Clinical trial NCT03290781: An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 366
Sex: ALL
Minimum age (years): 16
Maximum age (years): 81
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).


Eligibility criteria: Inclusion Criteria:

* Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
* Participants must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
* Participants must have completed the 12-week induction treatment period (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]).
* Participants must have achieved clinical response in induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). Clinical response is defined as:

  i) A decrease from the induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) baseline in the composite score of patient reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub score for rectal bleeding greater than or equal to (\>=) 1 point or a sub score for rectal bleeding less than or equal to (\<=) 1 OR ii) A decrease from the induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1.

For eligibility assessment, clinical response will be determined based on the centrally read endoscopy performed during screening and at Week 12 of induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]).

- Participants receiving any treatment(s) for ulcerative colitis (UC) are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.

Exclusion Criteria:

* Participants who had major protocol deviation(s) (as determined by the sponsor) in induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]).
* Participants who permanently discontinued investigational product because of an adverse event (AE), regardless of relatedness to investigational product, in induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]).
* Participants who are likely to require surgery for UC during the study period.
* Participants are females who became pregnant during induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]), females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue using appropriate contraception methods (that is \[i.e,\] highly effective methods for female and medically appropriate methods for male study participants) through the conclusion of study participation.
* Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
* Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
* Participants who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
* Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example \[eg\], renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic \[eg, Felty's syndrome\], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
* Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) and who are without a generally accepted course of treatment.
* Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study.
* Participants who are participating in or plan to participate in other investigational studies (other than induction study SHP647- 301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) during study SHP647-303 \[NCT03290781\].

Primary outcomes:
measure: Number of Participants With Remission Based on Composite Score at Week 52
timeFrame: At Week 52
Secondary outcomes:
measure: Number of Participants With Endoscopic Remission at Week 52
timeFrame: At Week 52
measure: Number of Participants With Clinical Remission at Week 52
timeFrame: At Week 52
measure: Number of Participants With Sustained Remission at Week 52
timeFrame: At Week 52
measure: Number of Participants With Clinical Response Based on Composite Score at Week 52
timeFrame: At Week 52
measure: Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52
timeFrame: At Week 52
measure: Number of Participants With Glucocorticoid-free Clinical Remission at Week 52
timeFrame: At Week 52
measure: Number of Participants With Glucocorticoid-free Remission at Week 52
timeFrame: At Week 52
measure: Number of Participants With Remission Based on Total Mayo Score at Week 52
timeFrame: At Week 52
measure: Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
timeFrame: At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: Number of Participants With Sustained Endoscopic Remission at Week 52
timeFrame: At Week 52
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From start of study drug administration up to follow-up (Week 64)
measure: Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab
timeFrame: At Week 12, 24, 36 and 52
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona Digestive Health Mesa - East
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies - Phoenix - Clinedge - PPDS
state: Arizona
city: Little Rock
country: United States
facility: Atria Clinical Research - Clinedge - PPDS
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials, LLC
state: California
city: Encinitas
country: United States
facility: United Medical Doctors
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Lancaster
country: United States
facility: OM Research LLC - Lancaster - ClinEdge - PPDS
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System - NAVREF - PPDS
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: Poway
country: United States
facility: Alliance Clinical Research-(Vestavia Hills)
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: San Pablo
country: United States
facility: Care Access Research, San Pablo
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates PC - CRN - PPDS
state: Colorado
city: Cape Coral
country: United States
facility: Renaissance Research Medical Group, INC
state: Florida
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Coral Gables
country: United States
facility: Advanced Clinical Research Network
state: Florida
city: Coral Springs
country: United States
facility: Alliance Medical Research LLC
state: Florida
city: Jacksonville
country: United States
facility: ENCORE Borland-Groover Clinical Research - ERN - PPDS
state: Florida
city: Kissimmee
country: United States
facility: SIH Research
state: Florida
city: Miami Lakes
country: United States
facility: Crystal Biomedical Research
state: Florida
city: Miami
country: United States
facility: Hi Tech and Global Research, LLc
state: Florida
city: Miami
country: United States
facility: Nuren Medical and Research Center
state: Florida
city: Miami
country: United States
facility: Sanchez Clinical Research, Inc
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Naples
country: United States
facility: Pharma Research International Inc
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants LLC - Clinedge - PPDS
state: Florida
city: Pinellas Park
country: United States
facility: Accel Research Sites - St. Petersburg - ERN - PPDS
state: Florida
city: Plantation
country: United States
facility: BRCR Medical Center, Inc
state: Florida
city: Saint Augustine
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Tamarac
country: United States
facility: DBC Research
state: Florida
city: Tampa
country: United States
facility: Bayside Clinical Research - New Port Richey
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Specialists, PC
state: Georgia
city: Atlanta
country: United States
facility: Infinite Clinical Trials
state: Georgia
city: Columbus
country: United States
facility: Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS
state: Georgia
city: Decatur
country: United States
facility: Atlanta Center For Gastroenterology PC
state: Georgia
city: Chicago
country: United States
facility: Loretto Hospital
state: Illinois
city: Gurnee
country: United States
facility: IL Gastroenterology Group
state: Illinois
city: Hines
country: United States
facility: Edward Hines Jr VA Hospital - NAVREF - PPDS
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Dupage Medical Group
state: Illinois
city: Evansville
country: United States
facility: Medisphere Medical Research Center LLC
state: Indiana
city: Michigan City
country: United States
facility: Laporte County Institute For Clinical Research
state: Indiana
city: Hazard
country: United States
facility: Gastroenterology Associates of Hazard
state: Kentucky
city: Houma
country: United States
facility: CroNOLA, LLC.
state: Louisiana
city: Lake Charles
country: United States
facility: Clinical Trials of SWLA, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center LLC
state: Louisiana
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Brockton
country: United States
facility: Commonwealth Clinical Studies LLC
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Hamtramck
country: United States
facility: National Clinical, LLC
state: Michigan
city: Duluth
country: United States
facility: Mayo Clinic Health System - PPDS
state: Minnesota
city: Ocean Springs
country: United States
facility: Digestive Health Center PA
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: St Louis Center For Clinical Research
state: Missouri
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: North Las Vegas
country: United States
facility: Encompass Care
state: Nevada
city: Brooklyn
country: United States
facility: New York Total Medical Care PC
state: New York
city: Lake Success
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Orchard Park
country: United States
facility: Southtowns Gastroenterology, PLLC
state: New York
city: Jacksonville
country: United States
facility: East Carolina Gastroenterology
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants For Clinical Research Inc
state: Ohio
city: Cincinnati
country: United States
facility: Consultants For Clinical Research Inc
state: Ohio
city: Fairfield
country: United States
facility: Consultants For Clinical Research Inc
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Mentor
country: United States
facility: Ohio Clinical Research Partners LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Veteran's Research and Education Foundation - NAVREF - PPDS
state: Oklahoma
city: Pittsburgh
country: United States
facility: Veterans Research Foundation of Pittsburgh - NAVREF - PPDS
state: Pennsylvania
city: Wyomissing
country: United States
facility: Digestive Disease Associates
state: Pennsylvania
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Union City
country: United States
facility: Advanced Gastroenterology-Union City
state: Tennessee
city: Baytown
country: United States
facility: Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS
state: Texas
city: Cypress
country: United States
facility: Northside Gastroenterology
state: Texas
city: Garland
country: United States
facility: Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
state: Texas
city: Houston
country: United States
facility: Precision Research Institute, LLC
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic Inc.
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: Houston
country: United States
facility: Aztec Medical Research
state: Texas
city: Houston
country: United States
facility: BI Research Center
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute LLC
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - ERN - PPDS
state: Texas
city: Bountiful
country: United States
facility: HP Clinical Research
state: Utah
city: Galax
country: United States
facility: Mid Atlantic Health Specialists
state: Virginia
city: Winchester
country: United States
facility: Winchester Gastroenterology Associates
state: Virginia
city: Tacoma
country: United States
facility: CHI Franciscan Digestive Care Associates
state: Washington
city: Elkins
country: United States
facility: Exemplar Research, Inc. - Elkins
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Fundación Favaloro
city: Córdoba
country: Argentina
facility: Hospital Privado Centro Médico de Córdoba
city: San Miguel De Tucumán
country: Argentina
facility: Sanatorio 9 de Julio SA
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: St Vincents Hospital Melbourne - PPDS
state: Victoria
city: St. Veit an der Glan
country: Austria
facility: A.ö. Krankenhaus der Barmherzigen Brüder
state: Kärnten
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten
state: Saint Pölten
city: Graz
country: Austria
facility: LKH-Universitätsklinikum Klinikum Graz
state: Steiermark
city: Klagenfurt am Wörthersee
country: Austria
facility: Klinikum Klagenfurt Am Woerthersee
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
city: Wien
country: Austria
facility: Medizinische Universitat Wien (Medical University of Vienna)
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
state: Vlaams Brabant
city: Kortrijk
country: Belgium
facility: AZ Groeninge
state: West-Vlaanderen
city: Mouscron
country: Belgium
facility: CHU Mouscron
city: Banja Luka
country: Bosnia and Herzegovina
facility: Clinical Center Banja Luka
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sveta Anna
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
state: Sofia-Grad
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Eurohospital
city: Ruse
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS
city: Sevlievo
country: Bulgaria
facility: Medical Center-1-Sevlievo EOOD
city: Sofia
country: Bulgaria
facility: Second Multiprofile Hospital for Active Treatment Sofia
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior OOD - PPDS
city: Sofia
country: Bulgaria
facility: Diagnostic and Consulting Center Aleksandrovska EOOD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
city: Sofia
country: Bulgaria
facility: Medical Center Convex EOOD
city: Varna
country: Bulgaria
facility: Diagnostic Consultative Centre Mladost - M OOD
city: Victoria
country: Canada
facility: Percuro Clinical Research LTD
state: British Columbia
city: Toronto
country: Canada
facility: Toronto Digestive Disease Associates Inc
state: Ontario
city: Medellin
country: Colombia
facility: Hospital Pablo Tobón Uribe
state: Antioquia
city: Bucaramanga
country: Colombia
facility: Servimed S.A.S
state: Santander
city: Cali
country: Colombia
facility: IPS Centro Médico Julián Coronel S.A.S. - PPDS
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
state: Grad Zagreb
city: Karlovac
country: Croatia
facility: Opca Bolnica Karlovac
state: Karlovacka Županija
city: Bjelovar
country: Croatia
facility: Opca bolnica Bjelovar
city: Osijek
country: Croatia
facility: Clinical Hospital Centre Osijek
city: Split
country: Croatia
facility: University Hospital Centre Split
city: Virovitica
country: Croatia
facility: General Hospital Virovitica
city: Vukovar
country: Croatia
facility: General County Hospital Vukovar and Croatian Veterans Hospital
city: Zadar
country: Croatia
facility: General Hospital Zadar
city: Hradec Králové
country: Czechia
facility: Hepato-Gastroenterologie HK, s. r. o.
state: Královéhradecký Kraj
city: Olomouc
country: Czechia
facility: PreventaMed s.r.o.
state: Olomoucký Kraj
city: Praha 4
country: Czechia
facility: Institut Klinicke A Experimentalni Mediciny
city: Praha 7
country: Czechia
facility: ISCARE I.V.F. a.s.
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
city: Ústi Nad Orlici
country: Czechia
facility: Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice
city: Kohta-Järve
country: Estonia
facility: East Viru Central Hospital
city: Parnu
country: Estonia
facility: OÜ LV Venter
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-Württemberg
city: Aachen
country: Germany
facility: Universitätsklinikum der RWTH Aachen
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Uniklinik Köln
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Gastro Campus Research GbR
state: Nordrhein-Westfalen
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Jena
country: Germany
facility: Universitatsklinikum Jena
state: Thüringen
city: Berlin-Zehlendorf
country: Germany
facility: Gastroenterologische Facharztpraxis am Mexikoplatz
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Biberach an der Riss
country: Germany
facility: Sana Klinikum Biberach
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Asklepios Westklinikum Hamburg Ggmbh
city: Munich
country: Germany
facility: Klinikum rechts der Isa der Technischen Universitaet Muenchen
city: Athens
country: Greece
facility: Ippokrateio General Hospital of Athens
state: Attiki
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Thessaloniki
country: Greece
facility: Theageneio Anticancer Oncology Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Euromedica - PPDS
city: Budapest
country: Hungary
facility: Magyar Honvédség Egészségügyi Központ
city: Budapest
country: Hungary
facility: Pannónia Magánorvosi Centrum Kft
city: Budapest
country: Hungary
facility: ENDOMEDIX Kft.
city: Békéscsaba
country: Hungary
facility: Bekes Megyei Kozponti Korhaz
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz
city: Mohacs
country: Hungary
facility: Mohacsi Korhaz
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa János Kórház
city: Szentes
country: Hungary
facility: Csongrad Megyei Dr. Bugyi Istvan Korhaz
city: Székesfehérvár
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Veszprém
country: Hungary
facility: Csolnoky Ferenc Korhaz
city: Vác
country: Hungary
facility: Jávorszky Ödön Kórház
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center - PPDS
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Nazareth
country: Israel
facility: Nazareth EMMS Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center PPDS
city: Tiberias
country: Israel
facility: Baruch Padeh Poriya Medical Center
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini Di Catanzaro
state: Calabria
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
state: Emilia-Romagna
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Di Modena Policlinico
state: Emilia-Romagna
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Lazio
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo Della Sofferenza IRCCS
state: Puglia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Negrar
country: Italy
facility: IRCCS Ospedale Sacro Cuore Don Calabria
state: Veneto
city: Padova
country: Italy
facility: Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino
state: Veneto
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia
city: Roma
country: Italy
facility: La Sapienza-Università di Roma-Policlinico Umberto I
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano di Torino
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaidô
city: Kobe-shi
country: Japan
facility: Medical Corporation Aoyama Clinic
state: Hyôgo
city: Nishinomiya-shi
country: Japan
facility: Hyogo College of Medicine
state: Hyôgo
city: Sagamihara
country: Japan
facility: Sagamihara Kyodo Hospital
state: Kanagawa
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center
state: Saitama
city: Chuo-Ku
country: Japan
facility: Nihonbashi Egawa Clinic
state: Tokyo
city: Minato-ku
country: Japan
facility: Jikei University Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Ome
country: Japan
facility: Ome Municipal General Hospital
state: Tokyo
city: Abiko
country: Japan
facility: Tokatsu Tsujinaka Hospital
city: Asahikawa
country: Japan
facility: Kunimoto Hospital
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital
city: Hakodate
country: Japan
facility: Hakodate Koseiin Hakodate Goryoukaku Hospital
city: Koganei
country: Japan
facility: Kawabe Clinic
city: Koga
country: Japan
facility: Yuai Memorial Hospital
city: Kurume-shi
country: Japan
facility: Hidaka Coloproctology Clinic
city: Matsumoto-shi
country: Japan
facility: Aizawa Hospital
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
city: Nishinomiya
country: Japan
facility: Nishinomiya Municipal Central Hospital
city: Oita
country: Japan
facility: Ishida Clinic of IBD and Gastroenterology
city: Onomichi
country: Japan
facility: Onomichi General Hospital
city: Osaka-shi
country: Japan
facility: Kinshukai Infusion Clinic
city: Osaka
country: Japan
facility: Chiinkai Dojima General & Gastroenterology Clinic
city: Otsu-Shi
country: Japan
facility: Shiga University of Medical Science Hospital
city: Sakai
country: Japan
facility: Bellland General Hospital
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
city: Sapporo-shi
country: Japan
facility: Sapporo Tokushukai Hospital
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
city: Sendai
country: Japan
facility: Tohoku Rosai Hospital
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital
city: Takatsuki
country: Japan
facility: Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital
city: Tokyo
country: Japan
facility: Koukokukai Ebisu Clinic
city: Beppu
country: Japan
facility: Shinbeppu Hospital
state: Ôita
city: Osaka
country: Japan
facility: Yodogawa Christian Hospital
state: Ôsaka
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Daegu Gwang'yeogsi
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Gang'weondo
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggido
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System - PPDS
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - PPDS
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center PPDS
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hospital
city: Beirut
country: Lebanon
facility: Rafik Hariri University Hospital
city: Saida
country: Lebanon
facility: Hammoud Hospital University Medical Center
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Vilnius
country: Lithuania
facility: Vilnius City Clinical Hospital
city: Cuernavaca
country: Mexico
facility: Clinica de Higado y Gastroenterologia Integral, S.C.
state: Morelos
city: Cuernavaca
country: Mexico
facility: JM Research S.C
state: Morelos
city: Merida
country: Mexico
facility: Unidad de Atencion Medica e Investigacion en Salud
state: Yucatán
city: Aguascalientes
country: Mexico
facility: Centro de Investigación Médica Aguascalientes
city: Cuautitlán Izcalli
country: Mexico
facility: Phylasis Clinicas Research S. de R.L. de C.V.
city: Distrito Federal
country: Mexico
facility: Centro de Investigacion Clinica Acelerada, S.C.
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
city: Monterrey
country: Mexico
facility: Accelerium, S. de R.L. de C.V.
city: Tlalnepantla De Baz
country: Mexico
facility: Clinical Research Institute
city: Zapopan
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
city: Tilburg
country: Netherlands
facility: ETZ-Elisabeth
state: Noord-Brabant
city: Alkmaar
country: Netherlands
facility: NWZ, location Alkmaar
state: Noord-Holland
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
state: Zuid-Holland
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Amsterdam
city: Grafton
country: New Zealand
facility: Auckland City Hospital
state: Auckland
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
state: South Island
city: Newtown
country: New Zealand
facility: Wellington Hospital
state: Wellington
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Wroclaw
country: Poland
facility: Melita Medical
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Lexmedica
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Vitamed Galaj i Cichomski sp.j.
state: Kujawsko-pomorskie
city: Torun
country: Poland
facility: Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
state: Kujawsko-pomorskie
city: Wloclawek
country: Poland
facility: Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.
state: Kujawsko-pomorskie
city: Lódz
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
state: Lódzkie
city: Lódz
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
state: Lódzkie
city: Lódz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
state: Lódzkie
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne
state: Malopolskie
city: Jozefow
country: Poland
facility: BioVirtus Centrum Medyczne
state: Mazowieckie
city: Warszawa
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej VIVAMED
state: Mazowieckie
city: Warszawa
country: Poland
facility: Miedzyleski Szpital Specjalistyczny w Warszawie
state: Mazowieckie
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
state: Podlaskie
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
state: Pomorskie
city: Katowice
country: Poland
facility: Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach
state: Slaskie
city: Konskie
country: Poland
facility: Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii
state: Swietokrzyskie
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecińskie Centrum Medyczne
state: Zachodniopomorskie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Pratia Bydgoszcz
city: Czestochowa
country: Poland
facility: Centrum Medyczne Czestochowa - PRATIA - PPDS
city: Gdynia
country: Poland
facility: Centrum Medyczne Gdynia - PRATIA - PPDS
city: Katowice
country: Poland
facility: NZOZ All Medicus
city: Krakow
country: Poland
facility: Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska
city: Ksawerow
country: Poland
facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
city: Lodz
country: Poland
facility: Med Gastr Sp.z.o.o Sp.k
city: Nowa Sól
country: Poland
facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol
city: Piaseczno
country: Poland
facility: Centrum Innowacyjnych Terapii
city: Poznan
country: Poland
facility: Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa
city: Rzeszow
country: Poland
facility: Korczowski Bartosz, Gabinet Lekarski
city: Szczecin
country: Poland
facility: Bandurskiego 98/U12
city: Szczecin
country: Poland
facility: Sonomed Sp. z o.o.
city: Tychy
country: Poland
facility: H-T. Centrum Medyczne Endoterapia
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: Centrum Medyczne Warszawa - PRATIA - PPDS
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW
city: Zamosc
country: Poland
facility: Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
city: Lisbon
country: Portugal
facility: Hospital da Luz
state: Lisboa
city: Braga
country: Portugal
facility: Hospital de Braga
city: Faro
country: Portugal
facility: Centro Hospitalar do Algarve - Hospital de Portimao
city: Guimarães
country: Portugal
facility: Hospital Senhora da Oliveira - Guimaraes, E.P.E
city: Setubal
country: Portugal
facility: Hospital de São Bernardo
city: Cluj-Napoca
country: Romania
facility: Cluj-Napoca Emergency Clinical County Hospital
state: Cluj
city: Bucharest
country: Romania
facility: Dr.Carol Davila Emergency University Central Military Hospital
city: Bucharest
country: Romania
facility: Sana Monitoring SRL
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital
city: Bucharest
country: Romania
facility: Prof. Dr. Matei Bals Institute of Infectious Diseases
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Bucuresti
country: Romania
facility: Centrul Medical Hifu Terramed Conformal S.R.L.
city: Constanta
country: Romania
facility: Affidea Romania SRL
city: Iasi
country: Romania
facility: Gastromedica SRL
city: Oradea
country: Romania
facility: Dr. Tirnaveanu Amelita Private Practice
city: Timisoara
country: Romania
facility: Dr. Goldis Gastroenterology Center SRL
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific Center
city: Moscow
country: Russian Federation
facility: Moscow Regional Research Clinical Institute Na Mfvladimirskiy
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
city: Novosibirsk
country: Russian Federation
facility: Research Institute of Physiology and Basic Medicine
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Saint Petersburg
country: Russian Federation
facility: Union Clinic, LLC
city: Saint Petersburg
country: Russian Federation
facility: Russian Medical Military Academy n.a. S.M. Kirov
city: Samara
country: Russian Federation
facility: Medical University Reaviz
city: Samara
country: Russian Federation
facility: Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city
city: Samara
country: Russian Federation
facility: Medical Company Hepatolog, LLC
city: Saratov
country: Russian Federation
facility: SHI Regional Clinical Hospital
city: Smolensk
country: Russian Federation
facility: Smolensk Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: St. Elizabeth Municipal Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: First St. Petersburg State Medical University n.a. I.P Pavlov
city: Stavropol
country: Russian Federation
facility: Stavropol State Medical University
city: Tyumen
country: Russian Federation
facility: Regional Consulting and Diagnostics Centre
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska Kosa
city: Nis
country: Serbia
facility: University Clinical Center Nis
city: Vrsac
country: Serbia
facility: General Hospital Vrsac
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
state: Šumadijski Okrug
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava
city: Nitra
country: Slovakia
facility: KM Management, spol. s r.o.
city: Presov
country: Slovakia
facility: Gastro LM, s.r.o.
city: Johannesburg
country: South Africa
facility: CLINRESCO, ARWYP Medical Suites
state: Gauteng
city: Pretoria
country: South Africa
facility: Dr. J Breedt
state: Gauteng
city: Claremont
country: South Africa
facility: Dr JP Wright
state: Western Cape
city: Cordoba
country: Spain
facility: C.H. Regional Reina Sofia - PPDS
state: Córdoba
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Vigo
country: Spain
facility: CHUVI - H.U. Alvaro Cunqueiro
state: Pontevedra
city: Barcelona
country: Spain
facility: Centro Medico Teknon - Grupo Quironsalud
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz - PPDS
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - PPDS
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Zürich
country: Switzerland
facility: Universität Zürich
state: Zürich (de)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"
state: Chernivets'ka Oblast
city: Kharkiv
country: Ukraine
facility: Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council
state: Kharkivs'ka Oblast
city: Kyiv
country: Ukraine
facility: Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
state: Kyïv
city: Vinnytsia
country: Ukraine
facility: Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
state: Vinnyts'ka Oblast
city: Zaporizhzhia
country: Ukraine
facility: Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council
state: Zaporiz'ka Oblast
city: Dnipro
country: Ukraine
facility: ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
city: Dnipro
country: Ukraine
facility: LLC Medical Center Family Medicine Clinic
city: Dnipro
country: Ukraine
facility: State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
city: Kharkiv
country: Ukraine
facility: Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine
city: Kharkiv
country: Ukraine
facility: Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital
city: Kharkiv
country: Ukraine
facility: MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection
city: Kherson
country: Ukraine
facility: Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh
city: Kryvyi Rih
country: Ukraine
facility: Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council
city: Kyiv
country: Ukraine
facility: Medical Center of LLC Medical Clinic Blagomed
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #18
city: Kyiv
country: Ukraine
facility: Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"
city: Kyiv
country: Ukraine
facility: Municipal Institution of KRC Kyiv Regional Hospital #2
city: Lviv
country: Ukraine
facility: Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway
city: Lviv
country: Ukraine
facility: Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital
city: Odesa
country: Ukraine
facility: Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council
city: Uzhhorod
country: Ukraine
facility: MNPE Central City Clinical Hospital of Uzhhorod City Council
city: Vinnytsia
country: Ukraine
facility: Medical Clinical Research Center of Medical Center LLC Health Clinic
city: Vinnytsia
country: Ukraine
facility: Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
city: Vinnytsia
country: Ukraine
facility: Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
city: Zaporizhzhia
country: Ukraine
facility: MNPE City Hospital No. 6 of Zaporizhzhia City Council
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary - PPDS
state: Aberdeen City
city: Lancashire
country: United Kingdom
facility: Fairfield General Hospital - PPDS
state: Bury
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
state: London, City Of
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
state: Northumberland
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
state: Shropshire
city: Edinburh
country: United Kingdom
facility: Western General Hospital Edinburgh - PPDS
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital - PPDS
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Shire
name: Study Director
role: STUDY_DIRECTOR
References: