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

Ulcerative Colitis Clinical Trial

— ELEVATE UC 52  

Official title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945188
• Other study ID #: APD334-301
• Secondary ID: 2018-003985-15
• Status: Completed
• Phase: Phase 3
• Start date: June 13, 2019
• Est. completion date: February 16, 2022

Study information

• Verified date: March 2022
• Source: Arena Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 433
• Est. completion date: February 16, 2022
• Est. primary completion date: February 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion criteria:

1. Diagnosed with ulcerative colitis (UC) = 3 months prior to screening

2. Active UC confirmed by endoscopy

Exclusion criteria:

1. Severe extensive colitis

2. Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD

3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
• Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment

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	CICE Sanatorio 9 de Julio	San Miguel de Tucuman	Tucuman
Australia	Bankstown-Lidcombe Hospital	Bankstown	New South Wales
Australia	Austin Health Gastroenterology Department	Heidelberg	Victoria
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	Coastal Digestive Health Pty Ltd	Maroochydore	Queensland
Australia	Coral Sea Clinical Research Institute	North Mackay	Queensland
Australia	Royal Melbourne Hospital	Parkville	Victoria
Austria	KH der Barmherzigen Brüder Linz	Linz
Austria	AKH - Medizinische Universität Wien	Wien
Austria	Wilhelminenspital der Stadt Wien	Wien
Belarus	Institution "Gomel Regional Clinical Hospital"	Gomel
Belarus	Grodno City Clinical Hospital #4	Grodno
Belarus	Health Care Institution "10th City Clinical Hospital"	Minsk
Belarus	Vitebsk Regional Clinical Hospital	Vitebsk
Belarus	Vitebsk Regional Clinical Specialized Center	Vitebsk
Belgium	AZ Sint-Lucas & Volkskliniek	Gent
Belgium	UZ Gent Gastroenterology	Gent
Belgium	ZNA Jan Palfijn	Merksem
Belgium	AZ Delta	Roeselare
Bulgaria	Medical center Medconsult Pleven OOD	Pleven
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 "Sv. Ivan Rilski", EAD,Clinic of gastroenterology	Sofia
Bulgaria	UMHAT Tsaritsa Yoanna-ISUL EAD	Sofia
Bulgaria	UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center, next to the chimney	Sofia
Bulgaria	Medical Center Nov Rehabilitatsionen Tsentar EOOD	Stara Zagora
Canada	Mount Sinai Hospital	Toronto	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
Croatia	General Hospital "Dr.Tomislav Bardek" Koprivnica	Koprivnica
Croatia	Clinical Hospital Centre Osijek	Osijek
Croatia	General Hospital Zadar	Zadar
Croatia	Clinical Hospital Dubrava	Zagreb
Croatia	Clinical Hospital Sveti Duh	Zagreb
Croatia	Polyclinic Bonifarm	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	ISCARE I.V.F. a.s.	Praha
Czechia	Nemocnice Na Bulovce	Praha
Czechia	Nemocnice Slany	Slany
Denmark	Aalborg University Hospital, department of medical gastroenterology	Aalborg	Nordjylland
Denmark	Herlev Hospital	Herlev
Estonia	Innomedica OÜ	Tallinn
Estonia	North Estonia Medical Centre Foundation	Tallinn
Estonia	West Tallinn Central Hospital	Tallinn
France	CHU Grenoble Alpes - Hôpital Michallon	Grenoble
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	CHRU-Nancy Brabois	Vandoeuvre-lès-Nancy
Georgia	JSC Infectious Diseases, AIDS and Clinical Immunology Research Center	Tbilisi
Georgia	LLC Vivamedi	Tbilisi
Georgia	LTD Acad. F. Todua Medical Center - LTD Research Institute 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	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	Obudai Egeszsegugyi Centrum Kft.	Budapest
Hungary	Pannonia Maganorvosi Centrum	Budapest
Hungary	Bugat Pal Korhaz	Gyongyos
Hungary	SZTE AOK I.st dept. of Internal Medicine.	Szeged
Hungary	1th 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	Asian Institute of Gastroenterology	Hyderabad	Andhra Pradesh
India	Shweta Paliwal/Vipin Kumar Jain	Jaipur	Rajasthan
India	Postgraduate department of Medicine, GSVM Medical college	Kanpur	Uttar Pradesh
India	Aster Medcity,Aster DM healthcare Ltd	Kochi	Kerala
India	Midas Multispeciality Hospital-Nagpur	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	Petach Tikva
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Rehovot
Italy	Spedali Civili di Brescia, U.O. Gastroenterologia	Brescia
Italy	Azienda Ospedaliera Saverio De Bellis	Castellana Grotte	Bari
Italy	Azienda Ospedaliera Ospedale Cannizzaro	Catania
Italy	Magna Graecia University	Catanzaro
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	I.R.C.C.S Policlinico San Donato	San Donato Milanese	Milano
Italy	Ospedale San Bortolo di Vicenza	Vicenza
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	Wonju Severance Christian Hospital	Wonju	Gangwon-do
Latvia	P. Stradins Clinical University Hospital	Riga
Lebanon	Saint George University Hospital Medical Center	Beirut
Lithuania	Kaunas Clinical Hospital	Kaunas
Lithuania	Klaipeda University Hospital, Department of Gastroenterology	Klaipeda
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	InspirePharma S. de R. L. de C.V.	Monterrey	Nuevo León
Mexico	Faicic S. de R.L. de Cv	Veracruz
Moldova, Republic of	Clinical Hospital of the Ministry of Health, Labor and Social Protection	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	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	Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna	Kraków
Poland	AmiCare Sp. z O.O. Sp.K.	Lodz
Poland	IP Clinic	Lodz
Poland	Med-Gastr Przychodnia Specjalistyczna	Lodz
Poland	Allmedica Badania Kliniczne Sp. z o.o. Sp.k.	Nowy Targ
Poland	Medicenter Nowy Targ	Nowy Targ
Poland	Medicome Sp. Zo.O.	Oswiecim
Poland	Centrum Medyczne Grunwald	Poznan
Poland	SOLUMED Centrum Medyczne	Poznan
Poland	Centrum Medyczne Medyk	Rzeszow
Poland	ENDOSKOPIA Sp.zo.o	Sopot
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
Poland	Jerzy Rozciecha- Lexmedica	Wroclaw
Portugal	Hospital de Braga	Braga
Portugal	Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia	Coimbra
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	Centrul Medical Unirea srl	Bucharest
Romania	Dr. Carol Davila Central University Emergency Military Hospital	Bucharest
Romania	Delta Health Care srl	Bucuresti
Romania	Institutul Clinic Fundeni	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
Romania	Cabinet Medical Dr. Fratila S.R.L	Oradea
Romania	S.C Pelican Impex S.R.L	Oradea
Russian Federation	LLC "Multidisciplinary Medical Clinic "Anthurium"	Barnaul
Russian Federation	LLC "Alyans Biomedical- Ural Group"	Irkutsk
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	Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"	Saint Petersburg
Russian Federation	LLC "Gastroenterological centre Expert"	Saint Petersburg
Russian Federation	LLC "Medinet"	Saint Petersburg
Russian Federation	LLC SM-Clinic	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
Serbia	Clinical Center " Dr Dragisa Misovic Dedinje"	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	Banska Bystrica
Slovakia	Alian S.R.O	Bardejov
Slovakia	Fakultna nemocnica Nitra	Nitra
Slovakia	KM Management spol. s r.o.	Nitra
Slovakia	GASTROENTEROLOG, s.r.o.	Nove Zamky
Slovakia	Gastro I, s.r.o.	Presov
Slovakia	Accout Center s.r.o.	Sahy
Slovakia	ENDOMED, s.r.o.	Vranov nad Toplou	Presov
South Africa	Dr JP Wright Practice	Cape Town	Western Cape
South Africa	Lenasia Clinical Trial Centre	Johannesburg	Gauteng
South Africa	Johese Clinical Research: Unitas	Lyttelton	Centurion
South Africa	Johese Clinical Research	Midstream	Centurion
Spain	Hospital Universitario La Paz	Madrid
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei
Thailand	Faculty of Medicine Siriraj Hospital	Bangkoknoi	Bangkok
Thailand	Ms. Arawan Larplertsakul	Chiang Mai
Thailand	Supaporn Lertkawinanan	Pathum Wan	Bangkok
Thailand	Phramongkutklao Hospital	Ratchathewi	Bangkok
Turkey	Gazi 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
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 City Clinical Hospital N 1	Kyiv
Ukraine	National Military Medical Clinical Center Main Military Clinical Hospital	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
Ukraine	Communal Institution City Clinical Hospital #6, Department of Gastroenterology	Zaporizhzhia
United Kingdom	Belfast Health and Social Care Trust Royal Victoria Hospital	Belfast
United Kingdom	West Hertfordshire Hospitals NHS Trust Hemel Hempstead General Hospital	Hemel Hempstead
United Kingdom	Barts Health NHS Trust - Whipps Cross University Hospital	London	Greater London
United Kingdom	Guys and St Thomas NHS Foundation Trust	London	Greater London
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich	Norfolk
United Kingdom	Yeovil Hospital NHS Foundation Trust	Yeovil	Somerset
United States	Texas Clinical Research Institute, LLC	Arlington	Texas
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Atlanta Gastroenterology Associates LLC	Atlanta	Georgia
United States	Texas Digestive Disease Consultants	Baton Rouge	Louisiana
United States	Coastal Medical Group	Baytown	Texas
United States	Washington Gastroenterology	Bellevue	Washington
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	University of Cincinnati	Cincinnati	Ohio
United States	Florida Center for Gastroenterology	Clearwater	Florida
United States	Gastro Florida	Clearwater	Florida
United States	West Central Gastroenterology d/b/a Gastro Florida	Clearwater	Florida
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Texas Gastroenterology Associates, PA	Cypress	Texas
United States	Texas Digestive Disease Consultants	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 GI Clinical Research Unit	Durham	North Carolina
United States	Flint Clinical Research	Flint	Michigan
United States	Gastrointestinal Associates	Flowood	Mississippi
United States	Digestive Health Associates of Texas	Garland	Texas
United States	Illinois Gastroenterology Group	Gurnee	Illinois
United States	Great Lakes Medical Research, LLC	Harrisburg	Pennsylvania
United States	CroNOLA	Houma	Louisiana
United States	Baylor Gastroenterology Assoc	Houston	Texas
United States	Biopharma Informatic, Inc. Research Center	Houston	Texas
United States	CliniCore Texas	Houston	Texas
United States	Marshall University Department of Clinical Research	Huntington	West Virginia
United States	GI for Kids	Knoxville	Tennessee
United States	Clinical Trials of SW Louisiana, LLC	Lake Charles	Louisiana
United States	Om Research, LLC	Lancaster	California
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Sierra Clinical Research	Las Vegas	Nevada
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	Ohio
United States	Clinical Trials Management, LLC	Metairie	Louisiana
United States	Javier Sobrado, MD	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	Gen1 Research	Moline	Illinois
United States	United Medical Doctors	Murrieta	California
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Office of Dr Meckstroth	Naples	Florida
United States	NSB Research	New Smyrna Beach	Florida
United States	Sarkis Clinical Trials - Parent	Ocala	Florida
United States	Digestive Disease Specialists, Inc.	Oklahoma City	Oklahoma
United States	IMIC, Inc.	Palmetto Bay	Florida
United States	Biopharma Informatic, Inc. Research Center	Pasadena	Texas
United States	Care Access Research	Poland	Ohio
United States	Advanced Medical Research Center	Port Orange	Florida
United States	Advanced Research Institute, Inc.	Saint Petersburg	Florida
United States	Theia Clinical Research, LLC	Saint Petersburg	Florida
United States	ACRC Studies, LLC	San Diego	California
United States	San Diego Gastroenterology Medical Associates	San Diego	California
United States	Texas Digestive Disease Consultants - San Marcos	San Marcos	Texas
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Arizona Digestive Health	Sun City	Arizona
United States	Lenus Research & Medical Group	Sweetwater	Florida
United States	GCP Clinical Research	Tampa	Florida
United States	Guardian Angel Research Center	Tampa	Florida
United States	USF Physicians Group	Tampa	Florida
United States	Tyler Research Institute, LLC	Tyler	Texas
United States	Victoria Gastroenterology	Victoria	Texas
United States	ASCLEPES Research Centers, P.C.	Weeki Wachee	Florida
United States	Robert Ferguson MD	West Bloomfield	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,  Croatia,  Czechia,  Denmark,  Estonia,  France,  Georgia,  Germany,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lebanon,  Lithuania,  Mexico,  Moldova, Republic of,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Clinical Remission at Week 12	Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily eDiary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline), RB subscore = 0, and ES = 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Week 12
Primary	Percentage of Participants Achieving Clinical Remission at Week 52	Clinical remission was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical remission was defined as SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline), RB subscore = 0, and ES = 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Week 52
Secondary	Percentage of Participants Achieving Endoscopic Improvement at Week 12	Endoscopic improvement was defined as an ES = 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease).	At Week 12
Secondary	Percentage of Participants Achieving Endoscopic Improvement at Week 52	Endoscopic improvement was defined as an ES = 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease).	At Week 52
Secondary	Percentage of Participants Achieving Symptomatic Remission at Week 12	Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.	At Week 12
Secondary	Percentage of Participants Achieving Symptomatic Remission at Week 52	Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.	At Week 52
Secondary	Percentage of Participants With Mucosal Healing at Week 12	Mucosal healing was defined as an ES = 1 (excluding friability) with histologic remission measured by a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.	At Week 12
Secondary	Percentage of Participants With Mucosal Healing at Week 52	Mucosal healing was defined as an ES = 1 (excluding friability) with histologic remission measured by a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.	At Week 52
Secondary	Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52	Corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline), RB subscore = 0, ES = 1 (excluding friability), and have not received corticosteroids for = 12 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Week 52
Secondary	Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52	Sustained clinical remission was defined as an SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline), RB subscore = 0, and ES = 1 (excluding friability) at both Week 12 and Week 52. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Weeks 12 and 52
Secondary	Percentage of Participants Achieving Clinical Response at Week 12	Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a = 2-point and = 30% decrease from Baseline MMS, and a = 1-point decrease from Baseline in RB subscore or an absolute RB subscore = 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Week 12
Secondary	Percentage of Participants Achieving Clinical Response at Week 52	Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a = 2-point and = 30% decrease from Baseline MMS, and a = 1-point decrease from Baseline in RB subscore or an absolute RB sub-score = 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Week 52
Secondary	Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52	Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a = 2-point and = 30% decrease from Baseline MMS, and a = 1-point decrease from Baseline in RB subscore or an absolute RB subscore = 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Weeks 12 and 52
Secondary	Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52	Mucosal healing was defined as an ES = 1 (excluding friability) with histologic remission measured by a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.	At Weeks 12 and 52
Secondary	Percentage of Participants Achieving Endoscopic Normalization at Week 12	Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).	At Week 12
Secondary	Percentage of Participants Achieving Endoscopic Normalization at Week 52	Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).	At Week 52
Secondary	Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52	Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).	At Weeks 12 and 52
Secondary	Percentage of Participants Achieving Symptomatic Remission by Study Visit	Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.	At Weeks 2, 4, 8, 16, 20, 24, 32, 40, and 48
Secondary	Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit	Complete symptomatic remission was defined as an SF subscore = 0 and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.	At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 52
Secondary	Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit	Non-invasive clinical response was defined as a = 30% decrease from Baseline in composite RB and SF subscores, and a = 1-point decrease from Baseline in RB subscore or RB subscore = 1. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.	At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Secondary	Percentage of Participants Achieving Symptomatic Response by Study Visit	Symptomatic response was defined as a = 30% decrease from Baseline in composite RB and SF subscores. The SF subscore ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0= no blood and 3= blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.	At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Secondary	Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline	Four-week corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline), RB subscore = 0, and ES = 1, and have not received corticosteroids for = 4 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Week 52
Secondary	Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12	Clinical remission and clinical response were based on the MMS which is a composite of 3 assessments: SF, RB and ES. Clinical remission was defined as an SF subscore = 0 (or = 1 with a = 1-point decrease from Baseline), RB subscore = 0, and ES = 1 (excluding friability). Clinical response was defined as a = 2-point and = 30% decrease from Baseline MMS, and a = 1-point decrease from Baseline in RB subscore or an absolute RB subscore = 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.	At Week 52