AzTrials
AzTrials

Crohn DiseasePhase 3NCT02596893

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

A Phase 3 study testing GED-0301 in people with Crohn Disease, run by Celgene at 538 sites in 35 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease
What is being tested?
GED-0301
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
701 participants
Where
538 sitesin 35 countries
Study dates
8 Dec 2015to 5 Jan 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must satisfy the following criteria to be enrolled in the study:
  • Male or female ≥ 18 years
  • 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 7 day 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.

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
  • Local manifestations of Crohn's Disease (CD) such as symptomatic/severe strictures, abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
  • 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.

Trial locations and contacts

538 sites in 35 countries.

538 sites in 35 countries

United States150 sites

  • Ohio Clinical Research Partners LLC

    Akron, Ohio, 44333

  • Southwest Gastroenterology Associates PC

    Albuquerque, New Mexico, 87109

  • HCP Clinical Research LLC

    Anaheim, California, 92801

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Texas Clinical Research Institute LLC

    Arlington, Texas, 76012

  • Texas Digestive Disease Consultants - Dallas

    Arlington, Texas, 76012

  • Asheville Gastroenterology Associates, PA

    Asheville, North Carolina, 28801

  • Atlanta Gastroenterology Associates, LLC

    Atlanta, Georgia, 30342

  • Georgia Regents University

    Augusta, Georgia, 30912

  • University Of Colorado

    Aurora, Colorado, 80045

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21218

  • Gastroenterology Associates LLC

    Baton Rouge, Louisiana, 70809

  • 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

  • Commonwealth Clinical Studies PLLC

    Brockton, Massachusetts, 02302

  • 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

  • Carolina Center for Liver Disease

    Charlotte, North Carolina, 28203

  • Gaffney Health Services

    Charlotte, North Carolina, 28205

  • Carolinas Medical Center

    Charlotte, North Carolina, 28207

  • 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

  • Metropolitan Gastroenterology

    Chevy Chase, Maryland, 20815

  • Northwestern University-Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • UC Health Clinical Trials Office

    Cincinnati, Ohio, 45206

  • Consultants for Clinical Research Inc.

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44106

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • University of Vermont

    Colchester, Vermont, 05446

  • Gastro Center of Maryland

    Columbia, Maryland, 21045

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Texas Digestive Disease Consultants Dallas

    Dallas, Texas, 75231

  • AGA Clinical Research Associates LLC

    Egg Harbor, New Jersey, 08234

  • T. Joseph Raoof MD Inc

    Encino, California, 91436

  • Texas Digestive Disease Consultants - Southlake

    Flower Mound, Texas, 75028

  • Sing Chan Private Practice

    Flushing, New York, 11355

  • Florida Medical Research - Southeastern Integrated Medical

    Gainesville, Florida, 32607

  • Sarkis Clinical Trials - Parent

    Gainesville, Florida, 32607

  • Valley View Internal Medicine

    Garden Grove, California, 92843

  • Gastro One

    Germantown, Tennessee, 38138

  • NYU Langone Nassau Gastroenterology 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

  • NorthShore University HealthSystem

    Highland Park, Illinois, 60035

  • Gulf Coast Research Group LLC

    Houston, Texas, 77004

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Houston Endoscopy and Research Center

    Houston, Texas, 77079

  • Clinical Inquest Center Ltd

    Huber Heights, Ohio, 45424-3239

  • ADDC Research LLC

    Huntsville, Alabama, 35802

  • Grand Teton Research Group PLLC

    Idaho Falls, Idaho, 83404

  • Indiana University

    Indianapolis, Indiana, 46202

  • Borland-Groover Clinic

    Jacksonville, Florida, 32256

  • 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

  • OM Research

    Lancaster, California, 93534

  • Florida Center for Gastroenterology

    Largo, Florida, 33777

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Emeritas Research Group

    Leesburg, Virginia, 20176

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40504

  • 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

  • Dean Clinic Oregon

    Madison, Wisconsin, 53716

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • The Feinstein Institute for Medical Research PRIME

    Manhasset, New York, 11030

  • Arizona Digestive Health

    Mesa, Arizona, 85024

  • Advance Medical Research Center

    Miami, Florida, 33155

  • Cordova Research Institute

    Miami, Florida, 33155

  • My Community Research Center inc

    Miami, Florida, 33155

  • Sanitas Research

    Miami, Florida, 33155

  • Galiz Research LLC

    Miami Springs, Florida, 33166

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226-3596

  • Winthrop University Hospital

    Mineola, New York, 11501

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • 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

  • North Shore Long Island Jewish Health System

    New Hyde Park, New York, 11040

  • Concord Medical Group PRIME

    New York, New York, 10016

  • New York University School of Medicine

    New York, New York, 10016

  • New York - Presbyterian/Weill Cornell Medical Center

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Henry Ford Medical Center - New Center One

    Novi, Michigan, 48377

  • Oklahoma University Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • GCRM

    Orlando, Florida, 32801

  • Center For Digestive Health

    Orlando, Florida, 32803

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • University of Pennsylvania School of Medicine

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • BRCR Medical Center Inc.

    Plantation, Florida, 33322

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Premier Medical Group of the Hudson Valley PC

    Poughkeepsie, New York, 12601

  • Health Science Research Center, LLC

    Pratt, Kansas, 67124

  • 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

    Salt Lake City, Utah, 84132

  • Sagact Pllc

    San Antonio, Texas, 78229

  • San Antonio Military Medical Center

    San Antonio, Texas, 78229

  • Medical Associates Research Group Inc.

    San Diego, California, 902123

  • Clinical Applications Laboratories Inc

    San Diego, California, 92103

  • University of California at San Francisco

    San Francisco, California, 94158

  • Colon & Digestive Health Specialists

    Scottsdale, Arizona, 85260-1315

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Swedish Medical Center

    Seattle, Washington, 98104

  • University of Washington School of Medicine

    Seattle, Washington, 98104

  • Louisiana Research Center LLC

    Shreveport, Louisiana, 71103

  • 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

  • Scott & White Medical Center

    Temple, Texas, 76508

  • Digestive Health Specialist of Tyler

    Tyler, Texas, 75701

  • The Vancouver Clinic

    Vancouver, Washington, 98664-4896

  • Ventura Clinical Trials

    Ventura, California, 93003

  • Mercy Clinic East Communities d/b/a Mercy Health Research

    Washington, Missouri, 63090

  • 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 LLC

    Winston-Salem, North Carolina, 27103-3914

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • 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

Germany35 sites

  • Charite Universitaetsmedizin Berlin Campus Benjamin Franklin

    Berlin, 12200

  • Charite Campus Virchow Klinikum

    Berlin, 13353

  • DRK Kliniken Berlin Westend

    Berlin, 14050

  • Krankenhaus Waldfriede e V

    Berlin, 14163

  • Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

    Bochum, 44789

  • Staedisches Klinikum Brandenburg

    Brandenburg an der Havel, 14770

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307

  • Zentrum fuer HIV und Hepatogastroenterologie GmbH

    Düsseldorf, 40237

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

  • Kliniken Essen-Mitte

    Essen, 45136

  • Katholische Kliniken Ruhrhalbinsel GmbH

    Essen, 45257

  • Agaplesion Markus Krankenhaus

    Frankfurt, 60431

  • Crohn Colitis Centrum Rhein Main

    Frankfurt, 60594

  • Universitaetsklinikum FreiburgInnere Med.1, Haematologie

    Freiburg im Breisgau, 79106

  • Universitaetsklinikum Halle Saale

    Halle, 06120

  • Asklepios Klinik Hamburg

    Hamburg, 22559

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120

  • Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter

    Heidelberg, 69121

  • Universitaetsklinikum Jena

    Jena, 07740

  • Universitaetsklinikum Schleswig Holstein Campus Kiel

    Kiel, 24105

  • University Leipzig

    Leipzig, 04103

  • Internistische Gemeinschaftspraxis f. Verdauungs- und Stoffwechselerkrankungen

    Leipzig, 04105

  • EUGASTRO GmbH

    Leipzig, 4103

  • Medizinisches Zentrum Klinikum Lueneburg

    Lüneburg, 21339

  • Universitaetsklinikum Magdeburg A oeR

    Magdeburg, 39120

  • Klinikum Mannheim GmbH Universitaetsklinikum

    Mannheim, 68167

  • Gastroenterologische Praxis Minden

    Minden, 32423

  • Isar Klinik GmbH

    München, 80331

  • Klinikum der Universitaet Muenchen

    München, 81377

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Gastro Campus Research

    Münster, 48159

  • Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer

    Niedersachsen, 38126

  • Universitaetsklinikum Regensburg

    Regensburg, 93053

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Canada28 sites

  • Barrie GI Associates

    Barrie, Ontario, L4M 7G1

  • Brandon Medical Arts Clinic

    Brandon, Manitoba, R7A 0N7

  • University of Calgary

    Calgary, Alberta, T2N 1N4

  • GI Research Institute

    Edmonton, Alberta, T5H 4B9

  • University of Alberta

    Edmonton, Alberta, T6G 2X8

  • South Edmonton Gastroenterology

    Edmonton, Alberta, T6L 6K3

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

    Greenfield Park, Quebec, J4V 2H1

  • McMaster University Health Sciences Center

    Hamilton, Ontario, L8N 3Z5

  • London Health Science Center U. Hospital

    London, Ontario, N6A 5A5

  • LHSC Victoria Hospital

    London, Ontario, N6A 5W9

  • Recherche GCP Research

    Montreal, Quebec, H1M 1B1

  • Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal

    Montreal, Quebec, H1T 2M4

  • CHUM Hôpital Saint-Luc

    Montreal, Quebec, H2X 3J4

  • McGill University Health Centre Glen Site Royal Victoria Hospital

    Montreal, Quebec, H4A 3J1

  • Montfort Hospital

    Ottawa, Ontario, K1K 0T2

  • Recherche Clinique Sigma Inc

    Québec, G1G 4A2

  • Recherche Medicale St Jerome Inc

    Saint-Jérôme, Quebec, J7Z 5T3

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • CHUS Hopital Fleurimont

    Sherbrooke, Quebec, J1H5N4

  • Humber River Hospital

    Toronto, Ontario, M3M 0B2

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

  • Toronto Digestive Disease Associates Inc

    Vaughan, Ontario, L4L 4Y7

  • PerCuro Clinical Research

    Victoria, British Columbia, V8V 3P9

  • Medicine Professional Corporation

    Waterloo, Ontario, N2J 1C4

  • Tarabain Osman MD

    Windsor, Ontario, N8W 1E6

Other trials in Canada

France23 sites

  • CHU Amiens Hopital Sud

    Amiens, 80054

  • CHU Besancon Hopital Jean Minjoz

    Besançon, 25030

  • CHU Tours Hopital Trousseau

    Chambray-lès-Tours, 37170

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63000

  • Hopital Beaujon

    Clichy, 92110

  • CHU Dijon - Hopital Bocage Central

    Dijon, 21000

  • CHU de Grenoble Hopital Nord

    Grenoble, 38043

  • Groupement Hospitalier Sud Hopital Bicetre

    Le Kremlin-Bicêtre, 94275

  • Hopital Claude Huriez CHRU Lille

    Lille, 59037

  • Hopital Nord

    Marseille, 13915

  • CHU Nantes Hotel Dieu

    Nantes, 44093

  • CHU Nice Hopital de lArchet 2

    Nice, 06200

  • Hopital Saint Antoine

    Paris, 75012

  • Hopital Saint Louis

    Paris, 75475

  • Groupe Hospitalier Sud Hopital Haut Leveque USN

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Reims Hopital Robert Debre

    Reims, 51092

  • CHU Rennes Hopital Pontchaillou

    Rennes, 35033

  • CHU de Rouen Hopital Charles Nicolle

    Rouen, 76031

  • CHU Saint Etienne Hopital Nord

    Saint-Etienne, 42055

  • CHU Strasbourg Hopital Hautepierre

    Strasbourg, 67098

  • CHU de Toulouse Hopital Rangueil

    Toulouse, 31059

  • Hopital de Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy20 sites

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

    Bari, 70124

  • Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Universitaria Policlinico G Martino

    Messina, 98125

  • Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Seconda Universita Degli Studi Di Napoli

    Naples, 80131

  • Azienda Ospedaliera Universitaria Federico II

    Napoli, Campania, 80131

  • Hospital of 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

  • Ospedale Sandro Pertini

    Roma, 00157

  • Complesso Integrato Columbus

    Roma, 00168

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, 00152

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome, 133

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

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

    Salerno, 84131

  • IRCCS Policlinico San Donato

    San Donato Milanese, 20097

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo FG, 71013

Other trials in Italy

Hungary19 sites

  • DRC Gyogyszervizsgalo Kozpont Kft

    Balatonfüred, 8230

  • Clinexpert Egeszsegugyi Szolg es Ker Kft

    Budapest, 1033

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062

  • Semmelweis Egyetem AOK

    Budapest, 1083

  • Semmelweis Egyetem AOK

    Budapest, 1088

  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

    Budapest, 1125

  • Pannonia Maganorvosi Centrum

    Budapest, 1136

  • Endomedix Diagnosztikai Kozpont

    Budapest, 1139

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Szent Pantaleon Korhaz Rendelointezet Dunaujvaros

    Dunaújváros, 2400

  • Markhot Ferenc Oktato Korhaz es Rendelointezet

    Eger, 3300

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9024

  • Bekes Megyei Pandy Kalman Korhaz

    Gyula, 5700

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400

  • Mohacsi Korhaz

    Mohács, 7700

  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

  • Mazso-Pharma Kutatas-fejlesztesi Kft

    Szeged, 6722

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • Clinfan Szolgaltato Kft

    Szekszárd, 7100

Other trials in Hungary

Russia19 sites

  • Irkutsk State Medical Academy of Continuing Education

    Irkutsk, 664049

  • TSBIH Territorial Clinical Hospital

    Krasnoyarsk, 660022

  • Medical Center Stolitsa-Medikl

    Moscow, 115088

  • SBHI of NN region RCH of NN n.a. N.A.Semashko

    Nizhny Novgorod, 603126

  • SBEIHPE Novosibirsk State Medical University

    Novosibirsk, 630054

  • RSHI State Novosibirsk Regional Clinical Hospital

    Novosibirsk, 630087

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

    Novosibirsk, 630117

  • BHI of Omsk region Clinical Oncology Dispensary

    Omsk, 644013

  • SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF

    Omsk, 644043

  • SBIH of Perm territory City Clinical Hospital 2 na Fedor Khristoforovich Gral

    Perm, 614068

  • Evromedservis

    Pushkin, 196603

  • SEIHPE Rostov State Medical University of MoH of RF

    Rostov-on-Don, 344022

  • City Mariinskaya Hospital

    Saint Petersburg, 194104

  • SPb SBIH City Hospital # 26

    Saint Petersburg, 196247

  • Private Educational Institution of Higher Education Medical university REAVIZ

    Samara, 443001

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

    Samara, 443041

  • SHI Regional Clinical Hospital

    Saratov, 410053

  • SBI of Healthcare of Leningrad region Clinical Interregional Hospital of Tosno

    Tosno, 187000

  • SBHI of Yaroslavl Region Clinical Hospital 8

    Yaroslavl, 150030

Other trials in Russia

Australia18 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Ballarat Base Hospital

    Ballarat, 3350

  • Bankstown-Lidcombe Hospital

    Bankstown, Australian Capital Territory, 2200

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • 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

  • Austin Hospital

    Heidelberg, 3084

  • Royal Brisbane and Women's Hospital

    Herston, 4006

  • Nepean Hospital

    Kingswood, NSW, 2751

  • 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

Ukraine18 sites

  • RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU

    Chernivtsi, 58001

  • CI of PH Kharkiv CCH #2

    Kharkiv, 61037

  • GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

    Kharkiv, 61039

  • Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus

    Kirovohrad, 25006

  • Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC

    Kyiv, 01030

  • Kyiv City Clinical Hospital #1

    Kyiv, 02091

  • SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU

    Kyiv, 04053

  • Lviv Regional Clinical Hospital D Halytskyi Lviv NMU

    Lviv, 79010

  • Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU

    Lviv, 79013

  • CI Odesa Regional Clinical Hospital

    Odesa, 65025

  • Communal Institution City Policlinic #20 Cabinet of Gastroenterology

    Odesa, 65114

  • M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy

    Poltava, 36011

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

    Sumy, 40022

  • Ternopil City Communal Emergency Medical Care Hospital

    Ternopil, 46000

  • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

    Vinnytsia, 21018

  • 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

Poland16 sites

  • SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

    Bialystok, 15-275

  • Clinsante S.C. Osrodek Badan Klinicznych

    Bydgoszcz, 85-794

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA

    Kielce, 25-364

  • Indywidualna Praktyka Lekarska Maciej Zymla

    Knurów, 44-190

  • Centrum Medyczne Plejady

    Krakow, 30-349

  • LUX MED Sp. z o.o.

    Krakow, 30-415

  • SPZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 31-531

  • SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow

    Lodz, 90-647

  • Centrum Medyczne AMED

    Lodz, 91-365

  • GASTROMED Sp.zo.o.

    Lublin, 20-582

  • Ai Centrum Medyczne Sp. Z O.O. Sp.K.

    Poznan, 61-113

  • Centrum Medyczne Medyk

    Rzeszów, 35-055

  • Endoskopia Sp. z o.o.

    Sopot, 81-756

  • Nzoz Vivamed

    Warsaw, 03-580

  • LexMedica Osrodek Badan Klinicznych

    Wroclaw, 53-114

Other trials in Poland

Turkey (Türkiye)16 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

  • Gaziantep University Medical Faculty Sahinbey Educational Research Hospital

    Gaziantep, 27310

  • Yeditepe University Medical School Hospital

    Istanbul, 31755

  • Istanbul University Cerrahpasa Medical Faculty Hospital

    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

  • Inonu Uni. Med. Fac.

    Malatya, 44280

  • Mersin University Medical Faculty

    Mersin, 33020

  • Kocaeli Derince Training and Research Hospital

    Umuttepe Kocaeli, 41380

Other trials in Turkey (Türkiye)

United Kingdom15 sites

  • Queen Elizabeth Hospital

    Birmingham, B152WB

  • Bristol Royal Infirmary

    Bristol, BS1 3NX

  • Royal Devon and Exeter Hospital Wonford

    Exeter, EX2 5DW

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Glasgow Royal Infirmary

    Glasgow, Scotland, G4 OSF UK

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • Royal London Hospital

    London, E1 1BB

  • St Marys Hospital

    London, W2 1NY

  • Manchester Royal Infirmary

    Manchester, M13 9WL

  • University Hospital of South Manchester NHS Foundation Trust -Wythenshawe Hospital - North West Lung

    Manchester, M23 9LT

  • Nottingham University Hospitals Queens Medical Centre

    Nottingham, NG7 2UH

  • John Radcliffe Hospital

    Oxford, OX3 9DU

  • Borders General Hospital

    Roxburghshire, TD6 9BS

  • Royal Shrewsbury Hospital

    Shrewsbury, SY38XQ

  • Southampton General Hospital

    Southhampton, SO01 6YD

Other trials in United Kingdom

South Korea14 sites

  • Dong-A University Hospital

    Busan, 49201

  • Pusan National University Hospital

    Busan, 49241

  • Yeungnam University Medical Center

    Daegu, 42415

  • Hanyang Univerisy Guri Hospital

    Guri-si, 11923

  • CHA Bundang Medical Center CHA University

    Seongnam-si, 13496

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Kyung Hee University Hospital

    Seoul, 02447

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Asan Medical Center

    Seoul, 05505

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Korea University Anam Hospital

    Seoul, 136-705

  • Ewha Womans University Mokdong Hospital

    Seoul, 158-710

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

    Suwon, 16247

Other trials in South Korea

Slovakia13 sites

  • Fakultna nemocnica s poliklinikou F. D. Roosevelta

    Banská Bystrica, 975 17

  • Alian s.r.o.

    Bardejov, 08501

  • Univerzitna nemocnica Bratislava Nemocnica Ruzinov

    Bratislava, 82606

  • Gastroentero-Hepatologicke centrum THALION

    Bratislava, 83104

  • Nemocnica A.Lena Humenne n o

    Humenné, 06601

  • B & B MED, s.r.o.

    Košice, 04022

  • KARDIO 1 s.r.o.

    Lučenec, 984 39

  • Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.

    Malacky, 90122

  • Fakultna nemocnica Nitra

    Nitra, 949 01

  • KM Management, spol. s r.o.

    Nitra, 94901

  • GASTRO I., s.r.o.

    Prešov, 080 01

  • Nemocnica s poliklinikou sv Barbory Roznava a s

    Rožňava, 04801

  • Fakultna nemocnica s poliklinikou Zilina

    Žilina, 01207

Other trials in Slovakia

Spain12 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Corporacion Sanitaria Parc Tauli

    Sabadell, 08208

  • Hospital Universitario Infanta Sofia

    San Sebastián de los Reyes, 28702

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Hospital Universitario Virgen Macarena

    Seville, 41017

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Israel11 sites

  • HaEmek Medical Center

    Afula, 18341

  • Soroka University Medical Center

    Beersheba, 84101

  • Rambam Health Care Campus

    Haifa, 3109601

  • Wolfson Medical Center

    Holon, 58100

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah University Hospital

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center Department of Hematology

    Tel Aviv, 64239

  • Assaf Harofeh Medical Center

    Tsrifin, 70300

Other trials in Israel

Austria10 sites

  • LKH Universitaetsklinikum Graz

    Graz, 8036

  • Medizinische Universitat Innsbruck

    Innsbruck, 6020

  • Klinikum Klagenfurt am Wörtersee

    Klagenfurt, 9020

  • KH der Barmherzigen Bruder Linz

    Linz, 4021

  • a.o.Krankenhaus d.Barmherz.Schwestern Ried

    Ried I Innkreis, 4910

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

  • Ordination Dr. Thomas Haas Darmpraxis Salzburg

    Salzburg, 5020

  • KH der Barmherzigen Brüder St.Veit an der Glan

    Sankt Veit an der Glan, 9300

  • Krankenanstalt Rudolfstiftung Wien

    Wein, 1030

  • AKH Medizinische Universitat Wien

    Wein, 1090

Other trials in Austria

Greece10 sites

  • University General Hospital of Alexandroupolis

    Alexandroupoli, 68100

  • General Hospital of Athens Evangelismos

    Athens, 10676

  • Athens Medical Center

    Athens, 15125

  • General Hospital of Nikaea Piraeus Ag. Panteleimon

    Athens, 18454

  • University General Hospital of Heraklion

    Heraklion, 711 10

  • General Hospital of Heraklion Benizeleio Pananeio

    Heraklion, 71409

  • University General Hospital of Ioannina

    Ioannina, 45500

  • University General Hospital of Patras

    Rio Patras, 26500

  • Anticancer Hospital of Thessaloniki THEAGENIO

    Thessaloniki, 54007

  • General Hospital of Thessaloniki Hippokration

    Thessaloniki, 54642

Other trials in Greece

Netherlands10 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • Academisch Medisch Centrum

    Amsterdam, 1105

  • Amphia Ziekenhuis

    Breda, 4819 EV

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Leiden Universitair Medisch Centrum

    Leiden, 2333 ZA

  • Medisch Centrum Haaglanden,Antoniushoeve

    Leidschendam, 2262 BA

  • Radboudumc

    Nijmegen, 6525 GA

  • Zuyderland Medisch Centrum

    Sittard-Geleen, 6162 BG

  • St. Elisabeth Ziekenhuis

    Tilburg, 5022 GC

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Bulgaria9 sites

  • MHAT Sv Nikolay Chudotvorets EOOD

    Lom, 3600

  • MHAT Kaspela EOOD

    Plovdiv, 4002

  • MHAT Ruse AD

    Rousse, 7002

  • Second MHAT Sofia AD

    Sofia, 1202

  • City Clinic UMHAC EOOD

    Sofia, 1407

  • UMHAT Sv Ivan Rilski EAD

    Sofia, 1431

  • UMHAT Tsaritsa Yoanna - ISUL EAD

    Sofia, 1527

  • Fourth MHAT Sofia EAD

    Sofia, 1606

  • MHAT Doverie AD

    Sofia, 1632

Other trials in Bulgaria

Czechia9 sites

  • Fakultni nemocnice u sv Anny v Brne

    Brno, 656 91

  • Hepato-Gastroenterologie HK

    Hradec Králové, 50012

  • Soukroma Gastroenterologicka ambulance a endoskopie

    Most, 43401

  • PreventaMed

    Olomouc, 77900

  • CCBR Czech as

    Pardubice, 530 02

  • CCBR Prague CZ

    Prague, 13000

  • IBD Centrum ISCARE IVF as

    Prague, 170 04

  • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La

    Ústí nad Labem, 40113

  • Nemocnice Znojmo

    Znojmo, 669 02

Other trials in Czechia

Denmark7 sites

  • Aarhus Universitetshospital

    Aahus C, 8000

  • Alborg University Hospital

    Aalborg, 9000

  • Nordsjaellands Hospital Frederikssund

    Frederikssund, 3600

  • Herlev Hospital

    Herlev, 2730

  • Hvidovre Hospital

    Hvidovre, 2650

  • Koge Sygehus

    Køge, 4600

  • Regionshospitalet Silkeborg

    Silkeborg, 8600

Other trials in Denmark

Serbia7 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Center Zvezdara

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Center Bezanijska Kosa

    Belgrade, 11080

  • Clinical Center Zemun

    Belgrade, 11080

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Center Nis

    Niš, 18000

Other trials in Serbia

Belgium6 sites

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Cliniques Universitaires St Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • CHU Sart Tilman

    Liège, 4000

  • Centre Hospitalier de Mouscron

    Mouscron, 9000

Other trials in Belgium

Croatia6 sites

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • Clinical Hospital Centre Rijeka

    Rijeka, 51000

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000

  • Clinical Hospital Dubrava

    Zagreb, 10000

  • Clinical Hospital Merkur

    Zagreb, 10000

  • Clinical Hospital Sveti Duh

    Zagreb, 10000

Other trials in Croatia

Portugal6 sites

  • Hospital de Braga

    Braga, 4710-243

  • Centro Hospitalar E Universitario de Coimbra EPE

    Coimbra, 3000-075

  • 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

Malaysia5 sites

  • Hospital Sultanah Bahiyah

    Alor Star, Kedah, 5460

  • Hospital Ampang

    Ampang, Selangor, 68000

  • Hospital Universiti Sains Malaysia

    Kelantan, Kelantan, 16150

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, Kelantan, 15586

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

Other trials in Malaysia

Norway5 sites

  • Sykehuset Ostfold Fredrikstad

    Fredrikstad, 1603

  • Akershus universitetssykehus HF

    Lørenskog, 1478

  • Oslo Universitetssykehus HF Ulleval

    Oslo, 0424

  • Oslo Universitetssykehus Rikshospitalet

    Oslo, N-0027

  • Stavanger Unviversitetssjukehus Helse Stavanger HF

    Stavanger, 4011

Other trials in Norway

Romania5 sites

  • S.C MedLife S.A

    Bucharest, 010719

  • Tvm Med Serv Srl

    Cluj-Napoca, 400132

  • Spitalul Clinic Judetean de Urgente Sf. Spiridon

    Iași, 700111

  • CMI Dr. Tirnaveanu Amelita

    Oradea, 410066

  • Centrul de Gastroenterologie Dr. Goldis

    Timișoara, 300002

Other trials in Romania

Switzerland5 sites

  • Universitaetsspital Basel

    Basel, 4031

  • Inselspital - Universitaetsspital Bern

    Bern, 3010

  • Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner

    Bern, 3012

  • Kantonsspital St.Gallen

    Sankt Gallen, 9000

  • Universitaetsspital Zuerich

    Zurich, 8091

Other trials in Switzerland

Latvia3 sites

  • Digestive Diseases Center Gastro

    Riga, LV-1006

  • Riga East Clinical University Hospital clinic Gailezers

    Riga, LV-1038

  • Pauls Stradins Clinical University Hospital

    Riga, LV1002

Other trials in Latvia

Sweden3 sites

  • Sodersjukhuset

    Stockholm, 11883

  • Danderyds Sjukhus AB

    Stockholm, 18288

  • Akademiska Sjukhuset

    Uppsala, 75185

Other trials in Sweden

Estonia2 sites

  • West Tallinn Central Hospital

    Tallinn, 10617

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Finland2 sites

  • Tampereen yliopistollinen sairaala

    Tampere, 33521

  • Turunmaan sairaala

    Turku, 20700

Other trials in Finland

New Zealand1 site

  • Waikato Hospital

    Hamilton, 3204

Other trials in New Zealand

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 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.

After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study. Participants who discontinued the study anytime or completed the study at Week 52 were then observed for an additional 4 weeks.

Conditions
Crohn Disease
Being tested
GED-0301, Placebo
Keywords
Crohn's Disease, GED-0301, Mongersen, IBD, Safety, Efficacy
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

  • PlaceboDrug

Study groups in NCT02596893
Study groupRoleWhat they receive
GED0301 160mg x 12 weeks followed by periodic 160 mg GED0301ExperimentalGED-0301 160 mg once daily (QD) for 12 weeks; followed by placebo QD for 4 weeks; followed by alternating GED-0301 160 mg QD for 4 weeks and placebo QD for 4 weeks, until the the Week 52 Visit
Receives: Drug: GED-0301; Drug: Placebo
GED0301 160mg x 12 weeks followed by periodic GED0301 40mgExperimentalGED-0301 160 mg once daily (QD) for 12 weeks; followed by placebo QD for 4 weeks; followed by alternating GED-0301 40 mg QD for 4 weeks and placebo QD for 4 weeks, until the Week 52 Visit
Receives: Drug: GED-0301; Drug: Placebo
GED0301 160mg x 12 weeks followed by continuous GED0301 40mgExperimentalGED-0301 160 mg once daily (QD) for 12 weeks; followed by continuous GED-0301 40 mg QD, until the Week 52 Visit
Receives: Drug: GED-0301
PlaceboPlacebo comparatorPlacebo once daily (QD) until the Week 52 Visit
Receives: Drug: Placebo

What is being measured

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

  1. The Percentage of Participants Who Achieved a Clinical Remission at Week 12

    Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the affect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.

    Measured: Week 12

Secondary outcomes (11)

  1. Percentage of Participants Who Achieved Clinical Remission at Week 52

    Clinical remission is defined as a CDAI score < 150 and is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.

    Measured: Week 52

  2. Percentage of Participants With Endoscopic Response-50 Centrally Read at Week 52

    An endoscopic response-50 is defined as a reduction of at least 50% compared with baseline in simple endoscopic score for Crohn's Disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include:

    • Ulcers scored as: 0: no
    1. aphthous (0.1-0.5 cm)
    2. large (0.5-2 cm)
    3. very large (>2 cm)
    • Surface involved disease 0: 0%
    1. <50%
    2. 50-75%
    3. >75%

    Surface involved by ulcerations:

    0: 0%

    1. <10%
    2. 10-30%
    3. >30% - Narrowings:

    0: No

    1. Single, can be passed
    2. Multiple, can be passed
    3. Cannot be passed Grand Total = SES-CD score

    Measured: Week 52

  3. The Percentage of Participants Who Achieved a Clinical Response at Week 12

    A clinical response is defined as a CDAI score decrease from baseline ≥ 100 points. The CDAI is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.

    Measured: Week 12

  4. The Percentage of Participants Who Achieved a Clinical Response at Week 4

    A clinical response is defined as a decrease from baseline in CDAI ≥ 100 points. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.

    Measured: Week 4

  5. The Percentage of Participants Who Achieved a Clinical Remission at Week 4

    A clinical remission is a CDAI score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.

    Measured: Week 4

  6. The Percentage of Participants Who Achieved a Corticosteroid-Free Clinical Remission at Week 52

    The percentage of participants who were receiving oral corticosteroids for Crohn's disease, at baseline and achieved a clinical remission (CDAI score <150) at Week 52 without corticosteroids. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.

    Measured: Week 52

  7. Percentage of Participants Who Achieved a Sustained Clinical Remission at Both Week 12 and 52

    For participants who achieved a sustained clinical remission at both week 12 and 52, the clinical remission is a CDAI score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.

    Measured: Weeks 12 and 52

  8. Percentage of Participants With Endoscopic Response-25 Centrally Read at Week 12

    An endoscopic response-25 is defined as a reduction of at least 25% compared with baseline in simple endoscopic score for Crohn's disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include:

    • Ulcers scored as: 0: no
    1. aphthous (0.1-0.5 cm)
    2. large (0.5-2 cm)
    3. very large (>2 cm)
    • Surface involved disease 0: 0%
    1. <50%
    2. 50-75%
    3. >75%

    Surface involved by ulcerations:

    0: 0%

    1. <10%
    2. 10-30%
    3. >30% - Narrowings:

    0: No

    1. Single, can be passed
    2. Multiple, can be passed
    3. Cannot be passed Grand Total = SES-CD score

    Measured: Week 0, Week 12

  9. Percentage of Participants With Endoscopic Remission Centrally Read at Week 52

    Endoscopic remission is defined as a simple endoscopic score for Crohn's disease (SES-CD) of ≤2 at the specified timeframe. The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include:

    • Ulcers scored as: 0: no
    1. aphthous (0.1-0.5 cm)
    2. large (0.5-2 cm)
    3. very large (>2 cm)
    • Surface involved disease 0: 0%
    1. <50%
    2. 50-75%
    3. >75%

    Surface involved by ulcerations:

    0: 0%

    1. <10%
    2. 10-30%
    3. >30% - Narrowings:

    0: No

    1. Single, can be passed
    2. Multiple, can be passed
    3. Cannot be passed Grand Total = SES-CD score

    Measured: Week 52

  10. The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE) From Week 0 to Week 52

    A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED-0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.

    Measured: From the first day of GED-0301 until 28 days after the last dose of investigational product (IP); maximum treatment duration was 52.6 weeks

  11. The Number of Participants Who Discontinued IP Due to an Treatment Emergent Adverse Events

    A TEAE was defined as any AE occurring or worsening on or after the first dose of GED-0301 and up to 28 days after the last GED-0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.

    Measured: From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 52.6 weeks

Timeline

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

  1. First posted4 Nov 2015 (estimated)
  2. Study start8 Dec 2015
  3. Primary completion5 Jan 2018
  4. Study completion5 Jan 2018

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
701 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02596893
Sponsor's protocol ID
GED-0301-CD-002
Status last verified
Aug 2019
First submitted
3 Nov 2015
Last updated
28 Aug 2019
Data monitoring committee
Yes

Publications

  • Gold SL, Cohen-Mekelburg S, Schneider Y, Steinlauf A. Perianal Fistulas in Patients With Crohn's Disease, Part 2: Surgical, Endoscopic, and Future Therapies. Gastroenterol Hepatol (N Y). 2018 Sep;14(9):521-528.

    PubMed 30364296

  • Sands BE, Feagan BG, Sandborn WJ, Schreiber S, Peyrin-Biroulet L, Frederic Colombel J, Rossiter G, Usiskin K, Ather S, Zhan X, D'Haens G. Mongersen (GED-0301) for Active Crohn's Disease: Results of a Phase 3 Study. Am J Gastroenterol. 2020 May;115(5):738-745. doi: 10.14309/ajg.0000000000000493.

    PubMed 31850931

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 538 sites in 35 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 538 sites in United States, Germany, Canada, France, Italy and 30 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?

Yes. Results are posted in the registry (first posted 23 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Percentage of Participants Who Achieved a Clinical Remission at Week 12 (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 NCT02596893, which also lists 2 linked publications.

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 28 Aug 2019.

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