AzTrials
AzTrials

Ulcerative ColitisPhase 3ELEVATE UC 52NCT03945188

Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

A Phase 3 study testing Etrasimod in people with Ulcerative Colitis, run by Arena Pharmaceuticals at 315 sites in 40 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Etrasimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
433 participants
Where
315 sitesin 40 countries
Study dates
13 Jun 2019to 16 Feb 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

315 sites in 40 countries.

315 sites in 40 countries

United States67 sites

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012

  • Atlanta Gastroenterology Associates LLC

    Atlanta, Georgia, 30342

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Texas Digestive Disease Consultants

    Baton Rouge, Louisiana, 70809

  • Coastal Medical Group

    Baytown, Texas, 77521

  • Washington Gastroenterology

    Bellevue, Washington, 98004

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Gastro Florida

    Clearwater, Florida, 33761

  • West Central Gastroenterology d/b/a Gastro Florida

    Clearwater, Florida, 33762

  • Florida Center for Gastroenterology

    Clearwater, Florida, 33777

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80920

  • Texas Gastroenterology Associates, PA

    Cypress, Texas, 77429

  • Texas Digestive Disease Consultants

    Dallas, Texas, 76092

  • Atlanta Center for Gastroenterology, P.C.

    Decatur, Georgia, 30033

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • Duke University Medical Center GI Clinical Research Unit

    Durham, North Carolina, 27710

  • Flint Clinical Research

    Flint, Michigan, 48503

  • Gastrointestinal Associates

    Flowood, Mississippi, 39232

  • Digestive Health Associates of Texas

    Garland, Texas, 75044

  • Illinois Gastroenterology Group

    Gurnee, Illinois, 60031

  • Great Lakes Medical Research, LLC

    Harrisburg, Pennsylvania, 17110

  • CroNOLA

    Houma, Louisiana, 70360

  • CliniCore Texas

    Houston, Texas, 77029

  • Baylor Gastroenterology Assoc

    Houston, Texas, 77030

  • Biopharma Informatic, Inc. Research Center

    Houston, Texas, 77043

  • Marshall University Department of Clinical Research

    Huntington, West Virginia, 25701

  • GI for Kids

    Knoxville, Tennessee, 37916

  • Clinical Trials of SW Louisiana, LLC

    Lake Charles, Louisiana, 70601

  • Om Research, LLC

    Lancaster, California, 93534

  • Sierra Clinical Research

    Las Vegas, Nevada, 89106

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Entertainment Medical Group, Inc.

    Los Angeles, California, 90036

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Rio Grande Gastroenterology

    McAllen, Texas, 78503

  • Great Lakes Medical Research, LLC

    Mentor, Ohio, 44060

  • Clinical Trials Management, LLC

    Metairie, Louisiana, 70006

  • Javier Sobrado, MD

    Miami, Florida, 33156

  • Life Medical Center & Research, INC

    Miami Lakes, Florida, 33014

  • Medical College of Wisconsin Clinical Trials Office

    Milwaukee, Wisconsin, 53226-0509

  • Gen1 Research

    Moline, Illinois, 61265

  • United Medical Doctors

    Murrieta, California, 92563

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Office of Dr Meckstroth

    Naples, Florida, 34110

  • NSB Research

    New Smyrna Beach, Florida, 32168

  • Sarkis Clinical Trials - Parent

    Ocala, Florida, 34474

  • Digestive Disease Specialists, Inc.

    Oklahoma City, Oklahoma, 73112

  • IMIC, Inc.

    Palmetto Bay, Florida, 33157

  • Biopharma Informatic, Inc. Research Center

    Pasadena, Texas, 77505

  • Care Access Research

    Poland, Ohio, 44514

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • San Diego Gastroenterology Medical Associates

    San Diego, California, 92103

  • ACRC Studies, LLC

    San Diego, California, 92119

  • Texas Digestive Disease Consultants - San Marcos

    San Marcos, Texas, 78130

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Theia Clinical Research, LLC

    St. Petersburg, Florida, 33709

  • Advanced Research Institute, Inc.

    St. Petersburg, Florida, 33710

  • Arizona Digestive Health

    Sun City, Arizona, 85351

  • Lenus Research & Medical Group

    Sweetwater, Florida, 33172

  • USF Physicians Group

    Tampa, Florida, 33606

  • GCP Clinical Research

    Tampa, Florida, 33609

  • Guardian Angel Research Center

    Tampa, Florida, 33614

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • Victoria Gastroenterology

    Victoria, Texas, 77904

  • ASCLEPES Research Centers, P.C.

    Weeki Wachee, Florida, 34607

  • Robert Ferguson MD

    West Bloomfield, Michigan, 48323

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida, 33542

Other trials in United States

Poland21 sites

  • Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz

    Będzin, 42-500

  • Gastromed Kralisz, Romatowski, Stachurska sp.j

    Bialystok, 15-322

  • Centrum Medyczne Pratia Czestochowa

    Częstochowa, 42-200

  • Karkonoskie Centrum Badan Klinicznych Lexmedica

    Jelenia Góra, 58-500

  • Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna

    Krakow, 31-506

  • AmiCare Sp. z O.O. Sp.K.

    Lodz, 90-644

  • IP Clinic

    Lodz, 90-752

  • Med-Gastr Przychodnia Specjalistyczna

    Lodz, 91-034

  • Allmedica Badania Kliniczne Sp. z o.o. Sp.k.

    Nowy Targ, 34-400

  • Medicenter Nowy Targ

    Nowy Targ, 34-400

  • Medicome Sp. Zo.O.

    Oświęcim, 32-600

  • Centrum Medyczne Grunwald

    Poznan, 60-369

  • SOLUMED Centrum Medyczne

    Poznan, 60-529

  • Centrum Medyczne Medyk

    Rzeszów, 35-326

  • ENDOSKOPIA Sp.zo.o

    Sopot, 81-756

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • Centrum Zdrowia MDM

    Warsaw, 00-635

  • Centralny Szpital Kliniczny MSW w Warszawie

    Warsaw, 02-507

  • EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia - Dzial Farmacji

    Wroclaw, 144-148

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

  • Jerzy Rozciecha- Lexmedica

    Wroclaw, 53-114

Other trials in Poland

Russia19 sites

  • LLC "Multidisciplinary Medical Clinic "Anthurium"

    Barnaul, 656043

  • LLC "Alyans Biomedical- Ural Group"

    Irkutsk, 664049

  • Kazan State Medical University

    Kazan', 420012

  • SAIH "Kemerovo Regional Clinical Hospital

    Kemerovo, 650066

  • SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"

    Nizhny Novgorod, 603126

  • LLC Medicine Center SibNovoMed

    Novosibirsk, 630005

  • CDC Ultramed

    Omsk, 644024

  • State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"

    Penza, 440026

  • LLC "Medinet"

    Saint Petersburg, 194356

  • Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"

    Saint Petersburg, 195067

  • LLC SM-Clinic

    Saint Petersburg, 195279

  • LLC "Gastroenterological centre Expert"

    Saint Petersburg, 197110

  • Irkutsk State Medical Academy of Continuing Education

    Samara, 443011

  • Private Educational Institution of Higher Education "Medical University REAVIZ"

    Samara, 443011

  • LLC Medical Company "Hepatologist"

    Samara, 443093

  • SPb SBIH "City Hospital # 40 of Kurortnyi region"

    Sestroretsk, 197706

  • LLC Uromed

    Smolensk, 214031

  • Stavropol Regional Clinical Diagnostic Centre

    Stavropol, 355017

  • LLC "Polyclinic of ultrasonography 4D"

    Stavropol, 357000

Other trials in Russia

Ukraine17 sites

  • I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

    Dnipro, 49005

  • Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University

    Ivano-Frankivsk, 76018

  • Municipal non-profit enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council", Ga

    Ivano-Frankivsk, 76018

  • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

    Kharkiv, 61037

  • Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

    Kharkiv, 61058

  • Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council

    Kharkiv, 61124

  • Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City

    Kherson, 73000

  • Kremenchuk first city hospital n.a. O.T. Bohaievskyi

    Kremenchuk, 39617

  • National Military Medical Clinical Center Main Military Clinical Hospital

    Kyiv, 01133

  • Kyiv City Clinical Hospital N 1

    Kyiv, 02091

  • Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care

    Lviv, 79059

  • Odesa regional clinical hospital, regional center of gastroenterology, surgical department

    Odesa, 65025

  • A. Novak Transcarpathian Regional Clinical Hospital

    Uzhhorod, 88000

  • Medical Clinical Investigational Center of Medical Center Health Clinic LLC

    Vinnytsia, 21009

  • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

    Vinnytsia, 21018

  • SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

    Vinnytsia, 21029

  • Communal Institution City Clinical Hospital #6, Department of Gastroenterology

    Zaporizhzhya, 69035

Other trials in Ukraine

Romania12 sites

  • S.C Policlinica CCBR S.R.L

    Bucharest, 030463

  • S.C MedLife SA

    Bucharest, 10719

  • Dr. Carol Davila Central University Emergency Military Hospital

    Bucharest, 10825

  • Delta Health Care srl

    Bucharest, 14142

  • S.C Euroclinic Hospital S.A

    Bucharest, 14461

  • Spitalul Clinic Colentina

    Bucharest, 20125

  • Institutul Clinic Fundeni

    Bucharest, 22328

  • Centrul Medical Unirea srl

    Bucharest, 540136

  • Spitalul Clinic Judetean de Urgenta Cluj Napoca

    Cluj-Napoca, 400006

  • Spitalul Clinic Judetean de Urgenta

    Craiova, 200640

  • Cabinet Medical Dr. Fratila S.R.L

    Oradea, 410167

  • S.C Pelican Impex S.R.L

    Oradea, 410469

Other trials in Romania

Bulgaria11 sites

  • Medical center Medconsult Pleven OOD

    Pleven, 5800

  • UMHAT Kanev AD, Ruse

    Rousse, 7002

  • Diagnostic-Consultative Center I - Sliven, EOOD

    Sliven, 8800

  • ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center

    Sofia, 1407

  • DCC "Alexandrovska", EOOD

    Sofia, 1431

  • UMHAT "Sv. Ivan Rilski", EAD,Clinic of gastroenterology

    Sofia, 1431

  • UMHAT Tsaritsa Yoanna-ISUL EAD

    Sofia, 1527

  • UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center, next to the chimney

    Sofia, 1606

  • Diagnostic Consultation Center CONVEX EOOD

    Sofia, 1680

  • Acibadem City Clinic University Hospital EOOD

    Sofia, 1784

  • Medical Center Nov Rehabilitatsionen Tsentar EOOD

    Stara Zagora, 6000

Other trials in Bulgaria

Italy11 sites

  • Spedali Civili di Brescia, U.O. Gastroenterologia

    Brescia, 25123

  • Azienda Ospedaliera Saverio De Bellis

    Castellana Grotte, Bari, 70013

  • Azienda Ospedaliera Ospedale Cannizzaro

    Catania, 95126

  • Magna Graecia University

    Catanzaro, 88100

  • A.O.U. Policlinico di Modena

    Modena, 41124

  • Ospedale Sacro Cuore Don Calabria

    Negrar, Verona, 37024

  • Ospedale di Circolo

    Rho, Milano, 20017

  • Ospedale Sandro Pertini

    Roma, 00157

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD

    Roma, 00168

  • I.R.C.C.S Policlinico San Donato

    San Donato Milanese, Milano, 20097

  • Ospedale San Bortolo di Vicenza

    Vicenza, 36100

Other trials in Italy

Hungary9 sites

  • DRC Gyogyszervizsgalo Kozpont Kft.

    Balatonfüred, 8230

  • Bekes Megyei Kozpont Korhaz Dr Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia

    Békéscsaba, 5600

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036

  • Pannonia Maganorvosi Centrum

    Budapest, 1136

  • Bugat Pal Korhaz

    Gyöngyös, 3200

  • SZTE AOK I.st dept. of Internal Medicine.

    Szeged, 6720

  • 1th Dept of Gastroenterology, Szent Gyorgy Hospital

    Székesfehérvár, 8000

  • Clinfan Ltd. Outpatient Clinic

    Szekszárd, 7100

  • Szent Borbala Korhaz

    Tatabánya, 2800

Other trials in Hungary

India9 sites

  • Fortis Memorial Research Institute

    Gurgaon, Haryana, 122002

  • Asian Institute of Gastroenterology

    Hyderabad, Andhra Pradesh, 500032

  • Shweta Paliwal/Vipin Kumar Jain

    Jaipur, Rajasthan, 302001

  • Postgraduate department of Medicine, GSVM Medical college

    Kanpur, Uttar Pradesh, 208002

  • Aster Medcity,Aster DM healthcare Ltd

    Kochi, Kerala, 682027

  • Midas Multispeciality Hospital-Nagpur

    Nagpur, Maharashtra, 440010

  • Ruby Hall Clinic

    Pune, Maharashtra, 411001

  • Nirmal Hospitals Pvt Ltd

    Surat, Gujarat, 395002

  • Surat Institute of Digestive Sciences

    Surat, Gujarat, 395002

Other trials in India

Israel9 sites

  • HaEmek Medical Center

    Afula, 1834111

  • Bnei Zion Medical Center

    Haifa, 3339419

  • Wolfson Medical Center

    Holon, 5810001

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001

  • Galilee Medical Center

    Nahariya, 2210001

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 5262000

  • Kaplan Medical Center

    Rehovot, 7610001

Other trials in Israel

Czechia8 sites

  • Fakultni nemocnice u svate Anny v Brne

    Brno, 656 91

  • Hepato-Gastroenterologie HK, s.r.o.,

    Hradec Králové, 500 12

  • GASTRO JeKa, s.r.o.

    Klatovy, 339 01

  • PreventaMed s.r.o.

    Olomouc, 779 00

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52

  • ISCARE I.V.F. a.s.

    Prague, 170 04

  • Nemocnice Na Bulovce

    Prague, 180 81

  • Nemocnice Slany

    Slaný, 274 01

Other trials in Czechia

Georgia8 sites

  • LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine

    Tbilisi, 0112

  • LTD Israeli-Georgian Medical Research clinic Helsicore

    Tbilisi, 0112

  • LLC Vivamedi

    Tbilisi, 0131

  • LTD Institute of Clinical Cardiology

    Tbilisi, 0159

  • JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

    Tbilisi, 0160

  • LTD Aversi Clinic

    Tbilisi, 0160

  • LTD Central University Clinic After Academic N. Kipshidze

    Tbilisi, 0160

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

    Tbilisi, 0172

Other trials in Georgia

Slovakia8 sites

  • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica

    Banská Bystrica, 975 17

  • Alian S.R.O

    Bardejov, 085 01

  • KM Management spol. s r.o.

    Nitra, 949 01

  • Fakultna nemocnica Nitra

    Nitra, 950 01

  • GASTROENTEROLOG, s.r.o.

    Nové Zámky, 940 01

  • Gastro I, s.r.o.

    Prešov, 080 01

  • Accout Center s.r.o.

    Šahy, 936 01

  • ENDOMED, s.r.o.

    Vranov nad Topľou, Presov, 093 01

Other trials in Slovakia

Croatia7 sites

  • General Hospital "Dr.Tomislav Bardek" Koprivnica

    Koprivnica, 48000

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • General Hospital Zadar

    Zadar, 23000

  • Clinical Hospital Dubrava

    Zagreb, 10000

  • Clinical Hospital Sveti Duh

    Zagreb, 10000

  • Polyclinic Bonifarm

    Zagreb, 10000

  • University hospital centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Germany7 sites

  • Krankenhaus Waldfriede

    Berlin, 14163

  • Schwerpunktpraxis Bonn

    Bonn, Rhineland-Palatinate, 53123

  • Florence-Nightingale-Krankenhaus

    Düsseldorf, 40489

  • Clinic for Internal Medicine I, University hospital Schleswig-Holstein, Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • Johanna Etienne Krankenhaus

    Neuss, 41462

  • Praxis Dr. Joergensen

    Remscheid, North Rhine-Westphalia, 42859

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055

Other trials in Germany

Australia6 sites

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales, 2200

  • Austin Health Gastroenterology Department

    Heidelberg, Victoria, 3084

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • Coastal Digestive Health Pty Ltd

    Maroochydore, Queensland, 4558

  • Coral Sea Clinical Research Institute

    North Mackay, Queensland, 4740

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

South Korea6 sites

  • Dong-A University Hospital

    Busan, 49201

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Kyungpook National University Hospital

    Junggu, Daegu, 41944

  • Severance Hospital, Yonsei University Health System

    Seoul, Seodaemun-gu, 03722

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggi-do, 16247

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

United Kingdom6 sites

  • Belfast Health and Social Care Trust Royal Victoria Hospital

    Belfast, BT12 6BA

  • West Hertfordshire Hospitals NHS Trust Hemel Hempstead General Hospital

    Hemel Hempstead, HP2 4AD

  • Barts Health NHS Trust - Whipps Cross University Hospital

    London, Greater London, E11 1NR

  • Guys and St Thomas NHS Foundation Trust

    London, Greater London, SE1 9RT

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich, Norfolk, NR4 7UQ

  • Yeovil Hospital NHS Foundation Trust

    Yeovil, Somerset, BA21 4AT

Other trials in United Kingdom

Belarus5 sites

  • Grodno City Clinical Hospital #4

    Grodno, 230026

  • Institution "Gomel Regional Clinical Hospital"

    Homyel, 246029

  • Health Care Institution "10th City Clinical Hospital"

    Minsk, 220096

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210037

  • Vitebsk Regional Clinical Specialized Center

    Vitebsk, 210604

Other trials in Belarus

Chile5 sites

  • Enroll SpA

    Santiago, 7500588

  • Biomedica Research Group

    Santiago, 7500710

  • Hospital Sotero del Rio

    Santiago, 8150000

  • Centro de Investigación del Maule SPA

    Talca, 3465586

  • Clinical Research Chile SpA

    Valdivia, 5090000

Other trials in Chile

France5 sites

  • CHU Grenoble Alpes - Hôpital Michallon

    Grenoble, 38043

  • CHU Montpellier - HOPITAL SAINT-ELOI

    Montpellier, Herault, 34295

  • CHU Nantes Hôtel-Dieu

    Nantes, Loire Atlantique, 44000

  • CHU Nice - Hôpital de l'Archet 2

    Nice, Alpes Maritimes, 06202

  • CHRU-Nancy Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Lithuania5 sites

  • Kaunas Clinical Hospital

    Kaunas, LT-47144

  • Klaipeda University Hospital, Department of Gastroenterology

    Klaipėda, LT-92288

  • Republican Panevezys Hospital, Department of Gastroenterology

    Panevezys, LT-35144

  • UAB "Inlita", Santaros Clinical Trials Centre

    Vilnius, LT-08406

  • Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology

    Vilnius, LT-08661

Other trials in Lithuania

Mexico5 sites

  • Scientia Investigación Clínica S.C.

    Chihuahua City, 31203

  • Hospital Angeles Chihuahua

    Chihuahua City, 31238

  • Centro de Investigacion Medico Biologica y Terapia Avanzada s.c.

    Guadalajara, Jalisco, 44130

  • InspirePharma S. de R. L. de C.V.

    Monterrey, Nuevo León, 64660

  • Faicic S. de R.L. de Cv

    Veracruz, 91900

Other trials in Mexico

Serbia5 sites

  • Clinical Center " Dr Dragisa Misovic Dedinje"

    Belgrade, 11000

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Health Center Zvezdara

    Belgrade, 11000

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • General Hospital Sremska Mitrovica

    Sremska Mitrovica, 22000

Other trials in Serbia

Argentina4 sites

  • Clinica Adventista Belgrano

    CABA, Buenos Aires, C1430EGF

  • Mautalen Salud e Investigacion

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF

  • Fundación Respirar- Centro Médico Dra. De Salvo

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP

  • CICE Sanatorio 9 de Julio

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Belgium4 sites

  • AZ Sint-Lucas & Volkskliniek

    Ghent, 9000

  • UZ Gent Gastroenterology

    Ghent, 9000

  • ZNA Jan Palfijn

    Merksem, 2170

  • AZ Delta

    Roeselare

Other trials in Belgium

Moldova4 sites

  • Clinical Hospital of the Ministry of Health, Labor and Social Protection

    Chisinau, MD-2005

  • Rtl Sm Srl

    Chisinau, MD-2025

  • Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology

    Chisinau, MD-2025

  • RTL SM SRL, Institutia Medico-Sanitara Publica Spitalul Clinic, Sectia Proctologie

    Chisinau, MD-2068

Other trials in Moldova

Portugal4 sites

  • Hospital de Braga

    Braga, 4710-243

  • Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia

    Coimbra, 3000-075

  • Centro Hospitalar de São João, EPE

    Porto, 4200-319

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

South Africa4 sites

  • Dr JP Wright Practice

    Cape Town, Western Cape, 7708

  • Lenasia Clinical Trial Centre

    Johannesburg, Gauteng, 1827

  • Johese Clinical Research: Unitas

    Lyttelton, Centurion, 0157

  • Johese Clinical Research

    Midstream, Centurion, 1692

Other trials in South Africa

Thailand4 sites

  • Faculty of Medicine Siriraj Hospital

    Bangkoknoi, Bangkok, 10700

  • Ms. Arawan Larplertsakul

    Chiang Mai, 50200

  • Supaporn Lertkawinanan

    Pathum Wan, Bangkok, 10330

  • Phramongkutklao Hospital

    Ratchathewi, Bangkok, 10400

Other trials in Thailand

Turkey (Türkiye)4 sites

  • Gazi University Medical Faculty

    Ankara, 06500

  • Antalya Training and Research Hospital

    Antalya, 07030

  • Uludag University Medical Faculty

    Beşevler, Yenimahalle / Ankara, 16059

  • Kocaeli University Research and Training Hospital

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Austria3 sites

  • KH der Barmherzigen Brüder Linz

    Linz, 4020

  • AKH - Medizinische Universität Wien

    Vienna, 1090

  • Wilhelminenspital der Stadt Wien

    Vienna, 1160

Other trials in Austria

Estonia3 sites

  • Innomedica OÜ

    Tallinn, 10117

  • West Tallinn Central Hospital

    Tallinn, 10617

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

Other trials in Estonia

Denmark2 sites

  • Aalborg University Hospital, department of medical gastroenterology

    Aalborg, North Denmark, 9000

  • Herlev Hospital

    Herlev, 2730

Other trials in Denmark

Netherlands2 sites

  • Zuyderland Medisch Centrum - Sittard-Geleen

    Geleen, 6162 BG

  • ETZ Elisabeth

    Tilburg, 5022 GC

Other trials in Netherlands

Taiwan2 sites

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Canada1 site

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

Other trials in Canada

Latvia1 site

  • P. Stradins Clinical University Hospital

    Riga, LV-1002

Other trials in Latvia

Lebanon1 site

  • Saint George University Hospital Medical Center

    Beirut, 1100 2807

Other trials in Lebanon

Spain1 site

  • Hospital Universitario La Paz

    Madrid, 28046

Other trials in Spain

About this study

Official title: 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.

Being tested
Etrasimod, Placebo
Keywords
Ulcerative Colitis, Etrasimod, APD334
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtrasimodDrug

    Also called APD334

    Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment

  • PlaceboDrug

    Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment

Study groups in NCT03945188
Study groupRoleWhat they receive
Etrasimod 2 mgExperimentalNot described
Receives: Drug: Etrasimod
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At Week 12

  2. 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.

    Measured: At Week 52

Secondary outcomes (21)

  1. 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).

    Measured: At Week 12

  2. 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).

    Measured: At Week 52

  3. 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.

    Measured: At Week 12

  4. 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.

    Measured: At Week 52

  5. 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.

    Measured: At Week 12

  6. 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.

    Measured: At Week 52

  7. 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.

    Measured: At Week 52

  8. 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.

    Measured: At Weeks 12 and 52

  9. 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.

    Measured: At Week 12

  10. 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.

    Measured: At Week 52

  11. 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.

    Measured: At Weeks 12 and 52

  12. 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.

    Measured: At Weeks 12 and 52

  13. 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).

    Measured: At Week 12

  14. 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).

    Measured: At Week 52

  15. 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).

    Measured: At Weeks 12 and 52

  16. 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.

    Measured: At Weeks 2, 4, 8, 16, 20, 24, 32, 40, and 48

  17. 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.

    Measured: At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 52

  18. 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.

    Measured: At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52

  19. 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.

    Measured: At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52

  20. 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.

    Measured: At Week 52

  21. 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.

    Measured: At Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2019
  2. Study start13 Jun 2019
  3. Primary completion8 Feb 2022
  4. Study completion16 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
433 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03945188
Sponsor's protocol ID
APD334-301
Other IDs
2018-003985-15, 2018
Acronym
ELEVATE UC 52
Status last verified
Mar 2022
First submitted
8 May 2019
Last updated
20 Dec 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Siegmund B, Crosby CM, Ryan RD, Smith J, Abreu MT, Vermeire S, Dotan I, Rabinowitz KM, Komori HK, Goetsch M, Wosik K, Woolcott JC, Danese S. Etrasimod reduces circulating and mucosal inflammatory lymphocyte populations and alters innate immune and non-immune cell signatures in intestinal mucosa: ELEVATE UC phase 3 clinical data. J Crohns Colitis. 2026 Oct 9;20(10):jjag159. doi: 10.1093/ecco-jcc/jjag159.

    PubMed 42864953

  • Sands B, Dubinsky M, Feagan BG, Panaccione R, Jairath V, Yarur AJ, Chiorean MV, Walsh A, Goetsch M, Sahin B, Cognata C, Abbatemarco AM, Matharu GS, Kudela M, Ghosh S. Maintenance of Efficacy Outcomes at Week 52 among Etrasimod Induction Responders: An Analysis from the Phase 3 ELEVATE UC 52 Trial. Dig Dis. 2026 Oct 8:1. doi: 10.1159/ddi/acnag011. Online ahead of print.

    PubMed 42848715

  • Dubinsky MC, Cohen ER, Irving PM, Goetsch M, Lazin K, Bhattacharjee A, Pradeep G, Hur P, Cognata C, Wosik K, Panaccione R. Bowel urgency in ulcerative colitis is associated with clinical endpoints, health-related quality of life, and biomarkers: data from the etrasimod ELEVATE UC 52 trial. Crohns Colitis 360. 2026 Jul 16;8(3):otag072. doi: 10.1093/crocol/otag072. eCollection 2026 Jul.

    PubMed 42542725

  • Rubin DT, Lees CW, Baert F, Kudela M, Bhattacharjee A, Lazin K, Goetsch M, Abbatemarco AM, Wosik K, Marshall JK. The efficacy and safety of etrasimod as a first-line advanced therapy for ulcerative colitis: prespecified and post hoc subgroup data from the ELEVATE UC clinical program. Ther Adv Gastroenterol. 2026 Jul 27;19:17562848261470909. doi: 10.1177/17562848261470909. eCollection 2026.

    PubMed 42523912

  • Danese S, Goetsch M, Peyrin-Biroulet L, Yarur AJ, Dubinsky M, Rubin DT, Feagan BG, D'Haens G, Baert F, Lazin K, Gu G, Yu J, Lawendy N, Zang C, Wang W, Menon S, Law EH, Modesto I, Wosik K, Sidhu S, Niezychowski W, Vermeire S. The Efficacy and Safety of Etrasimod in Mildly to Moderately Active Ulcerative Colitis: Results From the Phase II GLADIATOR Trial. Clin Gastroenterol Hepatol. 2026 Jun 4:S1542-3565(26)00405-2. doi: 10.1016/j.cgh.2026.05.024. Online ahead of print.

    PubMed 42248437

  • Dubinsky MC, Chaparro M, Irving PM, Hur P, Sidhu S, Woolcott JC, Wang W, Goetsch M, Torres J, Panaccione R. Rapid symptomatic improvement with etrasimod in ulcerative colitis: a post-hoc analysis of the ELEVATE UC program. Inflamm Bowel Dis. 2026 Jun 1;32(6):1075-1085. doi: 10.1093/ibd/izaf333.

    PubMed 41655066

  • 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.

    PubMed 40889900

  • Yarur 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.

    PubMed 40618942

  • Lichtenstein 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.

    PubMed 40184206

  • Sands 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.

    PubMed 40036804

  • Afzali 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.

    PubMed 39891572

  • Yarur 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.

    PubMed 39878434

  • Vermeire 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.

    PubMed 39778975

  • Yarur 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.

    PubMed 39671695

  • Lees 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. Ther Adv Gastroenterol. 2024 Nov 7;17:17562848241293643. doi: 10.1177/17562848241293643. eCollection 2024.

    PubMed 39526078

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etrasimod in people with Ulcerative Colitis, run by Arena Pharmaceuticals at 315 sites in 40 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 315 sites in United States, Poland, Russia, Ukraine, Romania and 35 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Clinical Remission at Week 12 (time frame: At Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03945188, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.

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