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

About this trial

Eligibility Criteria

Sites / Locations

• Center for Digestive Health (Colonoscopy Location)
• Digestive Health Specialists
• Dothan Eyecare-Dr. Brent McKinley (OCT Location)
• Pulmonary Associates (Secondary PFT Location)
• Flowers Hospital (PFT Location)
• Arizona Retina Institute/ Phoenix Retina Associates(OCT)
• SimonMed Imaging (Imaging)
• Sun City Endoscopy (Endoscopy)
• Euclid Endoscopy Center-El Cajon (Endoscopy procedure only)
• Center for Clinical Research (CCR)
• UCI Gavin Herbert Eye Institute
• UCI Gottschalk Medical Plaza
• Koman Family Outpatient Pavilion (Endoscopy)
• Perlman Medical Offices (IBD Clinic)
• UCSD Clinical and Translational Research Institute (Research Clinic)
• UCSD Health System (PFT/Endoscopy)
• UCSD lnvestigational Drug Service Pharmacy
• Shiley Eye Institute (OCT)
• Dr. Raed Al-Naser -Sharp Grossmont outpatient (DLCO procedure only)
• Dr. Sally s. Lee in La Mesa (Ophthalmologist procedure only)
• Inland Pulmonary Specialists [PFT Only]
• Advanced Endoscopy and Pain Center (Colonoscopy)
• Advanced Imaging Center (Chest X-Ray)
• Antelope Valley Eye Care (Ophthalmologist)
• AV Pediatrics, Allergy and Family Medicine (PFT, Physical Exam, ECG Review, Lab Review)
• Jatinder S. Pruthi, MD FACG CPI (Physical Exam, ECG Review, Lab Review)
• OM Research LLC
• Abraham M. lshaaya MD (X-Ray)
• Entertainment Medical Group, Inc (Main Site, Subject Visits, IP Delivery/Storage, Regulatory,
• Advanced Vision Care (OCT)
• Century City Endoscopy (Colonoscopy - Nicholas Karyotakis M.D. Endoscopist)
• Gastrointestinal Biosciences Clinical Trials, LLC
• United Surgery Center Murrieta [Endoscopy Only]
• United Medical Doctors
• CCR-ICTS Center for Innovative Patient Care
• UCI Health Eye Care Services (Ophthalmoscopy and OCTs)
• UCI Health H. H. Chao Comprehensive Digestive Disease Center
• UCI Investigational Drug Services (IDSP - Pharmacy)
• UCI Irvine Medical Center - Pulmonology Services - PFTs
• ACRC Studies
• California Eye Professionals [OCT Only]
• United Surgery Center Temecula [Endoscopy Only]
• Front Range Endoscopy Center
• Peak Gastroenterology Associates
• Colorado Springs Pulmonary Consultants, PC
• The Wright Eye Center (OCT Facility)
• Colorado Springs Imaging
• Peak Gastroenterology Associates
• Yale Ophtalmology
• Yale School of Medicine
• Yale New Haven Hospital - Winchester Chest Clinic - PFT
• Yale New Haven Hospital MEMC- Endoscopy
• Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD
• Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test)
• GASTRO FLORIDA (ADMINISTRATIVE DUTIES etc. CRA visits)
• West Coast Endoscopy (Colonoscopy Procedures)
• West Coast Endoscopy Center (Endoscopy Procedures)
• West Coast Radiology (Chest X-ray)
• Northwood Vision- Optical Coherence Tomography (OCT)
• Beraja Medical Institute (OCT)
• Juan Barrio, MD (PFT when needed)
• Retina Consultants of Southwest Florida, PA "OCT"
• The Endoscopy Center (Endoscopy Procedure)
• Research Associates of South Florida
• Kendall Endoscopy and Surgery Center (Endoscopy)
• Clarin Eye Care Center (OCT/Ophthalmoscopy)
• Bruce Roy, MD "PFT"
• Gastroenterology Group of Naples
• Gulfshore Endoscopy Center
• Radiology Regional Center "Chest x-ray"
• NSB Research
• IMIC Inc
• Advanced Medical Research Center
• Larkin Community Hospital (Endoscopy Procedure)
• Absolute Surgical Specialists - Craig Amshel, MD
• SimonMed Imaging
• Perez Eye Center(OCT & Ophthalmoscopy only)
• Tampa Bay Endoscopy Center(Proctosigmoidoscopy & colonoscopy ONLY)
• Lyracore Health Alliance, Tampa Bay Pulmonology (PFT only)
• Pulmonary and Sleep of Tampa Bay(PFT with DLCO only)
• GCP Clinical Research,LLC
• LoCicero Medical Group (PFT Procedure Only)
• NewsomEye (OCT only)
• South Tampa Surgery Center
• Florida Medical Clinic, LLC (Endoscopy)
• Florida Medical Clinic, LLC (OCT)
• Florida Medical Clinic, LLC (PFT)
• Florida Medical Clinic, LLC
• GI Alliance (Patients Seen; IP Delivered)
• Medical Eye Services LTD (Ophthalmoscopy with OCT)
• North Shore Endoscopy Center (Endoscopy)
• Libertyville Imaging Center (Diagnostic Imaging)
• Chevy Chase Endoscopy Center (Endoscopy Facility Only)
• Chevy Chase Pulmonary Associate (PFT Only)
• Retina Group of Washington (Ophthalmoscopy and OCT Only)
• Charter Radiology
• Cascades Endoscopy Center
• Gastro Center of Maryland, LLC
• Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only)
• Lung Center (Pulmonary Function Test only)
• Beth Israel Deaconess Medical Center
• Barnes-Jewish West County Hospital (Additional Endoscopy Location)
• Center for Outpatient Health
• Barnes-Jewish Hospital
• Center for Advanced Medicine
• Washington University School of Medicine
• Dartmouth-Hitchcock Medical Center
• Advantage Diagnostics(X-Ray only)
• Geauga Sleep Center(PFT only)
• UC Health Physicians Office
• UC Health (Pulmonary Function Testing)
• University of Cincinnati College of Medicine
• The Endoscopy Center of Lake County
• Vitreo Retinal Consultants(OCT only)
• Retina Specialists of Ohio(OCT only)
• Lake Pulmonary Associates (PFT only)
• West Shore Endoscopy Center
• Medical Arts Allergy,PC (PFT Only)
• Farrel Opthalmology(OCT only)
• Pinnacle Health Imaging at Tristan (X-Ray only)
• Susquehanna Research Group
• Advanced Radiology Associates (x-Ray only)
• Texas Retina Associates (OCT Location)
• Alkek Eye Center Jamail Specialtu Care Center (OCT)
• Baylor College of Medicine- Baylor Medical Center
• Baylor College of Medicine-Baylor Medical Center (Chest X-ray location)
• Baylor College of Medicine-Baylor Medical Center (IP Storage)
• Baylor College of Medicine-Baylor Medical Center (Patients seen address, ECG location, PFT)
• Baylor St. Luke's Medical Center Endoscopy- Mc Nair Campus (Endoscopy Location)
• Lonestar Endoscopy
• Buena Vista Optical ( OCT only)
• Endoscopy Center at Med Point (Endoscopy only)
• Valley Pulmonary Group (PFT only)
• Envision Imaging
• Lonestar Endoscopy
• Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
• Heaton Eye Associates (OCT only)
• Christus Trinity Mother Frances Endoscopy Center
• Christus Trinity Mother Frances Endosopy Center ( endoscopies only)
• Tyler Open MRI (chest x-ray only)
• UT Health East Texas Physicians (pulmonary functions only)
• Citizen Healthplex (PFT)
• Gastro Health & Nutrition - Victoria
• Surgery Center (Endoscopy)
• Victoria Eye Center (OCT and Opthalmoscopy)
• University of Utah Huntsman Cancer Hospital Endoscopy
• University of Utah Clinic and Endoscopy Suite - Sugarhouse
• University of Utah Hospitals and Clinics (PFT)
• University of Utah Moran Eye Center (Opthalmoscopy/OCT)
• Harman Eye Center (OCT only)
• Lynchburg Pulmonary Associates, Inc. (PFT only)
• Blue Ridge Medical Research
• Radiology Consultants of Lynchburg (X-ray only)
• Eastside Endoscopy Center
• Overlake Clinics- Pulmonary Medicine
• Washington Gastroenterology
• Northwest Vision (OCT only)
• Swedish Gastroenterology
• Swedish Medical Center
• Swedish Medical Center First Hill Endoscopy Center
• Swedish Medical Center
• Froedtert Memorial Lutheran Hospital
• Bankstown-Lidcombe Hospital
• Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility )
• Sunshine Coast Radiology
• Sunshine Coast University Private Hospital
• Buderim Eye Centre( OCT and Ophthalmoscopy Facility)
• Coral Sea Clinical Research Institute Pty.Ltd
• Coastal Digestive Helath Pty. Ltd
• Dr.Shiran DeSilva Respiratory Clinic (PFT)
• Mater Misericordiae Hospital ( Endoscopy)
• Queensland X-Ray
• Vision Eye Institute Mackay (OCT)
• Austin Health
• Melbourne Health
• Institution "Gomel Regional Specialized Clinical Hospital"
• Institution "Gomel Regional Clinical Hospital"
• Foreign Medical and Pharmaceutical Unitary Enterprise "Medical center "Novoe Zrenie"
• Health Care Institution "Grodno City Clinical Hospital #4"
• Vitebsk Regional Clinical Hospital
• Health Care Institution "Vitebsk Regional Clinical Specialized Center"
• AZ Sint-Lucas
• AZ Delta
• UMHAT ,,Kanev" AD
• Diagnostic-Consultative Center I - Sliven, EOOD
• Acibadem City Clinic University Hospital EOOD
• DCC Alexandrovska, EOOD
• UMHAT "Tsaritsa Yoanna-ISUL" EAD
• University multiprofile hospital for active treatment and emergency medicine N.l Pirogov EAD
• Diagnostic Consultation Center CONVEX EOOD
• Medical Centre MEDICA Plus OOD
• University of Calgary, Department of Medicine - Respirology (PFT Only)
• University of Calgary, Heritage Medical Research Clinic
• University of Calgary, Department of Medicine - Opthalmology (OCT Only)
• St. Joseph's Hospital (OCT Procedure only)
• London Health Sciences Centre - University Hospital
• McGill University Health Center- Montreal General Hospital (Electrocardiogram Clinic)
• McGill University Health Center- Montreal General Hospital (Endoscopy clinic)
• McGill University Health Center- Montreal General Hospital (IP Address)
• McGill University Health Center- Montreal General Hospital (Research Site)
• Montreal General Hospital (MUHC-Radiology)
• Eye Health MD (OCT)
• Gastroenterologicka ambulance
• Hepato-Gastroenterologie HK, s.r.o.
• VISUS, spol s.r.o.
• Gastroenterologicka ordinace MUDr. Pavla Skalova s.r.o., MUDr. Frantisek Sincl s.r.o.
• MUDr. Pavlina Kazinotova, s.r.o.
• Ocni ordinace Olomouc
• PreventaMed s.r.o.
• Fakultni nemocnice Ostrava
• Ocni centrum Praha, a.s.
• ISCARE a.s.
• Prvni plicni ambulance. s.r.o.
• Gastroenterologicka ambulance MUDr. Marcela Vyslouzilova
• Privatni gastroenterologicka ambulance s.r.o. MUDr. Zdenek Vlk
• Nemocnice Slany
• Poliklinika Slany, spol. s.r.o.
• Centre Hospitalier Universitaire de Clermont-Ferrand - Hopital Estaing
• Centre Hospitalier Universitaire de Genoble Alpes - CHU Michallon
• Centre Hospitalier Universitaire de Nantes - Hotel-Dieu
• Centre Hospitalier Universitaire de Nice - Hopital de l'Archet 2
• CHU RENNES - Hopital Pontchaillou
• LLC Academic Pridon Todua Medical Center - LLC Research Institute of Clinical Medicine
• LLC Todua Clinic
• LTD Israeli-Georgian Medical Research Clinic Helsicore
• LTD Vivamedi
• LTD Institute of Clinical Cardiology
• Medical Center CITO LTD
• JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
• LTD Academician Nikoloz Kipshidze Central University Clinic
• LTD Aversi Clinic
• LTD Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
• Charite - Universitatsmedizin Berlin, Campus Mitte (CCM)
• OCT Charite - Universitatsmedizin Berlin
• PFT Klinik fur Infektiologie & Pneumologie
• Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
• Florence-Nightingale-Krankenhaus
• OCT: nordBLICK Augenklinik Bellevue
• Universitatsklinikum Schleswig-Holstein, Campus Kiel
• OCT: Dr. med. Christopher Kallen
• Johanna Etienne Krankenhaus
• OCT: AOZ Neuss
• OCT: Augenpraxisklinik REMSCHEID
• Magen-Darm-Zentrum Remscheid
• Bugat Pal Korhaz
• DLCO and ophthalmology tests: Szent Borbala Korhaz
• Clinfan Szolgaltato Kft.
• Ophthalmology tests: Tolna Megyei Balassa Janos Korhaz
• Ophthalmology tests: Tosho Kft.
• Mediszem Kft.
• Endoexpert EgeszsegUgyi Szolgaltato Kft.
• Magyar Honvedseg Egeszsegugyi Kozpont (Ophthalmology Tests)
• Pulmonary function test: Vasutegeszsegugyi Nonprofit Kozhasznu Kft.
• Vasutegeszsegugyi Nonprofit Kozhasznu Kft. (Pulmonary function)
• Vasutegeszsegugyi Nonprofit Kozhasznu Kft.
• Honvedkorhaz II. telephely
• Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
• Pannonia Maganorvosi Centrum Kft.
• Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Gasztroenterologia
• Opthalmology tests: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont,Szemeszeti Klinika
• Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Belgyogyaszati Klinika
• Edith Wolfson Medical Center
• Shaare Zedek Medical Center
• Galilee Medical Center
• Rabin Medical Center
• Kaplan Medical Center
• Azienda Ospedaliera Saverio De Bellis
• ASST Rhodense - Pneumology Unit
• IRCCS Ospedale San Raffaele, Unita di Gastroenterologia
• ASST Rhodense - Ophthalmology Unit (For Ophthalmoscopy)
• ASST Rhodense - Ophthalmology Unit
• ASST Rhodense - U.O.C. di Gastroenterologia ed Endoscopia Digestiva
• Fondazione Policlinico Agostino Gemelli IRCCS
• Ospedale San Bortolo di Vicenza, Gastroenterologia
• Yonsei University Wonju Severance Christian Hospital
• Endoscopy Facility in Kyungpook National University Chilgok Hospital
• Kyungpook National University Chilgok Hospital
• OCT Facility in Kyungpook National University Chilgok Hospital
• PFT Facility in Kyungpook National University Chilgok Hospital
• Endoscopy Facility in kyungpook National University Hospital
• Kyungpook National University Hospital
• OCT Facility In kyungpook Natioanl University Hospital
• PFT Facility in kyungpook Natioanl University Hospital
• Endoscopy Facility in Severance Hospital, Yonsei University Health System
• OCT(1) Facility in Severance Hospital, Yonsei University Health System
• OCT(2) Facility in Severance Hospital, Yonsei University Health System
• PFT(1) Facility Severance Hospital, Yonsei University Health System
• PFT(2) Facility Severance Hospital, Yonsei University Health System
• Severance Hospital, Yonsei University Health System
• Centrum Medyczne Oporow
• OKOLEK
• EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu
• Amicare Sp. z o.o. Sp.k.
• IP Clinic Sp. z o.o.
• Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
• Medicome Sp. z o.o.
• Centrum Zdrowia MDM
• lnstytut Gruzlicy i Chorob Pluc
• Centrum Medyczne Grunwald
• Specjalistyczny Okulistyczny Niepubliczny Zaklad Opieki Zdrowotnej OCUSERVICE
• NSZOZ Termedica
• Szpital Sw. Wojciecha
• Spoldzielnia Pracy Lekarzy Specjalistow Medicus (for OCT)
• Twoja Przychodnia-Szczecinskie Centrum Medyczne
• Przychodnia EVOMED Pracownia USG i RTG
• Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)
• Centrum Medyczne Ksiezy Mlyn sp. z o.o. (Ophtalmoscopy, OCT)
• Centra Medyczne 'MEDYCEUSZ" (Chest X-Ray)
• Wojewodzki Szpital Specjalistyczny im.dr. WI. Bieganskiego (endoscopy)
• Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
• MEDICOME- Oswiecimskie Centrum Medyczne (OCT)
• Centrum Medyczne Grunwald
• Centrum Medyczne Grunwald
• Centrum Zdrowia MDM
• Endomed
• Centro Hospitalar Universitario de Sao Joao, E.P.E
• "Clinic Ultrasound 4D" LLC
• "Platnaya poliklinika" LLC
• SBHI of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko
• BHI of Omsk region "Clinical oncology dispensary"
• Clinicodiagnostic center "Ultramed"
• Medical center "Intervzglyad"
• FSBEI of Higher Education "I.P.Pavlov First Saint Petersburg State Medical University" of MoH of RF
• Private Institution, Educational Organization of Higher Education "Medical University "Reaviz"
• Private Institution, Educational Organization of Higher Education "Medical University "Reaviz",
• Clinical Hospital Russian Railways - Medicina
• Medical Company "Hepatolog" LLC
• Medical Company "Hepatolog" LLC
• Samara Diagnostic center
• Regional Medical center LLC (Branchevsky's clinic)
• Inter-branch scientific and technical complex "Eye microsurgery"
• Multidisciplinary Medical center "Clinic Park"
• "Uromed" LLC
• FSBEI of Higher Education "North-Western State Medical University n.a. I.I. Mechnikov" of MoH RF
• Autonomous Noncommercial Medical Organization "Stavropol Regional Clinical Advisory-Diagnostic
• Hospital General Universitario de Alicante
• Hospital Universitario la Paz
• Limited Liability Company "Lookout "Medical Center"
• Limited Liability Company "MDC EXPERT"
• Municipal Enterprise <<Dnipro Reg Clinical Hosp named after M. I.I. Mechnikov>>
• Clinical Diagnostical Center "Simedgroup"
• CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council,Department of Gastroenterology
• Llc "Ldts-Skaymed"
• CNE Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv City Council, Department of Proctology
• Llc Medical Center Oftalmika
• CNE Kyiv City Clinical Hospital #1 of Executive Body of Kyiv City Council (Kyiv City State
• Transcarpathian Center of Eye Microsurgery
• CNE Andrii Novak Transcarpathian Regional Clinical Hospital of
• Medical Center of LLC Health Clinic, Med Clinical lnvestigational Center, Unit of Gastroenterology,
• CNE "Vinnytsia Reg Clinical Hosp named after N.I.Pirogov Vinnytsia Regional Council", Reg Specialize
• Podilskyi tsentr zoru
• Scientific and Research Institute of lnvalid Rehabilitation (Educational and Scientific
• Diagnostic Center "Mediscan"
• Llc "Optimal M"

Arms of the Study

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information