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Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (ELEVATE UC 52)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Etrasimod
Placebo
Sponsored by
Arena Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Etrasimod, APD334

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Digestive Health Specialists of the Southeast
  • Arizona Digestive Health
  • Om Research, LLC
  • Entertainment Medical Group, Inc.
  • United Medical Doctors
  • San Diego Gastroenterology Medical Associates
  • ACRC Studies, LLC
  • Peak Gastroenterology Associates
  • Gastro Florida
  • West Central Gastroenterology d/b/a Gastro Florida
  • Florida Center for Gastroenterology
  • Life Medical Center & Research, INC
  • Javier Sobrado, MD
  • Gastroenterology Group of Naples
  • Office of Dr Meckstroth
  • NSB Research
  • Sarkis Clinical Trials - Parent
  • IMIC, Inc.
  • Advanced Medical Research Center
  • Theia Clinical Research, LLC
  • Advanced Research Institute, Inc.
  • Lenus Research & Medical Group
  • USF Physicians Group
  • GCP Clinical Research
  • Guardian Angel Research Center
  • ASCLEPES Research Centers, P.C.
  • Florida Medical Clinic, P.A.
  • Atlanta Gastroenterology Associates LLC
  • Atlanta Gastroenterology Associates
  • Atlanta Center for Gastroenterology, P.C.
  • Illinois Gastroenterology Group
  • Gen1 Research
  • Texas Digestive Disease Consultants
  • CroNOLA
  • Clinical Trials of SW Louisiana, LLC
  • Clinical Trials Management, LLC
  • Chevy Chase Clinical Research
  • Flint Clinical Research
  • Robert Ferguson MD
  • Gastrointestinal Associates
  • Sierra Clinical Research
  • Las Vegas Medical Research
  • Duke University Medical Center GI Clinical Research Unit
  • University of Cincinnati
  • Great Lakes Medical Research, LLC
  • Care Access Research
  • Digestive Disease Specialists, Inc.
  • Great Lakes Medical Research, LLC
  • GI for Kids
  • Texas Clinical Research Institute, LLC
  • Coastal Medical Group
  • Texas Gastroenterology Associates, PA
  • Texas Digestive Disease Consultants
  • Digestive Health Associates of Texas
  • CliniCore Texas
  • Baylor Gastroenterology Assoc
  • Biopharma Informatic, Inc. Research Center
  • Rio Grande Gastroenterology
  • Biopharma Informatic, Inc. Research Center
  • Texas Digestive Disease Consultants - San Marcos
  • Tyler Research Institute, LLC
  • Victoria Gastroenterology
  • Blue Ridge Medical Research
  • Washington Gastroenterology
  • Virginia Mason Medical Center
  • Marshall University Department of Clinical Research
  • Medical College of Wisconsin Clinical Trials Office
  • Clinica Adventista Belgrano
  • Mautalen Salud e Investigacion
  • Fundación Respirar- Centro Médico Dra. De Salvo
  • CICE Sanatorio 9 de Julio
  • Bankstown-Lidcombe Hospital
  • Nepean Hospital
  • Coastal Digestive Health Pty Ltd
  • Coral Sea Clinical Research Institute
  • Austin Health Gastroenterology Department
  • Royal Melbourne Hospital
  • KH der Barmherzigen Brüder Linz
  • AKH - Medizinische Universität Wien
  • Wilhelminenspital der Stadt Wien
  • Institution "Gomel Regional Clinical Hospital"
  • Grodno City Clinical Hospital #4
  • Health Care Institution "10th City Clinical Hospital"
  • Vitebsk Regional Clinical Hospital
  • Vitebsk Regional Clinical Specialized Center
  • AZ Sint-Lucas & Volkskliniek
  • UZ Gent Gastroenterology
  • ZNA Jan Palfijn
  • AZ Delta
  • Medical center Medconsult Pleven OOD
  • UMHAT Kanev AD, Ruse
  • Diagnostic-Consultative Center I - Sliven, EOOD
  • ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center
  • DCC "Alexandrovska", EOOD
  • UMHAT "Sv. Ivan Rilski", EAD,Clinic of gastroenterology
  • UMHAT Tsaritsa Yoanna-ISUL EAD
  • UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center, next to the chimney
  • Diagnostic Consultation Center CONVEX EOOD
  • Acibadem City Clinic University Hospital EOOD
  • Medical Center Nov Rehabilitatsionen Tsentar EOOD
  • Mount Sinai Hospital
  • Enroll SpA
  • Biomedica Research Group
  • Hospital Sotero del Rio
  • Centro de Investigación del Maule SPA
  • Clinical Research Chile SpA
  • General Hospital "Dr.Tomislav Bardek" Koprivnica
  • Clinical Hospital Centre Osijek
  • General Hospital Zadar
  • Clinical Hospital Dubrava
  • Clinical Hospital Sveti Duh
  • Polyclinic Bonifarm
  • University hospital centre Zagreb
  • Fakultni nemocnice u svate Anny v Brne
  • Hepato-Gastroenterologie HK, s.r.o.,
  • GASTRO JeKa, s.r.o.
  • PreventaMed s.r.o.
  • Fakultni nemocnice Ostrava
  • ISCARE I.V.F. a.s.
  • Nemocnice Na Bulovce
  • Nemocnice Slany
  • Aalborg University Hospital, department of medical gastroenterology
  • Herlev Hospital
  • Innomedica OÜ
  • West Tallinn Central Hospital
  • North Estonia Medical Centre Foundation
  • CHU Nice - Hôpital de l'Archet 2
  • CHU Montpellier - HOPITAL SAINT-ELOI
  • CHU Nantes Hôtel-Dieu
  • CHU Grenoble Alpes - Hôpital Michallon
  • CHRU-Nancy Brabois
  • LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine
  • LTD Israeli-Georgian Medical Research clinic Helsicore
  • LLC Vivamedi
  • LTD Institute of Clinical Cardiology
  • JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
  • LTD Aversi Clinic
  • LTD Central University Clinic After Academic N. Kipshidze
  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
  • Praxis Dr. Joergensen
  • Schwerpunktpraxis Bonn
  • Clinic for Internal Medicine I, University hospital Schleswig-Holstein, Campus Kiel
  • Krankenhaus Waldfriede
  • Florence-Nightingale-Krankenhaus
  • Johanna Etienne Krankenhaus
  • Klinische Forschung Schwerin GmbH
  • DRC Gyogyszervizsgalo Kozpont Kft.
  • Bekes Megyei Kozpont Korhaz Dr Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia
  • Obudai Egeszsegugyi Centrum Kft.
  • Pannonia Maganorvosi Centrum
  • Bugat Pal Korhaz
  • SZTE AOK I.st dept. of Internal Medicine.
  • 1th Dept of Gastroenterology, Szent Gyorgy Hospital
  • Clinfan Ltd. Outpatient Clinic
  • Szent Borbala Korhaz
  • Asian Institute of Gastroenterology
  • Nirmal Hospitals Pvt Ltd
  • Surat Institute of Digestive Sciences
  • Fortis Memorial Research Institute
  • Aster Medcity,Aster DM healthcare Ltd
  • Midas Multispeciality Hospital-Nagpur
  • Ruby Hall Clinic
  • Shweta Paliwal/Vipin Kumar Jain
  • Postgraduate department of Medicine, GSVM Medical college
  • HaEmek Medical Center
  • Bnei Zion Medical Center
  • Wolfson Medical Center
  • Shaare Zedek Medical Center
  • Hadassah University Hospital - Ein Kerem
  • Galilee Medical Center
  • Rabin Medical Center
  • Chaim Sheba Medical Center
  • Kaplan Medical Center
  • Azienda Ospedaliera Saverio De Bellis
  • Ospedale di Circolo
  • I.R.C.C.S Policlinico San Donato
  • Ospedale Sacro Cuore Don Calabria
  • Spedali Civili di Brescia, U.O. Gastroenterologia
  • Azienda Ospedaliera Ospedale Cannizzaro
  • Magna Graecia University
  • A.O.U. Policlinico di Modena
  • Ospedale Sandro Pertini
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD
  • Ospedale San Bortolo di Vicenza
  • Kyungpook National University Hospital
  • Wonju Severance Christian Hospital
  • The Catholic University of Korea, St. Vincent's Hospital
  • Severance Hospital, Yonsei University Health System
  • Dong-A University Hospital
  • Kyungpook National University Chilgok Hospital
  • P. Stradins Clinical University Hospital
  • Saint George University Hospital Medical Center
  • Kaunas Clinical Hospital
  • Klaipeda University Hospital, Department of Gastroenterology
  • Republican Panevezys Hospital, Department of Gastroenterology
  • UAB "Inlita", Santaros Clinical Trials Centre
  • Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology
  • Centro de Investigacion Medico Biologica y Terapia Avanzada s.c.
  • InspirePharma S. de R. L. de C.V.
  • Scientia Investigación Clínica S.C.
  • Hospital Angeles Chihuahua
  • Faicic S. de R.L. de Cv
  • Clinical Hospital of the Ministry of Health, Labor and Social Protection
  • Rtl Sm Srl
  • Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology
  • RTL SM SRL, Institutia Medico-Sanitara Publica Spitalul Clinic, Sectia Proctologie
  • Zuyderland Medisch Centrum - Sittard-Geleen
  • ETZ Elisabeth
  • Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz
  • Gastromed Kralisz, Romatowski, Stachurska sp.j
  • Centrum Medyczne Pratia Czestochowa
  • Karkonoskie Centrum Badan Klinicznych Lexmedica
  • Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna
  • AmiCare Sp. z O.O. Sp.K.
  • IP Clinic
  • Med-Gastr Przychodnia Specjalistyczna
  • Allmedica Badania Kliniczne Sp. z o.o. Sp.k.
  • Medicenter Nowy Targ
  • Medicome Sp. Zo.O.
  • Centrum Medyczne Grunwald
  • SOLUMED Centrum Medyczne
  • Centrum Medyczne Medyk
  • ENDOSKOPIA Sp.zo.o
  • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Centrum Zdrowia MDM
  • Centralny Szpital Kliniczny MSW w Warszawie
  • EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia - Dzial Farmacji
  • Centrum Medyczne Oporow
  • Jerzy Rozciecha- Lexmedica
  • Hospital de Braga
  • Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia
  • Centro Hospitalar de São João, EPE
  • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
  • Dr. Carol Davila Central University Emergency Military Hospital
  • Centrul Medical Unirea srl
  • S.C Policlinica CCBR S.R.L
  • S.C MedLife SA
  • Delta Health Care srl
  • S.C Euroclinic Hospital S.A
  • Spitalul Clinic Colentina
  • Institutul Clinic Fundeni
  • Spitalul Clinic Judetean de Urgenta Cluj Napoca
  • Spitalul Clinic Judetean de Urgenta
  • Cabinet Medical Dr. Fratila S.R.L
  • S.C Pelican Impex S.R.L
  • LLC "Multidisciplinary Medical Clinic "Anthurium"
  • LLC "Alyans Biomedical- Ural Group"
  • Kazan State Medical University
  • SAIH "Kemerovo Regional Clinical Hospital
  • SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
  • LLC Medicine Center SibNovoMed
  • CDC Ultramed
  • State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"
  • LLC "Medinet"
  • Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"
  • LLC SM-Clinic
  • LLC "Gastroenterological centre Expert"
  • Irkutsk State Medical Academy of Continuing Education
  • Private Educational Institution of Higher Education "Medical University REAVIZ"
  • LLC Medical Company "Hepatologist"
  • SPb SBIH "City Hospital # 40 of Kurortnyi region"
  • LLC Uromed
  • Stavropol Regional Clinical Diagnostic Centre
  • LLC "Polyclinic of ultrasonography 4D"
  • Clinical Center " Dr Dragisa Misovic Dedinje"
  • Clinical Center of Serbia
  • Clinical Health Center Zvezdara
  • Clinical Center Kragujevac
  • General Hospital Sremska Mitrovica
  • ENDOMED, s.r.o.
  • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
  • Alian S.R.O
  • KM Management spol. s r.o.
  • Fakultna nemocnica Nitra
  • GASTROENTEROLOG, s.r.o.
  • Gastro I, s.r.o.
  • Accout Center s.r.o.
  • Johese Clinical Research: Unitas
  • Johese Clinical Research
  • Lenasia Clinical Trial Centre
  • Dr JP Wright Practice
  • Hospital Universitario La Paz
  • Taichung Veterans General Hospital
  • Taipei Veterans General Hospital
  • Faculty of Medicine Siriraj Hospital
  • Supaporn Lertkawinanan
  • Phramongkutklao Hospital
  • Ms. Arawan Larplertsakul
  • Uludag University Medical Faculty
  • Gazi University Medical Faculty
  • Antalya Training and Research Hospital
  • Kocaeli University Research and Training Hospital
  • I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
  • Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University
  • Municipal non-profit enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council", Ga
  • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
  • Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
  • Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council
  • Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City
  • Kremenchuk first city hospital n.a. O.T. Bohaievskyi
  • National Military Medical Clinical Center Main Military Clinical Hospital
  • Kyiv City Clinical Hospital N 1
  • Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care
  • Odesa regional clinical hospital, regional center of gastroenterology, surgical department
  • A. Novak Transcarpathian Regional Clinical Hospital
  • Medical Clinical Investigational Center of Medical Center Health Clinic LLC
  • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
  • SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
  • Communal Institution City Clinical Hospital #6, Department of Gastroenterology
  • Barts Health NHS Trust - Whipps Cross University Hospital
  • Guys and St Thomas NHS Foundation Trust
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
  • Yeovil Hospital NHS Foundation Trust
  • Belfast Health and Social Care Trust Royal Victoria Hospital
  • West Hertfordshire Hospitals NHS Trust Hemel Hempstead General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Etrasimod 2 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 8, 2019
Last Updated
November 28, 2022
Sponsor
Arena Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03945188
Brief Title
Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
February 8, 2022 (Actual)
Study Completion Date
February 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arena Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis, Etrasimod, APD334

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
433 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etrasimod 2 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Etrasimod
Other Intervention Name(s)
APD334
Intervention Description
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Clinical Remission at Week 12
Description
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.
Time Frame
At Week 12
Title
Percentage of Participants Achieving Clinical Remission at Week 52
Description
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.
Time Frame
At Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Endoscopic Improvement at Week 12
Description
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).
Time Frame
At Week 12
Title
Percentage of Participants Achieving Endoscopic Improvement at Week 52
Description
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).
Time Frame
At Week 52
Title
Percentage of Participants Achieving Symptomatic Remission at Week 12
Description
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.
Time Frame
At Week 12
Title
Percentage of Participants Achieving Symptomatic Remission at Week 52
Description
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.
Time Frame
At Week 52
Title
Percentage of Participants With Mucosal Healing at Week 12
Description
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.
Time Frame
At Week 12
Title
Percentage of Participants With Mucosal Healing at Week 52
Description
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.
Time Frame
At Week 52
Title
Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52
Description
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.
Time Frame
At Week 52
Title
Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52
Description
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.
Time Frame
At Weeks 12 and 52
Title
Percentage of Participants Achieving Clinical Response at Week 12
Description
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.
Time Frame
At Week 12
Title
Percentage of Participants Achieving Clinical Response at Week 52
Description
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.
Time Frame
At Week 52
Title
Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52
Description
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.
Time Frame
At Weeks 12 and 52
Title
Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52
Description
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.
Time Frame
At Weeks 12 and 52
Title
Percentage of Participants Achieving Endoscopic Normalization at Week 12
Description
Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).
Time Frame
At Week 12
Title
Percentage of Participants Achieving Endoscopic Normalization at Week 52
Description
Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).
Time Frame
At Week 52
Title
Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52
Description
Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease).
Time Frame
At Weeks 12 and 52
Title
Percentage of Participants Achieving Symptomatic Remission by Study Visit
Description
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.
Time Frame
At Weeks 2, 4, 8, 16, 20, 24, 32, 40, and 48
Title
Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit
Description
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.
Time Frame
At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 52
Title
Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit
Description
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.
Time Frame
At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Percentage of Participants Achieving Symptomatic Response by Study Visit
Description
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.
Time Frame
At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Title
Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline
Description
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.
Time Frame
At Week 52
Title
Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12
Description
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.
Time Frame
At Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arena CT.gov Administrator
Organizational Affiliation
Arena Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Digestive Health Specialists of the Southeast
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Arizona Digestive Health
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Om Research, LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Entertainment Medical Group, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
United Medical Doctors
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
San Diego Gastroenterology Medical Associates
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
ACRC Studies, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92119
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Gastro Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
West Central Gastroenterology d/b/a Gastro Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33762
Country
United States
Facility Name
Florida Center for Gastroenterology
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Life Medical Center & Research, INC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Javier Sobrado, MD
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Office of Dr Meckstroth
City
Naples
State/Province
Florida
ZIP/Postal Code
34110
Country
United States
Facility Name
NSB Research
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Sarkis Clinical Trials - Parent
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
IMIC, Inc.
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Advanced Medical Research Center
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Theia Clinical Research, LLC
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Advanced Research Institute, Inc.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Lenus Research & Medical Group
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
USF Physicians Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
GCP Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Guardian Angel Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
ASCLEPES Research Centers, P.C.
City
Weeki Wachee
State/Province
Florida
ZIP/Postal Code
34607
Country
United States
Facility Name
Florida Medical Clinic, P.A.
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Atlanta Gastroenterology Associates LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta Center for Gastroenterology, P.C.
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Illinois Gastroenterology Group
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Gen1 Research
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
CroNOLA
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Clinical Trials of SW Louisiana, LLC
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Flint Clinical Research
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Robert Ferguson MD
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48323
Country
United States
Facility Name
Gastrointestinal Associates
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Sierra Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Las Vegas Medical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Duke University Medical Center GI Clinical Research Unit
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Great Lakes Medical Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Care Access Research
City
Poland
State/Province
Ohio
ZIP/Postal Code
44514
Country
United States
Facility Name
Digestive Disease Specialists, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Great Lakes Medical Research, LLC
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
GI for Kids
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Texas Clinical Research Institute, LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Coastal Medical Group
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Texas Gastroenterology Associates, PA
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Dallas
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Digestive Health Associates of Texas
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
CliniCore Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77029
Country
United States
Facility Name
Baylor Gastroenterology Assoc
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Biopharma Informatic, Inc. Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Rio Grande Gastroenterology
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Biopharma Informatic, Inc. Research Center
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77505
Country
United States
Facility Name
Texas Digestive Disease Consultants - San Marcos
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Tyler Research Institute, LLC
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Victoria Gastroenterology
City
Victoria
State/Province
Texas
ZIP/Postal Code
77904
Country
United States
Facility Name
Blue Ridge Medical Research
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Washington Gastroenterology
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Marshall University Department of Clinical Research
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Medical College of Wisconsin Clinical Trials Office
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-0509
Country
United States
Facility Name
Clinica Adventista Belgrano
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
Mautalen Salud e Investigacion
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1128AAF
Country
Argentina
Facility Name
Fundación Respirar- Centro Médico Dra. De Salvo
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
CICE Sanatorio 9 de Julio
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Bankstown-Lidcombe Hospital
City
Bankstown
State/Province
New South Wales
ZIP/Postal Code
2200
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Coastal Digestive Health Pty Ltd
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Coral Sea Clinical Research Institute
City
North Mackay
State/Province
Queensland
ZIP/Postal Code
4740
Country
Australia
Facility Name
Austin Health Gastroenterology Department
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
KH der Barmherzigen Brüder Linz
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
AKH - Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Wilhelminenspital der Stadt Wien
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Institution "Gomel Regional Clinical Hospital"
City
Gomel
ZIP/Postal Code
246029
Country
Belarus
Facility Name
Grodno City Clinical Hospital #4
City
Grodno
ZIP/Postal Code
230026
Country
Belarus
Facility Name
Health Care Institution "10th City Clinical Hospital"
City
Minsk
ZIP/Postal Code
220096
Country
Belarus
Facility Name
Vitebsk Regional Clinical Hospital
City
Vitebsk
ZIP/Postal Code
210037
Country
Belarus
Facility Name
Vitebsk Regional Clinical Specialized Center
City
Vitebsk
ZIP/Postal Code
210604
Country
Belarus
Facility Name
AZ Sint-Lucas & Volkskliniek
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Gent Gastroenterology
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
ZNA Jan Palfijn
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
Country
Belgium
Facility Name
Medical center Medconsult Pleven OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT Kanev AD, Ruse
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Diagnostic-Consultative Center I - Sliven, EOOD
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
DCC "Alexandrovska", EOOD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT "Sv. Ivan Rilski", EAD,Clinic of gastroenterology
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT Tsaritsa Yoanna-ISUL EAD
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center, next to the chimney
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Diagnostic Consultation Center CONVEX EOOD
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Facility Name
Acibadem City Clinic University Hospital EOOD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Medical Center Nov Rehabilitatsionen Tsentar EOOD
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Enroll SpA
City
Santiago
ZIP/Postal Code
7500588
Country
Chile
Facility Name
Biomedica Research Group
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Hospital Sotero del Rio
City
Santiago
ZIP/Postal Code
8150000
Country
Chile
Facility Name
Centro de Investigación del Maule SPA
City
Talca
ZIP/Postal Code
3465586
Country
Chile
Facility Name
Clinical Research Chile SpA
City
Valdivia
ZIP/Postal Code
5090000
Country
Chile
Facility Name
General Hospital "Dr.Tomislav Bardek" Koprivnica
City
Koprivnica
ZIP/Postal Code
48000
Country
Croatia
Facility Name
Clinical Hospital Centre Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
General Hospital Zadar
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Facility Name
Clinical Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Clinical Hospital Sveti Duh
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Polyclinic Bonifarm
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University hospital centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Fakultni nemocnice u svate Anny v Brne
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK, s.r.o.,
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
GASTRO JeKa, s.r.o.
City
Klatovy
ZIP/Postal Code
339 01
Country
Czechia
Facility Name
PreventaMed s.r.o.
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
ISCARE I.V.F. a.s.
City
Praha
ZIP/Postal Code
170 04
Country
Czechia
Facility Name
Nemocnice Na Bulovce
City
Praha
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Nemocnice Slany
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Aalborg University Hospital, department of medical gastroenterology
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Innomedica OÜ
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Facility Name
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
North Estonia Medical Centre Foundation
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
CHU Nice - Hôpital de l'Archet 2
City
Nice Cedex 3
State/Province
Alpes Maritimes
ZIP/Postal Code
06202
Country
France
Facility Name
CHU Montpellier - HOPITAL SAINT-ELOI
City
Montpellier cedex 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Nantes Hôtel-Dieu
City
Nantes
State/Province
Loire Atlantique
ZIP/Postal Code
44000
Country
France
Facility Name
CHU Grenoble Alpes - Hôpital Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHRU-Nancy Brabois
City
Vandoeuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
LTD Israeli-Georgian Medical Research clinic Helsicore
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
LLC Vivamedi
City
Tbilisi
ZIP/Postal Code
0131
Country
Georgia
Facility Name
LTD Institute of Clinical Cardiology
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
LTD Aversi Clinic
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
LTD Central University Clinic After Academic N. Kipshidze
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
City
Tbilisi
ZIP/Postal Code
0172
Country
Georgia
Facility Name
Praxis Dr. Joergensen
City
Remscheid
State/Province
Nordrhein Westfalen
ZIP/Postal Code
42859
Country
Germany
Facility Name
Schwerpunktpraxis Bonn
City
Bonn
State/Province
Rheinland Pfalz
ZIP/Postal Code
53123
Country
Germany
Facility Name
Clinic for Internal Medicine I, University hospital Schleswig-Holstein, Campus Kiel
City
Kiel
State/Province
Schleswig Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Krankenhaus Waldfriede
City
Berlin
ZIP/Postal Code
14163
Country
Germany
Facility Name
Florence-Nightingale-Krankenhaus
City
Düsseldorf
ZIP/Postal Code
40489
Country
Germany
Facility Name
Johanna Etienne Krankenhaus
City
Neuss
ZIP/Postal Code
41462
Country
Germany
Facility Name
Klinische Forschung Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
DRC Gyogyszervizsgalo Kozpont Kft.
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Bekes Megyei Kozpont Korhaz Dr Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Bugat Pal Korhaz
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
SZTE AOK I.st dept. of Internal Medicine.
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
1th Dept of Gastroenterology, Szent Gyorgy Hospital
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Clinfan Ltd. Outpatient Clinic
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Szent Borbala Korhaz
City
Tatabanya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Asian Institute of Gastroenterology
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500032
Country
India
Facility Name
Nirmal Hospitals Pvt Ltd
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
Surat Institute of Digestive Sciences
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
Fortis Memorial Research Institute
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122002
Country
India
Facility Name
Aster Medcity,Aster DM healthcare Ltd
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682027
Country
India
Facility Name
Midas Multispeciality Hospital-Nagpur
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Shweta Paliwal/Vipin Kumar Jain
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302001
Country
India
Facility Name
Postgraduate department of Medicine, GSVM Medical college
City
Kanpur
State/Province
Uttar Pradesh
ZIP/Postal Code
208002
Country
India
Facility Name
HaEmek Medical Center
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Bnei Zion Medical Center
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
5810001
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah University Hospital - Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Azienda Ospedaliera Saverio De Bellis
City
Castellana Grotte
State/Province
Bari
ZIP/Postal Code
70013
Country
Italy
Facility Name
Ospedale di Circolo
City
Rho
State/Province
Milano
ZIP/Postal Code
20017
Country
Italy
Facility Name
I.R.C.C.S Policlinico San Donato
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
Facility Name
Ospedale Sacro Cuore Don Calabria
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
Facility Name
Spedali Civili di Brescia, U.O. Gastroenterologia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliera Ospedale Cannizzaro
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
Magna Graecia University
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
A.O.U. Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Ospedale Sandro Pertini
City
Roma
ZIP/Postal Code
00157
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Ospedale San Bortolo di Vicenza
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Kyungpook National University Hospital
City
Junggu
State/Province
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Wonju
State/Province
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seodaemun-gu
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
P. Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Saint George University Hospital Medical Center
City
Beirut
ZIP/Postal Code
1100 2807
Country
Lebanon
Facility Name
Kaunas Clinical Hospital
City
Kaunas
ZIP/Postal Code
LT-47144
Country
Lithuania
Facility Name
Klaipeda University Hospital, Department of Gastroenterology
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Republican Panevezys Hospital, Department of Gastroenterology
City
Panevezys
ZIP/Postal Code
LT-35144
Country
Lithuania
Facility Name
UAB "Inlita", Santaros Clinical Trials Centre
City
Vilnius
ZIP/Postal Code
LT-08406
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Centro de Investigacion Medico Biologica y Terapia Avanzada s.c.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Facility Name
InspirePharma S. de R. L. de C.V.
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64660
Country
Mexico
Facility Name
Scientia Investigación Clínica S.C.
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Facility Name
Hospital Angeles Chihuahua
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
Facility Name
Faicic S. de R.L. de Cv
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Clinical Hospital of the Ministry of Health, Labor and Social Protection
City
Chisinau
ZIP/Postal Code
MD-2005
Country
Moldova, Republic of
Facility Name
Rtl Sm Srl
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
Facility Name
Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
Facility Name
RTL SM SRL, Institutia Medico-Sanitara Publica Spitalul Clinic, Sectia Proctologie
City
Chisinau
ZIP/Postal Code
MD-2068
Country
Moldova, Republic of
Facility Name
Zuyderland Medisch Centrum - Sittard-Geleen
City
Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
ETZ Elisabeth
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz
City
Bedzin
ZIP/Postal Code
42-500
Country
Poland
Facility Name
Gastromed Kralisz, Romatowski, Stachurska sp.j
City
Białystok
ZIP/Postal Code
15-322
Country
Poland
Facility Name
Centrum Medyczne Pratia Czestochowa
City
Czestochowa
ZIP/Postal Code
42-200
Country
Poland
Facility Name
Karkonoskie Centrum Badan Klinicznych Lexmedica
City
Jelenia Gora
ZIP/Postal Code
58-500
Country
Poland
Facility Name
Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna
City
Kraków
ZIP/Postal Code
31-506
Country
Poland
Facility Name
AmiCare Sp. z O.O. Sp.K.
City
Lodz
ZIP/Postal Code
90-644
Country
Poland
Facility Name
IP Clinic
City
Lodz
ZIP/Postal Code
90-752
Country
Poland
Facility Name
Med-Gastr Przychodnia Specjalistyczna
City
Lodz
ZIP/Postal Code
91-034
Country
Poland
Facility Name
Allmedica Badania Kliniczne Sp. z o.o. Sp.k.
City
Nowy Targ
ZIP/Postal Code
34-400
Country
Poland
Facility Name
Medicenter Nowy Targ
City
Nowy Targ
ZIP/Postal Code
34-400
Country
Poland
Facility Name
Medicome Sp. Zo.O.
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Centrum Medyczne Grunwald
City
Poznan
ZIP/Postal Code
60-369
Country
Poland
Facility Name
SOLUMED Centrum Medyczne
City
Poznan
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Centrum Medyczne Medyk
City
Rzeszow
ZIP/Postal Code
35-326
Country
Poland
Facility Name
ENDOSKOPIA Sp.zo.o
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Twoja Przychodnia-Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warsaw
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSW w Warszawie
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Facility Name
EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia - Dzial Farmacji
City
Wroclaw
ZIP/Postal Code
144-148
Country
Poland
Facility Name
Centrum Medyczne Oporow
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Facility Name
Jerzy Rozciecha- Lexmedica
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar de São João, EPE
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Dr. Carol Davila Central University Emergency Military Hospital
City
Bucharest
ZIP/Postal Code
10825
Country
Romania
Facility Name
Centrul Medical Unirea srl
City
Bucharest
ZIP/Postal Code
540136
Country
Romania
Facility Name
S.C Policlinica CCBR S.R.L
City
Bucuresti
ZIP/Postal Code
030463
Country
Romania
Facility Name
S.C MedLife SA
City
Bucuresti
ZIP/Postal Code
10719
Country
Romania
Facility Name
Delta Health Care srl
City
Bucuresti
ZIP/Postal Code
14142
Country
Romania
Facility Name
S.C Euroclinic Hospital S.A
City
Bucuresti
ZIP/Postal Code
14461
Country
Romania
Facility Name
Spitalul Clinic Colentina
City
Bucuresti
ZIP/Postal Code
20125
Country
Romania
Facility Name
Institutul Clinic Fundeni
City
Bucuresti
ZIP/Postal Code
22328
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj Napoca
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta
City
Craiova
ZIP/Postal Code
200640
Country
Romania
Facility Name
Cabinet Medical Dr. Fratila S.R.L
City
Oradea
ZIP/Postal Code
410167
Country
Romania
Facility Name
S.C Pelican Impex S.R.L
City
Oradea
ZIP/Postal Code
410469
Country
Romania
Facility Name
LLC "Multidisciplinary Medical Clinic "Anthurium"
City
Barnaul
ZIP/Postal Code
656043
Country
Russian Federation
Facility Name
LLC "Alyans Biomedical- Ural Group"
City
Irkutsk
ZIP/Postal Code
664049
Country
Russian Federation
Facility Name
Kazan State Medical University
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
SAIH "Kemerovo Regional Clinical Hospital
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
LLC Medicine Center SibNovoMed
City
Novosibirsk
ZIP/Postal Code
630005
Country
Russian Federation
Facility Name
CDC Ultramed
City
Omsk
ZIP/Postal Code
644024
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
Facility Name
LLC "Medinet"
City
Saint Petersburg
ZIP/Postal Code
194356
Country
Russian Federation
Facility Name
Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"
City
Saint Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
LLC SM-Clinic
City
Saint Petersburg
ZIP/Postal Code
195279
Country
Russian Federation
Facility Name
LLC "Gastroenterological centre Expert"
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Irkutsk State Medical Academy of Continuing Education
City
Samara
ZIP/Postal Code
443011
Country
Russian Federation
Facility Name
Private Educational Institution of Higher Education "Medical University REAVIZ"
City
Samara
ZIP/Postal Code
443011
Country
Russian Federation
Facility Name
LLC Medical Company "Hepatologist"
City
Samara
ZIP/Postal Code
443093
Country
Russian Federation
Facility Name
SPb SBIH "City Hospital # 40 of Kurortnyi region"
City
Sestroretsk
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
LLC Uromed
City
Smolensk
ZIP/Postal Code
214031
Country
Russian Federation
Facility Name
Stavropol Regional Clinical Diagnostic Centre
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
Facility Name
LLC "Polyclinic of ultrasonography 4D"
City
Stavropol
ZIP/Postal Code
357000
Country
Russian Federation
Facility Name
Clinical Center " Dr Dragisa Misovic Dedinje"
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Health Center Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
General Hospital Sremska Mitrovica
City
Sremska Mitrovica
ZIP/Postal Code
22000
Country
Serbia
Facility Name
ENDOMED, s.r.o.
City
Vranov nad Toplou
State/Province
Presov
ZIP/Postal Code
093 01
Country
Slovakia
Facility Name
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Alian S.R.O
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
KM Management spol. s r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Fakultna nemocnica Nitra
City
Nitra
ZIP/Postal Code
950 01
Country
Slovakia
Facility Name
GASTROENTEROLOG, s.r.o.
City
Nove Zamky
ZIP/Postal Code
940 01
Country
Slovakia
Facility Name
Gastro I, s.r.o.
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Accout Center s.r.o.
City
Sahy
ZIP/Postal Code
936 01
Country
Slovakia
Facility Name
Johese Clinical Research: Unitas
City
Lyttelton
State/Province
Centurion
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Johese Clinical Research
City
Midstream
State/Province
Centurion
ZIP/Postal Code
1692
Country
South Africa
Facility Name
Lenasia Clinical Trial Centre
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1827
Country
South Africa
Facility Name
Dr JP Wright Practice
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Supaporn Lertkawinanan
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Phramongkutklao Hospital
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Ms. Arawan Larplertsakul
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Uludag University Medical Faculty
City
Beşevler
State/Province
Yenimahalle / Ankara
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Gazi University Medical Faculty
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Antalya Training and Research Hospital
City
Antalya
ZIP/Postal Code
07030
Country
Turkey
Facility Name
Kocaeli University Research and Training Hospital
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Municipal non-profit enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council", Ga
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
City
Kharkiv
ZIP/Postal Code
61058
Country
Ukraine
Facility Name
Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Kremenchuk first city hospital n.a. O.T. Bohaievskyi
City
Kremenchuk
ZIP/Postal Code
39617
Country
Ukraine
Facility Name
National Military Medical Clinical Center Main Military Clinical Hospital
City
Kyiv
ZIP/Postal Code
01133
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital N 1
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care
City
Lviv
ZIP/Postal Code
79059
Country
Ukraine
Facility Name
Odesa regional clinical hospital, regional center of gastroenterology, surgical department
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
A. Novak Transcarpathian Regional Clinical Hospital
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Medical Clinical Investigational Center of Medical Center Health Clinic LLC
City
Vinnytsia
ZIP/Postal Code
21009
Country
Ukraine
Facility Name
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Communal Institution City Clinical Hospital #6, Department of Gastroenterology
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Barts Health NHS Trust - Whipps Cross University Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation Trust
City
London
State/Province
Greater London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospitals NHS Foundation Trust
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UQ
Country
United Kingdom
Facility Name
Yeovil Hospital NHS Foundation Trust
City
Yeovil
State/Province
Somerset
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Facility Name
Belfast Health and Social Care Trust Royal Victoria Hospital
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
West Hertfordshire Hospitals NHS Trust Hemel Hempstead General Hospital
City
Hemel Hempstead
ZIP/Postal Code
HP2 4AD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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