Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)

PHASE3TerminatedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

July 17, 2018

Primary Completion Date

August 18, 2020

Study Completion Date

August 18, 2020

Conditions
Crohn's Disease
Interventions
BIOLOGICAL

Ontamalimab

Subcutaneous injection of ontamalimab will be administered using a prefilled syringe.

OTHER

Placebo

Subcutaneous injection of placebo matched with ontamalimab will be administered using a prefilled syringe.

Trial Locations (145)

4

St Vincent's University Hospital, Dublin

1062

Magyar Honvédség Egészségügyi Központ, Budapest

1135

Pannónia Magánorvosi Centrum Kft, Budapest

1139

ENDOMEDIX Kft., Budapest

1202

Second Multiprofile Hospital for Active Treatment Sofia, Sofia

1431

Diagnostic and Consulting Center Aleksandrovska EOOD, Sofia

University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD, Sofia

1527

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD, Sofia

1632

Medical Center Excelsior OOD - PPDS, Sofia

1680

Medical Center Convex EOOD, Sofia

1784

Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD, Sofia

3240

Waikato Hospital, Hamilton

4000

Multiprofile Hospital for Active Treatment Eurohospital, Plovdiv

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

5600

Bekes Megyei Kozponti Korhaz, Békéscsaba

6021

Wellington Hospital, Newtown

7100

Tolna Megyei Balassa János Kórház, Szekszárd

7700

CHU Mouscron, Mouscron

Mohacsi Korhaz, Mohács

8000

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

8022

Centro Medico Teknon - Grupo Quironsalud, Barcelona

8500

AZ Groeninge, Kortrijk

9000

UZ Gent, Ghent

Diagnostic Consultative Centre Mladost - M OOD, Varna

9016

Dunedin Hospital, Dunedin

10617

West Tallinn Central Hospital, Tallinn

11021

NYU Langone Long Island Clinical Research Associates, Great Neck

11527

Ippokrateio General Hospital of Athens, Athens

13496

CHA Bundang Medical Center, CHA University, Seongnam

14004

C.H. Regional Reina Sofia - PPDS, Córdoba

14127

Southtowns Gastroenterology, PLLC, Orchard Park

16247

The Catholic University of Korea, St. Vincent's Hospital, Suwon

16803

Penn State Hershey Medical Group, State College

17562

Iatriko Palaiou Falirou, Paliao Faliro

21005

Hospital Universitario Juan Ramon Jimenez, Huelva

21029

"Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital No1", Vinnytsia

21565

Gachon University Gil Medical Center, Incheon

22601

Winchester Gastroenterology Associates, Winchester

24333

Mid Atlantic Health Specialists, Galax

26426

Yonsei University Wonju Severance Christian Hospital, Wonju-si, Gangwon-do

26504

University General Hospital of Patras, Pátrai

28007

Hospital General Universitario Gregorio Maranon, Madrid

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28046

Hospital Universitario La Paz - PPDS, Madrid

28942

Hospital Universitario de Fuenlabrada, Fuenlabrada

30024

Atlanta Gastroenterology Specialists, PC, Suwanee

30033

Atlanta Center For Gastroenterology PC, Decatur

30349

Infinite Clinical Trials, Atlanta

33065

Crystal Biomedical Research, Miami Lakes

33071

Alliance Medical Research LLC, Coral Springs

33135

Hi Tech and Global Research, LLc, Miami

33157

Sanchez Clinical Research, Inc, Miami

33169

Mersin University Medical Faculty, Mersin

33321

DBC Research, Tamarac

33756

Gastro Florida, Clearwater

33781

Accel Research Sites - St. Petersburg - ERN - PPDS, Pinellas Park

33991

Renaissance Research Medical Group, INC, Cape Coral

34000

Instituto de Investigaciones Aplicadas a la Neurociencia A.C., Durango

34098

Istanbul Universitesi Cerrahpasa Tip Fakultesi, Istanbul

34110

Pharma Research International Inc, Naples

34655

Bayside Clinical Research - New Port Richey, New Port Richey

34741

SIH Research, Kissimmee

36312

CHUVI - H.U. Alvaro Cunqueiro, Vigo

41013

Hospital Universitario Virgen del Rocio - PPDS, Seville

41701

Gastroenterology Associates of Hazard, Hazard

41944

Kyungpook National University Hospital, Daegu

45030

Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V., Zapopan

48047

Clinical Research Institute of Michigan, Chesterfield

48108

Inje University Haeundae Paik Hospital, Busan

48109

University of Michigan, Ann Arbor

48212

National Clinical, LLC, Hamtramck

49038

LLC Medical Center Family Medicine Clinic, Dnipro

49241

Pusan National University Hospital, Busan

49519

Gastroenterology Associates of Western Michigan, PLC, Wyoming

54645

Euromedica - PPDS, Thessaloniki

55446

Minnesota Gastroenterology PA, Plymouth

55805

Mayo Clinic Health System - PPDS, Duluth

58001

"Regional Municipal Non-profit Enterprise Chernivtsi Regional Clinical Hospital", Chernivtsi

60031

IL Gastroenterology Group, Gurnee

60644

Loretto Hospital, Chicago

61037

Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council, Kharkiv

61058

Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital, Kharkiv

62170

Clinica de Higado y Gastroenterologia Integral, S.C., Cuernavaca

62290

JM Research S.C, Cuernavaca

63110

Washington University in St. Louis, St Louis

64000

Accelerium, S. de R.L. de C.V., Monterrey

66606

Cotton O'Neil Clinical Research Center, Topeka

69035

MNPE City Hospital No. 6 of Zaporizhzhia City Council, Zaporizhzhia

70115

DelRicht Clinical Research, LLC - ClinEdge - PPDS, New Orleans

70360

CroNOLA, LLC., Houma

71110

University General Hospital of Heraklion, Heraklion

73000

Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh, Kherson

75044

Digestive Health Associates of Texas, P.A.dba DHAT Research Institute, Garland

77039

Precision Research Institute, LLC, Houston

77043

Biopharma Informatic Inc., Houston

77074

Southwest Clinical Trials, Houston

77084

BI Research Center, Houston

78000

Clinical Center Banja Luka, Banja Luka

78229

Southern Star Research Institute LLC, San Antonio

79059

Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital, Lviv

80010

OÜ LV Venter, Pärnu

85018

Elite Clinical Studies - Phoenix - Clinedge - PPDS, Phoenix

85206

Arizona Digestive Health Mesa - East, Mesa

89086

Encompass Care, North Las Vegas

89123

Advanced Biomedical Research of America, Las Vegas

92064

Alliance Clinical Research-(Vestavia Hills), Poway

92805

Advanced Research Center, Anaheim

92879

Kindred Medical Institute for Clinical Trials, LLC, Corona

94806

Care Access Research, San Pablo, San Pablo

97000

Unidad de Atencion Medica e Investigacion en Salud, Mérida

760026

Fundación Valle Del Lili, Santiago de Cali

760035

IPS Centro Médico Julián Coronel S.A.S. - PPDS, Santiago de Cali

02302

Commonwealth Clinical Studies LLC, Brockton

01655

UMass Memorial Medical Center, Worcester

C1093AAS

Fundación Favaloro, Buenos Aires

Unknown

Hospital Privado Centro Médico de Córdoba, Córdoba

Al Zahraa University Hospital, Beirut

Hammoud Hospital University Medical Center, Saida

060-8543

Sapporo Medical University Hospital, Sapporo

650-0015

Medical Corporation Aoyama Clinic, Kobe

663-8501

Hyogo College of Medicine, Nishinomiya-shi

070-0061

Kunimoto Hospital, Asahikawa

530-0003

Chiinkai Dojima General & Gastroenterology Clinic, Osaka

530-0011

Kinshukai Infusion Clinic, Osaka

533-0024

Yodogawa Christian Hospital, Osaka

285-8741

Toho University Sakura Medical Center, Sakura

321-0293

Dokkyo Medical University Hospital, Shimotsuga-gun

103-0028

Nihonbashi Egawa Clinic, Tokyo

870-0823

Ishida Clinic of IBD and Gastroenterology, Ōita

03810

Health Pharma Professional Research S.A de C.V., Mexico City

07020

Centro de Investigacion Clinica Acelerada, S.C., Distrito Federal

1500-650

Hospital da Luz, Lisbon

4835-044

Hospital Senhora da Oliveira - Guimaraes, E.P.E, Guimarães

8500-338

Centro Hospitalar do Algarve - Hospital de Portimao, Portimão

949 01

KM Management, spol. s r.o., Nitra

080 01

Gastro LM, s.r.o., Prešov

702-210

Kyungpook National University Chilgok Hospital, Daegu

03080

Seoul National University Hospital, Seoul

03181

Kangbuk Samsung Hospital, Seoul

04551

Inje University Seoul Paik Hospital, Seoul

04107

Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital, Kyiv

01023

Medical Center of LLC Medical Clinic Blagomed, Kyiv

02091

Medical Center OK!Clinic+LLC International Institute of Clinical Research, Kyiv

02132

Medical Center of LLC Medical Center Dopomoga-Plus, Kyiv

04073

Communal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Hospital, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY