Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305)

PHASE3TerminatedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 29, 2018

Primary Completion Date

July 7, 2020

Study Completion Date

October 8, 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 (138)

1090

Medizinische Universitat Wien (Medical University of Vienna), Vienna

1619

CLINRESCO, ARWYP Medical Suites, Johannesburg

2139

Concord Repatriation General Hospital, Concord

2170

Liverpool Hospital, Liverpool

3004

The Alfred Hospital, Melbourne

3065

St Vincents Hospital Melbourne - PPDS, Melbourne

4101

Mater Hospital Brisbane, South Brisbane

5000

Royal Adelaide Hospital, Adelaide

5020

Salzburger Landeskliniken, Salzburg

7708

Dr JP Wright, Claremont

8036

LKH-Universitätsklinikum Klinikum Graz, Graz

10000

University Hospital Center Zagreb, Zagreb

10126

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

11080

Clinical Hospital Center ''Bezanijska Kosa'', Belgrade

11215

New York Total Medical Care PC, Brooklyn

13353

Charité - Universitätsmedizin Berlin, Berlin

14163

Gastroenterologische Facharztpraxis am Mexikoplatz, Berlin-Zehlendorf

15208

Baruch Padeh Poriya Medical Center, Tiberias

18000

University Clinical Center Nis, Niš

19610

Digestive Disease Associates, Wyomissing

20089

Istituto Clinico Humanitas, Rozzano (MI)

22100

Galilee Medical Center, Nahariya

24105

Universitatsklinikum Schleswig-Holstein, Kiel

26300

General Hospital Vrsac, Vršac

27100

Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia

28100

A.O.U. Maggiore della Carità, Novara

28625

Piedmont Healthcare, Statesville

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

33176

Advanced Clinical Research Network, Miami

34000

University Clinical Center Kragujevac, Kragujevac

34102

Gastroenterology Group of Naples, Naples

37024

Ospedale Sacro Cuore Don Calabria, Negrar

37212

Vanderbilt University Medical Center, Nashville

38138

Gastro One, Germantown

38261

Advanced Gastroenterology-Union City, Union City

41100

Azienda Ospedaliero Universitaria Di Modena Policlinico, Modena

43000

Opca bolnica Bjelovar, Bjelovar

45014

Consultants For Clinical Research Inc, Fairfield

45219

Consultants For Clinical Research Inc, Cincinnati

45249

Consultants For Clinical Research Inc, Cincinnati

46360

Laporte County Institute For Clinical Research, Michigan City

48159

Gastro Campus Research GbR, Münster

50134

Azienda Ospedaliera Universitaria Careggi, Florence

50937

Uniklinik Köln, Cologne

52074

Universitätsklinikum der RWTH Aachen, Aachen

60596

Universitätsklinikum Frankfurt, Frankfurt

70601

Clinical Trials of SWLA LLC, Lake Charles

71013

Ospedale Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo

71103

Louisiana Research Center LLC, Shreveport

72209

Atria Clinical Research - Clinedge - PPDS, Little Rock

77429

Northside Gastroenterology, Cypress

77521

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

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

85724

CATS Research Center - University of Arizona, Tucson

88100

Azienda Ospedaliera Mater Domini Di Catanzaro, Catanzaro

88400

Sana Klinikum Biberach, Biberach an der Riss

91031

Shaare Zedek Medical Center, Jerusalem

91120

Hadassah Medical Center - PPDS, Jerusalem

92377

Inland Empire Liver Foundation, Rialto

93534

OM Research LLC - Lancaster - ClinEdge - PPDS, Lancaster

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

A-1090

Klinikum Wels-Grieskirchen GmbH, Vienna

07747

Universitatsklinikum Jena, Jena

00161

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

004-0041

Sapporo Tokushukai Hospital, Sapporo

105-8471

Jikei University Hospital, Minato-ku

198-0042

Ome Municipal General Hospital, Ōme

839-0809

Hidaka Coloproctology Clinic, Kurume-shi

480-1195

Aichi Medical University Hospital, Nagakute

663-8014

Nishinomiya Municipal Central Hospital, Nishinomiya

Unknown

Onomichi General Hospital, Onomichi

Russian Medical Military Academy n.a. S.M. Kirov, Saint Petersburg

Clinical Hospital Center Zemun, Zemun

520-2192

Shiga University of Medical Science Hospital, Ōtsu

065-0033

Sapporo Higashi Tokushukai Hospital, Sapporo

220-0045

Colo-Proctology Center Matsushima Clinic, Yokohama

LT- 08661

Vilnius University Hospital Santaros Klinikos, Vilnius

LT-10207

Vilnius City Clinical Hospital, Vilnius

5022 GC

ETZ-Elisabeth, Tilburg

1782 GZ

NWZ, location Alkmaar, Den Helder

1105 AZ

Academisch Medisch Centrum Amsterdam, Amsterdam

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

00-660

Centrum Medyczne Warszawa - PRATIA - PPDS, Warsaw

02-781

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warsaw

03-580

Niepubliczny Zaklad 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 - Szczecińskie 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

05-410

BioVirtus Centrum Medyczne, Józefów

40-659

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

60-856

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

35-302

Korczowski Bartosz, Gabinet Lekarski, Rzeszów

70-361

Sonomed Sp. z o.o., Szczecin

00-635

Centrum Zdrowia M D M, Warsaw

02-507

Centralny Szpital Kliniczny MSW, Warsaw

22-400

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

26-200

Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii, Gmina Końskie

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

0084

Dr. J Breedt, Pretoria

Emmed Research, Pretoria

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