279
Participants
Start Date
December 5, 2017
Primary Completion Date
July 15, 2020
Study Completion Date
October 6, 2020
Ontamalimab
Participants will receive 1 mL of ontamalimab 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.
Medical Center Excelsior OOD - PPDS, Sofia
Auckland City Hospital, Grafton
Magyar Honvédség Egészségügyi Központ, Budapest
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
Medical Center Convex EOOD, Sofia
University Multiprofile Hospital for Active Treatment Sveta Anna, Sofia
Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD, Sofia
Jávorszky Ödön Kórház, Vác
UZ Gasthuisberg, Leuven
Waikato Hospital, Hamilton
Multiprofile Hospital for Active Treatment Eurohospital, Plovdiv
Debreceni Egyetem Klinikai Kozpont, Debrecen
Medical Center-1-Sevlievo EOOD, Sevlievo
Bekes Megyei Kozponti Korhaz, Békéscsaba
Bekes Megyei Kozponti Korhaz, Gyula
University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD, Pleven
Wellington Hospital, Newtown
Csongrad Megyei Dr. Bugyi Istvan Korhaz, Szentes
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS, Rousse
Tolna Megyei Balassa János Kórház, Szekszárd
CHU Mouscron, Mouscron
Mohacsi Korhaz, Mohács
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár
Universität Zürich, Zurich
Csolnoky Ferenc Korhaz, Veszprém
AZ Groeninge, Kortrijk
UZ Gent, Ghent
Diagnostic Consultative Centre Mladost - M OOD, Varna
Dunedin Hospital, Dunedin
Weill Cornell Medical College, New York
West Tallinn Central Hospital, Tallinn
NYU Langone Long Island Clinical Research Associates, Great Neck
Ippokrateio General Hospital of Athens, Athens
CHA Bundang Medical Center, CHA University, Seongnam
C.H. Regional Reina Sofia - PPDS, Córdoba
Southtowns Gastroenterology, PLLC, Orchard Park
Veterans Research Foundation of Pittsburgh - NAVREF - PPDS, Pittsburgh
The Catholic University of Korea, St. Vincent's Hospital, Suwon
Centro de Investigación Médica Aguascalientes, Aguascalientes
Chevy Chase Clinical Research, Chevy Chase
Municipal Nonprofit Enterprise Vinnytsia City Clinical Hospital #1, Vinnytsia
Hospital Universitario Juan Ramon Jimenez, Huelva
Medical Clinical Research Center of Medical Center LLC Health Clinic, Vinnytsia
Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC, Vinnytsia
Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC, Vinnytsia
City Clinical Hospital #1, Vinnytsia
"Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital №1", Vinnytsia
Winchester Gastroenterology Associates, Winchester
Mid Atlantic Health Specialists, Galax
Yonsei University Wonju Severance Christian Hospital, Wŏnju
University General Hospital of Patras, Pátrai
Hospital Universitario de La Princesa, Madrid
Hospital Universitario Fundacion Jimenez Diaz, Madrid
Hospital Universitario La Paz - PPDS, Madrid
East Carolina Gastroenterology, Jacksonville
Hospital Universitario de Fuenlabrada, Fuenlabrada
Atlanta Gastroenterology Specialists, PC, Suwanee
Atlanta Center For Gastroenterology PC, Decatur
Infinite Clinical Trials, Atlanta
East Viru Central Hospital, Kohta-Järve
ENCORE Borland-Groover Clinical Research - ERN - PPDS, Jacksonville
Alliance Medical Research LLC, Lighthouse PT
Crystal Biomedical Research, Miami Lakes
Hi Tech and Global Research, LLc, Coral Gables
Sanchez Clinical Research, Inc, Miami
Mersin University Medical Faculty, Mersin
DBC Research, Tamarac
BRCR Medical Center Inc., Plantation
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
Istanbul Universitesi Cerrahpasa Tip Fakultesi, Istanbul
Pharma Research International Inc, Naples
Bayside Clinical Research - New Port Richey, New Port Richey
SIH Research, Kissimmee
CHUVI - H.U. Alvaro Cunqueiro, Vigo
Hospital Universitario Virgen del Rocio - PPDS, Seville
Gastroenterology Associates of Hazard, Hazard
Kyungpook National University Hospital, Daegu
Yeungnam University Hospital, Daegu
Ohio Clinical Research Partners LLC, Mentor
Prestige Clinical Research, Franklin
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V., Zapopan, Jalisco
Hospital Universitari i Politecnic La Fe de Valencia, Valencia
Clinical Research Institute of Michigan, Chesterfield
Inje University Haeundae Paik Hospital, Busan
University of Michigan, Ann Arbor
National Clinical, LLC, Hamtramck
ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council, Dnipro
LLC Medical Center Family Medicine Clinic, Dnipro
"State Institution Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine", Dnipro
Pusan National University Hospital, Busan
Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council, Kryvyi Rih
Theageneio Anticancer Oncology Hospital of Thessaloniki, Thessaloniki
Clinical Research Institute, Tlalnepantla
Mayo Clinic Health System - PPDS, La Crosse
Euromedica - PPDS, Thessaloniki
Phylasis Clinicas Research S. de R.L. de C.V., Cuautitlán Izcalli
"Regional Municipal Non-profit Enterprise Chernivtsi Regional Clinical Hospital", Chernivtsi
IL Gastroenterology Group, Gurnee
Edward Hines Jr VA Hospital - NAVREF - PPDS, Hines
Dupage Medical Group, Oakbrook Terrace
Loretto Hospital, Chicago
Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council, Kharkiv
Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine, Kharkiv
Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital, Kharkiv
MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection, Kharkiv
Clinica de Higado y Gastroenterologia Integral, S.C., Cuernavaca
JM Research S.C, Cuernavaca
Washington University in St. Louis, St Louis
St Louis Center For Clinical Research, St Louis
Accelerium, S. de R.L. de C.V., Monterrey
Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council, Odesa
Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council, Zaporizhzhia
MNPE City Hospital No. 6 of Zaporizhzhia City Council, Zaporizhzhia
CroNOLA, LLC., Houma
Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh, Kherson
Veteran's Research and Education Foundation - NAVREF - PPDS, Oklahoma City
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
Aztec Medical Research, Houston
BI Research Center, Houston
Clinical Center Banja Luka, Banja Luka
Southern Star Research Institute LLC, San Antonio
Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway, Lviv
Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital, Lviv
OÜ LV Venter, Pärnu
Elite Clinical Studies - Phoenix - Clinedge - PPDS, Phoenix
Arizona Digestive Health Mesa - East, Mesa
MNPE Central City Clinical Hospital of Uzhhorod City Council, Uzhhorod
Encompass Care, North Las Vegas
Advanced Biomedical Research of America, Las Vegas
VA Long Beach Healthcare System - NAVREF - PPDS, Long Beach
Facey Medical Foundation, Mission Hills
United Medical Doctors, Encinitas
University of California San Diego, La Jolla
Alliance Clinical Research-(Vestavia Hills), Poway
United Medical Doctors, Murrieta
Advanced Research Center, Anaheim
Kindred Medical Institute for Clinical Trials, LLC, Corona
University of California San Francisco, San Francisco
Care Access Research, San Pablo, San Pablo
Unidad de Atencion Medica e Investigacion en Salud, Mérida
Fundación Clínica Shaio, Bogota
Servimed S.A.S, Bucaramanga
Commonwealth Clinical Studies LLC, Brockton
UMass Memorial Medical Center, Worcester
Sanatorio 9 de Julio SA, San Miguel de Tucumán
Fundación Favaloro, Buenos Aires
Hospital Privado Centro Médico de Córdoba, Córdoba
IPS Centro Médico Julián Coronel S.A.S. - PPDS, Santiago de Cali
Rafik Hariri University Hospital, Beirut
Hammoud Hospital University Medical Center, Saida
Percuro Clinical Research LTD, Victoria
Toronto Digestive Disease Associates Inc, Toronto
Hospital Pablo Tobón Uribe, Medellín
St Vincent's University Hospital, Dublin
Sapporo Medical University Hospital, Sapporo
Medical Corporation Aoyama Clinic, Kobe
Hyogo College of Medicine, Nishinomiya-shi
Kunimoto Hospital, Asahikawa
Fukuoka University Chikushi Hospital, Chikushino-shi
Aizawa Hospital, Matsumoto-shi
Chiinkai Dojima General & Gastroenterology Clinic, Osaka
Kinshukai Infusion Clinic, Osaka
Yodogawa Christian Hospital, Osaka
Ishida Clinic of IBD and Gastroenterology, Ōita
Bellland General Hospital, Sakai
Toho University Sakura Medical Center, Sakura
Tohoku Rosai Hospital, Sendai
Dokkyo Medical University Hospital, Shimotsuga-gun
Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital, Takatsuki
Nihonbashi Egawa Clinic, Tokyo
Koukokukai Ebisu Clinic, Tokyo
Health Pharma Professional Research S.A de C.V., Mexico City
Centro de Investigacion Clinica Acelerada, S.C., Distrito Federal
Hospital de Braga, Braga
Hospital Senhora da Oliveira - Guimaraes, E.P.E, Guimarães
Hospital da Luz, Lisbon
Centro Hospitalar do Algarve - Hospital de Portimao, Portimão
Hospital de São Bernardo, Setúbal
Univerzitna nemocnica Bratislava, Bratislava
KM Management, spol. s r.o., Nitra
Gastro LM, s.r.o., Prešov
Kyungpook National University Chilgok Hospital, Daegu
Gachon University Gil Medical Center, Incheon
Kyung Hee University Hospital, Seoul
Seoul National University Hospital, Seoul
Kangbuk Samsung Hospital, Seoul
Severance Hospital Yonsei University Health System - PPDS, Seoul
Asan Medical Center - PPDS, Seoul
Samsung Medical Center PPDS, Seoul
Inje University Seoul Paik Hospital, Seoul
Centro Medico Teknon - Grupo Quironsalud, Barcelona
Medical Center of LLC Medical Clinic Blagomed, Kyiv
Kyiv City Clinical Hospital #18, Kyiv
"Treatment and Diagnostic Center Healthy and Happy of LLC Healthy and Happy", Kyiv
Municipal Institution of KRC Kyiv Regional Hospital #2, Kyiv
Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital, Kyiv
Lead Sponsor
Shire
INDUSTRY