AzTrials
AzTrials

Crohn DiseasePhase 3NCT02974322

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

A Phase 3 study testing GED-0301 in people with Crohn Disease, run by Celgene at 311 sites in 30 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Crohn Disease
What is being tested?
GED-0301
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
311 sitesin 30 countries
Study dates
1 Dec 2017to 24 Dec 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

311 sites in 30 countries.

311 sites in 30 countries

United States136 sites

  • Ohio Clinical Research Partners LLC

    Akron, Ohio, 44333

  • University of Michigan Health System

    Ann Arbor, Michigan, 48105

  • Texas Clinical Research Institute LLC

    Arlington, Texas, 76012

  • Asheville Gastroenterology Associates, P.A.

    Asheville, North Carolina, 28801

  • Georgia Regents University

    Augusta, Georgia, 30912

  • University Of Colorado

    Aurora, Colorado, 80045

  • University of Maryland Medical Group

    Baltimore, Maryland, 21201

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21218

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana, 70809

  • Clinical Inquest Center Ltd

    Beavercreek, Ohio, 45431

  • Ehrhardt Clinical Research, LLC

    Belton, Missouri, 64012

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Graves Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • Connecticut Gastroenterology Institute

    Bristol, Connecticut, 06010

  • Lahey Clinic Inc. - PARENT ACCOUNT

    Burlington, Massachusetts, 01805

  • Medex Research Institute

    Caro, Michigan, 48723

  • Dr. Deepak Sarwal, MD

    Centerville, Ohio, 45429

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Carolinas Healthcare System

    Charleston, South Carolina, 28203

  • Carolina Center for Liver Disease

    Charlotte, North Carolina, 28203

  • Gaffney Health Services

    Charlotte, North Carolina, 28205

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Charlottesville Medical Research Center

    Charlottesville, Virginia, 22911

  • ClinSearch LLC

    Chattanooga, Tennessee, 37421

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Northwestern University-Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • UC Health Clinical Trials Office

    Cincinnati, Ohio, 45206

  • Consultants for Clinical Research Inc.

    Cincinnati, Ohio, 45219

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • AGA Clinical Research Associates LLC

    Egg Harbor, New Jersey, 08234

  • Northshore University Healthsystem Research Institute

    Evanston, Illinois, 60201

  • Valley View Internal Medicine

    Garden Grove, California, 92843

  • Gastro One

    Germantown, Tennessee, 38138

  • North Shore-LIJ Health System-Division of Rheumatology

    Great Neck, New York, 11021

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • PhysiqueMed Clinical Trials

    Greensboro, North Carolina, 27455

  • Medical Research Center of Connecticut LLC

    Hamden, Connecticut, 06518

  • Connecticut GI PC Research Division

    Hartford, Connecticut, 06106

  • Main Line Gastroenterology

    Havertown, Pennsylvania, 19083-2742

  • Gulf Coast Research Group LLC

    Houston, Texas, 77004

  • Methodist Hospital

    Houston, Texas, 77030

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Houston Endoscopy and Research Center

    Houston, Texas, 77079

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202-5121

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Jefferson City Medical Group

    Jefferson City, Missouri, 65203

  • Kinston Medical Specialists PA

    Kinston, North Carolina, 28501

  • Innovative Clinical Research

    Lafayette, Colorado, 80026

  • Clinical Trials of SW Louisiana LLC

    Lake Charles, Louisiana, 70601

  • Montefiore Medical Center PRIME

    Lake Success, New York, 11041

  • High Desert Gastroenterology, Inc.

    Lancaster, California, 93534

  • Florida Center for Gastroenterology

    Largo, Florida, 33777

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • Dcr-Pi Pc

    Litchfield Park, Arizona, 85340

  • Gastroenterology Associates PA

    Little Rock, Arkansas, 72205

  • University of Southern California Medical Center

    Los Angeles, California, 90032

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • University of Louisville

    Louisville, Kentucky, 40202

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53705

  • Dean Clinic Oregon

    Madison, Wisconsin, 53716

  • The Feinstein Institute for Medical Research PRIME

    Manhasset, New York, 11030

  • Arizona Digestive Health

    Mesa, Arizona, 85024

  • University of Miami

    Miami, Florida, 33136

  • Advance Medical Research Center

    Miami, Florida, 33155

  • Cordova Research Institute

    Miami, Florida, 33155

  • Sanitas Research

    Miami, Florida, 33155

  • Galiz Research LLC

    Miami Springs, Florida, 33166

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Facey Medical Foundation

    Mission Hills, California, 91345

  • Clinical Trials of America, LLC

    Mount Airy, North Carolina, 27030

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Yale University

    New Haven, Connecticut, 06520

  • New York University School of Medicine

    New York, New York, 10016

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Henry Ford Health System

    Novi, Michigan, 48377

  • Oklahoma Foundation for Digestive Research

    Oklahoma City, Oklahoma, 73104

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • GCRM

    Orlando, Florida, 32801

  • Center For Digestive Health

    Orlando, Florida, 32803

  • Digestive Health Center

    Pasadena, Texas, 77505

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania School of Medicine

    Philadelphia, Pennsylvania, 19104

  • Arizona Digestive Health

    Phoenix, Arizona, 85006

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • Oregon Health & Science University

    Portland, Oregon, 97229

  • Premier Medical Group of the Hudson Valley PC

    Poughkeepsie, New York, 12601

  • Health Science Research Center, LLC

    Pratt, Kansas, 67124

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Hunter Holmes Mcguire Ctr

    Richmond, Virginia, 23249

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • East Coast Institute for Research LLC

    Saint Augustine, Florida, 32086

  • University of Utah Division of Gastroenterology

    Salt Lake City, Utah, 84132

  • Medical Associates Research Group Inc.

    San Diego, California, 902123

  • University of California at San Francisco (PARENT)

    San Francisco, California, 94115

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Swedish Medical Center Cancer Institute Research

    Seattle, Washington, 98104

  • University of Washington School of Medicine

    Seattle, Washington, 98104

  • Louisiana Research Center LLC

    Shreveport, Louisiana, 71103

  • Texas Digestive Disease Consultants - Southlake

    Southlake, Texas, 76092

  • Mercy Research

    Springfield, Missouri, 65806

  • Springfield Health Care Center

    Springfield, Ohio, 45504

  • Saint Louis University

    St Louis, Missouri, 63110 - 0250

  • Penn State University Milton S Hershey Medical Center

    State College, Pennsylvania, 16803

  • Arizona Digestive Health

    Sun City, Arizona, 85351

  • Atlanta Gastroenterology Specialists PC

    Suwanee, Georgia, 30024

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33603

  • HCP Clinical Research LLC

    Torrance, California, 90502

  • Charm City Research Group

    Towson, Maryland, 21204

  • Digestive Health Specialists of Tyler

    Tyler, Texas, 75701

  • The Vancouver Clinic

    Vancouver, Washington, 98664-4896

  • Ventura Clinical Trials

    Ventura, California, 93003

  • Mercy Research

    Washington, Missouri, 63090

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Cleveland Clinic Florida Weston

    Weston, Florida, 33331

  • Heartland Research Associates LLC

    Wichita, Kansas, 67207

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

    Wichita, Kansas, 67208

  • Trial Management Associates LLC

    Wilmington, North Carolina, 28401

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789

  • UMass Medical Center

    Worcester, Massachusetts, 01655

  • Gastroenterology Associates of Western Michigan PLC

    Wyoming, Michigan, 49519

Other trials in United States

Germany17 sites

  • Charite - Campus Virchow-Klinikum

    Berlin, 13353

  • DRK Kliniken Berlin Westend

    Berlin, 14050

  • St. Josef-Hospital

    Bochum, 44791

  • Staedisches Klinikum Brandenburg

    Brandenburg an der Havel, 14770

  • Universitaetsklinikum Carl Gustav Carus

    Dresden, 01307

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

  • Universitaetsklinikum EssenZentrum fuer Innere Medizin

    Essen, 45122

  • Kliniken Essen-Mitte

    Essen, 45136

  • Katholische Kliniken Ruhrhalbinsel GmbH

    Essen, 45257

  • Crohn Colitis Centrum Rhein Main

    Frankfurt, 60594

  • Asklepios Klinik Hamburg

    Hamburg, 22559

  • Universitaetsklinikum Schleswig Holstein Campus Kiel

    Kiel, 24105

  • EUGASTRO GmbH

    Leipzig, 4103

  • Gastroenterologische Praxis Minden

    Minden, 32423

  • Universitatsklinikum Regensburg

    Regensburg, 93042

  • Universitaetsklinikum Ulm

    Ulm, 89081

  • HELIOS Klinikum Wuppertal

    Wuppertal, 42283

Other trials in Germany

Turkey (Türkiye)15 sites

  • Ankara University Medical Faculty

    Ankara, 06100

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Turkiye Yuksek Ihtisas Hospital

    Ankara, 06100

  • Gazi University Medical Faculty

    Ankara, 06500

  • Firat University Medical Faculty

    Elâzığ, 23119

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Acibadem Fulya Hospital

    Istanbul, 34349

  • Haydarpasa Numune Training and Research Hospital

    Istanbul, 34668

  • Istanbul Medeniyet Uni Goztepe Training&Res Hosp

    Istanbul, 34854

  • Marmara University Pendik Training and Research Hospital

    Istanbul, 34899

  • Ege University Medical Faculty

    Izmir, 35100

  • Dokuz Eylul University Izmir

    Izmir, 35340

  • Kocaeli Derince Training and Research Hospital

    Kocaeli, 41380

  • Inonu Uni. Med. Fac.

    Malatya, 44280

  • Mersin University Medical Faculty

    Mersin, 33020

Other trials in Turkey (Türkiye)

Australia14 sites

  • Royal Adelaide Hospital Institute of Medical and Veterinary Science

    Adelaide, South Australia, 5000

  • Ballarat Base Hospital

    Ballarat, 3350

  • Monash Medical Centre Clayton

    Bentleigh East, 3165

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St Vincents Hospital Melbourne

    Fitzroy, 3065

  • Centre For Digestive Diseases

    Five Dock, New South Wales, 2046

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Italy12 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi

    Bologna, 40138

  • Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Azienda Ospedaliera Di Padova

    Padova, 35128

  • Azienda Ospedaliera Vincenzo Cervello

    Palermo, 90146

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124

  • Universita Campus Bio-Medico di Roma

    Roma, 00128

  • Complesso Integrato Columbus

    Roma, 00168

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, 00152

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome, 133

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

    Salerno, 84131

  • IRCCS Policlinico San Donato

    San Donato Milanese, 20097

Other trials in Italy

France11 sites

  • CHU Amiens Hopital Sud

    Amiens, 80054

  • CHU Besancon Hopital Jean Minjoz

    Besançon, 25030

  • Hopital Claude Huriez CHRU Lille

    Lille, 59037

  • Hopital Nord CHU Marseille

    Marseille, 13915

  • CHU Nice Hopital de lArchet 2

    Nice, 06200

  • Hopital Saint Louis

    Paris, 75475

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Reims Hopital Robert Debre

    Reims, 51092

  • CHU de Rouen Hopital Charles Nicolle

    Rouen, 76031

  • CHU de Toulouse Hopital Rangueil

    Toulouse, 31059

  • Hopital de Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

Other trials in France

South Korea11 sites

  • Dong-A University Hospital

    Busan, 49201

  • Pusan National University Hospital

    Busan, 49241

  • Hanyang Univerisy Guri Hospital

    Guri-si, 471-701

  • CHA Bundang Medical Center CHA University

    Seongnam-si, 13496

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Kyung Hee University Hospital

    Seoul, 02447

  • Ewha Womans University Mokdong Hospital

    Seoul, 158-710

  • Seoul National University Hospital

    Seoul, 3080

  • Kangbuk Samsung Hospital

    Seoul, 3181

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

    Suwon, 16247

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, 220701

Other trials in South Korea

Spain9 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital del Mar

    Barcelona, 08003

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario de la Princessa

    Madrid, 28006

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Complejo Hospitalario de Pontevedra

    Pontevedra, 36164

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Ukraine9 sites

  • CI of PH Kharkiv CCH #2

    Kharkiv, 61037

  • Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus

    Kirovohrad, 25006

  • Kyiv City Clinical Hospital #1

    Kyiv, 02091

  • CI Odesa Regional Clinical Hospital

    Odesa, 65025

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

    Sumy, 40022

  • Ternopil City Communal Emergency Medical Care Hospital

    Ternopil, 46000

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

    Vinnytsia, 21029

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

    Zaporizhia, 69104

  • CI Zaporizhzhia Regional Clinical Hospital of ZRC

    Zaporizhzhya, 69600

Other trials in Ukraine

United Kingdom9 sites

  • Basingstoke and North Hampshire Hospital

    Basingstoke, RG24 9NA

  • University Hospital Coventry

    Coventry, CV2 2DX

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • Royal London Hospital

    London, E1 1BB

  • University College London Hospitals

    London, NW1 2PG

  • Manchester Royal Infirmary

    Manchester, M13 9WL

  • Nottingham University Hospitals Queens Medical Centre

    Nottingham, NG7 2UH

  • Borders General Hospital

    Roxburghshire, TD6 9BS

Other trials in United Kingdom

Canada8 sites

  • Barrie GI Associates

    Barrie, Ontario, L4M 7G1

  • Alberta Childrens Hospital

    Calgary, Alberta, T3B 6A8

  • Centre de sante et de services sociaux Champlain Charles Le Moyne

    Greenfield Park, Quebec, J4V 2H1

  • LHSC - Victoria Hospital

    London, Ontario, N6A 5W9

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

Denmark6 sites

  • Aarhus Universitetshospital

    Aahus C, 8000

  • Alborg Universitets Hospital

    Aalborg, 9000

  • Hvidovre Hospital

    Hvidovre, 2650

  • Koge Sygehus

    Køge, 4600

  • Odense Universitetshospital

    Odense C, 5000

  • Regionshospitalet Silkeborg

    Silkeborg, 8600

Other trials in Denmark

Poland6 sites

  • SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

    Bialystok, 15-275

  • Clinsante S.C. Osrodek Badan Klinicznych

    Bydgoszcz, 85-794

  • Centrum Medyczne A-Z Clinic

    Krakow, 31-315

  • Centrum Medyczne AMED

    Lodz, 91-365

  • Nzoz Vivamed

    Warsaw, 03-580

  • LexMedica Osrodek Badan Klinicznych

    Wroclaw, 53-114

Other trials in Poland

Belgium5 sites

  • Hopital Universitaire des Enfants

    Brussels, 1020

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZ Antwerpen

    Edegem, 2650

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • CHU Sart Tilman

    Liège, 4000

Other trials in Belgium

Portugal5 sites

  • Hospital de Braga

    Braga, 4710-243

  • Hospital da Senhora da Oliveira Guimaraes

    Guimarães, 4835-044

  • Hospital Da Luz

    Lisbon, 1500-650

  • Centro Hospitalar de Sao Joao, EPE

    Porto, 4200-319

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

    Viana do Castelo, 4904-858

Other trials in Portugal

Russia5 sites

  • Medical Center Stolitsa-Medikl

    Moscow, 115088

  • SBEIHPE Novosibirsk State Medical University

    Novosibirsk, 630084

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

    Novosibirsk, 630117

  • SPb SBIH City Hospital # 26

    Saint Petersburg, 196247

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

    Samara, 443041

Other trials in Russia

Czechia4 sites

  • Hepato-Gastroenterologie HK, s. r. o.

    Hradec Králové, 500 12

  • PreventaMed

    Olomouc, 77900

  • CCBR Prague CZ

    Prague, 13000

  • Thomayerova nemocnice

    Prague, 14059

Other trials in Czechia

Hungary4 sites

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036

  • Semmelweis Egyetem

    Budapest, 1088

  • Szent Margit Korhaz

    Budapest, H-1032

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy

    Szeged, 6720

Other trials in Hungary

Switzerland4 sites

  • Inselspital - Universitaetsspital Bern

    Bern, 3010

  • Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner

    Bern, 3012

  • Hopitaux Universitaires de Geneve-HUG

    Geneva, 1205

  • UniversitatSspital Zurich

    Zurich, 8091

Other trials in Switzerland

Austria3 sites

  • Klinikum Klagenfurt am Wörtersee

    Klagenfurt, 9020

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

  • Krankenanstalt Rudolfstiftung Wien

    Wein, 1030

Other trials in Austria

Greece3 sites

  • General Hospital of Athens Evangelismos

    Athens, 10676

  • Athens Medical Center

    Athens, 15125

  • University General Hospital of Patras

    Rio Patras, 26500

Other trials in Greece

Israel3 sites

  • Rabin Medical Center

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot, 76100

  • Assaf Harofeh Medical Center

    Tsrifin, 70300

Other trials in Israel

Finland2 sites

  • Helsingin yliopistollinen keskussairaala

    Helsinki, FI-00290

  • Tampereen yliopistollinen sairaala

    Tampere, 33521

Other trials in Finland

Latvia2 sites

  • Digestive Diseases Center Gastro

    Riga, LV-1006

  • Riga East Clinical University Hospital clinic Gailezers

    Riga, LV-1038

Other trials in Latvia

Netherlands2 sites

  • Amphia Ziekenhuis

    Breda, 4819 EV

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CE

Other trials in Netherlands

Romania2 sites

  • CMI Dr. Tirnaveanu Amelita

    Oradea, 410066

  • Centrul de Gastroenterologie Dr. Goldis

    Timișoara, 300002

Other trials in Romania

Croatia1 site

  • Clinical Hospital Centre Osijek

    Osijek, 31000

Other trials in Croatia

Serbia1 site

  • Clinical Center Bezanijska Kosa

    Belgrade, 11080

Other trials in Serbia

Slovakia1 site

  • GASTRO I., s.r.o.

    Prešov, 080 01

Other trials in Slovakia

Sweden1 site

  • Danderyds Sjukhus AB

    Stockholm, 18288

Other trials in Sweden

About this study

Official title: 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.

Conditions
Crohn Disease
Being tested
GED-0301, Placebo
Keywords
Crohn's Disease, GED-0301, Mongersen, Adolescent, Pediatric, Children
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GED-0301Drug

    Also called Mongersen

    GED-0301

  • PlaceboDrug

    Placebo

Study groups in NCT02974322
Study groupRoleWhat they receive
GED-0301 1 x 160 mg once dailyExperimentalGED-0301 1 x 160 mg tablet once daily (QD)
Receives: Drug: GED-0301
GED-0301 - 4 x 40 mg once dailyExperimentalGED-0301 4 x 40 mg tablets once daily (QD)
Receives: Drug: GED-0301
Placebo once dailyPlacebo comparatorPlacebo once daily (QD)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    The proportion of subjects achieving clinical remission at Week 12.

    Measured: week 12

Secondary outcomes (6)

  1. Clinical remission defined by an average daily liquid or soft stool frequency and abdominal pain score (US) and CDAI

    The proportion of subjects achieving clinical remission at Week 4, Week 12.

    Measured: Week 4, week 12

  2. Endoscopic improvement by the Simple Endoscopic Score for Crohn's Disease (SES-CD)

    Endoscopic improvement of the mucosa at Week 12.

    Measured: Week 12

  3. Clinical response defined by CDAI

    The proportion of subjects achieving clinical response at Week 4, Week 12.

    Measured: Week 4, week 12

  4. Clinical remission defined by PCDAI

    The proportion of subjects achieving clinical remission at Week 12 (adolescent subjects only).

    Measured: Week 12

  5. Adverse Events (AEs)

    Incidence and severity of adverse events

    Measured: Up to 20 weeks

  6. Pharmacokinetics (PK)- plasma concentration of GED-0301

    The plasma concentration of GED-0301 at Week 4, Week 8

    Measured: Week 4, week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2016 (estimated)
  2. Study start1 Dec 2017 (estimated)
  3. Primary completion17 Nov 2018 (estimated)
  4. Study completion24 Dec 2018 (estimated)

Why it stopped: Sponsor decision not to start trial

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02974322
Sponsor's protocol ID
GED-0301-CD-003
Status last verified
Nov 2017
First submitted
23 Nov 2016
Last updated
14 Nov 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GED-0301 in people with Crohn Disease, run by Celgene at 311 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 311 sites in United States, Germany, Turkey (Türkiye), Australia, Italy and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02974322.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in