A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 1, 2017

Primary Completion Date

November 17, 2018

Study Completion Date

December 24, 2018

Conditions
Crohn Disease
Interventions
DRUG

GED-0301

GED-0301

DRUG

Placebo

Placebo

Trial Locations (311)

133

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Rome

1020

Hopital Universitaire des Enfants, Brussels

1030

Krankenanstalt Rudolfstiftung Wien, Wein

1036

Obudai Egeszsegugyi Centrum Kft., Budapest

1088

Semmelweis Egyetem, Budapest

1200

Cliniques Universitaires Saint-Luc, Brussels

1205

Hopitaux Universitaires de Geneve-HUG, Geneva

2046

Centre For Digestive Diseases, Five Dock

2050

Royal Prince Alfred Hospital, Camperdown

2139

Concord Repatriation General Hospital, Concord

2170

Liverpool Hospital, Liverpool

2650

UZ Antwerpen, Edegem

Hvidovre Hospital, Hvidovre

3004

The Alfred Hospital, Melbourne

3010

Inselspital - Universitaetsspital Bern, Bern

3012

Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner, Bern

3065

St Vincents Hospital Melbourne, Fitzroy

3080

Seoul National University Hospital, Seoul

3128

Box Hill Hospital, Box Hill

3165

Monash Medical Centre Clayton, Bentleigh East

3181

Kangbuk Samsung Hospital, Seoul

3350

Ballarat Base Hospital, Ballarat

4000

CHU Sart Tilman, Liège

4029

Royal Brisbane and Women's Hospital, Herston

4101

Mater Adult Hospital, South Brisbane

4102

Princess Alexandra Hospital, Woolloongabba

4103

EUGASTRO GmbH, Leipzig

4600

Koge Sygehus, Køge

5000

Royal Adelaide Hospital Institute of Medical and Veterinary Science, Adelaide

Odense Universitetshospital, Odense C

5020

LKH - Universitätsklinikum der PMU Salzburg, Salzburg

6150

Fiona Stanley Hospital, Murdoch

6720

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy, Szeged

8000

Aarhus Universitetshospital, Aahus C

8091

UniversitatSspital Zurich, Zurich

8600

Regionshospitalet Silkeborg, Silkeborg

9000

Universitair Ziekenhuis Gent, Ghent

Alborg Universitets Hospital, Aalborg

9020

Klinikum Klagenfurt am Wörtersee, Klagenfurt

10016

New York University School of Medicine, New York

10029

Mount Sinai School of Medicine, New York

10032

Columbia University Medical Center, New York

10676

General Hospital of Athens Evangelismos, Athens

11021

North Shore-LIJ Health System-Division of Rheumatology, Great Neck

NYU Langone Long Island Clinical Research Associates, Great Neck

11030

The Feinstein Institute for Medical Research PRIME, Manhasset

11041

Montefiore Medical Center PRIME, Lake Success

11080

Clinical Center Bezanijska Kosa, Belgrade

11501

Winthrop University Hospital, Mineola

12601

Premier Medical Group of the Hudson Valley PC, Poughkeepsie

13000

CCBR Prague CZ, Prague

13353

Charite - Campus Virchow-Klinikum, Berlin

13496

CHA Bundang Medical Center CHA University, Seongnam-si

13620

Seoul National University Bundang Hospital, Seongnam-si

13915

Hopital Nord CHU Marseille, Marseille

14050

DRK Kliniken Berlin Westend, Berlin

14059

Thomayerova nemocnice, Prague

14642

University of Rochester, Rochester

14770

Staedisches Klinikum Brandenburg, Brandenburg

15125

Athens Medical Center, Athens

16247

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

16803

Penn State University Milton S Hershey Medical Center, State College

18288

Danderyds Sjukhus AB, Stockholm

19102

Drexel University College of Medicine, Philadelphia

19104

Childrens Hospital of Philadelphia, Philadelphia

University of Pennsylvania School of Medicine, Philadelphia

20097

IRCCS Policlinico San Donato, San Donato Milanese

20122

Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico, Milan

21029

SRI of Invalid Rehabilitation EST Complex of Vinnytsia M.I.Pyrogov NMU MOHU, Vinnytsia

21201

University of Maryland Medical Group, Baltimore

21204

Charm City Research Group, Towson

21218

Johns Hopkins University School of Medicine, Baltimore

22559

Asklepios Klinik Hamburg, Hamburg

22908

University of Virginia, Charlottesville

22911

Charlottesville Medical Research Center, Charlottesville

23119

Firat University Medical Faculty, Elâzığ

23249

Hunter Holmes Mcguire Ctr, Richmond

23320

Gastroenterology Associates of Tidewater, Chesapeake

23502

Digestive and Liver Disease Specialists, Norfolk

24105

Universitaetsklinikum Schleswig Holstein Campus Kiel, Kiel

25006

Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus, Kirovohrad

25030

CHU Besancon Hopital Jean Minjoz, Besançon

26500

University General Hospital of Patras, Rio Patras

27030

Clinical Trials of America, LLC, Mount Airy

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

27103

PMG Research of Winston-Salem, Winston-Salem

27455

PhysiqueMed Clinical Trials, Greensboro

27514

University of North Carolina at Chapel Hill, Chapel Hill

28006

Hospital Universitario de la Princessa, Madrid

28007

Hospital General Universitario Gregorio Maranon, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28046

Hospital Universitario La Paz, Madrid

28203

Carolina Center for Liver Disease, Charlotte

Carolinas Healthcare System, Charleston

28205

Gaffney Health Services, Charlotte

28401

Trial Management Associates LLC, Wilmington

28501

Kinston Medical Specialists PA, Kinston

28801

Asheville Gastroenterology Associates, P.A., Asheville

30024

Atlanta Gastroenterology Specialists PC, Suwanee

30912

Georgia Regents University, Augusta

31000

Clinical Hospital Centre Osijek, Osijek

31059

CHU de Toulouse Hopital Rangueil, Toulouse

31904

Columbus Regional Research Institute, Columbus

32086

East Coast Institute for Research LLC, Saint Augustine

32127

Advanced Medical Research Center, Port Orange

32224

Mayo Clinic - Jacksonville, Jacksonville

32423

Gastroenterologische Praxis Minden, Minden

32789

Shafran Gastroenterology Center, Winter Park

32801

GCRM, Orlando

32803

Center For Digestive Health, Orlando

33020

Mersin University Medical Faculty, Mersin

33136

University of Miami, Miami

33155

Advance Medical Research Center, Miami

Cordova Research Institute, Miami

Sanitas Research, Miami

33166

Galiz Research LLC, Miami Springs

33331

Cleveland Clinic Florida Weston, Weston

33521

Tampereen yliopistollinen sairaala, Tampere

33603

Clinical Research of West Florida, Inc., Tampa

33777

Florida Center for Gastroenterology, Largo

34098

Istanbul University Cerrahpasa Medical Faculty, Istanbul

34102

Gastroenterology Group of Naples, Naples

34349

Acibadem Fulya Hospital, Istanbul

34668

Haydarpasa Numune Training and Research Hospital, Istanbul

34854

Istanbul Medeniyet Uni Goztepe Training&Res Hosp, Istanbul

34899

Marmara University Pendik Training and Research Hospital, Istanbul

35100

Ege University Medical Faculty, Izmir

35128

Azienda Ospedaliera Di Padova, Padua

35340

Dokuz Eylul University Izmir, Izmir

36164

Complejo Hospitalario de Pontevedra, Pontevedra

37212

Vanderbilt University Medical Center, Nashville

37421

ClinSearch LLC, Chattanooga

38138

Gastro One, Germantown

40022

CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI, Sumy

40138

Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi, Bologna

40202

University of Louisville, Louisville

40536

University of Kentucky Medical Center, Lexington

41380

Kocaeli Derince Training and Research Hospital, Kocaeli

42101

Graves Gilbert Clinic, Bowling Green

42283

HELIOS Klinikum Wuppertal, Wuppertal

44106

University Hospitals Cleveland Medical Center, Cleveland

44195

The Cleveland Clinic Foundation, Cleveland

44280

Inonu Uni. Med. Fac., Malatya

44333

Ohio Clinical Research Partners LLC, Akron

44791

St. Josef-Hospital, Bochum

45122

Universitaetsklinikum EssenZentrum fuer Innere Medizin, Essen

45136

Kliniken Essen-Mitte, Essen

45206

UC Health Clinical Trials Office, Cincinnati

45219

Consultants for Clinical Research Inc., Cincinnati

45257

Katholische Kliniken Ruhrhalbinsel GmbH, Essen

45429

Dr. Deepak Sarwal, MD, Centerville

45431

Clinical Inquest Center Ltd, Beavercreek

45504

Springfield Health Care Center, Springfield

46000

Ternopil City Communal Emergency Medical Care Hospital, Ternopil

48047

Clinical Research Institute of Michigan, LLC, Chesterfield

48105

University of Michigan Health System, Ann Arbor

48377

Henry Ford Health System, Novi

48723

Medex Research Institute, Caro

49100

Rabin Medical Center, Petah Tikva

49201

Dong-A University Hospital, Busan

49241

Pusan National University Hospital, Busan

49519

Gastroenterology Associates of Western Michigan PLC, Wyoming

50009

Hospital Universitario Miguel Servet, Zaragoza

50325

Iowa Digestive Disease Center, Clive

51092

CHU Reims Hopital Robert Debre, Reims

53226

Medical College of Wisconsin, Milwaukee

53705

University of Wisconsin Hospital and Clinics, Madison

53716

Dean Clinic Oregon, Madison

54511

Hopital de Brabois Adultes, Vandœuvre-lès-Nancy

55905

Mayo Clinic, Rochester

56124

Azienda Ospedaliero Universitaria Pisana, Pisa

59037

Hopital Claude Huriez CHRU Lille, Lille

60201

Northshore University Healthsystem Research Institute, Evanston

60594

Crohn Colitis Centrum Rhein Main, Frankfurt

60611

Northwestern University-Feinberg School of Medicine, Chicago

60612

Rush University Medical Center, Chicago

61037

CI of PH Kharkiv CCH #2, Kharkiv

63090

Mercy Research, Washington

64012

Ehrhardt Clinical Research, LLC, Belton

65025

CI Odesa Regional Clinical Hospital, Odesa

65203

Jefferson City Medical Group, Jefferson City

65806

Mercy Research, Springfield

67124

Health Science Research Center, LLC, Pratt

67207

Heartland Research Associates LLC, Wichita

67208

Via Christi Research a division of Via Christi Hospitals Wichita Inc, Wichita

69104

SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU, Zaporizhia

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

69600

CI Zaporizhzhia Regional Clinical Hospital of ZRC, Zaporizhzhya

70300

Assaf Harofeh Medical Center, Ẕerifin

70601

Clinical Trials of SW Louisiana LLC, Lake Charles

70809

Gastroenterology Associates, LLC, Baton Rouge

71103

Louisiana Research Center LLC, Shreveport

72205

Gastroenterology Associates PA, Little Rock

73104

Oklahoma Foundation for Digestive Research, Oklahoma City

University of Oklahoma Health Sciences Center, Oklahoma City

75475

Hopital Saint Louis, Paris

75701

Digestive Health Specialists of Tyler, Tyler

76012

Texas Clinical Research Institute LLC, Arlington

76031

CHU de Rouen Hopital Charles Nicolle, Rouen

76092

Texas Digestive Disease Consultants - Southlake, Southlake

76100

Kaplan Medical Center, Rehovot

77004

Gulf Coast Research Group LLC, Houston

77030

Methodist Hospital, Houston

University of Texas Health Science Center at Houston, Houston

77079

Houston Endoscopy and Research Center, Houston

77505

Digestive Health Center, Pasadena

77900

PreventaMed, Olomouc

80026

Innovative Clinical Research, Lafayette

80045

University Of Colorado, Aurora

80054

CHU Amiens Hopital Sud, Amiens

84088

Advanced Clinical Research, West Jordan

84131

Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi dAragona, Salerno

84132

University of Utah Division of Gastroenterology, Salt Lake City

85006

Arizona Digestive Health, Phoenix

85016

Phoenix Childrens Hospital, Phoenix

85024

Arizona Digestive Health, Mesa

85259

Mayo Clinic Arizona, Scottsdale

85340

Dcr-Pi Pc, Litchfield Park

85351

Arizona Digestive Health, Sun City

89081

Universitaetsklinikum Ulm, Ulm

90032

University of Southern California Medical Center, Los Angeles

90048

Cedars Sinai Medical Center, Los Angeles

90146

Azienda Ospedaliera Vincenzo Cervello, Palermo

90502

HCP Clinical Research LLC, Torrance

91054

Universitaetsklinikum Erlangen, Erlangen

91345

Facey Medical Foundation, Mission Hills

92843

Valley View Internal Medicine, Garden Grove

93003

Ventura Clinical Trials, Ventura

93042

Universitatsklinikum Regensburg, Regensburg

93534

High Desert Gastroenterology, Inc., Lancaster

94115

University of California at San Francisco (PARENT), San Francisco

97229

Oregon Health & Science University, Portland

98101

Virginia Mason Medical Center, Seattle

98104

Harborview Medical Center, Seattle

Swedish Medical Center Cancer Institute Research, Seattle

University of Washington School of Medicine, Seattle

115088

Medical Center Stolitsa-Medikl, Moscow

196247

SPb SBIH City Hospital # 26, Saint Petersburg

220701

Yonsei University Wonju Severance Christian Hospital, Wŏnju

300002

Centrul de Gastroenterologie Dr. Goldis, Timișoara

410066

CMI Dr. Tirnaveanu Amelita, Oradea

443041

NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways, Samara

630084

SBEIHPE Novosibirsk State Medical University, Novosibirsk

630117

FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS, Novosibirsk

902123

Medical Associates Research Group Inc., San Diego

06010

Connecticut Gastroenterology Institute, Bristol

06518

Medical Research Center of Connecticut LLC, Hamden

06106

Connecticut GI PC Research Division, Hartford

06520

Yale University, New Haven

46202-5121

Indiana University School of Medicine, Indianapolis

02118

Boston Medical Center, Boston

01805

Lahey Clinic Inc. - PARENT ACCOUNT, Burlington

01655

UMass Medical Center, Worcester

63110 - 0250

Saint Louis University, St Louis

03756

Dartmouth-Hitchcock Medical Center, Lebanon

08234

AGA Clinical Research Associates LLC, Egg Harbor

19083-2742

Main Line Gastroenterology, Havertown

02903

Rhode Island Hospital, Providence

98664-4896

The Vancouver Clinic, Vancouver

T3B 6A8

Alberta Childrens Hospital, Calgary

V6Z 2K5

GI Research Institute, Vancouver

L4M 7G1

Barrie GI Associates, Barrie

N6A 5W9

LHSC - Victoria Hospital, London

M5G 1X5

Mount Sinai Hospital, Toronto

M5G 1X8

The Hospital for Sick Children, Toronto

J4V 2H1

Centre de sante et de services sociaux Champlain Charles Le Moyne, Greenfield Park

S7N 0W8

Royal University Hospital, Saskatoon

500 12

Hepato-Gastroenterologie HK, s. r. o., Hradec Králové

FI-00290

Helsingin yliopistollinen keskussairaala, Helsinki

06200

CHU Nice Hopital de lArchet 2, Nice

01307

Universitaetsklinikum Carl Gustav Carus, Dresden

H-1032

Szent Margit Korhaz, Budapest

00128

Universita Campus Bio-Medico di Roma, Roma

00168

Complesso Integrato Columbus, Roma

00152

Azienda Ospedaliera San Camillo Forlanini, Rome

LV-1006

Digestive Diseases Center Gastro, Riga

LV-1038

Riga East Clinical University Hospital clinic Gailezers, Riga

4819 EV

Amphia Ziekenhuis, Breda

3015 CE

Erasmus Medisch Centrum, Rotterdam

15-275

SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego, Bialystok

85-794

Clinsante S.C. Osrodek Badan Klinicznych, Bydgoszcz

31-315

Centrum Medyczne A-Z Clinic, Krakow

91-365

Centrum Medyczne AMED, Lodz

03-580

Nzoz Vivamed, Warsaw

53-114

LexMedica Osrodek Badan Klinicznych, Wroclaw

4710-243

Hospital de Braga, Braga

4835-044

Hospital da Senhora da Oliveira Guimaraes, Guimarães

1500-650

Hospital Da Luz, Lisbon

4200-319

Centro Hospitalar de Sao Joao, EPE, Porto

4904-858

Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE, Viana do Castelo

080 01

GASTRO I., s.r.o., Prešov

471-701

Hanyang Univerisy Guri Hospital, Guri-si

02447

Kyung Hee University Hospital, Seoul

158-710

Ewha Womans University Mokdong Hospital, Seoul

03010

Hospital General Universitario de Alicante, Alicante

08003

Hospital del Mar, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

06100

Ankara University Medical Faculty, Ankara

Hacettepe University Medical Faculty, Ankara

Turkiye Yuksek Ihtisas Hospital, Ankara

06500

Gazi University Medical Faculty, Ankara

02091

Kyiv City Clinical Hospital #1, Kyiv

RG24 9NA

Basingstoke and North Hampshire Hospital, Basingstoke

CV2 2DX

University Hospital Coventry, Coventry

G51 4TF

Queen Elizabeth University Hospital, Glasgow

HU3 2JZ

Hull Royal Infirmary, Hull

E1 1BB

Royal London Hospital, London

NW1 2PG

University College London Hospitals, London

M13 9WL

Manchester Royal Infirmary, Manchester

NG7 2UH

Nottingham University Hospitals Queens Medical Centre, Nottingham

TD6 9BS

Borders General Hospital, Roxburghshire

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY

NCT02974322 - A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease | Biotech Hunter | Biotech Hunter