A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease
Crohn Disease
About this trial
This is an interventional treatment trial for Crohn Disease focused on measuring Crohn's Disease, GED-0301, Mongersen, Adolescent, Pediatric, Children
Eligibility Criteria
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.
Sites / Locations
- Dcr-Pi Pc
- Arizona Digestive Health
- Arizona Digestive Health
- Phoenix Childrens Hospital
- Mayo Clinic Arizona
- Arizona Digestive Health
- Gastroenterology Associates PA
- Valley View Internal Medicine
- High Desert Gastroenterology, Inc.
- University of Southern California Medical Center
- Cedars Sinai Medical Center
- Facey Medical Foundation
- Medical Associates Research Group Inc.
- University of California at San Francisco (PARENT)
- HCP Clinical Research LLC
- Ventura Clinical Trials
- University Of Colorado
- Innovative Clinical Research
- Connecticut Gastroenterology Institute
- Medical Research Center of Connecticut LLC
- Connecticut GI PC Research Division
- Yale University
- Mayo Clinic - Jacksonville
- Florida Center for Gastroenterology
- Galiz Research LLC
- University of Miami
- Advance Medical Research Center
- Cordova Research Institute
- Sanitas Research
- Gastroenterology Group of Naples
- GCRM
- Center For Digestive Health
- Advanced Medical Research Center
- East Coast Institute for Research LLC
- Clinical Research of West Florida, Inc.
- Cleveland Clinic Florida Weston
- Shafran Gastroenterology Center
- Georgia Regents University
- Columbus Regional Research Institute
- Atlanta Gastroenterology Specialists PC
- Northwestern University-Feinberg School of Medicine
- Rush University Medical Center
- Northshore University Healthsystem Research Institute
- Indiana University School of Medicine
- Iowa Digestive Disease Center
- Health Science Research Center, LLC
- Heartland Research Associates LLC
- Via Christi Research a division of Via Christi Hospitals Wichita Inc
- Graves Gilbert Clinic
- University of Kentucky Medical Center
- University of Louisville
- Gastroenterology Associates, LLC
- Clinical Trials of SW Louisiana LLC
- Louisiana Research Center LLC
- University of Maryland Medical Group
- Johns Hopkins University School of Medicine
- Charm City Research Group
- Boston Medical Center
- Lahey Clinic Inc. - PARENT ACCOUNT
- UMass Medical Center
- University of Michigan Health System
- Medex Research Institute
- Clinical Research Institute of Michigan, LLC
- Henry Ford Health System
- Gastroenterology Associates of Western Michigan PLC
- Mayo Clinic
- Ehrhardt Clinical Research, LLC
- Jefferson City Medical Group
- Saint Louis University
- Mercy Research
- Mercy Research
- Dartmouth-Hitchcock Medical Center
- AGA Clinical Research Associates LLC
- North Shore-LIJ Health System-Division of Rheumatology
- NYU Langone Long Island Clinical Research Associates
- Montefiore Medical Center PRIME
- The Feinstein Institute for Medical Research PRIME
- Winthrop University Hospital
- New York University School of Medicine
- Mount Sinai School of Medicine
- Columbia University Medical Center
- Premier Medical Group of the Hudson Valley PC
- University of Rochester
- Asheville Gastroenterology Associates, P.A.
- University of North Carolina at Chapel Hill
- Carolina Center for Liver Disease
- Gaffney Health Services
- PhysiqueMed Clinical Trials
- Kinston Medical Specialists PA
- Clinical Trials of America, LLC
- Trial Management Associates LLC
- PMG Research of Winston-Salem
- Ohio Clinical Research Partners LLC
- Clinical Inquest Center Ltd
- Dr. Deepak Sarwal, MD
- UC Health Clinical Trials Office
- Consultants for Clinical Research Inc.
- University Hospitals Cleveland Medical Center
- The Cleveland Clinic Foundation
- Springfield Health Care Center
- Oklahoma Foundation for Digestive Research
- University of Oklahoma Health Sciences Center
- Oregon Health & Science University
- Main Line Gastroenterology
- Drexel University College of Medicine
- Childrens Hospital of Philadelphia
- University of Pennsylvania School of Medicine
- Penn State University Milton S Hershey Medical Center
- Rhode Island Hospital
- Carolinas Healthcare System
- ClinSearch LLC
- Gastro One
- Vanderbilt University Medical Center
- Texas Clinical Research Institute LLC
- Gulf Coast Research Group LLC
- Methodist Hospital
- University of Texas Health Science Center at Houston
- Houston Endoscopy and Research Center
- Digestive Health Center
- Texas Digestive Disease Consultants - Southlake
- Digestive Health Specialists of Tyler
- University of Utah Division of Gastroenterology
- Advanced Clinical Research
- University of Virginia
- Charlottesville Medical Research Center
- Gastroenterology Associates of Tidewater
- Digestive and Liver Disease Specialists
- Hunter Holmes Mcguire Ctr
- Virginia Mason Medical Center
- Harborview Medical Center
- Swedish Medical Center Cancer Institute Research
- University of Washington School of Medicine
- The Vancouver Clinic
- University of Wisconsin Hospital and Clinics
- Dean Clinic Oregon
- Medical College of Wisconsin
- Royal Prince Alfred Hospital
- Concord Repatriation General Hospital
- Centre For Digestive Diseases
- Liverpool Hospital
- Royal Brisbane and Women's Hospital
- Mater Adult Hospital
- Princess Alexandra Hospital
- Royal Adelaide Hospital Institute of Medical and Veterinary Science
- Box Hill Hospital
- The Alfred Hospital
- Fiona Stanley Hospital
- Ballarat Base Hospital
- Monash Medical Centre Clayton
- St Vincents Hospital Melbourne
- Klinikum Klagenfurt am Wörtersee
- LKH - Universitätsklinikum der PMU Salzburg
- Krankenanstalt Rudolfstiftung Wien
- Hopital Universitaire des Enfants
- Cliniques Universitaires Saint-Luc
- UZ Antwerpen
- Universitair Ziekenhuis Gent
- CHU Sart Tilman
- Alberta Childrens Hospital
- GI Research Institute
- Barrie GI Associates
- LHSC - Victoria Hospital
- Mount Sinai Hospital
- The Hospital for Sick Children
- Centre de sante et de services sociaux Champlain Charles Le Moyne
- Royal University Hospital
- Clinical Hospital Centre Osijek
- Hepato-Gastroenterologie HK, s. r. o.
- PreventaMed
- CCBR Prague CZ
- Thomayerova nemocnice
- Aarhus Universitetshospital
- Alborg Universitets Hospital
- Hvidovre Hospital
- Koge Sygehus
- Odense Universitetshospital
- Regionshospitalet Silkeborg
- Helsingin yliopistollinen keskussairaala
- Tampereen yliopistollinen sairaala
- CHU Amiens Hopital Sud
- CHU Besancon Hopital Jean Minjoz
- Hopital Claude Huriez CHRU Lille
- Hopital Nord CHU Marseille
- CHU Nice Hopital de lArchet 2
- Hopital Saint Louis
- Centre Hospitalier Lyon Sud
- CHU Reims Hopital Robert Debre
- CHU de Rouen Hopital Charles Nicolle
- CHU de Toulouse Hopital Rangueil
- Hopital de Brabois Adultes
- Charite - Campus Virchow-Klinikum
- DRK Kliniken Berlin Westend
- St. Josef-Hospital
- Staedisches Klinikum Brandenburg
- Universitaetsklinikum Carl Gustav Carus
- Universitaetsklinikum Erlangen
- Universitaetsklinikum EssenZentrum fuer Innere Medizin
- Kliniken Essen-Mitte
- Katholische Kliniken Ruhrhalbinsel GmbH
- Crohn Colitis Centrum Rhein Main
- Asklepios Klinik Hamburg
- Universitaetsklinikum Schleswig Holstein Campus Kiel
- EUGASTRO GmbH
- Gastroenterologische Praxis Minden
- Universitatsklinikum Regensburg
- Universitaetsklinikum Ulm
- HELIOS Klinikum Wuppertal
- General Hospital of Athens Evangelismos
- Athens Medical Center
- University General Hospital of Patras
- Obudai Egeszsegugyi Centrum Kft.
- Semmelweis Egyetem
- Szent Margit Korhaz
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy
- Rabin Medical Center
- Kaplan Medical Center
- Assaf Harofeh Medical Center
- Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
- Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
- Azienda Ospedaliera Di Padova
- Azienda Ospedaliera Vincenzo Cervello
- Fondazione IRCCS Policlinico San Matteo
- Azienda Ospedaliero Universitaria Pisana
- Universita Campus Bio-Medico di Roma
- Complesso Integrato Columbus
- Azienda Ospedaliera San Camillo Forlanini
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata
- Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi dAragona
- IRCCS Policlinico San Donato
- Dong-A University Hospital
- Pusan National University Hospital
- Hanyang Univerisy Guri Hospital
- CHA Bundang Medical Center CHA University
- Seoul National University Bundang Hospital
- Kyung Hee University Hospital
- Ewha Womans University Mokdong Hospital
- Seoul National University Hospital
- Kangbuk Samsung Hospital
- The Catholic University of Korea, St. Vincent's Hospital
- Yonsei University Wonju Severance Christian Hospital
- Digestive Diseases Center Gastro
- Riga East Clinical University Hospital clinic Gailezers
- Amphia Ziekenhuis
- Erasmus Medisch Centrum
- SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
- Clinsante S.C. Osrodek Badan Klinicznych
- Centrum Medyczne A-Z Clinic
- Centrum Medyczne AMED
- Nzoz Vivamed
- LexMedica Osrodek Badan Klinicznych
- Hospital de Braga
- Hospital da Senhora da Oliveira Guimaraes
- Hospital Da Luz
- Centro Hospitalar de Sao Joao, EPE
- Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE
- CMI Dr. Tirnaveanu Amelita
- Centrul de Gastroenterologie Dr. Goldis
- Medical Center Stolitsa-Medikl
- SBEIHPE Novosibirsk State Medical University
- FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS
- SPb SBIH City Hospital # 26
- NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways
- Clinical Center Bezanijska Kosa
- GASTRO I., s.r.o.
- Hospital General Universitario de Alicante
- Hospital del Mar
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitario de la Princessa
- Hospital General Universitario Gregorio Maranon
- Hospital Universitario Ramon y Cajal
- Hospital Universitario La Paz
- Complejo Hospitalario de Pontevedra
- Hospital Universitario Miguel Servet
- Danderyds Sjukhus AB
- Inselspital - Universitaetsspital Bern
- Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner
- Hopitaux Universitaires de Geneve-HUG
- UniversitatSspital Zurich
- Ankara University Medical Faculty
- Hacettepe University Medical Faculty
- Turkiye Yuksek Ihtisas Hospital
- Gazi University Medical Faculty
- Firat University Medical Faculty
- Istanbul University Cerrahpasa Medical Faculty
- Acibadem Fulya Hospital
- Haydarpasa Numune Training and Research Hospital
- Istanbul Medeniyet Uni Goztepe Training&Res Hosp
- Marmara University Pendik Training and Research Hospital
- Ege University Medical Faculty
- Dokuz Eylul University Izmir
- Kocaeli Derince Training and Research Hospital
- Inonu Uni. Med. Fac.
- Mersin University Medical Faculty
- CI of PH Kharkiv CCH #2
- Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus
- Kyiv City Clinical Hospital #1
- CI Odesa Regional Clinical Hospital
- CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI
- Ternopil City Communal Emergency Medical Care Hospital
- SRI of Invalid Rehabilitation EST Complex of Vinnytsia M.I.Pyrogov NMU MOHU
- SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
- CI Zaporizhzhia Regional Clinical Hospital of ZRC
- Basingstoke and North Hampshire Hospital
- University Hospital Coventry
- Queen Elizabeth University Hospital
- Hull Royal Infirmary
- Royal London Hospital
- University College London Hospitals
- Manchester Royal Infirmary
- Nottingham University Hospitals Queens Medical Centre
- Borders General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
GED-0301 1 x 160 mg once daily
GED-0301 - 4 x 40 mg once daily
Placebo once daily
GED-0301 1 x 160 mg tablet once daily (QD)
GED-0301 4 x 40 mg tablets once daily (QD)
Placebo once daily (QD)