Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
ELEVATE UC 12
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
2 other identifiers
interventional
354
38 countries
391
Brief Summary
The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).
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 Sep 2020
Shorter than P25 for phase_3
391 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
June 21, 2019
CompletedFirst Posted
Study publicly available on registry
June 24, 2019
CompletedStudy Start
First participant enrolled
September 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2021
CompletedResults Posted
Study results publicly available
December 21, 2022
CompletedDecember 21, 2022
January 1, 2022
1.2 years
June 21, 2019
November 28, 2022
November 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Clinical Remission
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 electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \[\>=\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Week 12
Secondary Outcomes (9)
Percentage of Participants Achieving Endoscopic Improvement
Week 12
Percentage of Participants Achieving Symptomatic Remission
Week 12
Percentage of Participants With Mucosal Healing
Week 12
Percentage of Participants Achieving Clinical Response
Week 12
Percentage of Participants Achieving Endoscopic Normalization
Week 12
- +4 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 (407)
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305, United States
East View Medical Research, LLC
Mobile, Alabama, 36606, 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
ACRC Studies,LLC
San Diego, California, 92119, United States
Paradigm Clinical Research Institute
Torrance, California, 90505, United States
University of Colorado
Aurora, Colorado, 80045, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80920, United States
Gastro Florida
Clearwater, Florida, 33761, United States
Gastro Florida
Clearwater, Florida, 33762, United States
Florida Center for Gastroenterology
Largo, Florida, 33777, United States
Global Life Research Network, LLC
Miami, Florida, 33155, United States
Life Medical Center & Research, Inc
Miami Lakes, Florida, 33014, United States
Gastroenterology Group of Naples
Naples, Florida, 34102, United States
NSB Research
New Smyrna Beach, Florida, 32168, United States
Pediatric & Adult Research Center
Orlando, Florida, 32825, 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
Lenus Research & Medical Group, LLC
Sweetwater, Florida, 33172, United States
USF Department of Surgery
Tampa, Florida, 33606, United States
GCP Clinical Research
Tampa, Florida, 33609, United States
Guardian Angel Research Center
Tampa, Florida, 33614, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33542, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, 30342, United States
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, 30033, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Illinois Gastroenterology Group
Gurnee, Illinois, 60031, United States
Texas Digestive Disease Consultants
Baton Rouge, Louisiana, 70809, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Gastro Center of Maryland
Columbia, Maryland, 21045, United States
West Michigan Clinical Research Center
Wyoming, Michigan, 49519, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Sierra Clinical Research
Las Vegas, Nevada, 89106, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Great Lakes Medical Research, LLC - Mentor
Mentor, Ohio, 44060, United States
Care Access Research
Poland, Ohio, 44514, United States
Great Lakes Medical Research, LLC - Harrisburg
Harrisburg, Pennsylvania, 17110, United States
Tri-Cities Gastroenterology
Kingsport, Tennessee, 37663, United States
GI for Kids
Knoxville, Tennessee, 37916, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
The University of Texas at Austin Dell Medical School
Austin, Texas, 78712, United States
Texas Gastroenterology Associates, PA
Cypress, Texas, 77429, United States
Texas Digestive Disease Consultants - Dallas
Dallas, Texas, 76092, United States
DHAT Research Institute
Garland, Texas, 75044, United States
Baylor Gastroenterology Assoc
Houston, Texas, 77030, United States
Rio Grande Gastroenterology
McAllen, Texas, 78503, 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
Care Access Research LLC
Ogden, Utah, 84403, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
Washington Gastroenterology
Bellevue, Washington, 98004, United States
Virginia Mason
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
Instituto de Investigaciones Clínicas Quilmes SRL
Quilmes, Buenos Aires, B1878GEG, 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
Maroochydore, Queensland, 4558, Australia
Coral Sea Clinical Research Institute
North Mackay, Queensland, 4740, Australia
Footscray Hospital
Footscray, Victoria, 3011, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Liverpool Hospital
Liverpool, 2170, Australia
Alfred Hospital
Melbourne, 3004, Australia
Lkh Univ. Klinikum Graz
Graz, 8036, Austria
KH der Barmherzigen Brüder Linz, Interne Abteilung
Linz, 4020, Austria
AKH - Medizinische Universität Wien
Vienna, 1090, Austria
Grodno City Clinical Hospital #4
Grodno, 230026, Belarus
Institution "Gomel Regional Clinical Hospital"
Homyel, 246029, Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, 210037, Belarus
Vitebsk Regional Clinical Specialized Center
Vitebsk, 210604, Belarus
University Hospital Antwerp Gastroenterology and Hepatology Department
Edegem, Antwerp, 2650, Belgium
Dr. Peter Bossuyt - GI Clinical Research Center
Bonheiden, 2820, Belgium
AZ Sint-Lucas & Volkskliniek
Ghent, 9000, Belgium
UZ Gent - Gastroenterology
Ghent, 9000, Belgium
UZ Leuven Campus Gasthuisberg
Leuven, 3000, Belgium
AZ Sint-Maarten
Mechelen, 2800, Belgium
ZNA Jan Palfijn
Merksem, 2170, Belgium
AZ Delta
Roeselare, 8800, Belgium
UMHAT "Sv. Georgi", EAD
Plovdiv, 4002, 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 "Tsaritsa Yoanna-ISUL" EAD
Sofia, 1527, Bulgaria
UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center
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
Medical Centre MEDICA Plus OOD
Veliko Tarnovo, 5000, Bulgaria
Heritage Medical Research Clinic
Calgary, Alberta, T2N 4Z6, Canada
LHSC - University Hospital
London, Ontario, N6A 5A5, 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
Clínica de la Costa Ltda.
Barranquilla, Atlántico, 080020, Colombia
Clinica de la Mujer Centro de Investigaciones
Bogota, Cundinamarca, 110221, Colombia
Hospital San Juan de Dios Fundacion Cardiomet-Cequin
Armenia, Quindío Department, 630004, Colombia
Clinica farallones centro de investigaciones clinicas CIC
Cali, Valle del Cauca Department, 760044, Colombia
General Hospital "Dr. Tomislav Bardek" Koprivnica
Koprivnica, 48000, Croatia
Clinical Hospital Centre Osijek
Osijek, 31000, Croatia
General Hospital Zadar
Zadar, 23000, Croatia
Clinical Hospital Sveti Duh
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
Axon Clinical s. r. o.
Prague, 150 00, Czechia
ISCARE I.V.F. a.s.
Prague, 170 04, Czechia
Nemocnice Na Bulovce
Prague, 180 81, Czechia
Oblastni nemocnice Pribram a.s.
Příbram, 261 01, Czechia
Nemocnice Slany
Slaný, 274 01, Czechia
Aalborg University Hospital, department of medical gastroenterology
Aalborg, North Denmark, 9000, Denmark
Herlev Hospital, Gastroenheden, 54Q2
Herlev, 2730, Denmark
Innomedica OÜ
Tallinn, 10117, Estonia
West Tallinn Central Hospital
Tallinn, 10617, Estonia
North Estonia Medical Centre Foundation
Tallinn, 13419, Estonia
Tartu University Hospital
Tartu, 50406, Estonia
CHU Nice - Hôpital de l'Archet 2
Nice, Alpes Maritimes, 06202, France
CHU Dijon - Hôpital Bocage Central
Dijon, Côte-d'Or, 21079, France
Hôpital Rangueil Service Gastro-entérologie et pancreatologie
Toulouse, Haute Garonne, 31059, France
CHU Montpellier - Hopital Saint Eloi
Montpellier, Herault, 34295, France
Chu Pontchaillou Rennes
Rennes, Ille Et Vilaine, 35033, France
CHU Nantes Hôtel-Dieu
Nantes, Loire Atlantique, 44000, France
CHRU-Nancy Brabois
Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54511, France
CHU Lille - Hôpital Claude Huriez
Lille, Nord, 59037, France
CHU Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand, Puy De Dome, 63003, France
Unite de Recherche Clinique-Urc
Montfermeil, Seine Saint Denis, 93370, France
Chu Amiens Picardie-Sit Sud
Amiens, Somme, 80054, France
Groupement Hospitalier Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, Val De Marne, 94275, France
CHU Grenoble Alpes - Hôpital Michallon
Grenoble, 38043, France
LTD Acad. F. Todua Medical Centre, LTD. Research Institution 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
Charité Universitätsmedizin Berlin - Campus Charité Mitte
Berlin, 10117, 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
Endoexpert Egeszsegugyi Szolgaltato Kft
Budapest, 1054, Hungary
Semmelweis Egyetem, II.sz. Belgyogyaszati Klinika
Budapest, 1088, Hungary
Pannonia Maganorvosi Centrum
Budapest, 1136, Hungary
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika -Gasztroenterologia
Debrecen, 4032, 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
Dept of Gastroenterology, Szent Gyorgy Hospital
Székesfehérvár, 8000, Hungary
Szent Borbala Korhaz
Tatabánya, 2800, Hungary
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
All India Institute of Medical Sciences
Kochi, Kerala, 682027, India
Aster Medcity,Aster DM healthcare Ltd
Kochi, Kerala, 682027, India
Government Medical College and Super Speciality Hospital
Nagpur, Maharashtra, 440009, India
Midas Multispeciality Hospital Pvt.Ltd.
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-Beilinson Campus
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
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese, Milano, 20097, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, Verona, 37024, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, 40138, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, 25123, Italy
Azienda Ospedaliera Ospedale Cannizzaro
Catania, 95126, Italy
Azienda Ospedaliero Universitaria Mater Domini
Catanzaro, 88100, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, 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
A.O. Ordine Mauriziano di Torino - P.O. Ospedale Umberto I
Torino, 10128, Italy
Centro Ricerche Cliniche di Verona
Verona, 37134, Italy
Ospedale San Bortolo di Vicenza
Vicenza, 36100, Italy
Koujunkai Daido Clinic
Nagoya, Aichi-ken, 457-8511, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, 441-8570, Japan
NHO Hirosaki National Hospital
Hirosaki-shi, Aomori, 036-8545, Japan
Hirosaki University Hospital
Hirosaki-shi, Aomori, 036-8563, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, Chiba, 277-0871, Japan
Saiseikai Matsuyama Hospital
Matsuyama, Ehime, 791-8026, Japan
Ehime University Hospital
Toon-shi, Ehime, 791-0295, Japan
Fukuoka Tokushukai Hospital
Kasuga, Fukuoka, 816-0864, Japan
JCHO Kyushu Hospital
Kitakyushu-shi, Fukuoka, 806-8501, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1247, Japan
Gifu University Hospital
Gifu, Gifu, 501-1194, Japan
Ogaki Municipal Hospital
Ogaki-shi, Gifu, 503-8502, Japan
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi, Gunma, 373-8585, Japan
NHO Fukuyama Medical Center
Fukuyama-shi, Hiroshima, 720-8520, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, 730-8518, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Asahikawa City Hospital
Asahikawa-shi, Hokkaido, 070-8610, Japan
Tokushukai Sapporo Tokushukai Hospital
Sapporo, Hokkaido, 004-0041, Japan
Sapporo-Kosei General Hospital
Sapporo, Hokkaido, 060-0033, Japan
NHO Mito Medical Center
Higashi, Ibaraki, 311-3193, Japan
Yuai Memorial Hospital
Koga-shi, Ibaraki, 306-0232, Japan
Tsuchiura Kyodo General Hospital
Tsuchiura-shi, Ibaraki, 300-0028, Japan
NHO Kanazawa Medical Center
Kanazawa, Ishikawa-ken, 920-8650, Japan
Iwate Medical University Uchimaru Medical Center
Morioka, Iwate, 020-8505, Japan
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, 760-0017, Japan
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557, Japan
Jiaikai Izuro Imamura Hospital
Kagoshima, Kagoshima-ken, 892-0824, Japan
Sameshima Hospital
Kagoshima, Kagoshima-ken, 892-0846, Japan
Gokeikai Ofuna Chuo Hospital
Kamakura-shi, Kanagawa, 247-0056, Japan
Sagamihara Kyodo Hospital
Sagamihara-shi, Kanagawa, 252-5188, Japan
NHO Yokohama Medical Center
Yokohama, Kanagawa, 245-8575, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, 861-8520, Japan
NHO Kyoto Medical Center
Kyoto, Kyoto, 612-8555, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
Mie Prefectural General Medical Center
Yokkaichi, Mie-ken, 510-8561, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
JOHAS Tohoku Rosai Hospital
Sendai, Miyagi, 981-8563, Japan
Sendai City Hospital
Sendai, Miyagi, 982-8502, Japan
Nara Medical University Hospital
Kashihara, Nara, 634-8522, Japan
Saiseikai Niigata Hospital
Niigata, Niigata, 950-1104, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191, Japan
Tokushukai Kishiwada Tokushukai Hospital
Kishiwada-shi, Osaka, 596-8522, Japan
Osaka City University Hospital
Osaka, Osaka, 545-8586, Japan
Japan Community Health care Organization Osaka Hospital
Osaka, Osaka, 553-0003, Japan
Osaka Medical College Hospital
Takatsuki-shi, Osaka, 569-8686, Japan
Saga University Hospital
Saga, Saga-ken, 849-8501, Japan
JCHO Saitama Medical Center
Saitama-shi, Saitama, 330-0074, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192, Japan
St. Luke's International Hospital
Chuo -ku, Tokyo, 104-8560, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, 173-8606, Japan
Showa General Hospital
Kodaira-shi, Tokyo, 187-0002, Japan
Jikei University Hospital
Minato-ku, Tokyo, 105-8471, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, 108-8642, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625, Japan
JCHO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo, 169-0073, Japan
Toyama Prefectural Central Hospital
Toyama, Toyama, 930-8550, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Saint George Hospital University Medical Center
Beirut, 1100-2807, Lebanon
American University of Beirut Medical Center
Beirut, 1107-2020, Lebanon
Hotel Dieu de France Hospital
Beirut, 16-6830, Lebanon
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
Consultorio Medico, InvesclinicMX
Irapuato, Guanajuato, 36650, Mexico
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
Republican Clinical Hospital, ARENSIA Exploratory Medicine
Chisinau, MD-2025, 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
Radboudumc
Nijmegen, 6525 GA, 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
Centrum Medyczne Plejady
Krakow, 30-363, 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
Allmedica Badania Kliniczne Sp. z o.o. Sp.k.
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
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302, Poland
Centrum Medyczne Medyk
Rzeszów, 35-326, Poland
ENDOSKOPIA Sp.zo.o
Sopot, 81-756, Poland
DC-MED
Swidnica, 58-100, 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
Hospital de Braga
Braga, 4710-243, Portugal
Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia
Coimbra, 3000-075, Portugal
Hospital da Senhora da Oliveira Guimarães
Guimarães, 4835-044, Portugal
Hospital da Luz Lisboa
Lisbon, 1500-650, 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 MedLife SA
Bucharest, 10719, Romania
S.C Delta Health Care S.R.L, Ponderas Academic Hospital
Bucharest, 14142, Romania
S.C Euroclinic Hospital S.A
Bucharest, 14461, Romania
Spitalul Clinic Colentina
Bucharest, 20125, Romania
Institutul Clinic Fundeni
Bucharest, 22328, Romania
S.C Policlinica CCBR S.R.L
Bucharest, 30463, Romania
S.C. Centrul Medical Unirea SRL
Bucharest, 540136, Romania
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca, 400006, Romania
Spitalul Clinic Judetean de Urgenta Craiova
Craiova, 200640, Romania
S.C Pelican Impex S.R.L
Oradea, 410469, Romania
LLC "Multidisciplinary Medical Clinic "Anthurium"
Barnaul, 656043, Russia
LLC "Alyans Biomedical- Ural Group"
Izhevsk, 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
Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"
Saint Petersburg, 195067, Russia
FSBI of higher Education "First Saint Petersburg State Medical University n.a. I.P.Pavlov
Saint Petersburg, 197022, Russia
LLC "Gastroenterological centre Expert"
Saint Petersburg, 197110, Russia
LLC SM-Clinic
Saint-Peterburg, 195279, 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
City Clinical Hospital #8
Yaroslavl, 150030, 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 Bezanijska Kosa
Belgrade, 11080, 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
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
Gastro I, s.r.o.
Prešov, 080 01, Slovakia
Accout Center s.r.o.
Šahy, 936 01, Slovakia
BeneDig s.r.o.
Žilina, 010 08, Slovakia
Johese Clinical Research: Unitas
Lyttelton, Centurion, 0157, South Africa
Johese Clinical Research
Midstream, Centurion, 1692, South Africa
Lenasia Clinical Trial Centre
Lenasia, Gauteng, 1827, South Africa
Dr JP Wright Practice
Cape Town, Western Cape, 7708, South Africa
Kyungpook National University Hospital
Junggu, Daegu, 41944, South Korea
Yonsei University 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 General Universitario de Alicante
Alicante, 03010, Spain
Centro Médico Teknon
Barcelona, 08022, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas, 35010, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Kantonsspital Baden
Baden, 5404, Switzerland
Inselspital, Gaby Saner, Gastroenterologie, Bauchzentrum
Bern, 3010, Switzerland
Berner IBD study group c/o Gastroenterologische Praxis Balsiger, Seibold &Partner
Bern, 3012, Switzerland
Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10330, Thailand
Phramongkutklao Hospital
Ratchathewi, Bangkok, 10400, Thailand
Uludag University Medical Faculty
Beşevler, Yenimahalle/Ankara, 16059, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, 06100, 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)
Karadeniz Tecnical Uni. Med. Fac.
Trabzon, 61100, 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
Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
Kyiv, 01030, 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
Whipps Cross University Hospital
London, Greater London, E11 1NR, United Kingdom
Guy's and Saint Thomas NHS Foundation Trust
London, Greater London, SE1 9RT, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UQ, United Kingdom
Yeovil District Hospital
Yeovil, Somerset, BA21 4AT, 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, Inc.
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
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2019
First Posted
June 24, 2019
Study Start
September 15, 2020
Primary Completion
December 7, 2021
Study Completion
December 7, 2021
Last Updated
December 21, 2022
Results First Posted
December 21, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share