380
Participants
Start Date
February 9, 2018
Primary Completion Date
July 22, 2020
Study Completion Date
October 23, 2020
Ontamalimab
Participants will receive 1 mL of SHP647 sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).
Placebo
Participants will receive 1 mL of sterile aqueous buffered solution.
Medizinische Universitat Wien (Medical University of Vienna), Vienna
CLINRESCO, ARWYP Medical Suites, Johannesburg
Concord Repatriation General Hospital, Concord
Liverpool Hospital, Liverpool
The Alfred Hospital, Melbourne
St Vincents Hospital Melbourne - PPDS, Fitzroy
Universitätsklinikum St. Pölten, Sankt Pölten
Royal Brisbane & Women's Hospital, Herston
Mater Hospital Brisbane, South Brisbane
Klinikum Wels-Grieskirchen GmbH, Wels
Royal Adelaide Hospital, Adelaide
Salzburger Landeskliniken, Salzburg
Dr JP Wright, Claremont
LKH-Universitätsklinikum Klinikum Graz, Graz
Klinikum Klagenfurt Am Woerthersee, Klagenfurt
A.ö. Krankenhaus der Barmherzigen Brüder, Sankt Veit an der Glan
University Hospital Center Zagreb, Zagreb
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino
Azienda Ospedaliera Ordine Mauriziano di Torino, Torino
Clinical Hospital Center ''Bezanijska Kosa'', Belgrade
New York Total Medical Care PC, Brooklyn
Charité - Universitätsmedizin Berlin, Berlin
Gastroenterologische Facharztpraxis am Mexikoplatz, Berlin-Zehlendorf
Baruch Padeh Poriya Medical Center, Tiberias
Allegheny Center For Digestive Health, Pittsburgh
Nazareth EMMS Hospital, Nazareth
University Clinical Center Nis, Niš
Digestive Disease Associates, Wyomissing
Istituto Clinico Humanitas, Rozzano (MI)
University Hospital Centre Split, Split
Galilee Medical Center, Nahariya
Asklepios Westklinikum Hamburg Ggmbh, Hamburg
Universitatsklinikum Schleswig-Holstein, Kiel
Exemplar Research, Inc. - Elkins, Elkins
General Hospital Vrsac, Vršac
West Virginia University Hospital, Morgantown
Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia
A.O.U. Maggiore della Carità, Novara
Piedmont Healthcare, Statesville
Clinical Hospital Centre Osijek, Osijek
Gastrointestinal Diseases, Inc. Research, Columbus
General County Hospital Vukovar and Croatian Veterans Hospital, Vukovar
East Coast Institute for Research, LLC, Saint Augustine
Omega Research Consultants LLC - Clinedge - PPDS, Orlando
General Hospital Virovitica, Virovitica
Advanced Clinical Research Network, Coral Gables
Nuren Medical and Research Center, Miami
University Clinical Center Kragujevac, Kragujevac
Gastroenterology Group of Naples, Naples
Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino - INCIPIT - PIN, Padua
Ospedale Sacro Cuore Don Calabria, Negrar
Vanderbilt University Medical Center, Nashville
Gastro One, Germantown
Advanced Gastroenterology-Union City, Union City
Digestive Health Center PA, Ocean Springs
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi, Bologna
Azienda Ospedaliero Universitaria Di Modena Policlinico, Modena
Opca bolnica Bjelovar, Bjelovar
Consultants For Clinical Research Inc, Fairfield
Consultants For Clinical Research Inc, Cincinnati
Consultants For Clinical Research Inc, Cincinnati
Laporte County Institute For Clinical Research, Michigan City
Opca Bolnica Karlovac, Karlovac
Medisphere Medical Research Center LLC, Evansville
Gastro Campus Research GbR, Münster
Azienda Ospedaliera Universitaria Careggi, Florence
Uniklinik Köln, Cologne
Universitätsklinikum der RWTH Aachen, Aachen
Universitätsklinikum Frankfurt, Frankfurt
Northwestern University, Chicago
University of Chicago Medical Center, Chicago
Clinical Trials of SWLA LLC, Lake Charles
Ospedale Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo (FG)
Louisiana Research Center LLC, Shreveport
Atria Clinical Research - Clinedge - PPDS, Little Rock
DM Clinical Research - ERN - PPDS, Tomball
Northside Gastroenterology, Cypress
Inquest Clinical Research/Coastal Gastroenterology Associates, PA, Baytown
Peak Gastroenterology Associates, Colorado Springs
Asthma and Allergy Associates PC - CRN - PPDS, Colorado Springs
Klinikum rechts der Isa der Technischen Universitaet Muenchen, Munich
HP Clinical Research, Bountiful
Azienda Ospedaliera Mater Domini Di Catanzaro, Catanzaro
Sana Klinikum Biberach, Biberach an der Riss
Universitätsklinikum Ulm, Ulm
Shaare Zedek Medical Center, Jerusalem
Hadassah Medical Center - PPDS, Jerusalem
Inland Empire Liver Foundation, Rialto
OM Research LLC - Lancaster - ClinEdge - PPDS, Lancaster
Digestive Health Center at UWMC, Seattle
University of Washington, Seattle
CHI Franciscan Digestive Care Associates, Tacoma
Moscow Clinical Scientific Center, Moscow
Moscow Regional Research Clinical Institute Na Mfvladimirskiy, Moscow
Union Clinic, LLC, Saint Petersburg
St. Elizabeth Municipal Clinical Hospital, Saint Petersburg
First St. Petersburg State Medical University n.a. I.P Pavlov, Saint Petersburg
Smolensk Regional Clinical Hospital, Smoensk
Dr. Goldis Gastroenterology Center SRL, Timișoara
Rostov State Medical University, Rostov-on-Don
Rostov State Medical University, Rostov-on-Don
Stavropol State Medical University, Stavropol
Cluj-Napoca Emergency Clinical County Hospital, Cluj-Napoca
SHI Regional Clinical Hospital, Saratov
Dr. Tirnaveanu Amelita Private Practice, Oradea
Kazan State Medical University, Kazan'
Medical University Reaviz, Samara
Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city, Samara
Medical Company Hepatolog, LLC, Samara
Nizhegorodskaya Regional Clinical Hospital n.a. Semashko, Nizhny Novgorod
Regional Consulting and Diagnostics Centre, Tyumen
Research Institute of Physiology and Basic Medicine, Novosibirsk
Gastromedica SRL, Iași
Tel Aviv Sourasky Medical Center PPDS, Tel Aviv
Massachusetts General Hospital, Boston
Instituto Goiano de Gastroenterologia E Endoscopia Digestiva Ltda, Goiânia
Hospital Da Cidade de Passo Fundo, Passo Fundo
CEMEC - Centro Multidisciplinar de Estudos Clínicos, Santo André
General Hospital Zadar, Zadar
Hepato-Gastroenterologie HK, s. r. o., Hradec Králové
PreventaMed s.r.o., Olomouc
Institut Klinicke A Experimentalni Mediciny, Prague
ISCARE I.V.F. a.s., Prague
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ústí nad Labem
Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice, Ústí nad Orlicí
Universitätsklinikum Jena, Jena
Azienda Ospedaliera San Camillo Forlanini, Rome
La Sapienza-Università di Roma-Policlinico Umberto I, Roma
Fondazione Policlinico Universitario A Gemelli, Roma
Sapporo Tokushukai Hospital, Sapporo
Sagamihara Kyodo Hospital, Sagamihara
Jikei University Hospital, Minato-ku
Kitasato University Kitasato Institute Hospital, Minato-ku
Ome Municipal General Hospital, Ōme
Tokatsu Tsujinaka Hospital, Abiko-shi, Chiba
Hakodate Koseiin Hakodate Goryoukaku Hospital, Hakodate
Yuai Memorial Hospital, Koga
Kawabe Clinic, Koganei
Dokkyo Medical University Saitama Medical Center, Koshigaya
Hidaka Coloproctology Clinic, Kurume-shi
Aichi Medical University Hospital, Nagakute
Nishinomiya Municipal Central Hospital, Nishinomiya
Onomichi General Hospital, Onomichi
Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa, Poznan
Russian Medical Military Academy n.a. S.M. Kirov, Saint Petersburg
Shiga University of Medical Science Hospital, Ōtsu
Sapporo Higashi Tokushukai Hospital, Sapporo
Shinbeppu Hospital, Beppu
Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas
Vilnius University Hospital Santaros Klinikos, Vilnius
Vilnius City Clinical Hospital, Vilnius
ETZ-Elisabeth, Tilburg
NWZ, location Alkmaar, Alkmaar
Leids Universitair Medisch Centrum, Leiden
VU Medisch Centrum, Amsterdam
Academisch Medisch Centrum Amsterdam, Amsterdam
Vitamed Galaj i Cichomski sp.j., Bydgoszcz
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj, Torun
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o., Włocławek
Krakowskie Centrum Medyczne, Krakow
Melita Medical, Wroclaw
Lexmedica, Wroclaw
Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny, Lódz
SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej UM w Lodzi, Lódz
Instytut Centrum Zdrowia Matki Polki, Lódz
Centrum Medyczne Warszawa - PRATIA - PPDS, Warsaw
Niepubliczny Zakład Opieki Zdrowotnej VIVAMED, Warsaw
Miedzyleski Szpital Specjalistyczny w Warszawie, Warsaw
Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok
Endoskopia Sp. z o.o., Sopot
H-T. Centrum Medyczne Endoterapia, Tychy
Twoja Przychodnia - Szczecińskie Centrum Medyczne, Szczecin
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Bydgoszcz
Centrum Medyczne Pratia Bydgoszcz, Bydgoszcz
Centrum Medyczne Czestochowa - PRATIA - PPDS, Częstochowa
Centrum Medyczne Gdynia - PRATIA - PPDS, Gdynia
BioVirtus Centrum Medyczne, Józefów
Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach, Katowice
NZOZ All Medicus, Katowice
Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska, Krakow
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J., Ksawerów
Med Gastr Sp.z.o.o Sp.k, Lodz
Twoja Przychodnia - Centrum Medyczne Nowa Sol, Nowa Sól
Centrum Innowacyjnych Terapii, Piaseczno
Korczowski Bartosz, Gabinet Lekarski, Rzeszów
Sonomed Sp. z o.o., Szczecin
Centrum Zdrowia MDM, Warsaw
Centralny Szpital Kliniczny MSW, Warsaw
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II, Zamość
Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii, Gmina Końskie
Dr.Carol Davila Emergency University Central Military Hospital, Bucharest
Sana Monitoring SRL, Bucharest
Colentina Clinical Hospital, Bucharest
Prof. Dr. Matei Bals Institute of Infectious Diseases, Bucharest
Fundeni Clinical Institute, Bucharest
Centrul Medical Hifu Terramed Conformal S.R.L., Bucharest
Affidea Romania SRL, Constanța
Dr. J Breedt, Pretoria
Fairfield General Hospital - PPDS, Lancashire
Pennine Acute Hospitals Trust, Lancashire
Whipps Cross University Hospital, London
North Tyneside General Hospital, North Shields
Royal Shrewsbury Hospital, Shrewsbury
Aberdeen Royal Infirmary - PPDS, Aberdeen
Western General Hospital Edinburgh - PPDS, Edinburh
Royal Gwent Hospital - PPDS, Newport
New Cross Hospital, Wolverhampton
Lead Sponsor
Shire
INDUSTRY