Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (ELEVATE UC 52)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

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

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Etrasimod; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 433
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1430EGF
      • Clinica Adventista Belgrano
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1128AAF
      • Mautalen Salud e Investigación
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
      • Fundación Respirar- Centro Médico Dra. De Salvo
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • CICE Sanatorio 9 de Julio
• Australia
  • New South Wales
    • Bankstown, New South Wales, Australia, 2200
      • Bankstown-Lidcombe Hospital
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Hospital
  • Queensland
    • Maroochydore, Queensland, Australia, 4558
      • Coastal Digestive Health Pty Ltd
    • North Mackay, Queensland, Australia, 4740
      • Coral Sea Clinical Research Institute
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health Gastroenterology Department
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
• Austria
  • Linz, Austria, 4020
    • KH der Barmherzigen Brüder Linz
  • Wien, Austria, 1160
    • Wilhelminenspital der Stadt Wien
  • Wien, Austria, 1090
    • AKH - Medizinische Universitat Wien
• Belarus
  • Gomel, Belarus, 246029
    • Institution "Gomel Regional Clinical Hospital"
  • Grodno, Belarus, 230026
    • Grodno City Clinical Hospital #4
  • Minsk, Belarus, 220096
    • Health care Institution "10th City Clinical Hospital"
  • Vitebsk, Belarus, 210037
    • Vitebsk Regional Clinical Hospital
  • Vitebsk, Belarus, 210604
    • Vitebsk Regional Clinical Specialized Center
• Belgium
  • Gent, Belgium, 9000
    • AZ Sint-Lucas & Volkskliniek
  • Gent, Belgium, 9000
    • UZ Gent Gastroenterology
  • Merksem, Belgium, 2170
    • ZNA Jan Palfijn
  • Roeselare, Belgium
    • AZ Delta
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Medical center Medconsult Pleven OOD
  • Ruse, Bulgaria, 7002
    • UMHAT Kanev AD, Ruse
  • Sliven, Bulgaria, 8800
    • Diagnostic-Consultative Center I - Sliven, EOOD
  • Sofia, Bulgaria, 1407
    • ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center
  • Sofia, Bulgaria, 1431
    • DCC "Alexandrovska", EOOD
  • Sofia, Bulgaria, 1680
    • Diagnostic Consultation Center CONVEX EOOD
  • Sofia, Bulgaria, 1784
    • Acibadem City clinic University Hospital EOOD
  • Sofia, Bulgaria, 1431
    • UMHAT "Sv. Ivan Rilski", EAD,Clinic of gastroenterology
  • Sofia, Bulgaria, 1527
    • UMHAT Tsaritsa Yoanna-ISUL EAD
  • Sofia, Bulgaria, 1606
    • UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center, next to the chimney
  • Stara Zagora, Bulgaria, 6000
    • Medical Center Nov Rehabilitatsionen Tsentar EOOD
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital
• Chile
  • Santiago, Chile, 7500710
    • BioMedica Research Group
  • Santiago, Chile, 7500588
    • Enroll Spa
  • Santiago, Chile, 8150000
    • Hospital Sótero del Río
  • Talca, Chile, 3465586
    • Centro de Investigación del Maule SpA
  • Valdivia, Chile, 5090000
    • Clinical Research Chile SpA
• Croatia
  • Koprivnica, Croatia, 48000
    • General Hospital "Dr.Tomislav Bardek" Koprivnica
  • Osijek, Croatia, 31000
    • Clinical Hospital Centre Osijek
  • Zadar, Croatia, 23000
    • General Hospital Zadar
  • Zagreb, Croatia, 10000
    • University Hospital Centre Zagreb
  • Zagreb, Croatia, 10000
    • Clinical Hospital Sveti Duh
  • Zagreb, Croatia, 10000
    • Clinical Hospital Dubrava
  • Zagreb, Croatia, 10000
    • Polyclinic Bonifarm
• Czechia
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u svate Anny v Brne
  • Hradec Kralove, Czechia, 500 12
    • Hepato-Gastroenterologie HK, s.r.o.,
  • Klatovy, Czechia, 339 01
    • GASTRO JeKa, s.r.o.
  • Olomouc, Czechia, 779 00
    • PreventaMed s.r.o.
  • Ostrava-Poruba, Czechia, 708 52
    • Fakultní nemocnice Ostrava
  • Praha, Czechia, 180 81
    • Nemocnice Na Bulovce
  • Praha, Czechia, 170 04
    • ISCARE I.V.F. a.s.
  • Slany, Czechia, 274 01
    • Nemocnice Slany
• Denmark
  • Herlev, Denmark, 2730
    • Herlev Hospital
  • Nordjylland
    • Aalborg, Nordjylland, Denmark, 9000
      • Aalborg University Hospital, Department of Medical Gastroenterology
• Estonia
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital
  • Tallinn, Estonia, 10117
    • Innomedica OÜ
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation
• France
  • Grenoble, France, 38043
    • CHU Grenoble Alpes - Hôpital Michallon
  • Vandoeuvre-lès-Nancy, France, 54500
    • CHRU-Nancy Brabois
  • Alpes Maritimes
    • Nice Cedex 3, Alpes Maritimes, France, 06202
      • CHU Nice - Hopital de l'Archet 2
  • Herault
    • Montpellier cedex 5, Herault, France, 34295
      • CHU Montpellier - Hôpital Saint-Eloi
  • Loire Atlantique
    • Nantes, Loire Atlantique, France, 44000
      • CHU Nantes Hôtel-Dieu
• Georgia
  • Tbilisi, Georgia, 0131
    • LLC Vivamedi
  • Tbilisi, Georgia, 0172
    • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
  • 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, 0160
    • LTD Central University Clinic After Academic N. Kipshidze
  • Tbilisi, Georgia, 0112
    • LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine
• Germany
  • Berlin, Germany, 14163
    • Krankenhaus Waldfriede
  • Düsseldorf, Germany, 40489
    • Florence-Nightingale-Krankenhaus
  • Neuss, Germany, 41462
    • Johanna Etienne Krankenhaus
  • Schwerin, Germany, 19055
    • Klinische Forschung Schwerin GmbH
  • Nordrhein Westfalen
    • Remscheid, Nordrhein Westfalen, Germany, 42859
      • Praxis Dr. Joergensen
  • Rheinland Pfalz
    • Bonn, Rheinland Pfalz, Germany, 53123
      • Schwerpunktpraxis Bonn
  • Schleswig Holstein
    • Kiel, Schleswig Holstein, Germany, 24105
      • Clinic for Internal Medicine I, University hospital Schleswig-Holstein, Campus Kiel
• Hungary
  • Balatonfured, Hungary, 8230
    • DRC Gyogyszervizsgalo Kozpont Kft.
  • Bekescsaba, Hungary, 5600
    • Bekes Megyei Kozpont Korhaz Dr Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia
  • Budapest, Hungary, 1136
    • Pannónia Magánorvosi Centrum
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft.
  • Gyongyos, Hungary, 3200
    • Bugat Pal Korhaz
  • Szeged, Hungary, 6720
    • SZTE AOK I.st dept. of Internal Medicine.
  • Szekesfehervar, Hungary, 8000
    • 1th Dept of Gastroenterology, Szent Gyorgy Hospital
  • Szekszard, Hungary, 7100
    • Clinfan Ltd. Outpatient Clinic
  • Tatabanya, Hungary, 2800
    • Szent Borbala Korhaz
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500032
      • Asian Institute of Gastroenterology
  • Gujarat
    • Surat, Gujarat, India, 395002
      • Surat Institute of Digestive Sciences
    • Surat, Gujarat, India, 395002
      • Nirmal Hospitals Pvt Ltd
  • Haryana
    • Gurgaon, Haryana, India, 122002
      • Fortis Memorial Research Institute
  • Kerala
    • Kochi, Kerala, India, 682027
      • Aster Medcity,Aster DM healthcare Ltd
  • Maharashtra
    • Nagpur, Maharashtra, India, 440010
      • Midas Multispeciality Hospital-Nagpur
    • Pune, Maharashtra, India, 411001
      • Ruby Hall Clinic
  • Rajasthan
    • Jaipur, Rajasthan, India, 302001
      • Shweta Paliwal/Vipin Kumar Jain
  • Uttar Pradesh
    • Kanpur, Uttar Pradesh, India, 208002
      • Postgraduate department of Medicine, GSVM Medical college
• Israel
  • Afula, Israel, 1834111
    • Haemek Medical Center
  • Haifa, Israel, 3339419
    • Bnei Zion Medical Center
  • Holon, Israel, 5810001
    • Wolfson Medical Center
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah University Hospital - Ein Kerem
  • Nahariya, Israel, 2210001
    • Galilee Medical Center
  • Petach Tikva, Israel, 4941492
    • Rabin Medical Center
  • Ramat Gan, Israel, 5262000
    • Chaim Sheba Medical Center
  • Rehovot, Israel, 7610001
    • Kaplan Medical Center
• Italy
  • Brescia, Italy, 25123
    • Spedali Civili di Brescia, U.O. Gastroenterologia
  • Catania, Italy, 95126
    • Azienda Ospedaliera Ospedale Cannizzaro
  • Catanzaro, Italy, 88100
    • Magna Graecia University
  • Modena, Italy, 41124
    • A.O.U. Policlinico di Modena
  • Roma, Italy, 00157
    • Ospedale Sandro Pertini
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD
  • Vicenza, Italy, 36100
    • Ospedale San Bortolo di Vicenza
  • Bari
    • Castellana Grotte, Bari, Italy, 70013
      • Azienda Ospedaliera Saverio De Bellis
  • Milano
    • Rho, Milano, Italy, 20017
      • Ospedale di Circolo
    • San Donato Milanese, Milano, Italy, 20097
      • I.R.C.C.S Policlinico San Donato
  • Verona
    • Negrar, Verona, Italy, 37024
      • Ospedale Sacro Cuore Don Calabria
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Chilgok Hospital
  • Daegu
    • Junggu, Daegu, Korea, Republic of, 41944
      • Kyungpook National University Hospital
  • Gangwon-do
    • Wonju, Gangwon-do, Korea, Republic of, 26426
      • Wonju Severance Christian Hospital
  • Gyeonggi-do
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
      • The Catholic University of Korea, St. Vincent's Hospital
  • Seodaemun-gu
    • Seoul, Seodaemun-gu, Korea, Republic of, 03722
      • Severance Hospital, Yonsei University Health System
• Latvia
  • Riga, Latvia, LV-1002
    • P. Stradins Clinical University Hospital
• Lebanon
  • Beirut, Lebanon, 1100 2807
    • Saint George University Hospital Medical Center
• Lithuania
  • Kaunas, Lithuania, LT-47144
    • Kaunas Clinical Hospital
  • Klaipeda, Lithuania, LT-92288
    • Klaipeda University Hospital, Department of Gastroenterology
  • Panevezys, Lithuania, LT-35144
    • Republican Panevezys Hospital, Department of Gastroenterology
  • Vilnius, Lithuania, LT-08406
    • UAB "Inlita", Santaros Clinical Trials Centre
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology
• Mexico
  • Chihuahua, Mexico, 31203
    • Scientia Investigacion Clinica S.C.
  • Chihuahua, Mexico, 31238
    • Hospital Angeles Chihuahua
  • Veracruz, Mexico, 91900
    • Faicic S. de R.L. de Cv
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44130
      • Centro de Investigacion Medico Biologica Y Terapia Avanzada S.C.
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64660
      • InspirePharma S. de R. L. de C.V.
• Moldova, Republic of
  • Chisinau, Moldova, Republic of, MD-2025
    • Rtl Sm Srl
  • Chisinau, Moldova, Republic of, MD-2025
    • Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology
  • Chisinau, Moldova, Republic of, MD-2005
    • Clinical Hospital of the Ministry of Health, Labor and Social Protection
  • Chisinau, Moldova, Republic of, MD-2068
    • RTL SM SRL, Institutia Medico-Sanitara Publica Spitalul Clinic, Sectia Proctologie
• Netherlands
  • Geleen, Netherlands, 6162 BG
    • Zuyderland Medisch Centrum - Sittard-Geleen
  • Tilburg, Netherlands, 5022 GC
    • ETZ Elisabeth
• Poland
  • Bedzin, Poland, 42-500
    • Centrum Dentystyczno-Lekarskie PROMEDICA Joanna Markiewicz
  • Białystok, Poland, 15-322
    • Gastromed Kralisz, Romatowski, Stachurska sp.j
  • Czestochowa, Poland, 42-200
    • Centrum Medyczne Pratia Czestochowa
  • Jelenia Gora, Poland, 58-500
    • Karkonoskie Centrum Badan Klinicznych Lexmedica
  • Kraków, Poland, 31-506
    • Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna
  • Lodz, Poland, 90-644
    • AmiCare Sp. z o.o. Sp.k.
  • Lodz, Poland, 90-752
    • IP Clinic
  • Lodz, Poland, 91-034
    • Med-Gastr Przychodnia Specjalistyczna
  • Nowy Targ, Poland, 34-400
    • Allmedica Badania Kliniczne sp. z o.o. sp.k.
  • Nowy Targ, Poland, 34-400
    • Medicenter Nowy Targ
  • Oswiecim, Poland, 32-600
    • Medicome Sp. Zo.O.
  • Poznan, Poland, 60-529
    • Solumed Centrum Medyczne
  • Poznan, Poland, 60-369
    • Centrum Medyczne Grunwald
  • Rzeszow, Poland, 35-326
    • Centrum Medyczne MEDYK
  • Sopot, Poland, 81-756
    • ENDOSKOPIA Sp.zo.o
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Warsaw, Poland, 00-635
    • Centrum Zdrowia MDM
  • Warsaw, Poland, 02-507
    • Centralny Szpital Kliniczny MSW w Warszawie
  • Wroclaw, Poland, 52-416
    • Centrum Medyczne Oporow
  • Wroclaw, Poland, 144-148
    • EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia - Dzial Farmacji
  • Wroclaw, Poland, 53-114
    • Jerzy Rozciecha- Lexmedica
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia
  • Porto, Portugal, 4200-319
    • Centro Hospitalar de Sao Joao, EPE
  • Vila Nova de Gaia, Portugal, 4434-502
    • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
• Romania
  • Bucharest, Romania, 10825
    • Dr. Carol Davila Central University Emergency Military Hospital
  • Bucharest, Romania, 540136
    • Centrul Medical Unirea SRL
  • Bucuresti, Romania, 22328
    • Institutul Clinic Fundeni
  • Bucuresti, Romania, 10719
    • S.C MedLife SA
  • Bucuresti, Romania, 14461
    • S.C Euroclinic Hospital S.A
  • Bucuresti, Romania, 20125
    • Spitalul Clinic Colentina
  • Bucuresti, Romania, 030463
    • S.C Policlinica Ccbr S.R.L
  • Bucuresti, Romania, 14142
    • Delta Health Care SRL
  • Cluj-Napoca, Romania, 400006
    • Spitalul Clinic Judetean de Urgenta Cluj Napoca
  • Craiova, Romania, 200640
    • Spitalul Clinic Județean de Urgență
  • Oradea, Romania, 410469
    • S.C Pelican Impex S.R.L
  • Oradea, Romania, 410167
    • Cabinet Medical Dr. Fratila S.R.L
• Russian Federation
  • Barnaul, Russian Federation, 656043
    • LLC "Multidisciplinary Medical Clinic "Anthurium"
  • Irkutsk, Russian Federation, 664049
    • LLC "Alyans Biomedical- Ural Group"
  • Kazan, Russian Federation, 420012
    • Kazan State Medical University
  • Kemerovo, Russian Federation, 650066
    • SAIH "Kemerovo Regional Clinical Hospital
  • Nizhniy Novgorod, Russian Federation, 603126
    • SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
  • Novosibirsk, Russian Federation, 630005
    • LLC Medicine Center SibNovoMed
  • Omsk, Russian Federation, 644024
    • CDC Ultramed
  • Penza, Russian Federation, 440026
    • State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"
  • Saint Petersburg, Russian Federation, 194356
    • Llc "Medinet"
  • Saint Petersburg, Russian Federation, 195067
    • Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"
  • Saint Petersburg, Russian Federation, 195279
    • LLC SM-Clinic
  • Saint Petersburg, Russian Federation, 197110
    • LLC "Gastroenterological centre Expert"
  • Samara, Russian Federation, 443011
    • Irkutsk State Medical Academy of Continuing Education
  • Samara, Russian Federation, 443093
    • LLC Medical company "Hepatologist"
  • Samara, Russian Federation, 443011
    • Private Educational Institution of Higher Education "Medical University REAVIZ"
  • Sestroretsk, Russian Federation, 197706
    • SPb SBIH "City Hospital # 40 of Kurortnyi region"
  • Smolensk, Russian Federation, 214031
    • LLC Uromed
  • Stavropol, Russian Federation, 355017
    • Stavropol Regional Clinical Diagnostic Centre
  • Stavropol, Russian Federation, 357000
    • LLC "Polyclinic of ultrasonography 4D"
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center " Dr Dragisa Misovic Dedinje"
  • Belgrade, Serbia, 11000
    • Clinical Health Center Zvezdara
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
  • Sremska Mitrovica, Serbia, 22000
    • General Hospital Sremska Mitrovica
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
    • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
  • Bardejov, Slovakia, 085 01
    • Alian s.r.o
  • Nitra, Slovakia, 950 01
    • Fakultna nemocnica Nitra
  • Nitra, Slovakia, 949 01
    • KM Management spol. s r.o.
  • Nove Zamky, Slovakia, 940 01
    • GASTROENTEROLOG, s.r.o.
  • Presov, Slovakia, 080 01
    • Gastro I, s.r.o.
  • Sahy, Slovakia, 936 01
    • Accout Center s.r.o.
  • Presov
    • Vranov nad Toplou, Presov, Slovakia, 093 01
      • Endomed, s.r.o.
• South Africa
  • Centurion
    • Lyttelton, Centurion, South Africa, 0157
      • Johese Clinical Research: Unitas
    • Midstream, Centurion, South Africa, 1692
      • Johese Clinical Research
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1827
      • Lenasia Clinical Trial Centre
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7708
      • Dr JP Wright Practice
• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• Thailand
  • Chiang Mai, Thailand, 50200
    • Ms. Arawan Larplertsakul
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital
    • Pathum Wan, Bangkok, Thailand, 10330
      • Supaporn Lertkawinanan
    • Ratchathewi, Bangkok, Thailand, 10400
      • Phramongkutklao Hospital
• Turkey
  • Ankara, Turkey, 06500
    • Gazi University Medical Faculty
  • Antalya, Turkey, 07030
    • Antalya Training And Research Hospital
  • Kocaeli, Turkey, 41380
    • Kocaeli University Research and Training Hospital
  • Yenimahalle / Ankara
    • Beşevler, Yenimahalle / Ankara, Turkey, 16059
      • Uludag University Medical Faculty
• Ukraine
  • Dnipro, Ukraine, 49005
    • I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
  • Ivano-Frankivsk, Ukraine, 76018
    • Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University
  • Ivano-Frankivsk, Ukraine, 76018
    • Municipal non-profit enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council", Ga
  • Kharkiv, Ukraine, 61037
    • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
  • Kharkiv, Ukraine, 61058
    • Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
  • Kharkiv, Ukraine, 61124
    • Communal Non-commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council
  • Kherson, Ukraine, 73000
    • Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City
  • Kremenchuk, Ukraine, 39617
    • Kremenchuk first city hospital n.a. O.T. Bohaievskyi
  • Kyiv, Ukraine, 02091
    • Kyiv City Clinical Hospital N 1
  • Kyiv, Ukraine, 01133
    • National Military Medical Clinical Center Main Military Clinical Hospital
  • Lviv, Ukraine, 79059
    • Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care
  • Odesa, Ukraine, 65025
    • Odesa regional clinical hospital, regional center of gastroenterology, surgical department
  • Uzhgorod, Ukraine, 88000
    • A. Novak Transcarpathian Regional Clinical Hospital
  • Vinnytsia, Ukraine, 21018
    • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
  • Vinnytsia, Ukraine, 21009
    • Medical Clinical Investigational Center of Medical Center Health Clinic LLC
  • Vinnytsia, Ukraine, 21029
    • SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
  • Zaporizhzhia, Ukraine, 69035
    • Communal Institution City Clinical Hospital #6, Department of Gastroenterology
• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Belfast Health and Social Care Trust Royal Victoria Hospital
  • Hemel Hempstead, United Kingdom, HP2 4AD
    • West Hertfordshire Hospitals NHS Trust Hemel Hempstead General Hospital
  • Greater London
    • London, Greater London, United Kingdom, E11 1NR
      • Barts Health NHS Trust - Whipps Cross University Hospital
    • London, Greater London, United Kingdom, SE1 9RT
      • Guys and St Thomas NHS Foundation Trust
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UQ
      • Norfolk and Norwich University Hospitals NHS Foundation Trust
  • Somerset
    • Yeovil, Somerset, United Kingdom, BA21 4AT
      • Yeovil Hospital NHS Foundation Trust
• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Digestive Health Specialists of the Southeast
  • Arizona
    • Sun City, Arizona, United States, 85351
      • Arizona Digestive Health
  • California
    • Lancaster, California, United States, 93534
      • Om Research, LLC
    • Los Angeles, California, United States, 90036
      • Entertainment Medical Group, Inc.
    • Murrieta, California, United States, 92563
      • United Medical Doctors
    • San Diego, California, United States, 92103
      • San Diego Gastroenterology Medical Associates
    • San Diego, California, United States, 92119
      • ACRC Studies, LLC
  • Colorado
    • Colorado Springs, Colorado, United States, 80920
      • Peak Gastroenterology Associates
  • Florida
    • Clearwater, Florida, United States, 33762
      • West Central Gastroenterology d/b/a Gastro Florida
    • Clearwater, Florida, United States, 33761
      • Gastro Florida
    • Clearwater, Florida, United States, 33777
      • Florida Center for Gastroenterology
    • Miami, Florida, United States, 33156
      • Javier Sobrado, MD
    • Miami Lakes, Florida, United States, 33014
      • Life Medical Center & Research, Inc
    • Naples, Florida, United States, 34102
      • Gastroenterology Group Of Naples
    • Naples, Florida, United States, 34110
      • Office of Dr Meckstroth
    • New Smyrna Beach, Florida, United States, 32168
      • NSB Research
    • Ocala, Florida, United States, 34474
      • Sarkis Clinical Trials - Parent
    • Palmetto Bay, Florida, United States, 33157
      • IMIC, Inc.
    • Port Orange, Florida, United States, 32127
      • Advanced Medical Research Center
    • Saint Petersburg, Florida, United States, 33709
      • Theia Clinical Research, LLC
    • Saint Petersburg, Florida, United States, 33710
      • Advanced Research Institute, Inc.
    • Sweetwater, Florida, United States, 33172
      • Lenus Research & Medical Group
    • Tampa, Florida, United States, 33614
      • Guardian Angel Research Center
    • Tampa, Florida, United States, 33609
      • GCP Clinical Research
    • Tampa, Florida, United States, 33606
      • USF Physicians Group
    • Weeki Wachee, Florida, United States, 34607
      • ASCLEPES Research Centers, P.C.
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic, P.A.
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates LLC
    • Decatur, Georgia, United States, 30033
      • Atlanta Center for Gastroenterology, P.C.
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • Illinois Gastroenterology Group
    • Moline, Illinois, United States, 61265
      • Gen1 Research
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Texas Digestive Disease Consultants
    • Houma, Louisiana, United States, 70360
      • CroNOLA
    • Lake Charles, Louisiana, United States, 70601
      • Clinical Trials of SW Louisiana, LLC
    • Metairie, Louisiana, United States, 70006
      • Clinical Trials Management, LLC
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Chevy Chase Clinical Research
  • Michigan
    • Flint, Michigan, United States, 48503
      • Flint Clinical Research
    • West Bloomfield, Michigan, United States, 48323
      • Robert Ferguson MD
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Gastrointestinal Associates
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Sierra Clinical Research
    • Las Vegas, Nevada, United States, 89113
      • Las Vegas Medical Research
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center GI Clinical Research Unit
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
    • Mentor, Ohio, United States, 44060
      • Great Lakes Medical Research, LLC
    • Poland, Ohio, United States, 44514
      • Care Access Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists, Inc.
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17110
      • Great Lakes Medical Research, LLC
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • GI For Kids
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Clinical Research Institute, LLC
    • Baytown, Texas, United States, 77521
      • Coastal Medical Group
    • Cypress, Texas, United States, 77429
      • Texas Gastroenterology Associates, PA
    • Dallas, Texas, United States, 76092
      • Texas Digestive Disease Consultants
    • Garland, Texas, United States, 75044
      • Digestive Health Associates of Texas
    • Houston, Texas, United States, 77030
      • Baylor Gastroenterology Assoc
    • Houston, Texas, United States, 77029
      • CliniCore Texas
    • Houston, Texas, United States, 77043
      • Biopharma Informatic, Inc. Research Center
    • McAllen, Texas, United States, 78503
      • Rio Grande Gastroenterology
    • Pasadena, Texas, United States, 77505
      • Biopharma Informatic, Inc. Research Center
    • San Marcos, Texas, United States, 78130
      • Texas Digestive Disease Consultants - San Marcos
    • Tyler, Texas, United States, 75701
      • Tyler Research Institute, LLC
    • Victoria, Texas, United States, 77904
      • Victoria Gastroenterology
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Blue Ridge Medical Research
  • Washington
    • Bellevue, Washington, United States, 98004
      • Washington Gastroenterology
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Marshall University Department of Clinical Research
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226-0509
      • Medical College of Wisconsin Clinical Trials Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 76 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
2. Active UC confirmed by endoscopy

Exclusion criteria:

1. Severe extensive colitis
2. Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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 at Week 12	Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily eDiary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Week 12
Percentage of Participants Achieving Clinical Remission at Week 52	Clinical remission was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Endoscopic Improvement at Week 12	Endoscopic improvement was defined as an ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease).	At Week 12
Percentage of Participants Achieving Endoscopic Improvement at Week 52	Endoscopic improvement was defined as an ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease).	At Week 52
Percentage of Participants Achieving Symptomatic Remission at Week 12	Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.	At Week 12
Percentage of Participants Achieving Symptomatic Remission at Week 52	Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.	At Week 52
Percentage of Participants With Mucosal Healing at Week 12	Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). 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 indicates more severe disease.	At Week 12
Percentage of Participants With Mucosal Healing at Week 52	Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). 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 indicates more severe disease.	At Week 52
Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52	Corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, ES ≤ 1 (excluding friability), and have not received corticosteroids for ≥ 12 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Week 52
Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52	Sustained clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability) at both Week 12 and Week 52. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Weeks 12 and 52
Percentage of Participants Achieving Clinical Response at Week 12	Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Week 12
Percentage of Participants Achieving Clinical Response at Week 52	Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB sub-score ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Week 52
Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52	Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Weeks 12 and 52
Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52	Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). 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 indicates more severe disease.	At Weeks 12 and 52
Percentage of Participants Achieving Endoscopic Normalization at Week 12	Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).	At Week 12
Percentage of Participants Achieving Endoscopic Normalization at Week 52	Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).	At Week 52
Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52	Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).	At Weeks 12 and 52
Percentage of Participants Achieving Symptomatic Remission by Study Visit	Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.	At Weeks 2, 4, 8, 16, 20, 24, 32, 40, and 48
Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit	Complete symptomatic remission was defined as an SF subscore = 0 and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.	At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 52
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit	Non-invasive clinical response was defined as a ≥ 30% decrease from Baseline in composite RB and SF subscores, and a ≥ 1-point decrease from Baseline in RB subscore or RB subscore ≤ 1. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.	At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Percentage of Participants Achieving Symptomatic Response by Study Visit	Symptomatic response was defined as a ≥ 30% decrease from Baseline in composite RB and SF subscores. The SF subscore ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0= no blood and 3= blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.	At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline	Four-week corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1, and have not received corticosteroids for ≥ 4 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Week 52
Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12	Clinical remission and clinical response were based on the MMS which is a composite of 3 assessments: SF, RB and ES. Clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Week 52

Collaborators and Investigators

• Sponsor: Arena Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Actual): February 8, 2022
• Study Completion (Actual): February 16, 2022

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Etrasimod; APD334
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: APD334-301; 2018-003985-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No