AzTrials
AzTrials

Ulcerative ColitisPhase 3ELEVATE UC 12NCT03996369

Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis

A Phase 3 study testing Etrasimod in people with Ulcerative Colitis, run by Arena Pharmaceuticals at 407 sites in 41 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 assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC). 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
354 participants
Where
407 sitesin 41 countries
Study dates
15 Sep 2020to 7 Dec 2021
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

407 sites in 41 countries.

407 sites in 41 countries

United States62 sites

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Children's Center for Digestive Health Care, LLC

    Atlanta, Georgia, 30342

  • University of Colorado

    Aurora, Colorado, 80045

  • The University of Texas at Austin Dell Medical School

    Austin, Texas, 78712

  • Texas Digestive Disease Consultants

    Baton Rouge, Louisiana, 70809

  • Washington Gastroenterology

    Bellevue, Washington, 98004

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Gastro Florida

    Clearwater, Florida, 33761

  • Gastro Florida

    Clearwater, Florida, 33762

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80920

  • Gastro Center of Maryland

    Columbia, Maryland, 21045

  • Texas Gastroenterology Associates, PA

    Cypress, Texas, 77429

  • Texas Digestive Disease Consultants - Dallas

    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

    Durham, North Carolina, 27710

  • DHAT Research Institute

    Garland, Texas, 75044

  • Illinois Gastroenterology Group

    Gurnee, Illinois, 60031

  • Great Lakes Medical Research, LLC - Harrisburg

    Harrisburg, Pennsylvania, 17110

  • Baylor Gastroenterology Assoc

    Houston, Texas, 77030

  • Marshall University Department of Clinical Research

    Huntington, West Virginia, 25701

  • Tri-Cities Gastroenterology

    Kingsport, Tennessee, 37663

  • GI for Kids

    Knoxville, Tennessee, 37916

  • Om Research, LLC

    Lancaster, California, 93534

  • Florida Center for Gastroenterology

    Largo, Florida, 33777

  • Sierra Clinical Research

    Las Vegas, Nevada, 89106

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • 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

    Mentor, Ohio, 44060

  • Global Life Research Network, LLC

    Miami, Florida, 33155

  • Life Medical Center & Research, Inc

    Miami Lakes, Florida, 33014

  • Medical College of Wisconsin Clinical Trials Office

    Milwaukee, Wisconsin, 53226-0509

  • East View Medical Research, LLC

    Mobile, Alabama, 36606

  • United Medical Doctors

    Murrieta, California, 92563

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • NSB Research

    New Smyrna Beach, Florida, 32168

  • Care Access Research LLC

    Ogden, Utah, 84403

  • Pediatric & Adult Research Center

    Orlando, Florida, 32825

  • IMIC, Inc.

    Palmetto Bay, Florida, 33157

  • Care Access Research

    Poland, Ohio, 44514

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • ACRC Studies,LLC

    San Diego, California, 92119

  • Texas Digestive Disease Consultants - San Marcos

    San Marcos, Texas, 78130

  • Virginia Mason

    Seattle, Washington, 98101

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Theia Clinical Research, LLC

    St. Petersburg, Florida, 33709

  • Arizona Digestive Health

    Sun City, Arizona, 85351

  • Lenus Research & Medical Group, LLC

    Sweetwater, Florida, 33172

  • USF Department of Surgery

    Tampa, Florida, 33606

  • GCP Clinical Research

    Tampa, Florida, 33609

  • Guardian Angel Research Center

    Tampa, Florida, 33614

  • Paradigm Clinical Research Institute

    Torrance, California, 90505

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • Victoria Gastroenterology

    Victoria, Texas, 77904

  • West Michigan Clinical Research Center

    Wyoming, Michigan, 49519

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida, 33542

Other trials in United States

Japan60 sites

  • Asahikawa City Hospital

    Asahikawa-shi, Hokkaido, 070-8610

  • St. Luke's International Hospital

    Chuo -ku, Tokyo, 104-8560

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1247

  • NHO Fukuyama Medical Center

    Fukuyama-shi, Hiroshima, 720-8520

  • Gifu University Hospital

    Gifu, Gifu, 501-1194

  • NHO Mito Medical Center

    Higashi, Ibaraki, 311-3193

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka, 573-1191

  • NHO Hirosaki National Hospital

    Hirosaki-shi, Aomori, 036-8545

  • Hirosaki University Hospital

    Hirosaki-shi, Aomori, 036-8563

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, Hiroshima, 730-8518

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Jiaikai Izuro Imamura Hospital

    Kagoshima, Kagoshima-ken, 892-0824

  • Sameshima Hospital

    Kagoshima, Kagoshima-ken, 892-0846

  • Gokeikai Ofuna Chuo Hospital

    Kamakura-shi, Kanagawa, 247-0056

  • NHO Kanazawa Medical Center

    Kanazawa, Ishikawa-ken, 920-8650

  • Nara Medical University Hospital

    Kashihara, Nara, 634-8522

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa, Chiba, 277-0871

  • Fukuoka Tokushukai Hospital

    Kasuga, Fukuoka, 816-0864

  • Tokushukai Kishiwada Tokushukai Hospital

    Kishiwada-shi, Osaka, 596-8522

  • JCHO Kyushu Hospital

    Kitakyushu-shi, Fukuoka, 806-8501

  • Showa General Hospital

    Kodaira-shi, Tokyo, 187-0002

  • Yuai Memorial Hospital

    Koga-shi, Ibaraki, 306-0232

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, Kumamoto, 861-8520

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011

  • NHO Kyoto Medical Center

    Kyoto, Kyoto, 612-8555

  • Saiseikai Matsuyama Hospital

    Matsuyama, Ehime, 791-8026

  • Jikei University Hospital

    Minato-ku, Tokyo, 105-8471

  • Kitasato University Kitasato Institute Hospital

    Minato-ku, Tokyo, 108-8642

  • Iwate Medical University Uchimaru Medical Center

    Morioka, Iwate, 020-8505

  • Koujunkai Daido Clinic

    Nagoya, Aichi-ken, 457-8511

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Saiseikai Niigata Hospital

    Niigata, Niigata, 950-1104

  • Ogaki Municipal Hospital

    Ogaki-shi, Gifu, 503-8502

  • Osaka City University Hospital

    Osaka, Osaka, 545-8586

  • Japan Community Health care Organization Osaka Hospital

    Osaka, Osaka, 553-0003

  • SUBARU Health Insurance Society Ota Memorial Hospital

    Ota-shi, Gunma, 373-8585

  • Shiga University of Medical Science Hospital

    Ōtsu, Shiga, 520-2192

  • Saga University Hospital

    Saga, Saga-ken, 849-8501

  • Sagamihara Kyodo Hospital

    Sagamihara-shi, Kanagawa, 252-5188

  • JCHO Saitama Medical Center

    Saitama-shi, Saitama, 330-0074

  • Tokushukai Sapporo Tokushukai Hospital

    Sapporo, Hokkaido, 004-0041

  • Sapporo-Kosei General Hospital

    Sapporo, Hokkaido, 060-0033

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • JOHAS Tohoku Rosai Hospital

    Sendai, Miyagi, 981-8563

  • Sendai City Hospital

    Sendai, Miyagi, 982-8502

  • NTT Medical Center Tokyo

    Shinagawa-ku, Tokyo, 141-8625

  • JCHO Tokyo Yamate Medical Center

    Shinjuku-ku, Tokyo, 169-0073

  • Teikyo University Hospital

    tabashi City, Tokyo, 173-8606

  • Takamatsu Red Cross Hospital

    Takamatsu, Kagawa-ken, 760-0017

  • Kagawa Prefectural Central Hospital

    Takamatsu, Kagawa-ken, 760-8557

  • Osaka Medical College Hospital

    Takatsuki-shi, Osaka, 569-8686

  • Ehime University Hospital

    Toon-shi, Ehime, 791-0295

  • Toyama Prefectural Central Hospital

    Toyama, Toyama, 930-8550

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, 441-8570

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

  • Tsuchiura Kyodo General Hospital

    Tsuchiura-shi, Ibaraki, 300-0028

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

  • Mie Prefectural General Medical Center

    Yokkaichi, Mie-ken, 510-8561

  • NHO Yokohama Medical Center

    Yokohama, Kanagawa, 245-8575

Other trials in Japan

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

  • Centrum Medyczne Plejady

    Krakow, 30-363

  • Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna

    Krakow, 31-506

  • AmiCare Sp. z O.O. Sp.K.

    Lodz, 90-644

  • IP Clinic

    Lodz, 90-752

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

    Nowy Targ, 34-400

  • Medicome Sp. Zo.O.

    Oświęcim, 32-600

  • Centrum Medyczne Grunwald

    Poznan, 60-369

  • SOLUMED Centrum Medyczne

    Poznan, 60-529

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, 35-302

  • Centrum Medyczne Medyk

    Rzeszów, 35-326

  • ENDOSKOPIA Sp.zo.o

    Sopot, 81-756

  • DC-MED

    Swidnica, 58-100

  • 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

Other trials in Poland

Russia20 sites

  • LLC "Multidisciplinary Medical Clinic "Anthurium"

    Barnaul, 656043

  • LLC "Alyans Biomedical- Ural Group"

    Izhevsk, 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

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

    Saint Petersburg, 195067

  • FSBI of higher Education "First Saint Petersburg State Medical University n.a. I.P.Pavlov

    Saint Petersburg, 197022

  • LLC "Gastroenterological centre Expert"

    Saint Petersburg, 197110

  • LLC SM-Clinic

    Saint-Peterburg, 195279

  • 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

  • City Clinical Hospital #8

    Yaroslavl, 150030

Other trials in Russia

Italy16 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia, 25123

  • Azienda Ospedaliera Saverio De Bellis

    Castellana Grotte, Bari, 70013

  • Azienda Ospedaliera Ospedale Cannizzaro

    Catania, 95126

  • Azienda Ospedaliero Universitaria Mater Domini

    Catanzaro, 88100

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • 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

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • I.R.C.C.S Policlinico San Donato

    San Donato Milanese, Milano, 20097

  • A.O. Ordine Mauriziano di Torino - P.O. Ospedale Umberto I

    Torino, 10128

  • Centro Ricerche Cliniche di Verona

    Verona, 37134

  • Ospedale San Bortolo di Vicenza

    Vicenza, 36100

Other trials in Italy

Ukraine16 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

  • Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU

    Kyiv, 01030

  • 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

Other trials in Ukraine

France13 sites

  • Chu Amiens Picardie-Sit Sud

    Amiens, Somme, 80054

  • CHU Clermont Ferrand - Hôpital d'Estaing

    Clermont-Ferrand, Puy De Dome, 63003

  • CHU Dijon - Hôpital Bocage Central

    Dijon, Côte-d'Or, 21079

  • CHU Grenoble Alpes - Hôpital Michallon

    Grenoble, 38043

  • Groupement Hospitalier Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre, Val De Marne, 94275

  • CHU Lille - Hôpital Claude Huriez

    Lille, Nord, 59037

  • Unite de Recherche Clinique-Urc

    Montfermeil, Seine Saint Denis, 93370

  • 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

  • Chu Pontchaillou Rennes

    Rennes, Ille Et Vilaine, 35033

  • Hôpital Rangueil Service Gastro-entérologie et pancreatologie

    Toulouse, Haute Garonne, 31059

  • CHRU-Nancy Brabois

    Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54511

Other trials in France

Hungary12 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

  • Endoexpert Egeszsegugyi Szolgaltato Kft

    Budapest, 1054

  • Semmelweis Egyetem, II.sz. Belgyogyaszati Klinika

    Budapest, 1088

  • Pannonia Maganorvosi Centrum

    Budapest, 1136

  • Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika -Gasztroenterologia

    Debrecen, 4032

  • Bugat Pal Korhaz

    Gyöngyös, 3200

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

    Szeged, 6720

  • Dept of Gastroenterology, Szent Gyorgy Hospital

    Székesfehérvár, 8000

  • Clinfan Ltd. Outpatient Clinic

    Szekszárd, 7100

  • Szent Borbala Korhaz

    Tatabánya, 2800

Other trials in Hungary

Bulgaria11 sites

  • UMHAT "Sv. Georgi", EAD

    Plovdiv, 4002

  • 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 "Tsaritsa Yoanna-ISUL" EAD

    Sofia, 1527

  • UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center

    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

  • Medical Centre MEDICA Plus OOD

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Czechia10 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

  • Axon Clinical s. r. o.

    Prague, 150 00

  • ISCARE I.V.F. a.s.

    Prague, 170 04

  • Nemocnice Na Bulovce

    Prague, 180 81

  • Oblastni nemocnice Pribram a.s.

    Příbram, 261 01

  • Nemocnice Slany

    Slaný, 274 01

Other trials in Czechia

India10 sites

  • Fortis Memorial Research Institute

    Gurgaon, Haryana, 122002

  • Shweta Paliwal/Vipin Kumar Jain

    Jaipur, Rajasthan, 302001

  • Postgraduate department of Medicine, GSVM Medical college

    Kanpur, Uttar Pradesh, 208002

  • All India Institute of Medical Sciences

    Kochi, Kerala, 682027

  • Aster Medcity,Aster DM healthcare Ltd

    Kochi, Kerala, 682027

  • Government Medical College and Super Speciality Hospital

    Nagpur, Maharashtra, 440009

  • Midas Multispeciality Hospital Pvt.Ltd.

    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

Romania10 sites

  • S.C MedLife SA

    Bucharest, 10719

  • S.C Delta Health Care S.R.L, Ponderas Academic Hospital

    Bucharest, 14142

  • S.C Euroclinic Hospital S.A

    Bucharest, 14461

  • Spitalul Clinic Colentina

    Bucharest, 20125

  • Institutul Clinic Fundeni

    Bucharest, 22328

  • S.C Policlinica CCBR S.R.L

    Bucharest, 30463

  • S.C. Centrul Medical Unirea SRL

    Bucharest, 540136

  • Spitalul Clinic Judetean de Urgenta Cluj Napoca

    Cluj-Napoca, 400006

  • Spitalul Clinic Judetean de Urgenta Craiova

    Craiova, 200640

  • S.C Pelican Impex S.R.L

    Oradea, 410469

Other trials in Romania

Australia9 sites

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales, 2200

  • Footscray Hospital

    Footscray, Victoria, 3011

  • Austin Health

    Heidelberg, Victoria, 3084

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • Liverpool Hospital

    Liverpool, 2170

  • Coastal Digestive Health

    Maroochydore, Queensland, 4558

  • Alfred Hospital

    Melbourne, 3004

  • Coral Sea Clinical Research Institute

    North Mackay, Queensland, 4740

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

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-Beilinson Campus

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 5262000

  • Kaplan Medical Center

    Rehovot, 7610001

Other trials in Israel

Belgium8 sites

  • Dr. Peter Bossuyt - GI Clinical Research Center

    Bonheiden, 2820

  • University Hospital Antwerp Gastroenterology and Hepatology Department

    Edegem, Antwerp, 2650

  • AZ Sint-Lucas & Volkskliniek

    Ghent, 9000

  • UZ Gent - Gastroenterology

    Ghent, 9000

  • UZ Leuven Campus Gasthuisberg

    Leuven, 3000

  • AZ Sint-Maarten

    Mechelen, 2800

  • ZNA Jan Palfijn

    Merksem, 2170

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Georgia8 sites

  • LTD Acad. F. Todua Medical Centre, LTD. Research Institution 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

Germany8 sites

  • Charité Universitätsmedizin Berlin - Campus Charité Mitte

    Berlin, 10117

  • 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

Slovakia8 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta

    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

  • 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

  • BeneDig s.r.o.

    Žilina, 010 08

Other trials in Slovakia

Mexico6 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

  • Consultorio Medico, InvesclinicMX

    Irapuato, Guanajuato, 36650

  • 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

Portugal6 sites

  • Hospital de Braga

    Braga, 4710-243

  • Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia

    Coimbra, 3000-075

  • Hospital da Senhora da Oliveira Guimarães

    Guimarães, 4835-044

  • Hospital da Luz Lisboa

    Lisbon, 1500-650

  • 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

Serbia6 sites

  • Clinical Center " Dr Dragisa Misovic Dedinje"

    Belgrade, 11000

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Health Center Zvezdara

    Belgrade, 11000

  • Clinical Center Bezanijska Kosa

    Belgrade, 11080

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • General Hospital Sremska Mitrovica

    Sremska Mitrovica, 22000

Other trials in Serbia

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

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

Turkey (Türkiye)6 sites

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • 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

  • Karadeniz Tecnical Uni. Med. Fac.

    Trabzon, 61100

Other trials in Turkey (Türkiye)

Argentina5 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

  • Instituto de Investigaciones Clínicas Quilmes SRL

    Quilmes, Buenos Aires, B1878GEG

  • CICE Sanatorio 9 de Julio

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

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

Croatia5 sites

  • General Hospital "Dr. Tomislav Bardek" Koprivnica

    Koprivnica, 48000

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • General Hospital Zadar

    Zadar, 23000

  • Clinical Hospital Sveti Duh

    Zagreb, 10000

  • University hospital centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Spain5 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Centro Médico Teknon

    Barcelona, 08022

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas, 35010

  • Hospital Universitario La Paz

    Madrid, 28046

Other trials in Spain

Belarus4 sites

  • Grodno City Clinical Hospital #4

    Grodno, 230026

  • Institution "Gomel Regional Clinical Hospital"

    Homyel, 246029

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210037

  • Vitebsk Regional Clinical Specialized Center

    Vitebsk, 210604

Other trials in Belarus

Colombia4 sites

  • Hospital San Juan de Dios Fundacion Cardiomet-Cequin

    Armenia, Quindío Department, 630004

  • Clínica de la Costa Ltda.

    Barranquilla, Atlántico, 080020

  • Clinica de la Mujer Centro de Investigaciones

    Bogota, Cundinamarca, 110221

  • Clinica farallones centro de investigaciones clinicas CIC

    Cali, Valle del Cauca Department, 760044

Other trials in Colombia

Estonia4 sites

  • Innomedica OÜ

    Tallinn, 10117

  • West Tallinn Central Hospital

    Tallinn, 10617

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

  • Tartu University Hospital

    Tartu, 50406

Other trials in Estonia

Moldova4 sites

  • Republican Clinical Hospital, ARENSIA Exploratory Medicine

    Chisinau, MD-2025

  • 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

South Africa4 sites

  • Dr JP Wright Practice

    Cape Town, Western Cape, 7708

  • Lenasia Clinical Trial Centre

    Lenasia, Gauteng, 1827

  • Johese Clinical Research: Unitas

    Lyttelton, Centurion, 0157

  • Johese Clinical Research

    Midstream, Centurion, 1692

Other trials in South Africa

United Kingdom4 sites

  • Whipps Cross University Hospital

    London, Greater London, E11 1NR

  • Guy's and Saint Thomas NHS Foundation Trust

    London, Greater London, SE1 9RT

  • Norfolk and Norwich University Hospital

    Norwich, Norfolk, NR4 7UQ

  • Yeovil District Hospital

    Yeovil, Somerset, BA21 4AT

Other trials in United Kingdom

Austria3 sites

  • Lkh Univ. Klinikum Graz

    Graz, 8036

  • KH der Barmherzigen Brüder Linz, Interne Abteilung

    Linz, 4020

  • AKH - Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Lebanon3 sites

  • Saint George Hospital University Medical Center

    Beirut, 1100-2807

  • American University of Beirut Medical Center

    Beirut, 1107-2020

  • Hotel Dieu de France Hospital

    Beirut, 16-6830

Other trials in Lebanon

Lithuania3 sites

  • 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

Netherlands3 sites

  • Zuyderland Medisch Centrum - Sittard-Geleen

    Geleen, 6162 BG

  • Radboudumc

    Nijmegen, 6525 GA

  • ETZ Elisabeth

    Tilburg, 5022 GC

Other trials in Netherlands

Switzerland3 sites

  • Kantonsspital Baden

    Baden, 5404

  • Inselspital, Gaby Saner, Gastroenterologie, Bauchzentrum

    Bern, 3010

  • Berner IBD study group c/o Gastroenterologische Praxis Balsiger, Seibold &Partner

    Bern, 3012

Other trials in Switzerland

Thailand3 sites

  • Siriraj Hospital

    Bangkoknoi, Bangkok, 10700

  • King Chulalongkorn Memorial Hospital

    Pathum Wan, Bangkok, 10330

  • Phramongkutklao Hospital

    Ratchathewi, Bangkok, 10400

Other trials in Thailand

Canada2 sites

  • Heritage Medical Research Clinic

    Calgary, Alberta, T2N 4Z6

  • LHSC - University Hospital

    London, Ontario, N6A 5A5

Other trials in Canada

Denmark2 sites

  • Aalborg University Hospital, department of medical gastroenterology

    Aalborg, North Denmark, 9000

  • Herlev Hospital, Gastroenheden, 54Q2

    Herlev, 2730

Other trials in Denmark

About this study

Official title: 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

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).

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 12-Week Induction Treatment Period

  • PlaceboDrug

    Etrasimod matching placebo tablet by mouth, once daily up to 12-Week Induction Treatment Period

Study groups in NCT03996369
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

    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.

    Measured: Week 12

Secondary outcomes (9)

  1. Percentage of Participants Achieving Endoscopic Improvement

    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); higher score indicated more severe disease.

    Measured: Week 12

  2. Percentage of Participants Achieving Symptomatic Remission

    Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.

    Measured: Week 12

  3. Percentage of Participants With Mucosal Healing

    Mucosal healing was defined as an ES <= 1 (excluding friability) with histologic remission measured by a Geboes Index score less than [<] 2.0). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system, was 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 indicated more severe disease.

    Measured: Week 12

  4. Percentage of Participants Achieving Clinical Response

    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 percent (%) decrease from Baseline MMS, and a >= 1-point decrease from Baseline in RB sub-score or an absolute RB sub-score <= 1. 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.

    Measured: Week 12

  5. Percentage of Participants Achieving Endoscopic Normalization

    Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease); higher score indicated more severe disease.

    Measured: Week 12

  6. Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8

    Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.

    Measured: Weeks 2, 4 and 8

  7. Percentage of Participants Achieving Complete Symptomatic Remission

    Complete symptomatic remission was defined as an SF sub-score = 0 and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.

    Measured: Weeks 2, 4, 8 and 12

  8. Percentage of Participants Achieving Non-invasive Clinical Response

    Non-invasive clinical response was defined as a >= 30% decrease from Baseline in composite RB and SF sub-scores, and a >= 1 point decrease from Baseline in RB sub-score or RB sub-score <= 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 sub-score 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: Weeks 2, 4, 8 and 12

  9. Percentage of Participants Achieving Symptomatic Response

    Symptomatic response was defined as a >= 30% decrease from Baseline in composite RB and SF score. The SF sub-score ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB sub-score 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: Weeks 2, 4, 8 and 12

Timeline

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

  1. First posted24 Jun 2019
  2. Study start15 Sep 2020
  3. Primary completion7 Dec 2021
  4. Study completion7 Dec 2021

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03996369
Sponsor's protocol ID
APD334-302
Other IDs
2018-003986-33, 2018
Acronym
ELEVATE UC 12
Status last verified
Jan 2022
First submitted
21 Jun 2019
Last updated
21 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

  • 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

  • Armuzzi 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.

    PubMed 39326009

  • Sands 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.

    PubMed 39306680

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 407 sites in 41 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 21 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 407 sites in United States, Japan, Poland, Russia, Italy and 36 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 21 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 (time frame: Week 12). 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 NCT03996369, which also lists 20 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 21 Dec 2022.

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