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

November 9, 2017 updated by: Celgene

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease

The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of exclusive enteral nutrition and growth hormone.

All patients who complete the study will have the option to enter a long term active treatment study.

Study Overview

Status

Withdrawn

Conditions

Crohn Disease

Intervention / Treatment

Study Type

Interventional

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Ballarat, Australia, 3350
    - Ballarat Base Hospital
  - Bentleigh East, Australia, 3165
    - Monash Medical Centre Clayton
  - Fitzroy, Australia, 3065
    - St Vincents Hospital Melbourne
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Royal Prince Alfred Hospital
  - Concord, New South Wales, Australia, 2139
    - Concord Repatriation General Hospital
  - Five Dock, New South Wales, Australia, 2046
    - Centre For Digestive Diseases
  - Liverpool, New South Wales, Australia, 2170
    - Liverpool Hospital
- Queensland
  - Herston, Queensland, Australia, 4029
    - Royal Brisbane and Women's Hospital
  - South Brisbane, Queensland, Australia, 4101
    - Mater Adult Hospital
  - Woolloongabba, Queensland, Australia, 4102
    - Princess Alexandra Hospital
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Royal Adelaide Hospital Institute of Medical and Veterinary Science
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Box Hill Hospital
  - Melbourne, Victoria, Australia, 3004
    - The Alfred Hospital
- Western Australia
  - Murdoch, Western Australia, Australia, 6150
    - Fiona Stanley Hospital
Austria
- - Klagenfurt, Austria, 9020
    - Klinikum Klagenfurt am Wörtersee
  - Salzburg, Austria, 5020
    - LKH - Universitätsklinikum der PMU Salzburg
  - Wein, Austria, 1030
    - Krankenanstalt Rudolfstiftung Wien
Belgium
- - Brussels, Belgium, 1200
    - Cliniques universitaires Saint-Luc
  - Brussels, Belgium, 1020
    - Hopital Universitaire des Enfants
  - Edegem, Belgium, 2650
    - UZ Antwerpen
  - Gent, Belgium, 9000
    - Universitair Ziekenhuis Gent
  - Liege, Belgium, 4000
    - CHU Sart Tilman
Canada
- Alberta
  - Calgary, Alberta, Canada, T3B 6A8
    - Alberta Childrens Hospital
- British Columbia
  - Vancouver, British Columbia, Canada, V6Z 2K5
    - GI Research Institute
- Ontario
  - Barrie, Ontario, Canada, L4M 7G1
    - Barrie GI Associates
  - London, Ontario, Canada, N6A 5W9
    - LHSC - Victoria Hospital
  - Toronto, Ontario, Canada, M5G 1X8
    - The Hospital for Sick Children
  - Toronto, Ontario, Canada, M5G 1X5
    - Mount Sinai Hospital
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - Centre de sante et de services sociaux Champlain Charles Le Moyne
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 0W8
    - Royal University Hospital
Croatia
- - Osijek, Croatia, 31000
    - Clinical Hospital Centre Osijek
Czechia
- - Hradec Králové, Czechia, 500 12
    - Hepato-Gastroenterologie HK, s. r. o.
  - Olomouc, Czechia, 77900
    - PreventaMed
  - Praha 3, Czechia, 13000
    - CCBR Prague CZ
  - Praha 4, Czechia, 14059
    - Thomayerova nemocnice
Denmark
- - Aahus C, Denmark, 8000
    - Aarhus Universitetshospital
  - Alborg, Denmark, 9000
    - Ålborg Universitets Hospital
  - Hvidovre, Denmark, 2650
    - Hvidovre Hospital
  - Koge, Denmark, 4600
    - Koge Sygehus
  - Odense C, Denmark, 5000
    - Odense Universitetshospital
  - Silkeborg, Denmark, 8600
    - Regionshospitalet Silkeborg
Finland
- - Helsinki, Finland, FI-00290
    - Helsingin Yliopistollinen Keskussairaala
  - Tampere, Finland, 33521
    - Tampereen yliopistollinen sairaala
France
- - Amiens Cedex, France, 80054
    - CHU Amiens Hôpital sud
  - Besancon Cedex, France, 25030
    - CHU Besancon Hopital Jean Minjoz
  - Lille cedex, France, 59037
    - Hopital Claude Huriez CHRU Lille
  - Marseille cedex 20, France, 13915
    - Hôpital Nord CHU MARSEILLE
  - Nice Cedex 3, France, 06200
    - CHU Nice Hopital de lArchet 2
  - Paris Cedex 10, France, 75475
    - Hôpital Saint Louis
  - Pierre Benite cedex, France, 69495
    - Centre Hospitalier Lyon Sud
  - Reims, France, 51092
    - CHU Reims Hopital Robert Debré
  - Rouen, France, 76031
    - Chu de Rouen Hopital Charles Nicolle
  - Toulouse Cedex 09, France, 31059
    - CHU de Toulouse Hôpital Rangueil
  - Vandoeuvre les Nancy, France, 54511
    - Hôpital de Brabois Adultes
Germany
- - Berlin, Germany, 13353
    - Charite - Campus Virchow-Klinikum
  - Berlin, Germany, 14050
    - DRK Kliniken Berlin Westend
  - Bochum, Germany, 44791
    - St. Josef-Hospital
  - Brandenburg an der Havel, Germany, 14770
    - Staedisches Klinikum Brandenburg
  - Dresden, Germany, 01307
    - Universitaetsklinikum Carl Gustav Carus
  - Erlangen, Germany, 91054
    - Universitaetsklinikum Erlangen
  - Essen, Germany, 45136
    - Kliniken Essen-Mitte
  - Essen, Germany, 45257
    - Katholische Kliniken Ruhrhalbinsel GmbH
  - Essen, Germany, 45122
    - Universitaetsklinikum EssenZentrum fuer Innere Medizin
  - Frankfurt, Germany, 60594
    - Crohn Colitis Centrum Rhein Main
  - Hamburg, Germany, 22559
    - Asklepios Klinik Hamburg
  - Kiel, Germany, 24105
    - Universitaetsklinikum Schleswig Holstein Campus Kiel
  - Leipzig, Germany, 4103
    - Eugastro GmbH
  - Minden, Germany, 32423
    - Gastroenterologische Praxis Minden
  - Regensburg, Germany, 93042
    - Universitätsklinikum Regensburg
  - Ulm, Germany, 89081
    - Universitaetsklinikum Ulm
  - Wuppertal, Germany, 42283
    - Helios Klinikum Wuppertal
Greece
- - Athens, Greece, 10676
    - General Hospital of Athens Evangelismos
  - Athens, Greece, 15125
    - Athens Medical Center
  - Rio Patras, Greece, 26500
    - University General Hospital of Patras
Hungary
- - Budapest, Hungary, 1088
    - Semmelweis Egyetem
  - Budapest, Hungary, 1036
    - Óbudai Egészségügyi Centrum Kft.
  - Budapest, Hungary, H-1032
    - Szent Margit Kórház
  - Szeged, Hungary, 6720
    - Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy
Israel
- - Petah Tikva, Israel, 49100
    - Rabin Medical Center
  - Rechovot, Israel, 76100
    - Kaplan Medical Center
  - Zerifin, Israel, 70300
    - Assaf Harofeh Medical Center
Italy
- - Bologna, Italy, 40138
    - Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
  - Milano, Italy, 20122
    - Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  - Padova, Italy, 35128
    - Azienda Ospedaliera di Padova
  - Palermo, Italy, 90146
    - Azienda Ospedaliera Vincenzo Cervello
  - Pavia, Italy, 27100
    - Fondazione IRCCS Policlinico San Matteo
  - Pisa, Italy, 56124
    - Azienda Ospedaliero Universitaria Pisana
  - Roma, Italy, 00168
    - Complesso Integrato Columbus
  - Roma, Italy, 00128
    - Università Campus Bio-Medico di Roma
  - Rome, Italy, 00152
    - Azienda Ospedaliera San Camillo Forlanini
  - Rome, Italy, 133
    - Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  - Salerno, Italy, 84131
    - Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi dAragona
  - San Donato Milanese, Italy, 20097
    - IRCCS Policlinico San Donato
Korea, Republic of
- - Busan, Korea, Republic of, 49241
    - Pusan National University Hospital
  - Busan, Korea, Republic of, 49201
    - Dong-A University Hospital
  - Guri-si, Korea, Republic of, 471-701
    - Hanyang Univerisy Guri Hospital
  - Seongnam-si, Korea, Republic of, 13620
    - Seoul National University Bundang Hospital
  - Seongnam-si,, Korea, Republic of, 13496
    - Cha Bundang Medical Center Cha University
  - Seoul, Korea, Republic of, 3080
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 02447
    - Kyung Hee University Hospital
  - Seoul, Korea, Republic of, 3181
    - Kangbuk Samsung Hospital
  - Seoul, Korea, Republic of, 158-710
    - Ewha Womans University Mokdong Hospital
  - Suwon-si, Korea, Republic of, 16247
    - The Catholic university of Korea, St. Vincent's Hospital
  - Wonju-Si, Korea, Republic of, 220701
    - Yonsei University Wonju Severance Christian Hospital
Latvia
- - Riga, Latvia, LV-1006
    - Digestive Diseases Center GASTRO
  - Riga, Latvia, LV-1038
    - Riga East Clinical University Hospital clinic Gailezers
Netherlands
- - Breda, Netherlands, 4819 EV
    - Amphia Ziekenhuis
  - Rotterdam, Netherlands, 3015 CE
    - Erasmus Medisch Centrum
Poland
- - Bialystok, Poland, 15-275
    - SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
  - Bydgoszcz, Poland, 85-794
    - Clinsante S.C. Osrodek Badan Klinicznych
  - Kraków, Poland, 31-315
    - Centrum Medyczne A-Z Clinic
  - Lodz, Poland, 91-365
    - Centrum Medyczne AMED
  - Warsaw, Poland, 03-580
    - NZOZ Vivamed
  - Wroclaw, Poland, 53-114
    - LexMedica Osrodek Badan Klinicznych
Portugal
- - Braga, Portugal, 4710-243
    - Hospital de Braga
  - Guimaraes, Portugal, 4835-044
    - Hospital da Senhora da Oliveira Guimarães
  - Lisboa, Portugal, 1500-650
    - Hospital da Luz
  - Porto, Portugal, 4200-319
    - Centro Hospitalar de Sao Joao, EPE
  - Viana do Castelo, Portugal, 4904-858
    - Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE
Romania
- - Oradea, Romania, 410066
    - CMI Dr. Tirnaveanu Amelita
  - Timisoara, Romania, 300002
    - Centrul de Gastroenterologie Dr. Goldis
Russian Federation
- - Moscow, Russian Federation, 115088
    - Medical Center Stolitsa-Medikl
  - Novosibirsk, Russian Federation, 630117
    - FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS
  - Novosibirsk, Russian Federation, 630084
    - SBEIHPE Novosibirsk State Medical University
  - Saint-Petersburg, Russian Federation, 196247
    - SPb SBIH City Hospital # 26
  - Samara, Russian Federation, 443041
    - NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways
Serbia
- - Belgrade, Serbia, 11080
    - Clinical Center Bezanijska Kosa
Slovakia
- - Presov, Slovakia, 080 01
    - Gastro I., s.r.o.
Spain
- - Alicante, Spain, 03010
    - Hospital General Universitario de Alicante
  - Barcelona, Spain, 08003
    - Hospital del Mar
  - Barcelona, Spain, 08041
    - Hospital de La Santa Creu I Sant Pau
  - Madrid, Spain, 28034
    - Hospital Universitario Ramon Y Cajal
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz
  - Madrid, Spain, 28007
    - Hospital General Universitario Gregorio Maranon
  - Madrid, Spain, 28006
    - Hospital Universitario de La Princessa
  - Pontevedra, Spain, 36164
    - Complejo Hospitalario de Pontevedra
  - Zaragoza, Spain, 50009
    - Hospital Universitario Miguel Servet
Sweden
- - Stockholm, Sweden, 18288
    - Danderyds sjukhus AB
Switzerland
- - Bern, Switzerland, 3010
    - Inselspital - Universitaetsspital Bern
  - Bern, Switzerland, 3012
    - Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner
  - Geneva, Switzerland, 1205
    - Hopitaux Universitaires de Geneve-HUG
  - Zuerich, Switzerland, 8091
    - Universitätsspital Zürich
Turkey
- - Ankara, Turkey, 06100
    - Hacettepe University Medical Faculty
  - Ankara, Turkey, 06100
    - Ankara University Medical Faculty
  - Ankara, Turkey, 06500
    - Gazi University Medical Faculty
  - Ankara, Turkey, 06100
    - Turkiye Yuksek Ihtisas Hospital
  - Elazig, Turkey, 23119
    - Firat University Medical Faculty
  - Istanbul, Turkey, 34098
    - Istanbul University Cerrahpasa Medical Faculty
  - Istanbul, Turkey, 34349
    - Acibadem Fulya Hospital
  - Istanbul, Turkey, 34668
    - Haydarpasa Numune Training and Research Hospital
  - Istanbul, Turkey, 34854
    - Istanbul Medeniyet Uni Goztepe Training&Res Hosp
  - Istanbul, Turkey, 34899
    - Marmara University Pendik Training and Research Hospital
  - Izmir, Turkey, 35100
    - Ege University Medical Faculty
  - Izmir, Turkey, 35340
    - Dokuz Eylul University Izmir
  - Kocaeli, Turkey, 41380
    - Kocaeli Derince Training and Research Hospital
  - Malatya, Turkey, 44280
    - Inonu Uni. Med. Fac.
  - Mersin, Turkey, 33020
    - Mersin University Medical Faculty
Ukraine
- - Kharkiv, Ukraine, 61037
    - CI of PH Kharkiv CCH #2
  - Kirovohrad, Ukraine, 25006
    - Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus
  - Kyiv, Ukraine, 02091
    - Kyiv City Clinical Hospital #1
  - Odessa, Ukraine, 65025
    - CI Odesa Regional Clinical Hospital
  - Sumy, Ukraine, 40022
    - CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI
  - Ternopil, Ukraine, 46000
    - Ternopil City Communal Emergency Medical Care Hospital
  - Vinnytsia, Ukraine, 21029
    - SRI of Invalid Rehabilitation EST Complex of Vinnytsia M.I.Pyrogov NMU MOHU
  - Zaporizhia, Ukraine, 69104
    - SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
  - Zaporozhje, Ukraine, 69600
    - CI Zaporizhzhia Regional Clinical Hospital of ZRC
United Kingdom
- - Basingstoke, United Kingdom, RG24 9NA
    - Basingstoke and North Hampshire Hospital
  - Coventry, United Kingdom, CV2 2DX
    - University Hospital Coventry
  - Glasgow, United Kingdom, G51 4TF
    - Queen Elizabeth University Hospital
  - Hull, United Kingdom, HU3 2JZ
    - Hull Royal Infirmary
  - London, United Kingdom, E1 1BB
    - Royal London Hospital
  - London, United Kingdom, NW1 2PG
    - University College London Hospitals
  - Manchester, United Kingdom, M13 9WL
    - Manchester Royal Infirmary
  - Nottingham, United Kingdom, NG7 2UH
    - Nottingham University Hospitals Queens Medical Centre
  - Roxburghshire, United Kingdom, TD6 9BS
    - Borders General Hospital
United States
- Arizona
  - Litchfield Park, Arizona, United States, 85340
    - Dcr-Pi Pc
  - Mesa, Arizona, United States, 85024
    - Arizona Digestive Health
  - Phoenix, Arizona, United States, 85016
    - Phoenix Childrens Hospital
  - Phoenix, Arizona, United States, 85006
    - Arizona Digestive Health
  - Scottsdale, Arizona, United States, 85259
    - Mayo Clinic Arizona
  - Sun City, Arizona, United States, 85351
    - Arizona Digestive Health
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Gastroenterology Associates PA
- California
  - Garden Grove, California, United States, 92843
    - Valley View Internal Medicine
  - Lancaster, California, United States, 93534
    - High Desert Gastroenterology, Inc.
  - Los Angeles, California, United States, 90048
    - Cedars Sinai Medical Center
  - Los Angeles, California, United States, 90032
    - University of Southern California Medical Center
  - Mission Hills, California, United States, 91345
    - Facey Medical Foundation
  - San Diego, California, United States, 902123
    - Medical Associates Research Group Inc.
  - San Francisco, California, United States, 94115
    - University of California at San Francisco (PARENT)
  - Torrance, California, United States, 90502
    - HCP Clinical Research LLC
  - Ventura, California, United States, 93003
    - Ventura Clinical Trials
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado
  - Lafayette, Colorado, United States, 80026
    - Innovative Clinical Research
- Connecticut
  - Bristol, Connecticut, United States, 06010
    - Connecticut Gastroenterology Institute
  - Hamden, Connecticut, United States, 06518
    - Medical Research Center of Connecticut LLC
  - Hartford, Connecticut, United States, 06106
    - Connecticut GI PC Research Division
  - New Haven, Connecticut, United States, 06520
    - Yale University
- Florida
  - Jacksonville, Florida, United States, 32224
    - Mayo Clinic - Jacksonville
  - Largo, Florida, United States, 33777
    - Florida Center for Gastroenterology
  - Miami, Florida, United States, 33136
    - University of Miami
  - Miami, Florida, United States, 33155
    - Cordova Research Institute
  - Miami, Florida, United States, 33155
    - Advance Medical Research Center
  - Miami, Florida, United States, 33155
    - Sanitas Research
  - Miami Springs, Florida, United States, 33166
    - Galiz Research LLC
  - Naples, Florida, United States, 34102
    - Gastroenterology Group Of Naples
  - Orlando, Florida, United States, 32803
    - Center for Digestive Health
  - Orlando, Florida, United States, 32801
    - GCRM
  - Port Orange, Florida, United States, 32127
    - Advanced Medical Research Center
  - Saint Augustine, Florida, United States, 32086
    - East Coast Institute for Research LLC
  - Tampa, Florida, United States, 33603
    - Clinical Research of West Florida, Inc.
  - Weston, Florida, United States, 33331
    - Cleveland Clinic Florida Weston
  - Winter Park, Florida, United States, 32789
    - Shafran Gastroenterology Center
- Georgia
  - Augusta, Georgia, United States, 30912
    - Georgia Regents University
  - Columbus, Georgia, United States, 31904
    - Columbus Regional Research Institute
  - Suwanee, Georgia, United States, 30024
    - Atlanta Gastroenterology Specialists PC
- Illinois
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
  - Chicago, Illinois, United States, 60611
    - Northwestern University-Feinberg School of Medicine
  - Evanston, Illinois, United States, 60201
    - NorthShore University HealthSystem Research Institute
- Indiana
  - Indianapolis, Indiana, United States, 46202-5121
    - Indiana University School of Medicine
- Iowa
  - Clive, Iowa, United States, 50325
    - Iowa Digestive Disease Center
- Kansas
  - Pratt, Kansas, United States, 67124
    - Health Science Research Center, LLC
  - Wichita, Kansas, United States, 67207
    - Heartland Research Associates LLC
  - Wichita, Kansas, United States, 67208
    - Via Christi Research a division of Via Christi Hospitals Wichita Inc
- Kentucky
  - Bowling Green, Kentucky, United States, 42101
    - Graves Gilbert Clinic
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky Medical Center
  - Louisville, Kentucky, United States, 40202
    - University of Louisville
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Gastroenterology Associates, LLC
  - Lake Charles, Louisiana, United States, 70601
    - Clinical Trials of SW Louisiana LLC
  - Shreveport, Louisiana, United States, 71103
    - Louisiana Research Center LLC
- Maryland
  - Baltimore, Maryland, United States, 21218
    - Johns Hopkins University School of Medicine
  - Baltimore, Maryland, United States, 21201
    - University of Maryland Medical Group
  - Towson, Maryland, United States, 21204
    - Charm City Research Group
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Boston Medical Center
  - Burlington, Massachusetts, United States, 01805
    - Lahey Clinic Inc. - PARENT ACCOUNT
  - Worcester, Massachusetts, United States, 01655
    - UMASS Medical Center
- Michigan
  - Ann Arbor, Michigan, United States, 48105
    - University of Michigan Health System
  - Caro, Michigan, United States, 48723
    - Medex Research Institute
  - Chesterfield, Michigan, United States, 48047
    - Clinical Research Institute of Michigan, LLC
  - Novi, Michigan, United States, 48377
    - Henry Ford Health System
  - Wyoming, Michigan, United States, 49519
    - Gastroenterology Associates of Western Michigan PLC
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic
- Missouri
  - Belton, Missouri, United States, 64012
    - Ehrhardt Clinical Research, LLC
  - Jefferson City, Missouri, United States, 65203
    - Jefferson City Medical Group
  - Saint Louis, Missouri, United States, 63110 - 0250
    - Saint Louis University
  - Springfield, Missouri, United States, 65806
    - Mercy Research
  - Washington, Missouri, United States, 63090
    - Mercy Research
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth-Hitchcock Medical Center
- New Jersey
  - Egg Harbor Township, New Jersey, United States, 08234
    - Aga Clinical Research Associates LLC
- New York
  - Great Neck, New York, United States, 11021
    - NYU Langone Long Island Clinical Research Associates
  - Great Neck, New York, United States, 11021
    - North Shore-LIJ Health System-Division of Rheumatology
  - Lake Success, New York, United States, 11041
    - Montefiore Medical Center PRIME
  - Manhasset, New York, United States, 11030
    - The Feinstein Institute for Medical Research PRIME
  - Mineola, New York, United States, 11501
    - Winthrop University Hospital
  - New York, New York, United States, 10032
    - Columbia University Medical Center
  - New York, New York, United States, 10016
    - New York University School of Medicine
  - New York, New York, United States, 10029
    - Mount Sinai School of Medicine
  - Poughkeepsie, New York, United States, 12601
    - Premier Medical Group of the Hudson Valley PC
  - Rochester, New York, United States, 14642
    - University of Rochester
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Asheville Gastroenterology Associates, P.A.
  - Chapel Hill, North Carolina, United States, 27514
    - University of North Carolina at Chapel Hill
  - Charlotte, North Carolina, United States, 28205
    - Gaffney Health Services
  - Charlotte, North Carolina, United States, 28203
    - Carolina Center for Liver Disease
  - Greensboro, North Carolina, United States, 27455
    - PhysiqueMed Clinical Trials
  - Kinston, North Carolina, United States, 28501
    - Kinston Medical Specialists PA
  - Mount Airy, North Carolina, United States, 27030
    - Clinical Trials of America, LLC
  - Wilmington, North Carolina, United States, 28401
    - Trial Management Associates LLC
  - Winston-Salem, North Carolina, United States, 27103
    - PMG Research of Winston-Salem
- Ohio
  - Akron, Ohio, United States, 44333
    - Ohio Clinical Research Partners LLC
  - Beavercreek, Ohio, United States, 45431
    - Clinical Inquest Center Ltd
  - Centerville, Ohio, United States, 45429
    - Dr. Deepak Sarwal, MD
  - Cincinnati, Ohio, United States, 45219
    - Consultants for Clinical Research Inc.
  - Cincinnati, Ohio, United States, 45206
    - UC Health Clinical Trials Office
  - Cleveland, Ohio, United States, 44106
    - University Hospitals Cleveland Medical Center
  - Cleveland, Ohio, United States, 44195
    - The Cleveland Clinic Foundation
  - Springfield, Ohio, United States, 45504
    - Springfield Health Care Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, United States, 73104
    - Oklahoma Foundation for Digestive Research
- Oregon
  - Portland, Oregon, United States, 97229
    - Oregon Health & Science University
- Pennsylvania
  - Havertown, Pennsylvania, United States, 19083-2742
    - Main Line Gastroenterology
  - Philadelphia, Pennsylvania, United States, 19102
    - Drexel University College of Medicine
  - Philadelphia, Pennsylvania, United States, 19104
    - Childrens Hospital Of Philadelphia
  - Philadelphia, Pennsylvania, United States, 19104
    - University of Pennsylvania School of Medicine
  - State College, Pennsylvania, United States, 16803
    - Penn State University Milton S Hershey Medical Center
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Rhode Island Hospital
- South Carolina
  - Charleston, South Carolina, United States, 28203
    - Carolinas Healthcare System
- Tennessee
  - Chattanooga, Tennessee, United States, 37421
    - ClinSearch LLC
  - Germantown, Tennessee, United States, 38138
    - Gastro One
  - Nashville, Tennessee, United States, 37212
    - Vanderbilt University Medical Center
- Texas
  - Arlington, Texas, United States, 76012
    - Texas Clinical Research Institute LLC
  - Houston, Texas, United States, 77079
    - Houston Endoscopy and Research Center
  - Houston, Texas, United States, 77030
    - Methodist Hospital
  - Houston, Texas, United States, 77030
    - University of Texas Health Science Center at Houston
  - Houston, Texas, United States, 77004
    - Gulf Coast Research Group LLC
  - Pasadena, Texas, United States, 77505
    - Digestive Health Center
  - Southlake, Texas, United States, 76092
    - Texas Digestive Disease Consultants - Southlake
  - Tyler, Texas, United States, 75701
    - Digestive Health Specialists of Tyler
- Utah
  - Salt Lake City, Utah, United States, 84132
    - University of Utah Division of Gastroenterology
  - West Jordan, Utah, United States, 84088
    - Advanced Clinical Research
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia
  - Charlottesville, Virginia, United States, 22911
    - Charlottesville Medical Research Center
  - Chesapeake, Virginia, United States, 23320
    - Gastroenterology Associates of Tidewater
  - Norfolk, Virginia, United States, 23502
    - Digestive and Liver Disease Specialists
  - Richmond, Virginia, United States, 23249
    - Hunter Holmes Mcguire Ctr
- Washington
  - Seattle, Washington, United States, 98104
    - Harborview Medical Center
  - Seattle, Washington, United States, 98101
    - Virginia Mason Medical Center
  - Seattle, Washington, United States, 98104
    - University of Washington School of Medicine
  - Seattle, Washington, United States, 98104
    - Swedish Medical Center Cancer Institute Research
  - Vancouver, Washington, United States, 98664-4896
    - The Vancouver Clinic
- Wisconsin
  - Madison, Wisconsin, United States, 53705
    - University of Wisconsin Hospital and Clinics
  - Madison, Wisconsin, United States, 53716
    - Dean Clinic Oregon
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

Male or female ≥ 12 years
Subject is able to swallow the IP tablets
Active Crohn's disease (CD) disease as determined by the Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's Disease (SES-CD)
Must meet a determined average minimum number of daily stools or rating of abdominal pain over a 7day period
Subject must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of CD (ie, infliximab, adalimumab, certolizumab, or vedolizumab).

Exclusion Criteria:

• The presence of any of the following will exclude a subject from enrollment: Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis, or colitis due to immunodeficiency

Local manifestations of Crohn's Disease (CD) such as abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
Subject has strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, subjects with colonic strictures that are not passable with an age-appropriate colonoscope, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded
Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit
Ileostomy or a colostomy
Subject has a history of any clinically significant medical condition that, in the investigator's opinion, would prevent the subject from participating in the study
Adolescents with delayed growth or pubertal development who are on corticosteroids at baseline and who should not continue treatment with the same dose of corticosteroids until the Week 12 visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GED-0301 1 x 160 mg once daily GED-0301 1 x 160 mg tablet once daily (QD)	Drug: GED-0301 GED-0301 Other Names: Mongersen
Experimental: GED-0301 - 4 x 40 mg once daily GED-0301 4 x 40 mg tablets once daily (QD)	Drug: GED-0301 GED-0301 Other Names: Mongersen
Placebo Comparator: Placebo once daily Placebo once daily (QD)	Drug: Placebo Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission defined by an average daily liquid or soft stool frequency and abdominal pain score (US) and Crohn's Disease Activity Index (CDAI) (Rest of World) Time Frame: week 12	The proportion of subjects achieving clinical remission at Week 12.	week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission defined by an average daily liquid or soft stool frequency and abdominal pain score (US) and CDAI Time Frame: Week 4, week 12	The proportion of subjects achieving clinical remission at Week 4, Week 12.	Week 4, week 12
Endoscopic improvement by the Simple Endoscopic Score for Crohn's Disease (SES-CD) Time Frame: Week 12	Endoscopic improvement of the mucosa at Week 12.	Week 12
Clinical response defined by CDAI Time Frame: Week 4, week 12	The proportion of subjects achieving clinical response at Week 4, Week 12.	Week 4, week 12
Clinical remission defined by PCDAI Time Frame: Week 12	The proportion of subjects achieving clinical remission at Week 12 (adolescent subjects only).	Week 12
Adverse Events (AEs) Time Frame: Up to 20 weeks	Incidence and severity of adverse events	Up to 20 weeks
Pharmacokinetics (PK)- plasma concentration of GED-0301 Time Frame: Week 4, week 8	The plasma concentration of GED-0301 at Week 4, Week 8	Week 4, week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

Study Director: Denesh Chitkara, MD, Celgene Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2017

Primary Completion (Anticipated)

November 17, 2018

Study Completion (Anticipated)

December 24, 2018

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimate)

November 28, 2016

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 9, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

GED-0301-CD-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Anticipated)

Primary Completion (Anticipated)

Study Completion (Anticipated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Crohn Disease

Clinical Trials on Placebo

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