Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis (ELEVATE UC 12)

November 28, 2022 updated by: Arena Pharmaceuticals

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

354

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1430EGF
        • Clinica Adventista Belgrano
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1128AAF
        • Mautalen Salud e Investigación
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
        • Fundación Respirar- Centro Médico Dra. De Salvo
      • Quilmes, Buenos Aires, Argentina, B1878GEG
        • Instituto de Investigaciones Clinicas Quilmes SRL
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • CICE Sanatorio 9 de Julio
  • Australia
      • Liverpool, Australia, 2170
        • Liverpool Hospital
      • Melbourne, Australia, 3004
        • Alfred Hospital
    • New South Wales
      • Bankstown, New South Wales, Australia, 2200
        • Bankstown-Lidcombe Hospital
      • Kingswood, New South Wales, Australia, 2747
        • Nepean Hospital
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Coastal Digestive Health
      • North Mackay, Queensland, Australia, 4740
        • Coral Sea Clinical Research Institute
    • Victoria
      • Footscray, Victoria, Australia, 3011
        • Footscray Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Austria
      • Graz, Austria, 8036
        • LKH Univ. Klinikum Graz
      • Linz, Austria, 4020
        • KH der Barmherzigen Brüder Linz, Interne Abteilung
      • Wien, Austria, 1090
        • AKH - Medizinische Universitat Wien
  • Belarus
      • Gomel, Belarus, 246029
        • Institution "Gomel Regional Clinical Hospital"
      • Grodno, Belarus, 230026
        • Grodno City Clinical Hospital #4
      • Vitebsk, Belarus, 210037
        • Vitebsk Regional Clinical Hospital
      • Vitebsk, Belarus, 210604
        • Vitebsk Regional Clinical Specialized Center
  • Belgium
      • Bonheiden, Belgium, 2820
        • Dr. Peter Bossuyt - GI Clinical Research Center
      • Gent, Belgium, 9000
        • AZ Sint-Lucas & Volkskliniek
      • Gent, Belgium, 9000
        • UZ Gent - Gastroenterology
      • Leuven, Belgium, 3000
        • UZ Leuven campus Gasthuisberg
      • Mechelen, Belgium, 2800
        • AZ Sint-Maarten
      • Merksem, Belgium, 2170
        • ZNA Jan Palfijn
      • Roeselare, Belgium, 8800
        • AZ Delta
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • University Hospital Antwerp Gastroenterology and Hepatology Department
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • UMHAT "Sv. Georgi", EAD
      • Ruse, Bulgaria, 7002
        • UMHAT Kanev AD, Ruse
      • Sliven, Bulgaria, 8800
        • Diagnostic-Consultative Center I - Sliven, EOOD
      • Sofia, Bulgaria, 1407
        • ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center
      • Sofia, Bulgaria, 1431
        • DCC "Alexandrovska", EOOD
      • Sofia, Bulgaria, 1527
        • UMHAT "Tsaritsa Yoanna-ISUL" EAD
      • Sofia, Bulgaria, 1606
        • UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center
      • Sofia, Bulgaria, 1680
        • Diagnostic Consultation Center CONVEX EOOD
      • Sofia, Bulgaria, 1784
        • Acibadem City Clinic University Hospital EOOD
      • Stara Zagora, Bulgaria, 6000
        • Medical center "Nov Rehabilitatsionen Tsentar" EOOD
      • Veliko Tarnovo, Bulgaria, 5000
        • Medical Centre MEDICA Plus OOD
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Heritage Medical Research Clinic
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • LHSC - University Hospital
  • Chile
      • Santiago, Chile, 7500710
        • Biomedica Research Group
      • Santiago, Chile, 7500588
        • Enroll SpA
      • Santiago, Chile, 8150000
        • Hospital Sotero del Rio
      • Talca, Chile, 3465586
        • Centro de Investigación del Maule SpA
      • Valdivia, Chile, 5090000
        • Clinical Research Chile SpA
  • Colombia
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • Clínica de la Costa Ltda.
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110221
        • Clinica de la Mujer Centro de Investigaciones
    • Quindio
      • Armenia, Quindio, Colombia, 630004
        • Hospital San Juan de Dios Fundacion Cardiomet-Cequin
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760044
        • Clinica farallones centro de investigaciones clinicas CIC
  • Croatia
      • Koprivnica, Croatia, 48000
        • General Hospital "Dr. Tomislav Bardek" Koprivnica
      • Osijek, Croatia, 31000
        • Clinical Hospital Centre Osijek
      • Zadar, Croatia, 23000
        • General Hospital Zadar
      • Zagreb, Croatia, 10000
        • University Hospital Centre Zagreb
      • Zagreb, Croatia, 10000
        • Clinical Hospital Sveti Duh
  • Czechia
      • Brno, Czechia, 656 91
        • Fakultni nemocnice u svate Anny v Brne
      • Hradec Kralove, Czechia, 500 12
        • Hepato Gastroenterologie HK s.r.o.
      • Klatovy, Czechia, 339 01
        • GASTRO JeKa s.r.o.
      • Olomouc, Czechia, 779 00
        • PreventaMed s.r.o.
      • Ostrava-Poruba, Czechia, 708 52
        • Fakultni Nemocnice Ostrava
      • Praha, Czechia, 180 81
        • Nemocnice Na Bulovce
      • Praha, Czechia, 150 00
        • Axon Clinical s. r. o.
      • Praha, Czechia, 170 04
        • ISCARE I.V.F. a.s.
      • Pribram, Czechia, 261 01
        • Oblastni nemocnice Pribram a.s.
      • Slany, Czechia, 274 01
        • Nemocnice Slany
  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital, Gastroenheden, 54Q2
    • Nordjylland
      • Aalborg, Nordjylland, Denmark, 9000
        • Aalborg University Hospital, department of medical gastroenterology
  • Estonia
      • Tallinn, Estonia, 10617
        • West Tallinn Central Hospital
      • Tallinn, Estonia, 10117
        • Innomedica OÜ
      • Tallinn, Estonia, 13419
        • North Estonia Medical Centre Foundation
      • Tartu, Estonia, 50406
        • Tartu University Hospital
  • France
      • Grenoble, France, 38043
        • CHU Grenoble Alpes - Hopital Michallon
    • Alpes Maritimes
      • Nice Cedex 3, Alpes Maritimes, France, 06202
        • CHU Nice - Hopital de l'Archet 2
    • Côte-d'Or
      • Dijon, Côte-d'Or, France, 21079
        • CHU Dijon - Hôpital Bocage Central
    • Haute Garonne
      • Toulouse cedex 9, Haute Garonne, France, 31059
        • Hôpital Rangueil Service Gastro-entérologie et pancreatologie
    • Herault
      • Montpellier cedex 5, Herault, France, 34295
        • CHU Montpellier - Hôpital Saint Eloi
    • Ille Et Vilaine
      • Rennes, Ille Et Vilaine, France, 35033
        • CHU Pontchaillou Rennes
    • Loire Atlantique
      • Nantes, Loire Atlantique, France, 44000
        • CHU Nantes Hôtel-Dieu
    • Meurthe Et Moselle
      • Vandoeuvre les Nancy, Meurthe Et Moselle, France, 54511
        • CHRU-Nancy Brabois
    • Nord
      • Lille cedex, Nord, France, 59037
        • CHU Lille - Hôpital Claude Huriez
    • Puy De Dome
      • Clermont-Ferrand, Puy De Dome, France, 63003
        • CHU Clermont Ferrand - Hôpital d'Estaing
    • Seine Saint Denis
      • Montfermeil, Seine Saint Denis, France, 93370
        • Unite de Recherche Clinique-Urc
    • Somme
      • AMIENS cedex 1, Somme, France, 80054
        • Chu Amiens Picardie-Sit Sud
    • Val De Marne
      • Le Kremlin Bicêtre, Val De Marne, France, 94275
        • Groupement Hospitalier Sud - Hôpital Bicêtre
  • Georgia
      • Tbilisi, Georgia, 0131
        • LLC Vivamedi
      • Tbilisi, Georgia, 0172
        • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
      • Tbilisi, Georgia, 0160
        • LTD Aversi Clinic
      • Tbilisi, Georgia, 0112
        • LTD Acad. F. Todua Medical Centre, LTD. Research Institution of Clinical Medicine
      • Tbilisi, Georgia, 0112
        • LTD Israeli-Georgian Medical Research Clinic Helsicore
      • Tbilisi, Georgia, 0159
        • LTD Institute of Clinical Cardiology
      • Tbilisi, Georgia, 0160
        • JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
      • Tbilisi, Georgia, 0160
        • LTD Central University Clinic After Academic N. Kipshidze
  • Germany
      • Berlin, Germany, 10117
        • Charité Universitätsmedizin Berlin - Campus Charité Mitte
      • Berlin, Germany, 14163
        • Krankenhaus Waldfriede
      • Düsseldorf, Germany, 40489
        • Florence-Nightingale-Krankenhaus
      • Neuss, Germany, 41462
        • Johanna Etienne Krankenhaus
      • Schwerin, Germany, 19055
        • Klinische Forschung Schwerin GmbH
    • Nordrhein Westfalen
      • Remscheid, Nordrhein Westfalen, Germany, 42859
        • Praxis Dr. Joergensen
    • Rheinland Pfalz
      • Bonn, Rheinland Pfalz, Germany, 53123
        • Schwerpunktpraxis Bonn
    • Schleswig Holstein
      • Kiel, Schleswig Holstein, Germany, 24105
        • Clinic for Internal Medicine I, University hospital Schleswig-Holstein, Campus Kiel
  • Hungary
      • Balatonfured, Hungary, 8230
        • DRC Gyogyszervizsgalo Kozpont Kft.
      • Bekescsaba, Hungary, 5600
        • Bekes Megyei Kozpont Korhaz Dr Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia
      • Budapest, Hungary, 1136
        • Pannónia Magánorvosi Centrum
      • Budapest, Hungary, 1036
        • Obudai Egeszsegugyi Centrum Kft.
      • Budapest, Hungary, 1054
        • Endoexpert Egeszsegugyi Szolgaltato Kft
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem, II.sz. Belgyogyaszati Klinika
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika -Gasztroenterologia
      • Gyongyos, Hungary, 3200
        • Bugát Pál Kórház
      • Szeged, Hungary, 6720
        • SZTE AOK I.st dept. of Internal Medicine.
      • Szekesfehervar, Hungary, 8000
        • Dept of Gastroenterology, Szent Gyorgy Hospital
      • Szekszard, Hungary, 7100
        • Clinfan Ltd. Outpatient Clinic
      • Tatabanya, Hungary, 2800
        • Szent Borbala Korhaz
  • India
    • Gujarat
      • Surat, Gujarat, India, 395002
        • Surat Institute of Digestive Sciences
      • Surat, Gujarat, India, 395002
        • Nirmal Hospitals Pvt Ltd
    • Haryana
      • Gurgaon, Haryana, India, 122002
        • Fortis Memorial Research Institute
    • Kerala
      • Kochi, Kerala, India, 682027
        • All India Institute of Medical Sciences
      • Kochi, Kerala, India, 682027
        • Aster Medcity,Aster DM healthcare Ltd
    • Maharashtra
      • Nagpur, Maharashtra, India, 440010
        • Midas Multispeciality Hospital Pvt.Ltd.
      • Nagpur, Maharashtra, India, 440009
        • Government Medical College and Super Speciality Hospital
      • Pune, Maharashtra, India, 411001
        • Ruby Hall Clinic
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
        • Shweta Paliwal/Vipin Kumar Jain
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208002
        • Postgraduate department of Medicine, GSVM Medical college
  • Israel
      • Afula, Israel, 1834111
        • HaEmek Medical Center
      • Haifa, Israel, 3339419
        • Bnei Zion Medical Center
      • Holon, Israel, 5810001
        • Wolfson Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah University Hospital - Ein Kerem
      • Nahariya, Israel, 2210001
        • Galilee Medical Center
      • Petach Tikva, Israel, 4941492
        • Rabin Medical Center-Beilinson Campus
      • Ramat Gan, Israel, 5262000
        • Chaim Sheba Medical Center
      • Rehovot, Israel, 7610001
        • Kaplan Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Catania, Italy, 95126
        • Azienda Ospedaliera Ospedale Cannizzaro
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliero Universitaria Mater Domini
      • Firenze, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Modena, Italy, 41124
        • A.O.U. Policlinico di Modena
      • Roma, Italy, 00157
        • Ospedale Sandro Pertini
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD
      • Torino, Italy, 10128
        • A.O. Ordine Mauriziano di Torino - P.O. Ospedale Umberto I
      • Verona, Italy, 37134
        • Centro Ricerche Cliniche Di Verona
      • Vicenza, Italy, 36100
        • Ospedale San Bortolo di Vicenza
    • Bari
      • Castellana Grotte, Bari, Italy, 70013
        • Azienda Ospedaliera Saverio De Bellis
    • Milano
      • Rho, Milano, Italy, 20017
        • Ospedale Di Circolo
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas
      • San Donato Milanese, Milano, Italy, 20097
        • I.R.C.C.S Policlinico San Donato
    • Verona
      • Negrar, Verona, Italy, 37024
        • Ospedale Sacro Cuore Don Calabria
  • Japan
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 457-8511
        • Koujunkai Daido Clinic
      • Nagoya-shi, Aichi, Japan, 467-8602
        • Nagoya City University Hospital
      • Toyohashi-shi, Aichi, Japan, 441-8570
        • Toyohashi Municipal Hospital
    • Aomori
      • Hirosaki-shi, Aomori, Japan, 036-8545
        • NHO Hirosaki National Hospital
    • Aomori-ken
      • Hirosaki-shi, Aomori-ken, Japan, 036-8563
        • Hirosaki University Hospital
    • Chiba
      • Kashiwa-city, Chiba, Japan, 277-0871
        • Tsujinaka Hospital Kashiwanoha
    • Ehime
      • Matsuyama-shi, Ehime, Japan, 791-8026
        • Saiseikai Matsuyama Hospital
      • Toon-shi, Ehime, Japan, 791-0295
        • Ehime University Hospital
    • Fukuoka
      • Kasuga, Fukuoka, Japan, 816-0864
        • Fukuoka Tokushukai Hospital
      • Kitakyushu-shi, Fukuoka, Japan, 806-8501
        • JCHO Kyushu Hospital
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital
    • Fukushima
      • Fukushima-shi, Fukushima, Japan, 960-1247
        • Fukushima Medical University Hospital
    • Gifu
      • Gifu-shi, Gifu, Japan, 501-1194
        • Gifu University Hospital
      • Ogaki-shi, Gifu, Japan, 503-8502
        • Ogaki Municipal Hospital
    • Gunma
      • Ota-shi, Gunma, Japan, 373-8585
        • SUBARU Health Insurance Society Ota Memorial Hospital
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Hiroshima-shi, Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital
    • Hiroshima-Ken
      • Fukuyama-shi, Hiroshima-Ken, Japan, 720-8520
        • NHO Fukuyama Medical Center
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 070-8610
        • Asahikawa City Hospital
      • Sapporo-shi, Hokkaido, Japan, 004-0041
        • Tokushukai Sapporo Tokushukai Hospital
      • Sapporo-shi, Hokkaido, Japan, 060-0033
        • Sapporo-Kosei General Hospital
    • Ibaraki
      • Higashi, Ibaraki, Japan, 311-3193
        • NHO Mito Medical Center
      • Koga-shi, Ibaraki, Japan, 306-0232
        • Yuai Memorial Hospital
      • Tsuchiura-shi, Ibaraki, Japan, 300-0028
        • Tsuchiura Kyodo General Hospital
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8650
        • NHO Kanazawa Medical Center
    • Iwate
      • Morioka-shi, Iwate, Japan, 020-8505
        • Iwate Medical University Uchimaru Medical Center
    • Kagawa
      • Takamatsu-shi, Kagawa, Japan, 760-0017
        • Takamatsu Red Cross Hospital
      • Takamatsu-shi, Kagawa, Japan, 760-8557
        • Kagawa Prefectural Central Hospital
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 892-0846
        • Sameshima Hospital
      • Kagoshima-shi, Kagoshima, Japan, 892-0824
        • Jiaikai Izuro Imamura Hospital
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan, 252-5188
        • Sagamihara Kyodo Hospital
      • Yokohama-shi, Kanagawa, Japan, 245-8575
        • NHO Yokohama Medical Center
    • Kanagawa-Ken
      • Kamakura-shi, Kanagawa-Ken, Japan, 247-0056
        • Gokeikai Ofuna Chuo Hospital
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 861-8520
        • Japanese Red Cross Kumamoto Hospital
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 612-8555
        • NHO Kyoto medical center
    • Mie
      • Yokkaichi-City, Mie, Japan, 510-8561
        • Mie Prefectural General Medical Center
    • Mie-Ken
      • Tsu-shi, Mie-Ken, Japan, 514-8507
        • Mie University Hospital
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
      • Sendai-shi, Miyagi, Japan, 981-8563
        • JOHAS Tohoku Rosai Hospital
      • Sendai-shi, Miyagi, Japan, 982-8502
        • Sendai City Hospital
    • Nara
      • Kashihara-city, Nara, Japan, 634-8522
        • Nara Medical University Hospital
    • Niigata
      • Niigata-shi, Niigata, Japan, 950-1104
        • Saiseikai Niigata Hospital
    • Osaka
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital
      • Kishiwada-shi, Osaka, Japan, 596-8522
        • Tokushukai Kishiwada Tokushukai Hospital
      • Osaka-shi, Osaka, Japan, 545-8586
        • Osaka City University Hospital
      • Osaka-shi, Osaka, Japan, 553-0003
        • Japan Community Health care Organization Osaka Hospital
      • Takatsuki-shi, Osaka, Japan, 569-8686
        • Osaka Medical College Hospital
    • Saga-ken
      • Saga-shi, Saga-ken, Japan, 849-8501
        • Saga University Hospital
    • Saitama-Ken
      • Saitama-shi, Saitama-Ken, Japan, 330-0074
        • JCHO Saitama Medical Center
    • Shiga-ken
      • Otsu-shi, Shiga-ken, Japan, 520-2192
        • Shiga University Of Medical Science Hospital
    • Tokyo
      • Chuo -ku, Tokyo, Japan, 104-8560
        • St. Luke's International Hospital
      • Itabashi-ku, Tokyo, Japan, 173-8606
        • Teikyo University Hospital
      • Kodaira-shi, Tokyo, Japan, 187-0002
        • Showa General Hospital
      • Minato-ku, Tokyo, Japan, 105-8471
        • Jikei University Hospital
      • Minato-ku, Tokyo, Japan, 108-8642
        • Kitasato University Kitasato Institute Hospital
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • NTT Medical Center Tokyo
      • Shinjuku-ku, Tokyo, Japan, 169-0073
        • JCHO Tokyo Yamate Medical Center
    • Toyama
      • Toyama-shi, Toyama, Japan, 930-8550
        • Toyama Prefectural Central Hospital
    • Wakayama-ken
      • Wakayama-shi, Wakayama-ken, Japan, 641-8510
        • Wakayama Medical University Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
    • Daegu
      • Junggu, Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital
    • Gangwon-do
      • Wonju, Gangwon-do, Korea, Republic of, 26426
        • Yonsei University Wonju Severance Christian Hospital
    • Gyeonggi-do
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
        • The Catholic University of Korea St. Vincent's Hospital
    • Seodaemun-gu
      • Seoul, Seodaemun-gu, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
  • Lebanon
      • Beirut, Lebanon, 16-6830
        • Hotel Dieu de France Hospital
      • Beirut, Lebanon, 1100-2807
        • Saint George Hospital University Medical Center
      • Beirut, Lebanon, 1107-2020
        • American University of Beirut Medical Center
  • Lithuania
      • Panevezys, Lithuania, LT-35144
        • Republican Panevezys Hospital, Department of Gastroenterology
      • Vilnius, Lithuania, LT-08406
        • UAB "Inlita", Santaros Clinical Trials Centre
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology
  • Mexico
      • Chihuahua, Mexico, 31203
        • Scientia Investigacion Clinica S.C.
      • Chihuahua, Mexico, 31238
        • Hospital Angeles Chihuahua
      • Veracruz, Mexico, 91900
        • Faicic S. de R.L. de Cv
    • Guanajuato
      • Irapuato, Guanajuato, Mexico, 36650
        • Consultorio Medico, InvesclinicMX
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44130
        • Centro de Investigacion Medico Biologica Y Terapia Avanzada S.C.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64660
        • InspirePharma S. de R. L. de C.V.
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, MD-2025
        • Republican Clinical Hospital, ARENSIA Exploratory Medicine
      • Chisinau, Moldova, Republic of, MD-2025
        • Rtl Sm Srl
      • Chisinau, Moldova, Republic of, MD-2025
        • Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology
      • Chisinau, Moldova, Republic of, MD-2068
        • RTL SM SRL, Institutia Medico- Sanitara Publica Spitalul Clinic, Sectia Proctologie
  • Netherlands
      • Geleen, Netherlands, 6162 BG
        • Zuyderland Medisch Centrum - Sittard-Geleen
      • Nijmegen, Netherlands, 6525 GA
        • Radboudumc
      • Tilburg, Netherlands, 5022 GC
        • ETZ Elisabeth
  • Poland
      • Bedzin, Poland, 42-500
        • Centrum Dentystyczno-Lekarskie PROMEDICA Joanna Markiewicz
      • Białystok, Poland, 15-322
        • Gastromed Kralisz, Romatowski, Stachurska sp.j
      • Czestochowa, Poland, 42-200
        • Centrum Medyczne Pratia Czestochowa
      • Jelenia Gora, Poland, 58-500
        • Karkonoskie Centrum Badan Klinicznych Lexmedica
      • Kraków, Poland, 30-363
        • Centrum Medyczne PLEJADY
      • Kraków, Poland, 31-506
        • Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna
      • Lodz, Poland, 90-644
        • Amicare Sp. z o.o. Sp.k.
      • Lodz, Poland, 90-752
        • IP Clinic
      • Nowy Targ, Poland, 34-400
        • Allmedica Badania Kliniczne Sp. z o.o. Sp.k.
      • Oswiecim, Poland, 32-600
        • Medicome Sp. Zo.O.
      • Poznan, Poland, 60-529
        • Solumed Centrum Medyczne
      • Poznan, Poland, 60-369
        • Centrum Medyczne Grunwald
      • Rzeszow, Poland, 35-302
        • Korczowski Bartosz, Gabinet Lekarski
      • Rzeszow, Poland, 35-326
        • Centrum Medyczne Medyk
      • Sopot, Poland, 81-756
        • ENDOSKOPIA Sp.zo.o
      • Swidnica, Poland, 58-100
        • Dc-Med
      • Szczecin, Poland, 71-434
        • Twoja Przychodnia-Szczecinskie Centrum Medyczne
      • Warsaw, Poland, 00-635
        • Centrum Zdrowia MDM
      • Warsaw, Poland, 02-507
        • Centralny Szpital Kliniczny MSW w Warszawie
      • Wroclaw, Poland, 52-416
        • Centrum Medyczne Oporow
      • Wroclaw, Poland, 144-148
        • EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia - Dzial Farmacji
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Coimbra, Portugal, 3000-075
        • Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia
      • Guimarães, Portugal, 4835-044
        • Hospital da Senhora da Oliveira Guimarães
      • Lisboa, Portugal, 1500-650
        • Hospital da Luz Lisboa
      • Porto, Portugal, 4200-319
        • Centro Hospitalar de Sao Joao, EPE
      • Vila Nova de Gaia, Portugal, 4434-502
        • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E
  • Romania
      • Bucharest, Romania, 540136
        • S.C. Centrul Medical Unirea SRL
      • Bucuresti, Romania, 22328
        • Institutul Clinic Fundeni
      • Bucuresti, Romania, 10719
        • S.C MedLife SA
      • Bucuresti, Romania, 14142
        • S.C Delta Health Care S.R.L, Ponderas Academic Hospital
      • Bucuresti, Romania, 14461
        • S.C Euroclinic Hospital S.A
      • Bucuresti, Romania, 20125
        • Spitalul Clinic Colentina
      • Bucuresti, Romania, 30463
        • S.C Policlinica Ccbr S.R.L
      • Cluj-Napoca, Romania, 400006
        • Spitalul Clinic Judetean de Urgenta Cluj Napoca
      • Craiova, Romania, 200640
        • Spitalul Clinic Judetean de Urgenta Craiova
      • Oradea, Romania, 410469
        • S.C Pelican Impex S.R.L
  • Russian Federation
      • Barnaul, Russian Federation, 656043
        • LLC "Multidisciplinary Medical Clinic "Anthurium"
      • Izhevsk, Russian Federation, 664049
        • LLC "Alyans Biomedical- Ural Group"
      • Kazan, Russian Federation, 420012
        • Kazan State Medical University
      • Kemerovo, Russian Federation, 650066
        • SAIH "Kemerovo Regional Clinical Hospital"
      • Nizhniy Novgorod, Russian Federation, 603126
        • SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
      • Novosibirsk, Russian Federation, 630005
        • LLC Medicine Center SibNovoMed
      • Omsk, Russian Federation, 644024
        • CDC "Ultramed"
      • Penza, Russian Federation, 440026
        • State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"
      • Saint-Peterburg, Russian Federation, 195279
        • LLC SM-Clinic
      • Saint-Petersburg, Russian Federation, 195067
        • Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"
      • Saint-Petersburg, Russian Federation, 197022
        • FSBI of higher Education "First Saint Petersburg State Medical University n.a. I.P.Pavlov
      • Saint-Petersburg, Russian Federation, 197110
        • LLC "Gastroenterological centre Expert"
      • Samara, Russian Federation, 443011
        • Private Educational Institution of Higher Education "Medical University "REAVIZ"
      • Samara, Russian Federation, 443011
        • Irkutsk State Medical Academy of Continuing Education
      • Samara, Russian Federation, 443093
        • LLC Medical company "Hepatologist"
      • Sestroretsk, Russian Federation, 197706
        • SPb SBIH "City Hospital # 40 of Kurortnyi region"
      • Smolensk, Russian Federation, 214031
        • LLC Uromed
      • Stavropol, Russian Federation, 355017
        • Stavropol Regional Clinical Diagnostic Centre
      • Stavropol, Russian Federation, 357000
        • LLC "Polyclinic of ultrasonography 4D"
      • Yaroslavl, Russian Federation, 150030
        • City Clinical Hospital #8
  • Serbia
      • Belgrade, Serbia, 11080
        • Clinical Center Bezanijska Kosa
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center " Dr Dragisa Misovic Dedinje"
      • Belgrade, Serbia, 11000
        • Clinical Health Center Zvezdara
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac
      • Sremska Mitrovica, Serbia, 22000
        • General Hospital Sremska Mitrovica
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Fakultna nemocnica s poliklinikou F.D. Roosevelta
      • Bardejov, Slovakia, 085 01
        • Alian s.r.o
      • Nitra, Slovakia, 950 01
        • Fakultna nemocnica Nitra
      • Nitra, Slovakia, 949 01
        • KM Management spol. s r.o.
      • Presov, Slovakia, 080 01
        • Gastro I, s.r.o.
      • Sahy, Slovakia, 936 01
        • Accout Center s.r.o.
      • Zilina, Slovakia, 010 08
        • BeneDig s.r.o.
    • Presov
      • Vranov nad Toplou, Presov, Slovakia, 093 01
        • Endomed, S.R.O
  • South Africa
    • Centurion
      • Lyttelton, Centurion, South Africa, 0157
        • Johese Clinical Research: Unitas
      • Midstream, Centurion, South Africa, 1692
        • Johese Clinical Research
    • Gauteng
      • Lenasia, Gauteng, South Africa, 1827
        • Lenasia Clinical Trial Centre
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7708
        • Dr JP Wright Practice
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Spain, 08022
        • Centro Médico Teknon
      • Las Palmas, Spain, 35010
        • Hospital Universitario de Gran Canaria Dr. Negrin
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
  • Switzerland
      • Baden, Switzerland, 5404
        • Kantonsspital Baden
      • Bern, Switzerland, 3010
        • Inselspital, Gaby Saner, Gastroenterologie, Bauchzentrum
      • Bern, Switzerland, 3012
        • Berner IBD study group c/o Gastroenterologische Praxis Balsiger, Seibold &Partner
  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Pathum wan, Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital
      • Ratchathewi, Bangkok, Thailand, 10400
        • Phramongkutklao Hospital
  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University Medical Faculty
      • Ankara, Turkey, 06500
        • Gazi University Medical Faculty
      • Antalya, Turkey, 07030
        • Antalya Training and Research Hospital
      • Kocaeli, Turkey, 41380
        • Kocaeli University Research and Training Hospital
      • Trabzon, Turkey, 61100
        • Karadeniz Tecnical Uni. Med. Fac.
    • Yenimahalle/Ankara
      • Beşevler, Yenimahalle/Ankara, Turkey, 16059
        • Uludag University Medical Faculty
  • Ukraine
      • Dnipro, Ukraine, 49005
        • I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
      • Ivano-Frankivsk, Ukraine, 76018
        • Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University
      • Ivano-Frankivsk, Ukraine, 76018
        • Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council, Ga
      • Kharkiv, Ukraine, 61037
        • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
      • Kharkiv, Ukraine, 61058
        • Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
      • Kharkiv, Ukraine, 61124
        • Communal Non-commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council
      • Kherson, Ukraine, 73000
        • Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City
      • Kremenchuk, Ukraine, 39617
        • Kremenchuk first city hospital n.a. O.T. Bohaievskyi
      • Kyiv, Ukraine, 01030
        • Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
      • Kyiv, Ukraine, 02091
        • Kyiv City Clinical Hospital N 1
      • Lviv, Ukraine, 79059
        • Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care
      • Odesa, Ukraine, 65025
        • Odesa regional clinical hospital, regional center of gastroenterology, surgical department
      • Uzhgorod, Ukraine, 88000
        • A. Novak Transcarpathian Regional Clinical Hospital
      • Vinnytsia, Ukraine, 21018
        • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
      • Vinnytsia, Ukraine, 21009
        • Medical Clinical Investigational Center of Medical Center Health Clinic LLC
      • Vinnytsia, Ukraine, 21029
        • SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, E11 1NR
        • Whipps Cross University Hospital
      • London, Greater London, United Kingdom, SE1 9RT
        • Guy's and Saint Thomas NHS Foundation Trust
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UQ
        • Norfolk and Norwich University Hospital
    • Somerset
      • Yeovil, Somerset, United Kingdom, BA21 4AT
        • Yeovil District Hospital
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists of the Southeast
      • Mobile, Alabama, United States, 36606
        • East View Medical Research, LLC
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Arizona Digestive Health
    • California
      • Lancaster, California, United States, 93534
        • Om Research, LLC
      • Los Angeles, California, United States, 90036
        • Entertainment Medical Group, Inc.
      • Murrieta, California, United States, 92563
        • United Medical Doctors
      • San Diego, California, United States, 92119
        • ACRC Studies,LLC
      • Torrance, California, United States, 90505
        • Paradigm Clinical Research Institute
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Colorado Springs, Colorado, United States, 80920
        • Peak Gastroenterology Associates
    • Florida
      • Clearwater, Florida, United States, 33761
        • Gastro Florida
      • Clearwater, Florida, United States, 33762
        • Gastro Florida
      • Largo, Florida, United States, 33777
        • Florida Center for Gastroenterology
      • Miami, Florida, United States, 33155
        • Global Life Research Network, Llc
      • Miami Lakes, Florida, United States, 33014
        • Life Medical Center & Research, Inc
      • Naples, Florida, United States, 34102
        • Gastroenterology Group of Naples
      • New Smyrna Beach, Florida, United States, 32168
        • NSB Research
      • Orlando, Florida, United States, 32825
        • Pediatric & Adult Research Center
      • Palmetto Bay, Florida, United States, 33157
        • IMIC, Inc.
      • Port Orange, Florida, United States, 32127
        • Advanced Medical Research Center
      • Saint Petersburg, Florida, United States, 33709
        • Theia Clinical Research, LLC
      • Sweetwater, Florida, United States, 33172
        • Lenus Research & Medical Group, LLC
      • Tampa, Florida, United States, 33614
        • Guardian Angel Research Center
      • Tampa, Florida, United States, 33606
        • USF Department of Surgery
      • Tampa, Florida, United States, 33609
        • GCP Clinical Research
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, P.A.
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Associates
      • Atlanta, Georgia, United States, 30342
        • Children's Center for Digestive Health Care, LLC
      • Decatur, Georgia, United States, 30033
        • Atlanta Center for Gastroenterology, P.C.
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Gurnee, Illinois, United States, 60031
        • Illinois Gastroenterology Group
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Texas Digestive Disease Consultants
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
      • Columbia, Maryland, United States, 21045
        • Gastro Center of Maryland
    • Michigan
      • Wyoming, Michigan, United States, 49519
        • West Michigan Clinical Research Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Sierra Clinical Research
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Medical Research
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Mentor, Ohio, United States, 44060
        • Great Lakes Medical Research, LLC - Mentor
      • Poland, Ohio, United States, 44514
        • Care Access Research
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Great Lakes Medical Research, LLC - Harrisburg
    • Tennessee
      • Kingsport, Tennessee, United States, 37663
        • Tri-Cities Gastroenterology
      • Knoxville, Tennessee, United States, 37916
        • GI for Kids
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute, LLC
      • Austin, Texas, United States, 78712
        • The University of Texas at Austin Dell Medical School
      • Cypress, Texas, United States, 77429
        • Texas Gastroenterology Associates, PA
      • Dallas, Texas, United States, 76092
        • Texas Digestive Disease Consultants - Dallas
      • Garland, Texas, United States, 75044
        • DHAT Research Institute
      • Houston, Texas, United States, 77030
        • Baylor Gastroenterology Assoc
      • McAllen, Texas, United States, 78503
        • Rio Grande Gastroenterology
      • San Marcos, Texas, United States, 78130
        • Texas Digestive Disease Consultants - San Marcos
      • Tyler, Texas, United States, 75701
        • Tyler Research Institute, LLC
      • Victoria, Texas, United States, 77904
        • Victoria Gastroenterology
    • Utah
      • Ogden, Utah, United States, 84403
        • Care Access Research LLC
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Blue Ridge Medical Research
    • Washington
      • Bellevue, Washington, United States, 98004
        • Washington Gastroenterology
      • Seattle, Washington, United States, 98101
        • Virginia Mason
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Marshall University Department of Clinical Research
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226-0509
        • Medical College of Wisconsin Clinical Trials Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 12-Week Induction Treatment Period
Experimental: Etrasimod 2 mg
Drug: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 12-Week Induction Treatment Period
Other Names:
  • APD334

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Clinical Remission
Time Frame: 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 electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Endoscopic Improvement
Time Frame: 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); higher score indicated more severe disease.
Week 12
Percentage of Participants Achieving Symptomatic Remission
Time Frame: Week 12
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.
Week 12
Percentage of Participants With Mucosal Healing
Time Frame: Week 12
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.
Week 12
Percentage of Participants Achieving Clinical Response
Time Frame: 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 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.
Week 12
Percentage of Participants Achieving Endoscopic Normalization
Time Frame: 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); higher score indicated more severe disease.
Week 12
Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8
Time Frame: 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.
Weeks 2, 4 and 8
Percentage of Participants Achieving Complete Symptomatic Remission
Time Frame: Weeks 2, 4, 8 and 12
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.
Weeks 2, 4, 8 and 12
Percentage of Participants Achieving Non-invasive Clinical Response
Time Frame: Weeks 2, 4, 8 and 12
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.
Weeks 2, 4, 8 and 12
Percentage of Participants Achieving Symptomatic Response
Time Frame: Weeks 2, 4, 8 and 12
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.
Weeks 2, 4, 8 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arena Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

December 7, 2021

Study Completion (Actual)

December 7, 2021

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

June 21, 2019

First Posted (Actual)

June 24, 2019

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APD334-302
  • 2018-003986-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulcerative Colitis

Clinical Trials on Etrasimod

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe