40
Participants
Start Date
February 6, 2019
Primary Completion Date
June 21, 2021
Study Completion Date
September 13, 2021
Ontamalimab
SC injection of 25 mg or 75 mg ontamalimab will be administered using a prefilled syringe.
Placebo
SC injection of placebo matched with ontamalimab will be administered using a prefilled syringe.
St Vincent's University Hospital, Dublin
Magyar Honvédség Egészségügyi Központ, Budapest
Medizinische Universitat Wien (Medical University of Vienna), Vienna
Pannónia Magánorvosi Centrum Kft, Budapest
ENDOMEDIX Kft., Budapest
Second Multiprofile Hospital for Active Treatment Sofia, Sofia
Diagnostic and Consulting Center Aleksandrovska EOOD, Sofia
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD, Sofia
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD, Sofia
CLINRESCO, ARWYP Medical Suites, Johannesburg
Medical Center Excelsior OOD - PPDS, Sofia
Medical Center Convex EOOD, Sofia
Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD, Sofia
Concord Repatriation General Hospital, Concord
Liverpool Hospital, Liverpool
Academisch Medisch Centrum Amsterdam, Bonheiden
The Alfred Hospital, Melbourne
St Vincents Hospital Melbourne - PPDS, Fitzroy
Waikato Hospital, Hamilton
Multiprofile Hospital for Active Treatment Eurohospital, Plovdiv
Debreceni Egyetem Klinikai Kozpont, Debrecen
Mater Hospital Brisbane, South Brisbane
Royal Adelaide Hospital, Adelaide
Salzburger Landeskliniken, Salzburg
Bekes Megyei Kozponti Korhaz, Békéscsaba
Wellington Hospital, Newtown
Tolna Megyei Balassa János Kórház, Szekszárd
CHU Mouscron, Mouscron
Mohacsi Korhaz, Mohács
Dr JP Wright, Claremont
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár
LKH-Universitätsklinikum Klinikum Graz, Graz
AZ Groeninge, Kortrijk
UZ Gent, Ghent
Diagnostic Consultative Centre Mladost - M OOD, Varna
Dunedin Hospital, Dunedin
University Hospital Center Zagreb, Zagreb
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino
West Tallinn Central Hospital, Tallinn
NYU Langone Long Island Clinical Research Associates, Great Neck
Clinical Hospital Center Bezanijska Kosa, Belgrade
New York Total Medical Care PC, Brooklyn
Ippokrateio General Hospital of Athens, Athens
Charité - Universitätsmedizin Berlin, Berlin
CHA Bundang Medical Center, CHA University, Seongnam
C.H. Regional Reina Sofia - PPDS, Córdoba
Southtowns Gastroenterology, PLLC, Orchard Park
Gastroenterologische Facharztpraxis am Mexikoplatz, Berlin-Zehlendorf
Baruch Padeh Poriya Medical Center, Tiberias
The Catholic University of Korea, St. Vincent's Hospital, Suwon
Penn State Hershey Medical Group, State College
Iatriko Palaiou Falirou, Paliao Faliro
University Clinical Center Nis, Niš
Digestive Disease Associates, Wyomissing
Istituto Clinico Humanitas, Rozzano (MI)
Hospital Universitario Juan Ramon Jimenez, Huelva
Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1, Vinnytsia
Gachon University Gil Medical Center, Incheon
Galilee Medical Center, Nahariya
Winchester Gastroenterology Associates, Winchester
Universitatsklinikum Schleswig-Holstein, Kiel
Mid Atlantic Health Specialists, Galax
General Hospital Vrsac, Vršac
Yonsei University Wonju Severance Christian Hospital, Wŏnju
University General Hospital of Patras, Pátrai
Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia
Hospital General Universitario Gregorio Maranon, Madrid
Hospital Universitario Fundacion Jimenez Diaz, Madrid
Hospital Universitario La Paz - PPDS, Madrid
A.O.U. Maggiore della Carità, Novara
Piedmont Healthcare, Statesville
Hospital Universitario de Fuenlabrada, Fuenlabrada
Atlanta Center For Gastroenterology PC, Decatur
Atlanta Gastroenterology Specialists, PC, Atlanta
Infinite Clinical Trials, Atlanta
Clinical Hospital Centre Osijek, Osijek
East Coast Institute for Research, LLC, Saint Augustine
Omega Research Consultants LLC - Clinedge - PPDS, Orlando
General Hospital Virovitica, Virovitica
Crystal Biomedical Research, Miami Lakes
Alliance Medical Research LLC, Coral Springs
Advanced Clinical Research Network, Coral Gables
Hi Tech and Global Research, LLc, Miami
Sanchez Clinical Research, Inc, Miami
Mersin University Medical Faculty, Mersin
DBC Research, Tamarac
Bayside Clinical Research - New Port Richey, Tampa
Gastro Florida, Clearwater
Accel Research Sites - St. Petersburg - ERN - PPDS, Pinellas Park
Renaissance Research Medical Group, INC, Cape Coral
Instituto de Investigaciones Aplicadas a la Neurociencia A.C., Durango
University Clinical Center Kragujevac, Kragujevac
Gastroenterology Group of Naples, Naples
Pharma Research International Inc, Naples
SIH Research, Kissimmee
CHUVI - H.U. Alvaro Cunqueiro, Vigo
IRCCS Ospedale Sacro Cuore Don Calabria, Negrar
Vanderbilt University Medical Center, Nashville
Gastro One, Germantown
Advanced Gastroenterology-Union City, Union City
Hospital Universitario Virgen del Rocio - PPDS, Seville
Azienda Ospedaliero Universitaria Di Modena Policlinico, Modena
Gastroenterology Associates of Hazard, Hazard
Kyungpook National University Hospital, Daegu
Opca bolnica Bjelovar, Bjelovar
Consultants For Clinical Research Inc, Fairfield
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V., Zapopan
Consultants For Clinical Research Inc, Cincinnati
Consultants For Clinical Research Inc, Cincinnati
Laporte County Institute For Clinical Research, Michigan City
Clinical Research Institute of Michigan, Chesterfield
Inje University Haeundae Paik Hospital, Busan
University of Michigan, Ann Arbor
Gastro Campus Research GbR, Münster
National Clinical, LLC, Hamtramck
LLC Medical Center Family Medicine Clinic, Dnipro
Pusan National University Hospital, Busan
Gastroenterology Associates of Western Michigan, PLC, Wyoming
Azienda Ospedaliera Universitaria Careggi, Florence
Uniklinik Köln, Cologne
Universitätsklinikum der RWTH Aachen, Aachen
Euromedica - PPDS, Thessaloniki
Minnesota Gastroenterology PA, Saint Paul
Mayo Clinic Health System - PPDS, Duluth
"Regional Municipal Non-profit Enterprise Chernivtsi Regional Clinical Hospital", Chernivtsi
IL Gastroenterology Group, Gurnee
Universitätsklinikum Frankfurt, Frankfurt
Loretto Hospital, Chicago
Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council, Kharkiv
Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital, Kharkiv
Clinica de Higado y Gastroenterologia Integral, S.C., Cuernavaca
JM Research S.C, Cuernavaca
Washington University in St. Louis, St Louis
Accelerium, S. de R.L. de C.V., Monterrey
Cotton O'Neil Clinical Research Center, Topeka
MNPE City Hospital No. 6 of Zaporizhzhia City Council, Zaporizhzhia
DelRicht Clinical Research, LLC - ClinEdge - PPDS, New Orleans
CroNOLA, LLC., Houma
Clinical Trials of SWLA, LLC, Lake Charles
Ospedale Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo
Louisiana Research Center LLC, Shreveport
University General Hospital of Heraklion, Heraklion
Atria Clinical Research - Clinedge - PPDS, Little Rock
Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh, Kherson
Digestive Health Associates of Texas, P.A.dba DHAT Research Institute, Garland
Precision Research Institute, LLC, Houston
Biopharma Informatic Inc., Houston
Southwest Clinical Trials, Houston
BI Research Center, Houston
Northside Gastroenterology, Cypress
Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS, Webster
Clinical Center Banja Luka, Banja Luka
Southern Star Research Institute LLC, San Antonio
Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital, Lviv
OÜ LV Venter, Pärnu
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
Elite Clinical Studies - Phoenix - Clinedge - PPDS, Phoenix
Arizona Digestive Health Mesa - East, Mesa
CATS Research Center - University of Arizona, Tucson
Azienda Ospedaliera Mater Domini Di Catanzaro, Catanzaro
Sana Klinikum Biberach, Biberach an der Riss
Encompass Care, North Las Vegas
Advanced Biomedical Research of America, Las Vegas
Shaare Zedek Medical Center, Jerusalem
Hadassah Medical Center - PPDS, Jerusalem
Alliance Clinical Research-(Vestavia Hills), Poway
Inland Empire Liver Foundation, Rialto
Advanced Research Center, Anaheim
Kindred Medical Institute for Clinical Trials, LLC, Corona
OM Research LLC - Lancaster - ClinEdge - PPDS, Lancaster
Care Access Research, San Pablo, San Pablo
Unidad de Atencion Medica e Investigacion en Salud, Mérida
St. Elizabeth Municipal Clinical Hospital, Saint Petersburg
Dr. Goldis Gastroenterology Center SRL, Timișoara
Rostov State Medical University, Rostov-on-Don
Cluj-Napoca Emergency Clinical County Hospital, Cluj-Napoca
SHI Regional Clinical Hospital, Saratov
Dr. Tirnaveanu Amelita Private Practice, Oradea
Medical University Reaviz, Samara
Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city, Samara
Gastromedica SRL, Iași
Fundación Valle Del Lili, Santiago de Cali
Commonwealth Clinical Studies LLC, Brockton
UMass Memorial Medical Center, Worcester
Fundación Favaloro, Buenos Aires
Hospital Privado Centro Médico de Córdoba, Córdoba
IPS Centro Médico Julián Coronel S.A.S. - PPDS, Santiago de Cali
Onomichi General Hospital, Onomichi
Al Zahraa University Hospital, Beirut
Hammoud Hospital University Medical Center, Saida
Russian Medical Military Academy n.a. S.M. Kirov, Saint Petersburg
Clinical Hospital Center Zemun, Zemun
Klinikum Wels-Grieskirchen GmbH, Vienna
Universitatsklinikum Jena, Jena
Fondazione Policlinico Universitario A Gemelli, Rome
La Sapienza-Università di Roma-Policlinico Umberto I, Roma
Sapporo Medical University Hospital, Sapporo
Medical Corporation Aoyama Clinic, Kobe
Hyogo College of Medicine, Nishinomiya-shi
Jikei University Hospital, Minato-ku
Ome Municipal General Hospital, Ōme
Kunimoto Hospital, Asahikawa
Hidaka Coloproctology Clinic, Kurume-shi
Aichi Medical University Hospital, Nagakute
Nishinomiya Municipal Central Hospital, Nishinomiya
Chiinkai Dojima General & Gastroenterology Clinic, Osaka
Kinshukai Infusion Clinic, Osaka
Yodogawa Christian Hospital, Osaka
Shiga University of Medical Science Hospital, Ōtsu
Toho University Sakura Medical Center, Sakura
Sapporo Higashi Tokushukai Hospital, Sapporo
Sapporo Tokushukai Hospital, Sapporo
Dokkyo Medical University Hospital, Shimotsuga-gun
Nihonbashi Egawa Clinic, Tokyo
Colo-Proctology Center Matsushima Clinic, Yokohama
Ishida Clinic of IBD and Gastroenterology, Ōita
Vilnius University Hospital Santaros Klinikos, Vilnius
Vilnius City Clinical Hospital, Vilnius
Centro de Investigacion Clinica Acelerada, S.C., Distrito Federal
ETZ-Elisabeth, Tilburg
NWZ, location Alkmaar, Den Helder
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
Melita Medical, Wroclaw
Lexmedica, Wroclaw
Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny, Lódz
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J., Lódz
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, 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
Twoja Przychodnia - Szczecinskie Centrum Medyczne, Szczecin
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Bydgoszcz
Centrum Medyczne Czestochowa - PRATIA - PPDS, Częstochowa
Centrum Medyczne Gdynia - PRATIA - PPDS, Gdynia
NZOZ All Medicus, Katowice
Med Gastr Sp.z.o.o Sp.k, Lodz
Instytut Centrum Zdrowia Matki Polki, Lodz
Twoja Przychodnia - Centrum Medyczne Nowa Sol, Nowa Sól
Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa, Poznan
Centrum Medyczne Warszawa - PRATIA - PPDS, Rzeszów
Korczowski Bartosz, Gabinet Lekarski, Rzeszów
Sonomed Sp. z o.o., Szczecin
Centrum Zdrowia M D M, Warsaw
Centralny Szpital Kliniczny MSW, Warsaw
BioVirtus Centrum Medyczne, Warsaw
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II, Zamość
Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii, Gmina Końskie
Hospital Senhora da Oliveira - Guimaraes, E.P.E, Guimarães
Hospital da Luz, Lisbon
Centro Hospitalar do Algarve - Hospital de Portimao, Portimão
Sana Monitoring SRL, Bucharest
Dr.Carol Davila Emergency University Central Military Hospital, 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
Emergency University Hospital, Bucharest
Affidea Romania SRL, Constanța
KM Management, spol. s r.o., Nitra
Gastro LM, s.r.o., Prešov
Dr. J Breedt, Pretoria
Kyungpook National University Chilgok Hospital, Daegu
Seoul National University Hospital, Seoul
Kangbuk Samsung Hospital, Seoul
Inje University Seoul Paik Hospital, Seoul
Centro Medico Teknon - Grupo Quironsalud, Barcelona
Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital, Kyiv
Medical Center of LLC Medical Clinic Blagomed, Kyiv
Medical Center OK!Clinic+LLC International Institute of Clinical Research, Kyiv
Medical Center of LLC Medical Center Dopomoga-Plus, Kyiv
Municipal Institution of KRC Kyiv Regional Hospital #2, Kyiv
North Tyneside General Hospital, North Shields
Aberdeen Royal Infirmary - PPDS, Aberdeen
Royal Gwent Hospital - PPDS, Newport
New Cross Hospital, Wolverhampton
Lead Sponsor
Shire
INDUSTRY