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
2 other identifiers
interventional
433
37 countries
303
Brief Summary
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2019
Typical duration for phase_3
303 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2019
CompletedFirst Posted
Study publicly available on registry
May 10, 2019
CompletedStudy Start
First participant enrolled
June 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 16, 2022
CompletedResults Posted
Study results publicly available
December 20, 2022
CompletedDecember 20, 2022
March 1, 2022
2.7 years
May 8, 2019
November 28, 2022
November 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (21)
Percentage of Participants Achieving Endoscopic Improvement at Week 12
At Week 12
Percentage of Participants Achieving Endoscopic Improvement at Week 52
At Week 52
Percentage of Participants Achieving Symptomatic Remission at Week 12
At Week 12
Percentage of Participants Achieving Symptomatic Remission at Week 52
At Week 52
Percentage of Participants With Mucosal Healing at Week 12
At Week 12
- +16 more secondary outcomes
Study Arms (2)
Etrasimod 2 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
- Active UC confirmed by endoscopy
You may not qualify if:
- Severe extensive colitis
- Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (315)
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305, United States
Arizona Digestive Health
Sun City, Arizona, 85351, United States
Om Research, LLC
Lancaster, California, 93534, United States
Entertainment Medical Group, Inc.
Los Angeles, California, 90036, United States
United Medical Doctors
Murrieta, California, 92563, United States
San Diego Gastroenterology Medical Associates
San Diego, California, 92103, United States
ACRC Studies, LLC
San Diego, California, 92119, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80920, United States
Gastro Florida
Clearwater, Florida, 33761, United States
West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida, 33762, United States
Florida Center for Gastroenterology
Clearwater, Florida, 33777, United States
Javier Sobrado, MD
Miami, Florida, 33156, United States
Life Medical Center & Research, INC
Miami Lakes, Florida, 33014, United States
Gastroenterology Group of Naples
Naples, Florida, 34102, United States
Office of Dr Meckstroth
Naples, Florida, 34110, United States
NSB Research
New Smyrna Beach, Florida, 32168, United States
Sarkis Clinical Trials - Parent
Ocala, Florida, 34474, United States
IMIC, Inc.
Palmetto Bay, Florida, 33157, United States
Advanced Medical Research Center
Port Orange, Florida, 32127, United States
Theia Clinical Research, LLC
St. Petersburg, Florida, 33709, United States
Advanced Research Institute, Inc.
St. Petersburg, Florida, 33710, United States
Lenus Research & Medical Group
Sweetwater, Florida, 33172, United States
USF Physicians Group
Tampa, Florida, 33606, United States
GCP Clinical Research
Tampa, Florida, 33609, United States
Guardian Angel Research Center
Tampa, Florida, 33614, United States
ASCLEPES Research Centers, P.C.
Weeki Wachee, Florida, 34607, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33542, United States
Atlanta Gastroenterology Associates LLC
Atlanta, Georgia, 30342, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, 30033, United States
Illinois Gastroenterology Group
Gurnee, Illinois, 60031, United States
Gen1 Research
Moline, Illinois, 61265, United States
Texas Digestive Disease Consultants
Baton Rouge, Louisiana, 70809, United States
CroNOLA
Houma, Louisiana, 70360, United States
Clinical Trials of SW Louisiana, LLC
Lake Charles, Louisiana, 70601, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Flint Clinical Research
Flint, Michigan, 48503, United States
Robert Ferguson MD
West Bloomfield, Michigan, 48323, United States
Gastrointestinal Associates
Flowood, Mississippi, 39232, United States
Sierra Clinical Research
Las Vegas, Nevada, 89106, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113, United States
Duke University Medical Center GI Clinical Research Unit
Durham, North Carolina, 27710, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Great Lakes Medical Research, LLC
Mentor, Ohio, 44060, United States
Care Access Research
Poland, Ohio, 44514, United States
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, 73112, United States
Great Lakes Medical Research, LLC
Harrisburg, Pennsylvania, 17110, United States
GI for Kids
Knoxville, Tennessee, 37916, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
Coastal Medical Group
Baytown, Texas, 77521, United States
Texas Gastroenterology Associates, PA
Cypress, Texas, 77429, United States
Texas Digestive Disease Consultants
Dallas, Texas, 76092, United States
Digestive Health Associates of Texas
Garland, Texas, 75044, United States
CliniCore Texas
Houston, Texas, 77029, United States
Baylor Gastroenterology Assoc
Houston, Texas, 77030, United States
Biopharma Informatic, Inc. Research Center
Houston, Texas, 77043, United States
Rio Grande Gastroenterology
McAllen, Texas, 78503, United States
Biopharma Informatic, Inc. Research Center
Pasadena, Texas, 77505, United States
Texas Digestive Disease Consultants - San Marcos
San Marcos, Texas, 78130, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
Victoria Gastroenterology
Victoria, Texas, 77904, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
Washington Gastroenterology
Bellevue, Washington, 98004, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Marshall University Department of Clinical Research
Huntington, West Virginia, 25701, United States
Medical College of Wisconsin Clinical Trials Office
Milwaukee, Wisconsin, 53226-0509, United States
Clinica Adventista Belgrano
CABA, Buenos Aires, C1430EGF, Argentina
Mautalen Salud e Investigacion
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF, Argentina
Fundación Respirar- Centro Médico Dra. De Salvo
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina
CICE Sanatorio 9 de Julio
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, 2200, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
Coastal Digestive Health Pty Ltd
Maroochydore, Queensland, 4558, Australia
Coral Sea Clinical Research Institute
North Mackay, Queensland, 4740, Australia
Austin Health Gastroenterology Department
Heidelberg, Victoria, 3084, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
KH der Barmherzigen Brüder Linz
Linz, 4020, Austria
AKH - Medizinische Universität Wien
Vienna, 1090, Austria
Wilhelminenspital der Stadt Wien
Vienna, 1160, Austria
Grodno City Clinical Hospital #4
Grodno, 230026, Belarus
Institution "Gomel Regional Clinical Hospital"
Homyel, 246029, Belarus
Health Care Institution "10th City Clinical Hospital"
Minsk, 220096, Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, 210037, Belarus
Vitebsk Regional Clinical Specialized Center
Vitebsk, 210604, Belarus
AZ Sint-Lucas & Volkskliniek
Ghent, 9000, Belgium
UZ Gent Gastroenterology
Ghent, 9000, Belgium
ZNA Jan Palfijn
Merksem, 2170, Belgium
AZ Delta
Roeselare, Belgium
Medical center Medconsult Pleven OOD
Pleven, 5800, Bulgaria
UMHAT Kanev AD, Ruse
Rousse, 7002, Bulgaria
Diagnostic-Consultative Center I - Sliven, EOOD
Sliven, 8800, Bulgaria
ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center
Sofia, 1407, Bulgaria
DCC "Alexandrovska", EOOD
Sofia, 1431, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD,Clinic of gastroenterology
Sofia, 1431, Bulgaria
UMHAT Tsaritsa Yoanna-ISUL EAD
Sofia, 1527, Bulgaria
UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center, next to the chimney
Sofia, 1606, Bulgaria
Diagnostic Consultation Center CONVEX EOOD
Sofia, 1680, Bulgaria
Acibadem City Clinic University Hospital EOOD
Sofia, 1784, Bulgaria
Medical Center Nov Rehabilitatsionen Tsentar EOOD
Stara Zagora, 6000, Bulgaria
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Enroll SpA
Santiago, 7500588, Chile
Biomedica Research Group
Santiago, 7500710, Chile
Hospital Sotero del Rio
Santiago, 8150000, Chile
Centro de Investigación del Maule SPA
Talca, 3465586, Chile
Clinical Research Chile SpA
Valdivia, 5090000, Chile
General Hospital "Dr.Tomislav Bardek" Koprivnica
Koprivnica, 48000, Croatia
Clinical Hospital Centre Osijek
Osijek, 31000, Croatia
General Hospital Zadar
Zadar, 23000, Croatia
Clinical Hospital Dubrava
Zagreb, 10000, Croatia
Clinical Hospital Sveti Duh
Zagreb, 10000, Croatia
Polyclinic Bonifarm
Zagreb, 10000, Croatia
University hospital centre Zagreb
Zagreb, 10000, Croatia
Fakultni nemocnice u svate Anny v Brne
Brno, 656 91, Czechia
Hepato-Gastroenterologie HK, s.r.o.,
Hradec Králové, 500 12, Czechia
GASTRO JeKa, s.r.o.
Klatovy, 339 01, Czechia
PreventaMed s.r.o.
Olomouc, 779 00, Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba, 708 52, Czechia
ISCARE I.V.F. a.s.
Prague, 170 04, Czechia
Nemocnice Na Bulovce
Prague, 180 81, Czechia
Nemocnice Slany
Slaný, 274 01, Czechia
Aalborg University Hospital, department of medical gastroenterology
Aalborg, North Denmark, 9000, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Innomedica OÜ
Tallinn, 10117, Estonia
West Tallinn Central Hospital
Tallinn, 10617, Estonia
North Estonia Medical Centre Foundation
Tallinn, 13419, Estonia
CHU Nice - Hôpital de l'Archet 2
Nice, Alpes Maritimes, 06202, France
CHU Montpellier - HOPITAL SAINT-ELOI
Montpellier, Herault, 34295, France
CHU Nantes Hôtel-Dieu
Nantes, Loire Atlantique, 44000, France
CHU Grenoble Alpes - Hôpital Michallon
Grenoble, 38043, France
CHRU-Nancy Brabois
Vandœuvre-lès-Nancy, 54500, France
LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine
Tbilisi, 0112, Georgia
LTD Israeli-Georgian Medical Research clinic Helsicore
Tbilisi, 0112, Georgia
LLC Vivamedi
Tbilisi, 0131, Georgia
LTD Institute of Clinical Cardiology
Tbilisi, 0159, Georgia
JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi, 0160, Georgia
LTD Aversi Clinic
Tbilisi, 0160, Georgia
LTD Central University Clinic After Academic N. Kipshidze
Tbilisi, 0160, Georgia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
Tbilisi, 0172, Georgia
Praxis Dr. Joergensen
Remscheid, North Rhine-Westphalia, 42859, Germany
Schwerpunktpraxis Bonn
Bonn, Rhineland-Palatinate, 53123, Germany
Clinic for Internal Medicine I, University hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105, Germany
Krankenhaus Waldfriede
Berlin, 14163, Germany
Florence-Nightingale-Krankenhaus
Düsseldorf, 40489, Germany
Johanna Etienne Krankenhaus
Neuss, 41462, Germany
Klinische Forschung Schwerin GmbH
Schwerin, 19055, Germany
DRC Gyogyszervizsgalo Kozpont Kft.
Balatonfüred, 8230, Hungary
Bekes Megyei Kozpont Korhaz Dr Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia
Békéscsaba, 5600, Hungary
Obudai Egeszsegugyi Centrum Kft.
Budapest, 1036, Hungary
Pannonia Maganorvosi Centrum
Budapest, 1136, Hungary
Bugat Pal Korhaz
Gyöngyös, 3200, Hungary
SZTE AOK I.st dept. of Internal Medicine.
Szeged, 6720, Hungary
Clinfan Ltd. Outpatient Clinic
Szekszárd, 7100, Hungary
1th Dept of Gastroenterology, Szent Gyorgy Hospital
Székesfehérvár, 8000, Hungary
Szent Borbala Korhaz
Tatabánya, 2800, Hungary
Asian Institute of Gastroenterology
Hyderabad, Andhra Pradesh, 500032, India
Nirmal Hospitals Pvt Ltd
Surat, Gujarat, 395002, India
Surat Institute of Digestive Sciences
Surat, Gujarat, 395002, India
Fortis Memorial Research Institute
Gurgaon, Haryana, 122002, India
Aster Medcity,Aster DM healthcare Ltd
Kochi, Kerala, 682027, India
Midas Multispeciality Hospital-Nagpur
Nagpur, Maharashtra, 440010, India
Ruby Hall Clinic
Pune, Maharashtra, 411001, India
Shweta Paliwal/Vipin Kumar Jain
Jaipur, Rajasthan, 302001, India
Postgraduate department of Medicine, GSVM Medical college
Kanpur, Uttar Pradesh, 208002, India
HaEmek Medical Center
Afula, 1834111, Israel
Bnei Zion Medical Center
Haifa, 3339419, Israel
Wolfson Medical Center
Holon, 5810001, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001, Israel
Galilee Medical Center
Nahariya, 2210001, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Chaim Sheba Medical Center
Ramat Gan, 5262000, Israel
Kaplan Medical Center
Rehovot, 7610001, Israel
Azienda Ospedaliera Saverio De Bellis
Castellana Grotte, Bari, 70013, Italy
Ospedale di Circolo
Rho, Milano, 20017, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese, Milano, 20097, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, Verona, 37024, Italy
Spedali Civili di Brescia, U.O. Gastroenterologia
Brescia, 25123, Italy
Azienda Ospedaliera Ospedale Cannizzaro
Catania, 95126, Italy
Magna Graecia University
Catanzaro, 88100, Italy
A.O.U. Policlinico di Modena
Modena, 41124, Italy
Ospedale Sandro Pertini
Roma, 00157, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD
Roma, 00168, Italy
Ospedale San Bortolo di Vicenza
Vicenza, 36100, Italy
P. Stradins Clinical University Hospital
Riga, LV-1002, Latvia
Saint George University Hospital Medical Center
Beirut, 1100 2807, Lebanon
Kaunas Clinical Hospital
Kaunas, LT-47144, Lithuania
Klaipeda University Hospital, Department of Gastroenterology
Klaipėda, LT-92288, Lithuania
Republican Panevezys Hospital, Department of Gastroenterology
Panevezys, LT-35144, Lithuania
UAB "Inlita", Santaros Clinical Trials Centre
Vilnius, LT-08406, Lithuania
Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology
Vilnius, LT-08661, Lithuania
Centro de Investigacion Medico Biologica y Terapia Avanzada s.c.
Guadalajara, Jalisco, 44130, Mexico
InspirePharma S. de R. L. de C.V.
Monterrey, Nuevo León, 64660, Mexico
Scientia Investigación Clínica S.C.
Chihuahua City, 31203, Mexico
Hospital Angeles Chihuahua
Chihuahua City, 31238, Mexico
Faicic S. de R.L. de Cv
Veracruz, 91900, Mexico
Clinical Hospital of the Ministry of Health, Labor and Social Protection
Chisinau, MD-2005, Moldova
Rtl Sm Srl
Chisinau, MD-2025, Moldova
Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology
Chisinau, MD-2025, Moldova
RTL SM SRL, Institutia Medico-Sanitara Publica Spitalul Clinic, Sectia Proctologie
Chisinau, MD-2068, Moldova
Zuyderland Medisch Centrum - Sittard-Geleen
Geleen, 6162 BG, Netherlands
ETZ Elisabeth
Tilburg, 5022 GC, Netherlands
Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz
Będzin, 42-500, Poland
Gastromed Kralisz, Romatowski, Stachurska sp.j
Bialystok, 15-322, Poland
Centrum Medyczne Pratia Czestochowa
Częstochowa, 42-200, Poland
Karkonoskie Centrum Badan Klinicznych Lexmedica
Jelenia Góra, 58-500, Poland
Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna
Krakow, 31-506, Poland
AmiCare Sp. z O.O. Sp.K.
Lodz, 90-644, Poland
IP Clinic
Lodz, 90-752, Poland
Med-Gastr Przychodnia Specjalistyczna
Lodz, 91-034, Poland
Allmedica Badania Kliniczne Sp. z o.o. Sp.k.
Nowy Targ, 34-400, Poland
Medicenter Nowy Targ
Nowy Targ, 34-400, Poland
Medicome Sp. Zo.O.
Oświęcim, 32-600, Poland
Centrum Medyczne Grunwald
Poznan, 60-369, Poland
SOLUMED Centrum Medyczne
Poznan, 60-529, Poland
Centrum Medyczne Medyk
Rzeszów, 35-326, Poland
ENDOSKOPIA Sp.zo.o
Sopot, 81-756, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
Centrum Zdrowia MDM
Warsaw, 00-635, Poland
Centralny Szpital Kliniczny MSW w Warszawie
Warsaw, 02-507, Poland
EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia - Dzial Farmacji
Wroclaw, 144-148, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
Jerzy Rozciecha- Lexmedica
Wroclaw, 53-114, Poland
Hospital de Braga
Braga, 4710-243, Portugal
Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia
Coimbra, 3000-075, Portugal
Centro Hospitalar de São João, EPE
Porto, 4200-319, Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, 4434-502, Portugal
S.C Policlinica CCBR S.R.L
Bucharest, 030463, Romania
S.C MedLife SA
Bucharest, 10719, Romania
Dr. Carol Davila Central University Emergency Military Hospital
Bucharest, 10825, Romania
Delta Health Care srl
Bucharest, 14142, Romania
S.C Euroclinic Hospital S.A
Bucharest, 14461, Romania
Spitalul Clinic Colentina
Bucharest, 20125, Romania
Institutul Clinic Fundeni
Bucharest, 22328, Romania
Centrul Medical Unirea srl
Bucharest, 540136, Romania
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca, 400006, Romania
Spitalul Clinic Judetean de Urgenta
Craiova, 200640, Romania
Cabinet Medical Dr. Fratila S.R.L
Oradea, 410167, Romania
S.C Pelican Impex S.R.L
Oradea, 410469, Romania
LLC "Multidisciplinary Medical Clinic "Anthurium"
Barnaul, 656043, Russia
LLC "Alyans Biomedical- Ural Group"
Irkutsk, 664049, Russia
Kazan State Medical University
Kazan', 420012, Russia
SAIH "Kemerovo Regional Clinical Hospital
Kemerovo, 650066, Russia
SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
Nizhny Novgorod, 603126, Russia
LLC Medicine Center SibNovoMed
Novosibirsk, 630005, Russia
CDC Ultramed
Omsk, 644024, Russia
State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"
Penza, 440026, Russia
LLC "Medinet"
Saint Petersburg, 194356, Russia
Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"
Saint Petersburg, 195067, Russia
LLC SM-Clinic
Saint Petersburg, 195279, Russia
LLC "Gastroenterological centre Expert"
Saint Petersburg, 197110, Russia
Irkutsk State Medical Academy of Continuing Education
Samara, 443011, Russia
Private Educational Institution of Higher Education "Medical University REAVIZ"
Samara, 443011, Russia
LLC Medical Company "Hepatologist"
Samara, 443093, Russia
SPb SBIH "City Hospital # 40 of Kurortnyi region"
Sestroretsk, 197706, Russia
LLC Uromed
Smolensk, 214031, Russia
Stavropol Regional Clinical Diagnostic Centre
Stavropol, 355017, Russia
LLC "Polyclinic of ultrasonography 4D"
Stavropol, 357000, Russia
Clinical Center " Dr Dragisa Misovic Dedinje"
Belgrade, 11000, Serbia
Clinical Center of Serbia
Belgrade, 11000, Serbia
Clinical Health Center Zvezdara
Belgrade, 11000, Serbia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
General Hospital Sremska Mitrovica
Sremska Mitrovica, 22000, Serbia
ENDOMED, s.r.o.
Vranov nad Topľou, Presov, 093 01, Slovakia
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, 975 17, Slovakia
Alian S.R.O
Bardejov, 085 01, Slovakia
KM Management spol. s r.o.
Nitra, 949 01, Slovakia
Fakultna nemocnica Nitra
Nitra, 950 01, Slovakia
GASTROENTEROLOG, s.r.o.
Nové Zámky, 940 01, Slovakia
Gastro I, s.r.o.
Prešov, 080 01, Slovakia
Accout Center s.r.o.
Šahy, 936 01, Slovakia
Johese Clinical Research: Unitas
Lyttelton, Centurion, 0157, South Africa
Johese Clinical Research
Midstream, Centurion, 1692, South Africa
Lenasia Clinical Trial Centre
Johannesburg, Gauteng, 1827, South Africa
Dr JP Wright Practice
Cape Town, Western Cape, 7708, South Africa
Kyungpook National University Hospital
Junggu, Daegu, 41944, South Korea
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seodaemun-gu, 03722, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Hospital Universitario La Paz
Madrid, 28046, Spain
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
Supaporn Lertkawinanan
Pathum Wan, Bangkok, 10330, Thailand
Phramongkutklao Hospital
Ratchathewi, Bangkok, 10400, Thailand
Ms. Arawan Larplertsakul
Chiang Mai, 50200, Thailand
Uludag University Medical Faculty
Beşevler, Yenimahalle / Ankara, 16059, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, 06500, Turkey (Türkiye)
Antalya Training and Research Hospital
Antalya, 07030, Turkey (Türkiye)
Kocaeli University Research and Training Hospital
Kocaeli, 41380, Turkey (Türkiye)
I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
Dnipro, 49005, Ukraine
Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University
Ivano-Frankivsk, 76018, Ukraine
Municipal non-profit enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council", Ga
Ivano-Frankivsk, 76018, Ukraine
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
Kharkiv, 61037, Ukraine
Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
Kharkiv, 61058, Ukraine
Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council
Kharkiv, 61124, Ukraine
Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City
Kherson, 73000, Ukraine
Kremenchuk first city hospital n.a. O.T. Bohaievskyi
Kremenchuk, 39617, Ukraine
National Military Medical Clinical Center Main Military Clinical Hospital
Kyiv, 01133, Ukraine
Kyiv City Clinical Hospital N 1
Kyiv, 02091, Ukraine
Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care
Lviv, 79059, Ukraine
Odesa regional clinical hospital, regional center of gastroenterology, surgical department
Odesa, 65025, Ukraine
A. Novak Transcarpathian Regional Clinical Hospital
Uzhhorod, 88000, Ukraine
Medical Clinical Investigational Center of Medical Center Health Clinic LLC
Vinnytsia, 21009, Ukraine
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia, 21018, Ukraine
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
Vinnytsia, 21029, Ukraine
Communal Institution City Clinical Hospital #6, Department of Gastroenterology
Zaporizhzhia, 69035, Ukraine
Barts Health NHS Trust - Whipps Cross University Hospital
London, Greater London, E11 1NR, United Kingdom
Guys and St Thomas NHS Foundation Trust
London, Greater London, SE1 9RT, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UQ, United Kingdom
Yeovil Hospital NHS Foundation Trust
Yeovil, Somerset, BA21 4AT, United Kingdom
Belfast Health and Social Care Trust Royal Victoria Hospital
Belfast, BT12 6BA, United Kingdom
West Hertfordshire Hospitals NHS Trust Hemel Hempstead General Hospital
Hemel Hempstead, HP2 4AD, United Kingdom
Related Publications (16)
Chaparro M, Panaccione R, Sands BE, Irving PM, Goetsch M, Kunina E, Wang W, Wu J, Woolcott JC, Bartolome L, Cognata C, Wosik K, Dubinsky MC. Etrasimod for the symptomatic relief of ulcerative colitis: a post-hoc analysis from the ELEVATE UC clinical programme. BMJ Open Gastroenterol. 2025 Aug 31;12(1):e001838. doi: 10.1136/bmjgast-2025-001838.
PMID: 40889900DERIVEDYarur AJ, Reinisch W, Chang S, Gecse KB, Green J, Abbatemarco AM, Wu J, Goetsch M, Lazin K, Pradeep G, Sands BE. Efficacy of Etrasimod in Ulcerative Colitis: Analysis of ELEVATE UC 52 and ELEVATE UC 12 by Baseline Endoscopic Severity. Clin Gastroenterol Hepatol. 2026 Jan;24(1):210-220.e3. doi: 10.1016/j.cgh.2025.06.020. Epub 2025 Jul 4.
PMID: 40618942DERIVEDLichtenstein GR, Allegretti JR, Loftus EV Jr, Irving PM, Banerjee R, Charabaty A, Kuehbacher T, Bananis E, Woolcott JC, Dalam AB, Lazin K, Keating M, McDonnell A, Danese S. Assessment and Impact of Age on the Safety and Efficacy of Etrasimod in Patients With Ulcerative Colitis: A Post Hoc Analysis of Data From the ELEVATE UC Clinical Program. Inflamm Bowel Dis. 2025 Sep 1;31(9):2352-2362. doi: 10.1093/ibd/izae308.
PMID: 40184206DERIVEDSands BE, Dubinsky MC, Kotze PG, Vermeire S, Panaccione R, Long MD, Woolcott JC, Wu J, McDonnell A, Goetsch M, Bananis E, Yarur AJ. Efficacy and Safety of Etrasimod in Patients With Moderately to Severely Active Ulcerative Colitis Stratified by Baseline Modified Mayo Score: A Post Hoc Analysis From the Phase 3 ELEVATE UC Clinical Program. Inflamm Bowel Dis. 2025 Oct 1;31(10):2681-2692. doi: 10.1093/ibd/izaf036.
PMID: 40036804DERIVEDAfzali A, Regueiro M, Yarur AJ, Zabana Y, Ng SC, Menon S, McDonnell A, Lazin K, Keating M, Bhattacharjee A, Branquinho D, Bananis E, Peyrin-Biroulet L. Concomitant Use of Etrasimod With Opioids or Antidepressants in Patients With Ulcerative Colitis-A Safety Analysis. United European Gastroenterol J. 2025 Jun;13(5):719-727. doi: 10.1002/ueg2.12745. Epub 2025 Feb 1.
PMID: 39891572DERIVEDYarur AJ, Long MD, Torres J, Nandi N, Cross RK, Abbatemarco AM, Blanco D, Niezychowski W, Crosby C, Wu J, Pradeep G, Goetsch M, Panaccione R. Body Mass Index Did Not Affect Efficacy and Safety of Etrasimod: A Post Hoc Analysis of the ELEVATE Ulcerative Colitis Clinical Program. Am J Gastroenterol. 2025 Nov 1;120(11):2611-2622. doi: 10.14309/ajg.0000000000003330. Epub 2025 Jan 29.
PMID: 39878434DERIVEDVermeire S, Rubin DT, Peyrin-Biroulet L, Dubinsky MC, Regueiro M, Irving PM, Goetsch M, Lazin K, Gu G, Wu J, Modesto I, McDonnell A, Guo X, Green J, Dalam AB, Yarur AJ. Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis. BMJ Open Gastroenterol. 2025 Jan 8;12(1):e001516. doi: 10.1136/bmjgast-2024-001516.
PMID: 39778975DERIVEDYarur AJ, Chiorean MV, Allegretti JR, Cross RK, Ha C, Goetsch M, McDonnell A, Dalam AB, Wu J, Blanco DA, Abbatemarco AM, Panes J. Etrasimod as a Monotherapy or With Concomitant Use of Corticosteroids and/or Aminosalicylates: Results From the ELEVATE UC Clinical Program. Inflamm Bowel Dis. 2025 Aug 1;31(8):2144-2153. doi: 10.1093/ibd/izae288.
PMID: 39671695DERIVEDLees CW, Torres J, Leung Y, Vermeire S, Fellmann M, Modesto I, McDonnell A, Lazin K, Keating M, Goetsch M, Wu J, Loftus EV Jr. Non-serious adverse events in patients with ulcerative colitis receiving etrasimod: an analysis of the phase II OASIS and phase III ELEVATE UC 52 and ELEVATE UC 12 clinical trials. Therap Adv Gastroenterol. 2024 Nov 7;17:17562848241293643. doi: 10.1177/17562848241293643. eCollection 2024.
PMID: 39526078DERIVEDArmuzzi A, Rubin DT, Schreiber S, Panes J, Fellmann M, Bartolome L, Gruben D, Goetsch M, Bhattacharjee A, Chaparro M, Dubinsky MC. Health-Related Quality of Life Outcomes With Etrasimod Treatment in Patients With Ulcerative Colitis: A Post Hoc Analysis of Data From ELEVATE UC 52 and ELEVATE UC 12. Inflamm Bowel Dis. 2025 Jun 13;31(6):1583-1594. doi: 10.1093/ibd/izae229.
PMID: 39326009DERIVEDSands BE, Leung Y, Rubin DT, Gecse KB, Panes J, Goetsch M, Wang W, Woolcott JC, Smith CC, Wosik K, Schreiber S. Etrasimod Corticosteroid-Free Efficacy, Impact of Concomitant Corticosteroids on Efficacy and Safety, and Corticosteroid-Sparing Effect in Ulcerative Colitis: Analyses of the ELEVATE UC Clinical Program. J Crohns Colitis. 2025 Mar 5;19(3):jjae150. doi: 10.1093/ecco-jcc/jjae150.
PMID: 39306680DERIVEDMagro F, Peyrin-Biroulet L, Sands BE, Danese S, Jairath V, Goetsch M, Bhattacharjee A, Wu J, Branquinho D, Modesto I, Feagan BG. Endoscopic, Histologic, and Composite Endpoints in Patients With Ulcerative Colitis Treated With Etrasimod. Clin Gastroenterol Hepatol. 2025 Feb;23(2):341-350.e6. doi: 10.1016/j.cgh.2024.07.010. Epub 2024 Jul 31.
PMID: 39089519DERIVEDVermeire S, Sands BE, Peyrin-Biroulet L, D'Haens GR, Panes J, Yarur AJ, Wolf DC, Ritter T, Schreiber S, Woolcott JC, Modesto I, Keating M, Shan K, Wu J, Chiorean MV, Baert F, Dubinsky MC, Goetsch M, Danese S, Feagan BG. Impact of Prior Biologic or Janus Kinase Inhibitor Therapy on Efficacy and Safety of Etrasimod in the ELEVATE UC 52 and ELEVATE UC 12 Trials. J Crohns Colitis. 2024 Nov 4;18(11):1780-1794. doi: 10.1093/ecco-jcc/jjae079.
PMID: 38877972DERIVEDRegueiro M, Siegmund B, Yarur AJ, Steinwurz F, Gecse KB, Goetsch M, Bhattacharjee A, Wu J, Green J, McDonnell A, Crosby C, Lazin K, Branquinho D, Modesto I, Abreu MT. Etrasimod for the Treatment of Ulcerative Colitis: Analysis of Infection Events from the ELEVATE UC Clinical Programme. J Crohns Colitis. 2024 Oct 15;18(10):1596-1605. doi: 10.1093/ecco-jcc/jjae060.
PMID: 38700040DERIVEDPeyrin-Biroulet L, Dubinsky MC, Sands BE, Panes J, Schreiber S, Reinisch W, Feagan BG, Danese S, Yarur AJ, D'Haens GR, Goetsch M, Wosik K, Keating M, Lazin K, Wu J, Modesto I, McDonnell A, Bartolome L, Vermeire S. Efficacy and Safety of Etrasimod in Patients with Moderately to Severely Active Isolated Proctitis: Results From the Phase 3 ELEVATE UC Clinical Programme. J Crohns Colitis. 2024 Aug 14;18(8):1270-1282. doi: 10.1093/ecco-jcc/jjae038.
PMID: 38613425DERIVEDSandborn WJ, Vermeire S, Peyrin-Biroulet L, Dubinsky MC, Panes J, Yarur A, Ritter T, Baert F, Schreiber S, Sloan S, Cataldi F, Shan K, Rabbat CJ, Chiorean M, Wolf DC, Sands BE, D'Haens G, Danese S, Goetsch M, Feagan BG. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies. Lancet. 2023 Apr 8;401(10383):1159-1171. doi: 10.1016/S0140-6736(23)00061-2. Epub 2023 Mar 2.
PMID: 36871574DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Arena CT.gov Administrator
- Organization
- Arena Pharmaceuticals, a wholly owned subsidiary of Pfizer
Study Officials
- STUDY DIRECTOR
Arena CT.gov Administrator
Arena Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2019
First Posted
May 10, 2019
Study Start
June 13, 2019
Primary Completion
February 8, 2022
Study Completion
February 16, 2022
Last Updated
December 20, 2022
Results First Posted
December 20, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share