.	From first dose of study treatment up to 4 weeks post last dose of study treatment (up to 56 Weeks)

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.

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)

April 12, 2021

Primary Completion (Actual)

June 19, 2024

Study Completion (Actual)

June 19, 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 (Actual)

July 15, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

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.

Clinical Trials on Ulcerative Colitis

Odyssey Therapeutics

Recruiting

Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis (UC) | UC - Ulcerative Colitis

Australia, Austria, Jordan, Poland, Ukraine, New Zealand, Canada, Czechia, Lithuania, Moldova
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin; MRSU 938 - Research Center of Saint...

Not yet recruiting

Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (T-FORE)

Pediatric Ulcerative Colitis in Remission

France
Ferring Pharmaceuticals

Completed

Canadian Active & Maintenance Modified Pentasa Study (CAMMP)

Active Ulcerative Colitis | Remission of Ulcerative Colitis

Canada
Rise Therapeutics LLC
University of Colorado, Denver; Mayo Clinic

Recruiting

R-3750 in Patients With Mild to Moderate Ulcerative Colitis

Ulcerative Colitis | Ulcerative Colitis Chronic Moderate | Ulcerative Colitis Chronic | Ulcerative Colitis Chronic Mild

United States
Palatin Technologies, Inc

Active, not recruiting

Phase 2a to Evaluate PL-8177 in Subjects with Active Ulcerative Colitis (UC) (PL8177-205)

Ulcerative Colitis | Ulcerative Colitis Flare | Ulcerative Colitis Acute | Ulcerative

United States
Theravance Biopharma

Completed

TD-1473 for Active Ulcerative Colitis (UC)

Ulcerative Colitis, Active Severe | Ulcerative Colitis, Active Moderate

United States, Georgia, Moldova, Republic of, Romania
Eli Lilly and Company

Recruiting

LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-3)

Ulcerative Colitis, Active Severe | Ulcerative Colitis (UC) | Ulcerative Colitis, Active Moderate

United States, China, Croatia, France, India, Japan, Israel, Taiwan, Brazil, Serbia, Greece, Hungary, Argentina, Italy, Poland, Czechia, Colombia, Lithuania, Latvia, Ukraine, South Africa, Portugal, Mexico, Canada, Slovakia, Turkey (Türkiye) and more
Merck Sharp & Dohme LLC

Recruiting

A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)

Ulcerative Colitis | Colitis Ulcerative

United States
InventisBio Co., Ltd

Recruiting

A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis (D2570-202)

Moderately to Severely Active Ulcerative Colitis | UC - Ulcerative Colitis

China
Dr Abdurrahman Yurtaslan Ankara Oncology Training...

Completed

Maresin-1 and Resolvin-D1 Levels and Disease Activity in Ulcerative Colitis

Disease Activity | Ulcerative Colitis Flare | Remission of Ulcerative Colitis

Turkey

Clinical Trials on Etrasimod

Pfizer

Recruiting

A Study to Learn How the Study Medicine Called Etrasimod is Taken up Into Blood and Breastmilk of Healthy Breastfeeding Women

Healthy Participant

Belgium
Pfizer

Recruiting

An Observational Study to Learn About Velsipity After Long Term Use in Patients With Ulcerative Colitis

Ulcerative Colitis (UC)

Japan
Pfizer
Arena is a wholly owned subsidiary of Pfizer

Active, not recruiting

An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis (ELEVATE UC OLE)

Ulcerative Colitis

United States, Israel, Lebanon, Czechia, Italy, Australia, Georgia, Hungary, Poland, Belgium, France, Japan, United Kingdom, Estonia, Bulgaria, Germany, India, Ukraine, Austria, Belarus, Latvia, Slovakia, South Africa, Romania, Spain, Mexico and more
Pfizer
In Expanded Access, treating physicians are the Sponsors

Available

Provide Pre-approval Single Patient Expanded Access (Compassionate Use) of Etrasimod for Patients.

Colitis, Ulcerative
Pfizer

Recruiting

An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis (ENDEAVOUR-UC)

Colitis, Ulcerative

United States
Pfizer

Recruiting

A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis (EFFECT-UC)

Colitis, Ulcerative

United Kingdom, Canada, Germany
Pfizer

Recruiting

A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis (ELEVATE-UCkids)

Colitis, Ulcerative

Japan, Germany, Poland, Canada
Pfizer
Arena is a wholly owned subsidiary of Pfizer

Recruiting

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Ulcerative Colitis

United States, Spain, Japan, Austria, Belgium, Poland, Slovakia
Arena Pharmaceuticals

Completed

A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis (ADVISE)

Atopic Dermatitis

United States, Australia, Canada
Maia Kayal
Pfizer

Not yet recruiting

Etrasimod as Prevention of Pouchitis (ESPIRIT)

Pouchitis

United States

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

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Expanded Access

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

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

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

Clinical Trials on Ulcerative Colitis

Clinical Trials on Etrasimod

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators