Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)

PHASE3TerminatedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

February 6, 2019

Primary Completion Date

June 21, 2021

Study Completion Date

September 13, 2021

Conditions
Crohn's Disease
Interventions
DRUG

Ontamalimab

SC injection of 25 mg or 75 mg ontamalimab will be administered using a prefilled syringe.

OTHER

Placebo

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

Trial Locations (281)

4

St Vincent's University Hospital, Dublin

1062

Magyar Honvédség Egészségügyi Központ, Budapest

1090

Medizinische Universitat Wien (Medical University of Vienna), Vienna

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

1619

CLINRESCO, ARWYP Medical Suites, Johannesburg

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

2139

Concord Repatriation General Hospital, Concord

2170

Liverpool Hospital, Liverpool

2820

Academisch Medisch Centrum Amsterdam, Bonheiden

3004

The Alfred Hospital, Melbourne

3065

St Vincents Hospital Melbourne - PPDS, Fitzroy

3240

Waikato Hospital, Hamilton

4004

Multiprofile Hospital for Active Treatment Eurohospital, Plovdiv

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

4101

Mater Hospital Brisbane, South Brisbane

5000

Royal Adelaide Hospital, Adelaide

5020

Salzburger Landeskliniken, Salzburg

5600

Bekes Megyei Kozponti Korhaz, Békéscsaba

6021

Wellington Hospital, Newtown

7100

Tolna Megyei Balassa János Kórház, Szekszárd

7700

CHU Mouscron, Mouscron

Mohacsi Korhaz, Mohács

7708

Dr JP Wright, Claremont

8000

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

8036

LKH-Universitätsklinikum Klinikum Graz, Graz

8500

AZ Groeninge, Kortrijk

9000

UZ Gent, Ghent

Diagnostic Consultative Centre Mladost - M OOD, Varna

9016

Dunedin Hospital, Dunedin

10000

University Hospital Center Zagreb, Zagreb

10126

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino

10617

West Tallinn Central Hospital, Tallinn

11021

NYU Langone Long Island Clinical Research Associates, Great Neck

11080

Clinical Hospital Center Bezanijska Kosa, Belgrade

11215

New York Total Medical Care PC, Brooklyn

11527

Ippokrateio General Hospital of Athens, Athens

13353

Charité - Universitätsmedizin Berlin, Berlin

13496

CHA Bundang Medical Center, CHA University, Seongnam

14004

C.H. Regional Reina Sofia - PPDS, Córdoba

14127

Southtowns Gastroenterology, PLLC, Orchard Park

14163

Gastroenterologische Facharztpraxis am Mexikoplatz, Berlin-Zehlendorf

15208

Baruch Padeh Poriya Medical Center, Tiberias

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

18000

University Clinical Center Nis, Niš

19610

Digestive Disease Associates, Wyomissing

20089

Istituto Clinico Humanitas, Rozzano (MI)

21005

Hospital Universitario Juan Ramon Jimenez, Huelva

21029

Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1, Vinnytsia

21565

Gachon University Gil Medical Center, Incheon

22100

Galilee Medical Center, Nahariya

22601

Winchester Gastroenterology Associates, Winchester

24105

Universitatsklinikum Schleswig-Holstein, Kiel

24333

Mid Atlantic Health Specialists, Galax

26300

General Hospital Vrsac, Vršac

26426

Yonsei University Wonju Severance Christian Hospital, Wŏnju

26504

University General Hospital of Patras, Pátrai

27100

Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia

28007

Hospital General Universitario Gregorio Maranon, Madrid

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28046

Hospital Universitario La Paz - PPDS, Madrid

28100

A.O.U. Maggiore della Carità, Novara

28625

Piedmont Healthcare, Statesville

28942

Hospital Universitario de Fuenlabrada, Fuenlabrada

30033

Atlanta Center For Gastroenterology PC, Decatur

30308

Atlanta Gastroenterology Specialists, PC, Atlanta

30349

Infinite Clinical Trials, Atlanta

31000

Clinical Hospital Centre Osijek, Osijek

32086

East Coast Institute for Research, LLC, Saint Augustine

32810

Omega Research Consultants LLC - Clinedge - PPDS, Orlando

33000

General Hospital Virovitica, Virovitica

33065

Crystal Biomedical Research, Miami Lakes

33071

Alliance Medical Research LLC, Coral Springs

33134

Advanced Clinical Research Network, Coral Gables

33135

Hi Tech and Global Research, LLc, Miami

33157

Sanchez Clinical Research, Inc, Miami

33169

Mersin University Medical Faculty, Mersin

33321

DBC Research, Tamarac

33604

Bayside Clinical Research - New Port Richey, Tampa

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

University Clinical Center Kragujevac, Kragujevac

34102

Gastroenterology Group of Naples, Naples

34110

Pharma Research International Inc, Naples

34741

SIH Research, Kissimmee

36312

CHUVI - H.U. Alvaro Cunqueiro, Vigo

37024

IRCCS Ospedale Sacro Cuore Don Calabria, Negrar

37212

Vanderbilt University Medical Center, Nashville

38138

Gastro One, Germantown

38261

Advanced Gastroenterology-Union City, Union City

41013

Hospital Universitario Virgen del Rocio - PPDS, Seville

41100

Azienda Ospedaliero Universitaria Di Modena Policlinico, Modena

41701

Gastroenterology Associates of Hazard, Hazard

41944

Kyungpook National University Hospital, Daegu

43000

Opca bolnica Bjelovar, Bjelovar

45014

Consultants For Clinical Research Inc, Fairfield

45030

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

45219

Consultants For Clinical Research Inc, Cincinnati

45249

Consultants For Clinical Research Inc, Cincinnati

46360

Laporte County Institute For Clinical Research, Michigan City

48047

Clinical Research Institute of Michigan, Chesterfield

48108

Inje University Haeundae Paik Hospital, Busan

48109

University of Michigan, Ann Arbor

48159

Gastro Campus Research GbR, Münster

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

50134

Azienda Ospedaliera Universitaria Careggi, Florence

50937

Uniklinik Köln, Cologne

52074

Universitätsklinikum der RWTH Aachen, Aachen

54645

Euromedica - PPDS, Thessaloniki

55114

Minnesota Gastroenterology PA, Saint Paul

55805

Mayo Clinic Health System - PPDS, Duluth

58001

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

60031

IL Gastroenterology Group, Gurnee

60596

Universitätsklinikum Frankfurt, Frankfurt

60644

Loretto Hospital, Chicago

61037

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

61058

Communal Non-Commercial Enterprize 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

70601

Clinical Trials of SWLA, LLC, Lake Charles

71013

Ospedale Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo

71103

Louisiana Research Center LLC, Shreveport

71110

University General Hospital of Heraklion, Heraklion

72209

Atria Clinical Research - Clinedge - PPDS, Little Rock

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

77429

Northside Gastroenterology, Cypress

77598

Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS, Webster

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

80903

Peak Gastroenterology Associates, Colorado Springs

80907

Asthma and Allergy Associates PC - CRN - PPDS, Colorado Springs

81675

Klinikum rechts der Isa der Technischen Universitaet Muenchen, Munich

84010

HP Clinical Research, Bountiful

85018

Elite Clinical Studies - Phoenix - Clinedge - PPDS, Phoenix

85206

Arizona Digestive Health Mesa - East, Mesa

85724

CATS Research Center - University of Arizona, Tucson

88100

Azienda Ospedaliera Mater Domini Di Catanzaro, Catanzaro

88400

Sana Klinikum Biberach, Biberach an der Riss

89086

Encompass Care, North Las Vegas

89123

Advanced Biomedical Research of America, Las Vegas

91031

Shaare Zedek Medical Center, Jerusalem

91120

Hadassah Medical Center - PPDS, Jerusalem

92064

Alliance Clinical Research-(Vestavia Hills), Poway

92377

Inland Empire Liver Foundation, Rialto

92805

Advanced Research Center, Anaheim

92879

Kindred Medical Institute for Clinical Trials, LLC, Corona

93534

OM Research LLC - Lancaster - ClinEdge - PPDS, Lancaster

94806

Care Access Research, San Pablo, San Pablo

97000

Unidad de Atencion Medica e Investigacion en Salud, Mérida

195067

St. Elizabeth Municipal Clinical Hospital, Saint Petersburg

300002

Dr. Goldis Gastroenterology Center SRL, Timișoara

344091

Rostov State Medical University, Rostov-on-Don

400006

Cluj-Napoca Emergency Clinical County Hospital, Cluj-Napoca

410012

SHI Regional Clinical Hospital, Saratov

410066

Dr. Tirnaveanu Amelita Private Practice, Oradea

443011

Medical University Reaviz, Samara

443029

Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city, Samara

700506

Gastromedica SRL, Iași

760026

Fundación Valle Del Lili, 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

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

A-1090

Klinikum Wels-Grieskirchen GmbH, Vienna

07747

Universitatsklinikum Jena, Jena

00168

Fondazione Policlinico Universitario A Gemelli, Rome

00161

La Sapienza-Università di Roma-Policlinico Umberto I, Roma

060-8543

Sapporo Medical University Hospital, Sapporo

650-0015

Medical Corporation Aoyama Clinic, Kobe

663-8501

Hyogo College of Medicine, Nishinomiya-shi

105-8471

Jikei University Hospital, Minato-ku

198-0042

Ome Municipal General Hospital, Ōme

070-0061

Kunimoto Hospital, Asahikawa

839-0809

Hidaka Coloproctology Clinic, Kurume-shi

480-1195

Aichi Medical University Hospital, Nagakute

663-8014

Nishinomiya Municipal Central Hospital, Nishinomiya

530-0003

Chiinkai Dojima General & Gastroenterology Clinic, Osaka

530-0011

Kinshukai Infusion Clinic, Osaka

533-0024

Yodogawa Christian Hospital, Osaka

520-2192

Shiga University of Medical Science Hospital, Ōtsu

285-8741

Toho University Sakura Medical Center, Sakura

065-0033

Sapporo Higashi Tokushukai Hospital, Sapporo

Sapporo Tokushukai Hospital, Sapporo

321-0293

Dokkyo Medical University Hospital, Shimotsuga-gun

103-0028

Nihonbashi Egawa Clinic, Tokyo

220-0045

Colo-Proctology Center Matsushima Clinic, Yokohama

870-0823

Ishida Clinic of IBD and Gastroenterology, Ōita

LT- 08661

Vilnius University Hospital Santaros Klinikos, Vilnius

LT-10207

Vilnius City Clinical Hospital, Vilnius

07020

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

5022 GC

ETZ-Elisabeth, Tilburg

1782 GZ

NWZ, location Alkmaar, Den Helder

85-079

Vitamed Galaj i Cichomski sp.j., Bydgoszcz

87-100

Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj, Torun

87-800

Centrum Diagnostyczno - Lecznicze Barska sp. z o.o., Włocławek

50-449

Melita Medical, Wroclaw

53-114

Lexmedica, Wroclaw

90-302

Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny, Lódz

90-647

Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J., Lódz

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Warsaw

03-580

Niepubliczny Zakład Opieki Zdrowotnej VIVAMED, Warsaw

04-749

Miedzyleski Szpital Specjalistyczny w Warszawie, Warsaw

15-276

Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok

81-756

Endoskopia Sp. z o.o., Sopot

71-434

Twoja Przychodnia - Szczecinskie Centrum Medyczne, Szczecin

85-168

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Bydgoszcz

42-200

Centrum Medyczne Czestochowa - PRATIA - PPDS, Częstochowa

81-338

Centrum Medyczne Gdynia - PRATIA - PPDS, Gdynia

40-660

NZOZ All Medicus, Katowice

91-034

Med Gastr Sp.z.o.o Sp.k, Lodz

93-338

Instytut Centrum Zdrowia Matki Polki, Lodz

67-100

Twoja Przychodnia - Centrum Medyczne Nowa Sol, Nowa Sól

60-848

Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa, Poznan

35-068

Centrum Medyczne Warszawa - PRATIA - PPDS, Rzeszów

35-302

Korczowski Bartosz, Gabinet Lekarski, Rzeszów

71-685

Sonomed Sp. z o.o., Szczecin

00-635

Centrum Zdrowia M D M, Warsaw

02-507

Centralny Szpital Kliniczny MSW, Warsaw

02-797

BioVirtus Centrum Medyczne, Warsaw

22-400

Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II, Zamość

26-200

Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii, Gmina Końskie

4835-044

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

1500-650

Hospital da Luz, Lisbon

8500-338

Centro Hospitalar do Algarve - Hospital de Portimao, Portimão

011025

Sana Monitoring SRL, Bucharest

010825

Dr.Carol Davila Emergency University Central Military Hospital, Bucharest

020125

Colentina Clinical Hospital, Bucharest

021105

Prof. Dr. Matei Bals Institute of Infectious Diseases, Bucharest

022328

Fundeni Clinical Institute, Bucharest

031864

Centrul Medical Hifu Terramed Conformal S.R.L., Bucharest

050098

Emergency University Hospital, Bucharest

RO-900591

Affidea Romania SRL, Constanța

949 01

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

080 01

Gastro LM, s.r.o., Prešov

0084

Dr. J Breedt, Pretoria

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

08022

Centro Medico Teknon - Grupo Quironsalud, Barcelona

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

Municipal Institution of KRC Kyiv Regional Hospital #2, Kyiv

NE29 8NH

North Tyneside General Hospital, North Shields

AB25 2ZN

Aberdeen Royal Infirmary - PPDS, Aberdeen

NP20 2UB

Royal Gwent Hospital - PPDS, Newport

WV10 0QP

New Cross Hospital, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY