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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03996369
Other study ID # APD334-302
Secondary ID 2018-003986-33
Status Completed
Phase Phase 3
First received
Last updated
Start date September 15, 2020
Est. completion date December 7, 2021

Study information

Verified date January 2022
Source Arena Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


Recruitment information / eligibility

Status Completed
Enrollment 354
Est. completion date December 7, 2021
Est. primary completion date December 7, 2021
Accepts healthy volunteers No
Gender All
Age group 16 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 12-Week Induction Treatment Period
Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 12-Week Induction Treatment Period

Locations

Country Name City State
Argentina Clinica Adventista Belgrano Caba Buenos Aires
Argentina Fundación Respirar- Centro Médico Dra. De Salvo Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Mautalen Salud e Investigacion Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Instituto de Investigaciones Clínicas Quilmes SRL Quilmes Buenos Aires
Argentina CICE Sanatorio 9 de Julio San Miguel de Tucuman Tucuman
Australia Bankstown-Lidcombe Hospital Bankstown New South Wales
Australia Footscray Hospital Footscray Victoria
Australia Austin Health Heidelberg Victoria
Australia Nepean Hospital Kingswood New South Wales
Australia Liverpool Hospital Liverpool
Australia Coastal Digestive Health Maroochydore Queensland
Australia Alfred Hospital Melbourne
Australia Coral Sea Clinical Research Institute North Mackay Queensland
Australia Royal Melbourne Hospital Parkville Victoria
Austria Lkh Univ. Klinikum Graz Graz
Austria KH der Barmherzigen Brüder Linz, Interne Abteilung Linz
Austria AKH - Medizinische Universität Wien Wien
Belarus Institution "Gomel Regional Clinical Hospital" Gomel
Belarus Grodno City Clinical Hospital #4 Grodno
Belarus Vitebsk Regional Clinical Hospital Vitebsk
Belarus Vitebsk Regional Clinical Specialized Center Vitebsk
Belgium Dr. Peter Bossuyt - GI Clinical Research Center Bonheiden
Belgium University Hospital Antwerp Gastroenterology and Hepatology Department Edegem Antwerp
Belgium AZ Sint-Lucas & Volkskliniek Gent
Belgium UZ Gent - Gastroenterology Gent
Belgium UZ Leuven Campus Gasthuisberg Leuven
Belgium AZ Sint-Maarten Mechelen
Belgium ZNA Jan Palfijn Merksem
Belgium AZ Delta Roeselare
Bulgaria UMHAT "Sv. Georgi", EAD Plovdiv
Bulgaria UMHAT Kanev AD, Ruse Ruse
Bulgaria Diagnostic-Consultative Center I - Sliven, EOOD Sliven
Bulgaria ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center Sofia
Bulgaria Acibadem City Clinic University Hospital EOOD Sofia
Bulgaria DCC "Alexandrovska", EOOD Sofia
Bulgaria Diagnostic Consultation Center CONVEX EOOD Sofia
Bulgaria UMHAT "Tsaritsa Yoanna-ISUL" EAD Sofia
Bulgaria UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center Sofia
Bulgaria Medical center "Nov Rehabilitatsionen Tsentar" EOOD Stara Zagora
Bulgaria Medical Centre MEDICA Plus OOD Veliko Tarnovo
Canada Heritage Medical Research Clinic Calgary Alberta
Canada LHSC - University Hospital London Ontario
Chile Biomedica Research Group Santiago
Chile Enroll SpA Santiago
Chile Hospital Sotero del Rio Santiago
Chile Centro de Investigación del Maule SPA Talca
Chile Clinical Research Chile SpA Valdivia
Colombia Hospital San Juan de Dios Fundacion Cardiomet-Cequin Armenia Quindio
Colombia Clínica de la Costa Ltda. Barranquilla Atlantico
Colombia Clinica de la Mujer Centro de Investigaciones Bogota Cundinamarca
Colombia Clinica farallones centro de investigaciones clinicas CIC Cali Valle Del Cauca
Croatia General Hospital "Dr. Tomislav Bardek" Koprivnica Koprivnica
Croatia Clinical Hospital Centre Osijek Osijek
Croatia General Hospital Zadar Zadar
Croatia Clinical Hospital Sveti Duh Zagreb
Croatia University hospital centre Zagreb Zagreb
Czechia Fakultni nemocnice u svate Anny v Brne Brno
Czechia Hepato Gastroenterologie HK s.r.o. Hradec Kralove
Czechia GASTRO JeKa s.r.o. Klatovy
Czechia PreventaMed s.r.o. Olomouc
Czechia Fakultni nemocnice Ostrava Ostrava-Poruba
Czechia Axon Clinical s. r. o. Praha
Czechia ISCARE I.V.F. a.s. Praha
Czechia Nemocnice Na Bulovce Praha
Czechia Oblastni nemocnice Pribram a.s. Pribram
Czechia Nemocnice Slany Slany
Denmark Aalborg University Hospital, department of medical gastroenterology Aalborg Nordjylland
Denmark Herlev Hospital, Gastroenheden, 54Q2 Herlev
Estonia Innomedica OÜ Tallinn
Estonia North Estonia Medical Centre Foundation Tallinn
Estonia West Tallinn Central Hospital Tallinn
Estonia Tartu University Hospital Tartu
France Chu Amiens Picardie-Sit Sud AMIENS cedex 1 Somme
France CHU Clermont Ferrand - Hôpital d'Estaing Clermont-Ferrand Puy De Dome
France CHU Dijon - Hôpital Bocage Central Dijon Côte-d'Or
France CHU Grenoble Alpes - Hôpital Michallon Grenoble
France Groupement Hospitalier Sud - Hôpital Bicêtre Le Kremlin Bicêtre Val De Marne
France CHU Lille - Hôpital Claude Huriez Lille cedex Nord
France Unite de Recherche Clinique-Urc Montfermeil Seine Saint Denis
France CHU Montpellier - Hopital Saint Eloi Montpellier cedex 5 Herault
France CHU Nantes Hôtel-Dieu Nantes Loire Atlantique
France CHU Nice - Hôpital de l'Archet 2 Nice Cedex 3 Alpes Maritimes
France Chu Pontchaillou Rennes Rennes Ille Et Vilaine
France Hôpital Rangueil Service Gastro-entérologie et pancreatologie Toulouse cedex 9 Haute Garonne
France CHRU-Nancy Brabois Vandoeuvre les Nancy Meurthe Et Moselle
Georgia JSC Infectious Diseases, AIDS and Clinical Immunology Research Center Tbilisi
Georgia LLC Vivamedi Tbilisi
Georgia LTD Acad. F. Todua Medical Centre, LTD. Research Institution of Clinical Medicine Tbilisi
Georgia LTD Aversi Clinic Tbilisi
Georgia LTD Central University Clinic After Academic N. Kipshidze Tbilisi
Georgia LTD Institute of Clinical Cardiology Tbilisi
Georgia LTD Israeli-Georgian medical research clinic Helsicore Tbilisi
Georgia Malkhaz Katsiashvili Multiprofile Emergency Medicine Center Tbilisi
Germany Charité Universitätsmedizin Berlin - Campus Charité Mitte Berlin
Germany Krankenhaus Waldfriede Berlin
Germany Schwerpunktpraxis Bonn Bonn Rheinland Pfalz
Germany Florence-Nightingale-Krankenhaus Düsseldorf
Germany Clinic for Internal Medicine I, University hospital Schleswig-Holstein, Campus Kiel Kiel Schleswig Holstein
Germany Johanna Etienne Krankenhaus Neuss
Germany Praxis Dr. Joergensen Remscheid Nordrhein Westfalen
Germany Klinische Forschung Schwerin GmbH Schwerin
Hungary DRC Gyogyszervizsgalo Kozpont Kft. Balatonfured
Hungary Bekes Megyei Kozpont Korhaz Dr Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia Bekescsaba
Hungary Endoexpert Egeszsegugyi Szolgaltato Kft Budapest
Hungary Obudai Egeszsegugyi Centrum Kft. Budapest
Hungary Pannonia Maganorvosi Centrum Budapest
Hungary Semmelweis Egyetem, II.sz. Belgyogyaszati Klinika Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika -Gasztroenterologia Debrecen
Hungary Bugat Pal Korhaz Gyongyos
Hungary SZTE AOK I.st dept. of Internal Medicine. Szeged
Hungary Dept of Gastroenterology, Szent Gyorgy Hospital Szekesfehervar
Hungary Clinfan Ltd. Outpatient Clinic Szekszard
Hungary Szent Borbala Korhaz Tatabanya
India Fortis Memorial Research Institute Gurgaon Haryana
India Shweta Paliwal/Vipin Kumar Jain Jaipur Rajasthan
India Postgraduate department of Medicine, GSVM Medical college Kanpur Uttar Pradesh
India All India Institute of Medical Sciences Kochi Kerala
India Aster Medcity,Aster DM healthcare Ltd Kochi Kerala
India Government Medical College and Super Speciality Hospital Nagpur Maharashtra
India Midas Multispeciality Hospital Pvt.Ltd. Nagpur Maharashtra
India Ruby Hall Clinic Pune Maharashtra
India Nirmal Hospitals Pvt Ltd Surat Gujarat
India Surat Institute of Digestive Sciences Surat Gujarat
Israel HaEmek Medical Center Afula
Israel Bnei Zion Medical Center Haifa
Israel Wolfson Medical Center Holon
Israel Hadassah University Hospital - Ein Kerem Jerusalem
Israel Shaare Zedek Medical Center Jerusalem
Israel Galilee Medical Center Nahariya
Israel Rabin Medical Center-Beilinson Campus Petach Tikva
Israel Chaim Sheba Medical Center Ramat Gan
Israel Kaplan Medical Center Rehovot
Italy Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Bologna
Italy Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Brescia
Italy Azienda Ospedaliera Saverio De Bellis Castellana Grotte Bari
Italy Azienda Ospedaliera Ospedale Cannizzaro Catania
Italy Azienda Ospedaliero Universitaria Mater Domini Catanzaro
Italy Azienda Ospedaliera Universitaria Careggi Firenze
Italy A.O.U. Policlinico di Modena Modena
Italy Ospedale Sacro Cuore Don Calabria Negrar Verona
Italy Ospedale di Circolo Rho Milano
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD Roma
Italy Ospedale Sandro Pertini Roma
Italy Istituto Clinico Humanitas Rozzano Milano
Italy I.R.C.C.S Policlinico San Donato San Donato Milanese Milano
Italy A.O. Ordine Mauriziano di Torino - P.O. Ospedale Umberto I Torino
Italy Centro Ricerche Cliniche di Verona Verona
Italy Ospedale San Bortolo di Vicenza Vicenza
Japan Asahikawa City Hospital Asahikawa-shi Hokkaido
Japan St. Luke's International Hospital Chuo -ku Tokyo
Japan Fukuoka University Hospital Fukuoka
Japan Fukushima Medical University Hospital Fukushima-shi Fukushima
Japan NHO Fukuyama Medical Center Fukuyama-shi Hiroshima-Ken
Japan Gifu University Hospital Gifu-shi Gifu
Japan NHO Mito Medical Center Higashi Ibaraki
Japan Kansai Medical University Hospital Hirakata-shi Osaka
Japan Hirosaki University Hospital Hirosaki-shi Aomori-ken
Japan NHO Hirosaki National Hospital Hirosaki-shi Aomori
Japan Hiroshima City Hiroshima Citizens Hospital Hiroshima-shi Hiroshima
Japan Hiroshima University Hospital Hiroshima-shi Hiroshima
Japan Teikyo University Hospital Itabashi-ku Tokyo
Japan Jiaikai Izuro Imamura Hospital Kagoshima-shi Kagoshima
Japan Sameshima Hospital Kagoshima-shi Kagoshima
Japan Gokeikai Ofuna Chuo Hospital Kamakura-shi Kanagawa-Ken
Japan NHO Kanazawa Medical Center Kanazawa Ishikawa
Japan Nara Medical University Hospital Kashihara-city Nara
Japan Tsujinaka Hospital Kashiwanoha Kashiwa-city Chiba
Japan Fukuoka Tokushukai Hospital Kasuga Fukuoka
Japan Tokushukai Kishiwada Tokushukai Hospital Kishiwada-shi Osaka
Japan JCHO Kyushu Hospital Kitakyushu-shi Fukuoka
Japan Showa General Hospital Kodaira-shi Tokyo
Japan Yuai Memorial Hospital Koga-shi Ibaraki
Japan Japanese Red Cross Kumamoto Hospital Kumamoto-shi Kumamoto
Japan Kurume University Hospital Kurume-shi Fukuoka
Japan NHO Kyoto Medical Center Kyoto-shi Kyoto
Japan Saiseikai Matsuyama Hospital Matsuyama-shi Ehime
Japan Jikei University Hospital Minato-ku Tokyo
Japan Kitasato University Kitasato Institute Hospital Minato-ku Tokyo
Japan Iwate Medical University Uchimaru Medical Center Morioka-shi Iwate
Japan Koujunkai Daido Clinic Nagoya Aichi
Japan Nagoya City University Hospital Nagoya-shi Aichi
Japan Saiseikai Niigata Hospital Niigata-shi Niigata
Japan Ogaki Municipal Hospital Ogaki-shi Gifu
Japan Japan Community Health care Organization Osaka Hospital Osaka-shi Osaka
Japan Osaka City University Hospital Osaka-shi Osaka
Japan SUBARU Health Insurance Society Ota Memorial Hospital Ota-shi Gunma
Japan Shiga University of Medical Science Hospital Otsu-shi Shiga-ken
Japan Saga University Hospital Saga-shi Saga-ken
Japan Sagamihara Kyodo Hospital Sagamihara-shi Kanagawa
Japan JCHO Saitama Medical Center Saitama-shi Saitama-Ken
Japan Sapporo-Kosei General Hospital Sapporo-shi Hokkaido
Japan Tokushukai Sapporo Tokushukai Hospital Sapporo-shi Hokkaido
Japan JOHAS Tohoku Rosai Hospital Sendai-shi Miyagi
Japan Sendai City Hospital Sendai-shi Miyagi
Japan Tohoku University Hospital Sendai-shi Miyagi
Japan NTT Medical Center Tokyo Shinagawa-ku Tokyo
Japan JCHO Tokyo Yamate Medical Center Shinjuku-ku Tokyo
Japan Kagawa Prefectural Central Hospital Takamatsu-shi Kagawa
Japan Takamatsu Red Cross Hospital Takamatsu-shi Kagawa
Japan Osaka Medical College Hospital Takatsuki-shi Osaka
Japan Ehime University Hospital Toon-shi Ehime
Japan Toyama Prefectural Central Hospital Toyama-shi Toyama
Japan Toyohashi Municipal Hospital Toyohashi-shi Aichi
Japan Mie University Hospital Tsu-shi Mie-Ken
Japan Tsuchiura Kyodo General Hospital Tsuchiura-shi Ibaraki
Japan Wakayama Medical University Hospital Wakayama-shi Wakayama-ken
Japan Mie Prefectural General Medical Center Yokkaichi-City Mie
Japan NHO Yokohama Medical Center Yokohama-shi Kanagawa
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Kyungpook National University Chilgok Hospital Daegu
Korea, Republic of Kyungpook National University Hospital Junggu Daegu
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul Seodaemun-gu
Korea, Republic of The Catholic University of Korea St. Vincent's Hospital Suwon-si Gyeonggi-do
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju Gangwon-do
Lebanon American University of Beirut Medical Center Beirut
Lebanon Hotel Dieu de France Hospital Beirut
Lebanon Saint George Hospital University Medical Center Beirut
Lithuania Republican Panevezys Hospital, Department of Gastroenterology Panevezys
Lithuania UAB "Inlita", Santaros Clinical Trials Centre Vilnius
Lithuania Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology Vilnius
Mexico Hospital Angeles Chihuahua Chihuahua
Mexico Scientia Investigación Clínica S.C. Chihuahua
Mexico Centro de Investigacion Medico Biologica y Terapia Avanzada s.c. Guadalajara Jalisco
Mexico Consultorio Medico, InvesclinicMX Irapuato Guanajuato
Mexico InspirePharma S. de R. L. de C.V. Monterrey Nuevo León
Mexico Faicic S. de R.L. de Cv Veracruz
Moldova, Republic of Republican Clinical Hospital, ARENSIA Exploratory Medicine Chisinau
Moldova, Republic of Rtl Sm Srl Chisinau
Moldova, Republic of RTL SM SRL, Institutia Medico- Sanitara Publica Spitalul Clinic, Sectia Proctologie Chisinau
Moldova, Republic of Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology Chisinau
Netherlands Zuyderland Medisch Centrum - Sittard-Geleen Geleen
Netherlands Radboudumc Nijmegen
Netherlands ETZ Elisabeth Tilburg
Poland Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz Bedzin
Poland Gastromed Kralisz, Romatowski, Stachurska sp.j Bialystok
Poland Centrum Medyczne Pratia Czestochowa Czestochowa
Poland Karkonoskie Centrum Badan Klinicznych Lexmedica Jelenia Gora
Poland Centrum Medyczne Plejady Kraków
Poland Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna Kraków
Poland AmiCare Sp. z O.O. Sp.K. Lodz
Poland IP Clinic Lodz
Poland Allmedica Badania Kliniczne Sp. z o.o. Sp.k. Nowy Targ
Poland Medicome Sp. Zo.O. Oswiecim
Poland Centrum Medyczne Grunwald Poznan
Poland SOLUMED Centrum Medyczne Poznan
Poland Centrum Medyczne Medyk Rzeszow
Poland Korczowski Bartosz, Gabinet Lekarski Rzeszow
Poland ENDOSKOPIA Sp.zo.o Sopot
Poland DC-MED Swidnica
Poland Twoja Przychodnia-Szczecinskie Centrum Medyczne Szczecin
Poland Centralny Szpital Kliniczny MSW w Warszawie Warsaw
Poland Centrum Zdrowia MDM Warsaw
Poland Centrum Medyczne Oporow Wroclaw
Poland EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia - Dzial Farmacji Wroclaw
Portugal Hospital de Braga Braga
Portugal Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia Coimbra
Portugal Hospital da Senhora da Oliveira Guimarães Guimarães
Portugal Hospital da Luz Lisboa Lisboa
Portugal Centro Hospitalar de São João, EPE Porto
Portugal Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E Vila Nova de Gaia
Romania S.C. Centrul Medical Unirea SRL Bucharest
Romania Institutul Clinic Fundeni Bucuresti
Romania S.C Delta Health Care S.R.L, Ponderas Academic Hospital Bucuresti
Romania S.C Euroclinic Hospital S.A Bucuresti
Romania S.C MedLife SA Bucuresti
Romania S.C Policlinica CCBR S.R.L Bucuresti
Romania Spitalul Clinic Colentina Bucuresti
Romania Spitalul Clinic Judetean de Urgenta Cluj Napoca Cluj-Napoca
Romania Spitalul Clinic Judetean de Urgenta Craiova Craiova
Romania S.C Pelican Impex S.R.L Oradea
Russian Federation LLC "Multidisciplinary Medical Clinic "Anthurium" Barnaul
Russian Federation LLC "Alyans Biomedical- Ural Group" Izhevsk
Russian Federation Kazan State Medical University Kazan
Russian Federation SAIH "Kemerovo Regional Clinical Hospital" Kemerovo
Russian Federation SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko" Nizhniy Novgorod
Russian Federation LLC Medicine Center SibNovoMed Novosibirsk
Russian Federation CDC "Ultramed" Omsk
Russian Federation State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko" Penza
Russian Federation LLC SM-Clinic Saint-Peterburg
Russian Federation Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University" Saint-Petersburg
Russian Federation FSBI of higher Education "First Saint Petersburg State Medical University n.a. I.P.Pavlov Saint-Petersburg
Russian Federation LLC "Gastroenterological centre Expert" Saint-Petersburg
Russian Federation Irkutsk State Medical Academy of Continuing Education Samara
Russian Federation LLC Medical Company "Hepatologist" Samara
Russian Federation Private Educational Institution of Higher Education "Medical University "REAVIZ" Samara
Russian Federation SPb SBIH "City Hospital # 40 of Kurortnyi region" Sestroretsk
Russian Federation LLC Uromed Smolensk
Russian Federation LLC "Polyclinic of ultrasonography 4D" Stavropol
Russian Federation Stavropol Regional Clinical Diagnostic Centre Stavropol
Russian Federation City Clinical Hospital #8 Yaroslavl
Serbia Clinical Center " Dr Dragisa Misovic Dedinje" Belgrade
Serbia Clinical Center Bezanijska Kosa Belgrade
Serbia Clinical Center of Serbia Belgrade
Serbia Clinical Health Center Zvezdara Belgrade
Serbia Clinical Center Kragujevac Kragujevac
Serbia General Hospital Sremska Mitrovica Sremska Mitrovica
Slovakia Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
Slovakia Alian S.R.O Bardejov
Slovakia Fakultna nemocnica Nitra Nitra
Slovakia KM Management spol. s r.o. Nitra
Slovakia Gastro I, s.r.o. Presov
Slovakia Accout Center s.r.o. Sahy
Slovakia Endomed, S.R.O Vranov nad Toplou Presov
Slovakia BeneDig s.r.o. Zilina
South Africa Dr JP Wright Practice Cape Town Western Cape
South Africa Lenasia Clinical Trial Centre Lenasia Gauteng
South Africa Johese Clinical Research: Unitas Lyttelton Centurion
South Africa Johese Clinical Research Midstream Centurion
Spain Hospital General Universitario de Alicante Alicante
Spain Centro Médico Teknon Barcelona
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitario de Gran Canaria Dr. Negrin Las Palmas
Spain Hospital Universitario La Paz Madrid
Switzerland Kantonsspital Baden Baden
Switzerland Berner IBD study group c/o Gastroenterologische Praxis Balsiger, Seibold &Partner Bern
Switzerland Inselspital, Gaby Saner, Gastroenterologie, Bauchzentrum Bern
Thailand Siriraj Hospital Bangkoknoi Bangkok
Thailand King Chulalongkorn Memorial Hospital Pathum wan Bangkok
Thailand Phramongkutklao Hospital Ratchathewi Bangkok
Turkey Gazi University Medical Faculty Ankara
Turkey Hacettepe University Medical Faculty Ankara
Turkey Antalya Training and Research Hospital Antalya
Turkey Uludag University Medical Faculty Besevler Yenimahalle/Ankara
Turkey Kocaeli University Research and Training Hospital Kocaeli
Turkey Karadeniz Tecnical Uni. Med. Fac. Trabzon
Ukraine I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital Dnipro
Ukraine Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University Ivano-Frankivsk
Ukraine Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council, Ga Ivano-Frankivsk
Ukraine CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC Kharkiv
Ukraine Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council Kharkiv
Ukraine Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital Kharkiv
Ukraine Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City Kherson
Ukraine Kremenchuk first city hospital n.a. O.T. Bohaievskyi Kremenchuk
Ukraine Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU Kyiv
Ukraine Kyiv City Clinical Hospital N 1 Kyiv
Ukraine Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care Lviv
Ukraine Odesa regional clinical hospital, regional center of gastroenterology, surgical department Odesa
Ukraine A. Novak Transcarpathian Regional Clinical Hospital Uzhgorod
Ukraine M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU Vinnytsia
Ukraine Medical Clinical Investigational Center of Medical Center Health Clinic LLC Vinnytsia
Ukraine SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU Vinnytsia
United Kingdom Guy's and Saint Thomas NHS Foundation Trust London Greater London
United Kingdom Whipps Cross University Hospital London Greater London
United Kingdom Norfolk and Norwich University Hospital Norwich Norfolk
United Kingdom Yeovil District Hospital Yeovil Somerset
United States Texas Clinical Research Institute, LLC Arlington Texas
United States Atlanta Gastroenterology Associates Atlanta Georgia
United States Children's Center for Digestive Health Care, LLC Atlanta Georgia
United States University of Colorado Aurora Colorado
United States The University of Texas at Austin Dell Medical School Austin Texas
United States Texas Digestive Disease Consultants Baton Rouge Louisiana
United States Washington Gastroenterology Bellevue Washington
United States Chevy Chase Clinical Research Chevy Chase Maryland
United States University of Chicago Medical Center Chicago Illinois
United States University of Cincinnati Cincinnati Ohio
United States Gastro Florida Clearwater Florida
United States Gastro Florida Clearwater Florida
United States Peak Gastroenterology Associates Colorado Springs Colorado
United States Gastro Center of Maryland Columbia Maryland
United States Texas Gastroenterology Associates, PA Cypress Texas
United States Texas Digestive Disease Consultants - Dallas Dallas Texas
United States Atlanta Center for Gastroenterology, P.C. Decatur Georgia
United States Digestive Health Specialists of the Southeast Dothan Alabama
United States Duke University Medical Center Durham North Carolina
United States DHAT Research Institute Garland Texas
United States Illinois Gastroenterology Group Gurnee Illinois
United States Great Lakes Medical Research, LLC - Harrisburg Harrisburg Pennsylvania
United States Baylor Gastroenterology Assoc Houston Texas
United States Marshall University Department of Clinical Research Huntington West Virginia
United States Tri-Cities Gastroenterology Kingsport Tennessee
United States GI for Kids Knoxville Tennessee
United States Om Research, LLC Lancaster California
United States Florida Center for Gastroenterology Largo Florida
United States Las Vegas Medical Research Las Vegas Nevada
United States Sierra Clinical Research Las Vegas Nevada
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Entertainment Medical Group, Inc. Los Angeles California
United States Blue Ridge Medical Research Lynchburg Virginia
United States Rio Grande Gastroenterology McAllen Texas
United States Great Lakes Medical Research, LLC - Mentor Mentor Ohio
United States Global Life Research Network, LLC Miami Florida
United States Life Medical Center & Research, Inc Miami Lakes Florida
United States Medical College of Wisconsin Clinical Trials Office Milwaukee Wisconsin
United States East View Medical Research, LLC Mobile Alabama
United States United Medical Doctors Murrieta California
United States Gastroenterology Group of Naples Naples Florida
United States NSB Research New Smyrna Beach Florida
United States Care Access Research LLC Ogden Utah
United States Pediatric & Adult Research Center Orlando Florida
United States IMIC, Inc. Palmetto Bay Florida
United States Care Access Research Poland Ohio
United States Advanced Medical Research Center Port Orange Florida
United States Washington University School of Medicine Saint Louis Missouri
United States Theia Clinical Research, LLC Saint Petersburg Florida
United States ACRC Studies,LLC San Diego California
United States Texas Digestive Disease Consultants - San Marcos San Marcos Texas
United States Virginia Mason Seattle Washington
United States Arizona Digestive Health Sun City Arizona
United States Lenus Research & Medical Group, LLC Sweetwater Florida
United States GCP Clinical Research Tampa Florida
United States Guardian Angel Research Center Tampa Florida
United States USF Department of Surgery Tampa Florida
United States Paradigm Clinical Research Institute Torrance California
United States Tyler Research Institute, LLC Tyler Texas
United States Victoria Gastroenterology Victoria Texas
United States West Michigan Clinical Research Center Wyoming Michigan
United States Florida Medical Clinic, P.A. Zephyrhills Florida

Sponsors (1)

Lead Sponsor Collaborator
Arena Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Bulgaria,  Canada,  Chile,  Colombia,  Croatia,  Czechia,  Denmark,  Estonia,  France,  Georgia,  Germany,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Lebanon,  Lithuania,  Mexico,  Moldova, Republic of,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Switzerland,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Achieving Clinical Remission Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. Week 12
Secondary 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. Week 12
Secondary 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. Week 12
Secondary 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. Week 12
Secondary 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. Week 12
Secondary 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. Week 12
Secondary 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. Weeks 2, 4 and 8
Secondary 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. Weeks 2, 4, 8 and 12
Secondary 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. Weeks 2, 4, 8 and 12
Secondary 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. Weeks 2, 4, 8 and 12
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