Back to resultsEtrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis (ELEVATE UC 12)
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Etrasimod
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Etrasimod, APD334
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
Sites / Locations
- Digestive Health Specialists of the Southeast
- East View Medical Research, LLC
- Arizona Digestive Health
- Om Research, LLC
- Entertainment Medical Group, Inc.
- United Medical Doctors
- ACRC Studies,LLC
- Paradigm Clinical Research Institute
- University of Colorado
- Peak Gastroenterology Associates
- Gastro Florida
- Gastro Florida
- Florida Center for Gastroenterology
- Life Medical Center & Research, Inc
- Global Life Research Network, LLC
- Gastroenterology Group of Naples
- NSB Research
- Pediatric & Adult Research Center
- IMIC, Inc.
- Advanced Medical Research Center
- Theia Clinical Research, LLC
- Lenus Research & Medical Group, LLC
- USF Department of Surgery
- GCP Clinical Research
- Guardian Angel Research Center
- Florida Medical Clinic, P.A.
- Atlanta Gastroenterology Associates
- Children's Center for Digestive Health Care, LLC
- Atlanta Center for Gastroenterology, P.C.
- University of Chicago Medical Center
- Illinois Gastroenterology Group
- Texas Digestive Disease Consultants
- Chevy Chase Clinical Research
- Gastro Center of Maryland
- West Michigan Clinical Research Center
- Washington University School of Medicine
- Sierra Clinical Research
- Las Vegas Medical Research
- Dartmouth-Hitchcock Medical Center
- Duke University Medical Center
- University of Cincinnati
- Great Lakes Medical Research, LLC - Mentor
- Care Access Research
- Great Lakes Medical Research, LLC - Harrisburg
- Tri-Cities Gastroenterology
- GI for Kids
- Texas Clinical Research Institute, LLC
- The University of Texas at Austin Dell Medical School
- Texas Gastroenterology Associates, PA
- Texas Digestive Disease Consultants - Dallas
- DHAT Research Institute
- Baylor Gastroenterology Assoc
- Rio Grande Gastroenterology
- Texas Digestive Disease Consultants - San Marcos
- Tyler Research Institute, LLC
- Victoria Gastroenterology
- Care Access Research LLC
- Blue Ridge Medical Research
- Washington Gastroenterology
- Virginia Mason
- 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
- Instituto de Investigaciones Clínicas Quilmes SRL
- CICE Sanatorio 9 de Julio
- Bankstown-Lidcombe Hospital
- Nepean Hospital
- Coastal Digestive Health
- Coral Sea Clinical Research Institute
- Footscray Hospital
- Austin Health
- Royal Melbourne Hospital
- Liverpool Hospital
- Alfred Hospital
- Lkh Univ. Klinikum Graz
- KH der Barmherzigen Brüder Linz, Interne Abteilung
- AKH - Medizinische Universität Wien
- Institution "Gomel Regional Clinical Hospital"
- Grodno City Clinical Hospital #4
- Vitebsk Regional Clinical Hospital
- Vitebsk Regional Clinical Specialized Center
- University Hospital Antwerp Gastroenterology and Hepatology Department
- Dr. Peter Bossuyt - GI Clinical Research Center
- AZ Sint-Lucas & Volkskliniek
- UZ Gent - Gastroenterology
- UZ Leuven Campus Gasthuisberg
- AZ Sint-Maarten
- ZNA Jan Palfijn
- AZ Delta
- UMHAT "Sv. Georgi", EAD
- UMHAT Kanev AD, Ruse
- Diagnostic-Consultative Center I - Sliven, EOOD
- ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center
- DCC "Alexandrovska", EOOD
- UMHAT "Tsaritsa Yoanna-ISUL" EAD
- UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center
- Diagnostic Consultation Center CONVEX EOOD
- Acibadem City Clinic University Hospital EOOD
- Medical center "Nov Rehabilitatsionen Tsentar" EOOD
- Medical Centre MEDICA Plus OOD
- Heritage Medical Research Clinic
- LHSC - University Hospital
- Enroll SpA
- Biomedica Research Group
- Hospital Sotero del Rio
- Centro de Investigación del Maule SPA
- Clinical Research Chile SpA
- Clínica de la Costa Ltda.
- Clinica de la Mujer Centro de Investigaciones
- Hospital San Juan de Dios Fundacion Cardiomet-Cequin
- Clinica farallones centro de investigaciones clinicas CIC
- General Hospital "Dr. Tomislav Bardek" Koprivnica
- Clinical Hospital Centre Osijek
- General Hospital Zadar
- Clinical Hospital Sveti Duh
- 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
- Axon Clinical s. r. o.
- ISCARE I.V.F. a.s.
- Nemocnice Na Bulovce
- Oblastni nemocnice Pribram a.s.
- Nemocnice Slany
- Aalborg University Hospital, department of medical gastroenterology
- Herlev Hospital, Gastroenheden, 54Q2
- Innomedica OÜ
- West Tallinn Central Hospital
- North Estonia Medical Centre Foundation
- Tartu University Hospital
- CHU Nice - Hôpital de l'Archet 2
- CHU Dijon - Hôpital Bocage Central
- Hôpital Rangueil Service Gastro-entérologie et pancreatologie
- CHU Montpellier - Hopital Saint Eloi
- Chu Pontchaillou Rennes
- CHU Nantes Hôtel-Dieu
- CHRU-Nancy Brabois
- CHU Lille - Hôpital Claude Huriez
- CHU Clermont Ferrand - Hôpital d'Estaing
- Unite de Recherche Clinique-Urc
- Chu Amiens Picardie-Sit Sud
- Groupement Hospitalier Sud - Hôpital Bicêtre
- CHU Grenoble Alpes - Hôpital Michallon
- LTD Acad. F. Todua Medical Centre, LTD. Research Institution 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
- Charité Universitätsmedizin Berlin - Campus Charité Mitte
- 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.
- Endoexpert Egeszsegugyi Szolgaltato Kft
- Semmelweis Egyetem, II.sz. Belgyogyaszati Klinika
- Pannonia Maganorvosi Centrum
- Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika -Gasztroenterologia
- Bugat Pal Korhaz
- SZTE AOK I.st dept. of Internal Medicine.
- Dept of Gastroenterology, Szent Gyorgy Hospital
- Clinfan Ltd. Outpatient Clinic
- Szent Borbala Korhaz
- Nirmal Hospitals Pvt Ltd
- Surat Institute of Digestive Sciences
- Fortis Memorial Research Institute
- All India Institute of Medical Sciences
- Aster Medcity,Aster DM healthcare Ltd
- Government Medical College and Super Speciality Hospital
- Midas Multispeciality Hospital Pvt.Ltd.
- 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-Beilinson Campus
- Chaim Sheba Medical Center
- Kaplan Medical Center
- Azienda Ospedaliera Saverio De Bellis
- Ospedale di Circolo
- Istituto Clinico Humanitas
- I.R.C.C.S Policlinico San Donato
- Ospedale Sacro Cuore Don Calabria
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
- Azienda Ospedaliera Ospedale Cannizzaro
- Azienda Ospedaliero Universitaria Mater Domini
- Azienda Ospedaliera Universitaria Careggi
- A.O.U. Policlinico di Modena
- Ospedale Sandro Pertini
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD
- A.O. Ordine Mauriziano di Torino - P.O. Ospedale Umberto I
- Centro Ricerche Cliniche di Verona
- Ospedale San Bortolo di Vicenza
- Nagoya City University Hospital
- Koujunkai Daido Clinic
- Toyohashi Municipal Hospital
- Hirosaki University Hospital
- NHO Hirosaki National Hospital
- Tsujinaka Hospital Kashiwanoha
- Saiseikai Matsuyama Hospital
- Ehime University Hospital
- Fukuoka Tokushukai Hospital
- JCHO Kyushu Hospital
- Kurume University Hospital
- Fukushima Medical University Hospital
- Gifu University Hospital
- Ogaki Municipal Hospital
- SUBARU Health Insurance Society Ota Memorial Hospital
- NHO Fukuyama Medical Center
- Hiroshima City Hiroshima Citizens Hospital
- Hiroshima University Hospital
- Asahikawa City Hospital
- Tokushukai Sapporo Tokushukai Hospital
- Sapporo-Kosei General Hospital
- NHO Mito Medical Center
- Yuai Memorial Hospital
- Tsuchiura Kyodo General Hospital
- NHO Kanazawa Medical Center
- Iwate Medical University Uchimaru Medical Center
- Takamatsu Red Cross Hospital
- Kagawa Prefectural Central Hospital
- Jiaikai Izuro Imamura Hospital
- Sameshima Hospital
- Gokeikai Ofuna Chuo Hospital
- Sagamihara Kyodo Hospital
- NHO Yokohama Medical Center
- Japanese Red Cross Kumamoto Hospital
- NHO Kyoto Medical Center
- Mie University Hospital
- Mie Prefectural General Medical Center
- Tohoku University Hospital
- JOHAS Tohoku Rosai Hospital
- Sendai City Hospital
- Nara Medical University Hospital
- Saiseikai Niigata Hospital
- Kansai Medical University Hospital
- Tokushukai Kishiwada Tokushukai Hospital
- Osaka City University Hospital
- Japan Community Health care Organization Osaka Hospital
- Osaka Medical College Hospital
- Saga University Hospital
- JCHO Saitama Medical Center
- Shiga University of Medical Science Hospital
- St. Luke's International Hospital
- Teikyo University Hospital
- Showa General Hospital
- Jikei University Hospital
- Kitasato University Kitasato Institute Hospital
- NTT Medical Center Tokyo
- JCHO Tokyo Yamate Medical Center
- Toyama Prefectural Central Hospital
- Wakayama Medical University Hospital
- Fukuoka University Hospital
- Kyungpook National University Hospital
- Yonsei University 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
- Saint George Hospital University Medical Center
- American University of Beirut Medical Center
- Hotel Dieu de France Hospital
- Republican Panevezys Hospital, Department of Gastroenterology
- UAB "Inlita", Santaros Clinical Trials Centre
- Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology
- Consultorio Medico, InvesclinicMX
- 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
- Republican Clinical Hospital, ARENSIA Exploratory Medicine
- 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
- Radboudumc
- ETZ Elisabeth
- Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz
- Gastromed Kralisz, Romatowski, Stachurska sp.j
- Centrum Medyczne Pratia Czestochowa
- Karkonoskie Centrum Badan Klinicznych Lexmedica
- Centrum Medyczne Plejady
- Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna
- AmiCare Sp. z O.O. Sp.K.
- IP Clinic
- Allmedica Badania Kliniczne Sp. z o.o. Sp.k.
- Medicome Sp. Zo.O.
- Centrum Medyczne Grunwald
- SOLUMED Centrum Medyczne
- Korczowski Bartosz, Gabinet Lekarski
- Centrum Medyczne Medyk
- ENDOSKOPIA Sp.zo.o
- DC-MED
- 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
- Hospital de Braga
- Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia
- Hospital da Senhora da Oliveira Guimarães
- Hospital da Luz Lisboa
- Centro Hospitalar de São João, EPE
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E
- S.C. Centrul Medical Unirea SRL
- S.C MedLife SA
- S.C Delta Health Care S.R.L, Ponderas Academic Hospital
- S.C Euroclinic Hospital S.A
- Spitalul Clinic Colentina
- Institutul Clinic Fundeni
- S.C Policlinica CCBR S.R.L
- Spitalul Clinic Judetean de Urgenta Cluj Napoca
- Spitalul Clinic Judetean de Urgenta Craiova
- 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 SM-Clinic
- Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"
- FSBI of higher Education "First Saint Petersburg State Medical University n.a. I.P.Pavlov
- 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"
- City Clinical Hospital #8
- Clinical Center " Dr Dragisa Misovic Dedinje"
- Clinical Center of Serbia
- Clinical Health Center Zvezdara
- Clinical Center Bezanijska Kosa
- Clinical Center Kragujevac
- General Hospital Sremska Mitrovica
- Endomed, S.R.O
- Fakultna nemocnica s poliklinikou F.D. Roosevelta
- Alian S.R.O
- KM Management spol. s r.o.
- Fakultna nemocnica Nitra
- Gastro I, s.r.o.
- Accout Center s.r.o.
- BeneDig s.r.o.
- Johese Clinical Research: Unitas
- Johese Clinical Research
- Lenasia Clinical Trial Centre
- Dr JP Wright Practice
- Hospital General Universitario de Alicante
- Centro Médico Teknon
- Hospital Clinic de Barcelona
- Hospital Universitario de Gran Canaria Dr. Negrin
- Hospital Universitario La Paz
- Kantonsspital Baden
- Inselspital, Gaby Saner, Gastroenterologie, Bauchzentrum
- Berner IBD study group c/o Gastroenterologische Praxis Balsiger, Seibold &Partner
- Siriraj Hospital
- King Chulalongkorn Memorial Hospital
- Phramongkutklao Hospital
- Uludag University Medical Faculty
- Hacettepe University Medical Faculty
- Gazi University Medical Faculty
- Antalya Training and Research Hospital
- Kocaeli University Research and Training Hospital
- Karadeniz Tecnical Uni. Med. Fac.
- 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
- Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
- 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
- Whipps Cross University Hospital
- Guy's and Saint Thomas NHS Foundation Trust
- Norfolk and Norwich University Hospital
- Yeovil District 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
Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Secondary Outcome Measures
Percentage of Participants Achieving Endoscopic Improvement
Endoscopic improvement was defined as an ES <= 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease); higher score indicated more severe disease.
Percentage of Participants Achieving Symptomatic Remission
Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.
Percentage of Participants With Mucosal Healing
Mucosal healing was defined as an ES <= 1 (excluding friability) with histologic remission measured by a Geboes Index score less than [<] 2.0). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease.
Percentage of Participants Achieving Clinical Response
Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a >= 2-point and >= 30 percent (%) decrease from Baseline MMS, and a >= 1-point decrease from Baseline in RB sub-score or an absolute RB sub-score <= 1. Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Percentage of Participants Achieving Endoscopic Normalization
Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease); higher score indicated more severe disease.
Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8
Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.
Percentage of Participants Achieving Complete Symptomatic Remission
Complete symptomatic remission was defined as an SF sub-score = 0 and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.
Percentage of Participants Achieving Non-invasive Clinical Response
Non-invasive clinical response was defined as a >= 30% decrease from Baseline in composite RB and SF sub-scores, and a >= 1 point decrease from Baseline in RB sub-score or RB sub-score <= 1. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.
Percentage of Participants Achieving Symptomatic Response
Symptomatic response was defined as a >= 30% decrease from Baseline in composite RB and SF score. The SF sub-score ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0= no blood and 3= blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03996369
Brief Title
Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
Acronym
ELEVATE UC 12
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
December 7, 2021 (Actual)
Study Completion Date
December 7, 2021 (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 assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
354 (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 12-Week Induction Treatment Period
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Etrasimod matching placebo tablet by mouth, once daily up to 12-Week Induction Treatment Period
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Clinical Remission
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 electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to [>=] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Endoscopic Improvement
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); higher score indicated more severe disease.
Time Frame
Week 12
Title
Percentage of Participants Achieving Symptomatic Remission
Description
Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.
Time Frame
Week 12
Title
Percentage of Participants With Mucosal Healing
Description
Mucosal healing was defined as an ES <= 1 (excluding friability) with histologic remission measured by a Geboes Index score less than [<] 2.0). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease.
Time Frame
Week 12
Title
Percentage of Participants Achieving Clinical Response
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 percent (%) decrease from Baseline MMS, and a >= 1-point decrease from Baseline in RB sub-score or an absolute RB sub-score <= 1. Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Time Frame
Week 12
Title
Percentage of Participants Achieving Endoscopic Normalization
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); higher score indicated more severe disease.
Time Frame
Week 12
Title
Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8
Description
Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a >= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.
Time Frame
Weeks 2, 4 and 8
Title
Percentage of Participants Achieving Complete Symptomatic Remission
Description
Complete symptomatic remission was defined as an SF sub-score = 0 and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.
Time Frame
Weeks 2, 4, 8 and 12
Title
Percentage of Participants Achieving Non-invasive Clinical Response
Description
Non-invasive clinical response was defined as a >= 30% decrease from Baseline in composite RB and SF sub-scores, and a >= 1 point decrease from Baseline in RB sub-score or RB sub-score <= 1. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.
Time Frame
Weeks 2, 4, 8 and 12
Title
Percentage of Participants Achieving Symptomatic Response
Description
Symptomatic response was defined as a >= 30% decrease from Baseline in composite RB and SF score. The SF sub-score ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0= no blood and 3= blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease.
Time Frame
Weeks 2, 4, 8 and 12
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
East View Medical Research, LLC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36606
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
ACRC Studies,LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92119
Country
United States
Facility Name
Paradigm Clinical Research Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
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
Gastro Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33762
Country
United States
Facility Name
Florida Center for Gastroenterology
City
Largo
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
Global Life Research Network, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
NSB Research
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Pediatric & Adult Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
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
Lenus Research & Medical Group, LLC
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
USF Department of Surgery
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
Florida Medical Clinic, P.A.
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Children's Center for Digestive Health Care, LLC
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
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Illinois Gastroenterology Group
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Gastro Center of Maryland
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
West Michigan Clinical Research Center
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Duke University Medical Center
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 - Mentor
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
Great Lakes Medical Research, LLC - Harrisburg
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Tri-Cities Gastroenterology
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37663
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
The University of Texas at Austin Dell Medical School
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
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 - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
DHAT Research Institute
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
Baylor Gastroenterology Assoc
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Rio Grande Gastroenterology
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
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
Care Access Research LLC
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
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
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
Instituto de Investigaciones Clínicas Quilmes SRL
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878GEG
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
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
Footscray Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Austin Health
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
Liverpool Hospital
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Facility Name
Lkh Univ. Klinikum Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
KH der Barmherzigen Brüder Linz, Interne Abteilung
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
AKH - Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
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
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
University Hospital Antwerp Gastroenterology and Hepatology Department
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Dr. Peter Bossuyt - GI Clinical Research Center
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
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
UZ Leuven Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Sint-Maarten
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
ZNA Jan Palfijn
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
UMHAT "Sv. Georgi", EAD
City
Plovdiv
ZIP/Postal Code
4002
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 "Tsaritsa Yoanna-ISUL" EAD
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center
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
Medical Centre MEDICA Plus OOD
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Heritage Medical Research Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
LHSC - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
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
Clínica de la Costa Ltda.
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Clinica de la Mujer Centro de Investigaciones
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Hospital San Juan de Dios Fundacion Cardiomet-Cequin
City
Armenia
State/Province
Quindio
ZIP/Postal Code
630004
Country
Colombia
Facility Name
Clinica farallones centro de investigaciones clinicas CIC
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760044
Country
Colombia
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 Sveti Duh
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
Axon Clinical s. r. o.
City
Praha
ZIP/Postal Code
150 00
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
Oblastni nemocnice Pribram a.s.
City
Pribram
ZIP/Postal Code
261 01
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, Gastroenheden, 54Q2
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
Tartu University Hospital
City
Tartu
ZIP/Postal Code
50406
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 Dijon - Hôpital Bocage Central
City
Dijon
State/Province
Côte-d'Or
ZIP/Postal Code
21079
Country
France
Facility Name
Hôpital Rangueil Service Gastro-entérologie et pancreatologie
City
Toulouse cedex 9
State/Province
Haute Garonne
ZIP/Postal Code
31059
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 Pontchaillou Rennes
City
Rennes
State/Province
Ille Et Vilaine
ZIP/Postal Code
35033
Country
France
Facility Name
CHU Nantes Hôtel-Dieu
City
Nantes
State/Province
Loire Atlantique
ZIP/Postal Code
44000
Country
France
Facility Name
CHRU-Nancy Brabois
City
Vandoeuvre les Nancy
State/Province
Meurthe Et Moselle
ZIP/Postal Code
54511
Country
France
Facility Name
CHU Lille - Hôpital Claude Huriez
City
Lille cedex
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Clermont Ferrand - Hôpital d'Estaing
City
Clermont-Ferrand
State/Province
Puy De Dome
ZIP/Postal Code
63003
Country
France
Facility Name
Unite de Recherche Clinique-Urc
City
Montfermeil
State/Province
Seine Saint Denis
ZIP/Postal Code
93370
Country
France
Facility Name
Chu Amiens Picardie-Sit Sud
City
AMIENS cedex 1
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Facility Name
Groupement Hospitalier Sud - Hôpital Bicêtre
City
Le Kremlin Bicêtre
State/Province
Val De Marne
ZIP/Postal Code
94275
Country
France
Facility Name
CHU Grenoble Alpes - Hôpital Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
LTD Acad. F. Todua Medical Centre, LTD. Research Institution 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
Charité Universitätsmedizin Berlin - Campus Charité Mitte
City
Berlin
ZIP/Postal Code
10117
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
Endoexpert Egeszsegugyi Szolgaltato Kft
City
Budapest
ZIP/Postal Code
1054
Country
Hungary
Facility Name
Semmelweis Egyetem, II.sz. Belgyogyaszati Klinika
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika -Gasztroenterologia
City
Debrecen
ZIP/Postal Code
4032
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
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
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
All India Institute of Medical Sciences
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682027
Country
India
Facility Name
Aster Medcity,Aster DM healthcare Ltd
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682027
Country
India
Facility Name
Government Medical College and Super Speciality Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440009
Country
India
Facility Name
Midas Multispeciality Hospital Pvt.Ltd.
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-Beilinson Campus
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
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
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
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliera Ospedale Cannizzaro
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Mater Domini
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
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
A.O. Ordine Mauriziano di Torino - P.O. Ospedale Umberto I
City
Torino
ZIP/Postal Code
10128
Country
Italy
Facility Name
Centro Ricerche Cliniche di Verona
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Ospedale San Bortolo di Vicenza
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Nagoya City University Hospital
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Koujunkai Daido Clinic
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Toyohashi Municipal Hospital
City
Toyohashi-shi
State/Province
Aichi
ZIP/Postal Code
441-8570
Country
Japan
Facility Name
Hirosaki University Hospital
City
Hirosaki-shi
State/Province
Aomori-ken
ZIP/Postal Code
036-8563
Country
Japan
Facility Name
NHO Hirosaki National Hospital
City
Hirosaki-shi
State/Province
Aomori
ZIP/Postal Code
036-8545
Country
Japan
Facility Name
Tsujinaka Hospital Kashiwanoha
City
Kashiwa-city
State/Province
Chiba
ZIP/Postal Code
277-0871
Country
Japan
Facility Name
Saiseikai Matsuyama Hospital
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
791-8026
Country
Japan
Facility Name
Ehime University Hospital
City
Toon-shi
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Fukuoka Tokushukai Hospital
City
Kasuga
State/Province
Fukuoka
ZIP/Postal Code
816-0864
Country
Japan
Facility Name
JCHO Kyushu Hospital
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
806-8501
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
960-1247
Country
Japan
Facility Name
Gifu University Hospital
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
SUBARU Health Insurance Society Ota Memorial Hospital
City
Ota-shi
State/Province
Gunma
ZIP/Postal Code
373-8585
Country
Japan
Facility Name
NHO Fukuyama Medical Center
City
Fukuyama-shi
State/Province
Hiroshima-Ken
ZIP/Postal Code
720-8520
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Asahikawa City Hospital
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
070-8610
Country
Japan
Facility Name
Tokushukai Sapporo Tokushukai Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
004-0041
Country
Japan
Facility Name
Sapporo-Kosei General Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
NHO Mito Medical Center
City
Higashi
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Yuai Memorial Hospital
City
Koga-shi
State/Province
Ibaraki
ZIP/Postal Code
306-0232
Country
Japan
Facility Name
Tsuchiura Kyodo General Hospital
City
Tsuchiura-shi
State/Province
Ibaraki
ZIP/Postal Code
300-0028
Country
Japan
Facility Name
NHO Kanazawa Medical Center
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Iwate Medical University Uchimaru Medical Center
City
Morioka-shi
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Takamatsu Red Cross Hospital
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
760-0017
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
Jiaikai Izuro Imamura Hospital
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0824
Country
Japan
Facility Name
Sameshima Hospital
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0846
Country
Japan
Facility Name
Gokeikai Ofuna Chuo Hospital
City
Kamakura-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Sagamihara Kyodo Hospital
City
Sagamihara-shi
State/Province
Kanagawa
ZIP/Postal Code
252-5188
Country
Japan
Facility Name
NHO Yokohama Medical Center
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
245-8575
Country
Japan
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
861-8520
Country
Japan
Facility Name
NHO Kyoto Medical Center
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
612-8555
Country
Japan
Facility Name
Mie University Hospital
City
Tsu-shi
State/Province
Mie-Ken
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Mie Prefectural General Medical Center
City
Yokkaichi-City
State/Province
Mie
ZIP/Postal Code
510-8561
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
JOHAS Tohoku Rosai Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
981-8563
Country
Japan
Facility Name
Sendai City Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
982-8502
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara-city
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Saiseikai Niigata Hospital
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
950-1104
Country
Japan
Facility Name
Kansai Medical University Hospital
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Tokushukai Kishiwada Tokushukai Hospital
City
Kishiwada-shi
State/Province
Osaka
ZIP/Postal Code
596-8522
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Japan Community Health care Organization Osaka Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Facility Name
Osaka Medical College Hospital
City
Takatsuki-shi
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Saga University Hospital
City
Saga-shi
State/Province
Saga-ken
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
JCHO Saitama Medical Center
City
Saitama-shi
State/Province
Saitama-Ken
ZIP/Postal Code
330-0074
Country
Japan
Facility Name
Shiga University of Medical Science Hospital
City
Otsu-shi
State/Province
Shiga-ken
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
St. Luke's International Hospital
City
Chuo -ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Teikyo University Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
Showa General Hospital
City
Kodaira-shi
State/Province
Tokyo
ZIP/Postal Code
187-0002
Country
Japan
Facility Name
Jikei University Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Kitasato University Kitasato Institute Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
NTT Medical Center Tokyo
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
JCHO Tokyo Yamate Medical Center
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Toyama Prefectural Central Hospital
City
Toyama-shi
State/Province
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama-shi
State/Province
Wakayama-ken
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Kyungpook National University Hospital
City
Junggu
State/Province
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Yonsei University 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
Saint George Hospital University Medical Center
City
Beirut
ZIP/Postal Code
1100-2807
Country
Lebanon
Facility Name
American University of Beirut Medical Center
City
Beirut
ZIP/Postal Code
1107-2020
Country
Lebanon
Facility Name
Hotel Dieu de France Hospital
City
Beirut
ZIP/Postal Code
16-6830
Country
Lebanon
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
Consultorio Medico, InvesclinicMX
City
Irapuato
State/Province
Guanajuato
ZIP/Postal Code
36650
Country
Mexico
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
Republican Clinical Hospital, ARENSIA Exploratory Medicine
City
Chisinau
ZIP/Postal Code
MD-2025
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
Radboudumc
City
Nijmegen
ZIP/Postal Code
6525 GA
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
Centrum Medyczne Plejady
City
Kraków
ZIP/Postal Code
30-363
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
Allmedica Badania Kliniczne Sp. z o.o. Sp.k.
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
Korczowski Bartosz, Gabinet Lekarski
City
Rzeszow
ZIP/Postal Code
35-302
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
DC-MED
City
Swidnica
ZIP/Postal Code
58-100
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
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
Hospital da Senhora da Oliveira Guimarães
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Hospital da Luz Lisboa
City
Lisboa
ZIP/Postal Code
1500-650
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
S.C. Centrul Medical Unirea SRL
City
Bucharest
ZIP/Postal Code
540136
Country
Romania
Facility Name
S.C MedLife SA
City
Bucuresti
ZIP/Postal Code
10719
Country
Romania
Facility Name
S.C Delta Health Care S.R.L, Ponderas Academic Hospital
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
S.C Policlinica CCBR S.R.L
City
Bucuresti
ZIP/Postal Code
30463
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 Craiova
City
Craiova
ZIP/Postal Code
200640
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
Izhevsk
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 SM-Clinic
City
Saint-Peterburg
ZIP/Postal Code
195279
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
FSBI of higher Education "First Saint Petersburg State Medical University n.a. I.P.Pavlov
City
Saint-Petersburg
ZIP/Postal Code
197022
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
City Clinical Hospital #8
City
Yaroslavl
ZIP/Postal Code
150030
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 Bezanijska Kosa
City
Belgrade
ZIP/Postal Code
11080
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
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
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
BeneDig s.r.o.
City
Zilina
ZIP/Postal Code
010 08
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
Lenasia
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 General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Centro Médico Teknon
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario de Gran Canaria Dr. Negrin
City
Las Palmas
ZIP/Postal Code
35010
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Kantonsspital Baden
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
Facility Name
Inselspital, Gaby Saner, Gastroenterologie, Bauchzentrum
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Berner IBD study group c/o Gastroenterologische Praxis Balsiger, Seibold &Partner
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
Facility Name
Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
King Chulalongkorn Memorial Hospital
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
Uludag University Medical Faculty
City
Beşevler
State/Province
Yenimahalle/Ankara
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
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
Karadeniz Tecnical Uni. Med. Fac.
City
Trabzon
ZIP/Postal Code
61100
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
Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
City
Kyiv
ZIP/Postal Code
01030
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
Whipps Cross University Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Guy's and Saint Thomas NHS Foundation Trust
City
London
State/Province
Greater London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UQ
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil
State/Province
Somerset
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
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