A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, GED 0301, Mongersen, Safety, Irritable Bowel Disease
Eligibility Criteria
Inclusion Criteria for Adult Subjects:
Subjects must satisfy the following criteria to be screened and enrolled in the study:
- Male or female ≥ 18 years of age.
- Subject must have participated in the GED-0301-CD-002 or GED 0301 CD 003 study.
- Subject must use protocol approved contraception.
Inclusion Criteria for Adolescent Subjects:
Adolescent subjects must satisfy the following criteria to be screened and enrolled in the study
- Male or female 12 to 17 years of age.
- Subject must have participated in the GED 0301 CD 003 study.
- Subject is able to swallow the IP tablets.
- Subject must use protocol approved contraception.
Exclusion Criteria for Adult and Adolescent Subjects:
The presence of any of the following will exclude a subject from screening and enrollment:
- Subject had experienced a serious adverse event (SAE) related to the investigational product while participating in the previous Phase 3 GED-0301 study.
- Subject has initiated biologic agents, such as TNF-α blockers or integrin antagonists.
- Subject is pregnant or breastfeeding.
- Subject has developed a known hypersensitivity to oligonucleotides, GED 0301 or any ingredient in the investigational product.
Sites / Locations
- Medical Associates Research Group Inc.
- Atlanta Gastroenterology Associates, LLC
- Indiana University
- Health Science Research Center, LLC
- Via Christi Research a division of Via Christi Hospitals Wichita Inc
- Gastroenterology Associates LLC
- Metropolitan Gastroenterology
- Clinical Research Institute of Michigan, LLC
- Gastroenterology Associates of Western Michigan PLC
- Ehrhardt Clinical Research LLC
- Columbia University Medical Center
- Trial Management Associates LLC
- ClinSearch LLC
- Texas Clinical Research Institute LLC
- Texas Digestive Disease Consultants - Dallas
- Texas Digestive Disease Consultants - Southlake
- University of Texas Health Science Center at Houston
- Sagact Pllc
- San Antonio Military Medical Center
- Digestive Health Specialists of Tyler
- Virginia Mason Medical Center
- University of Washington School of Medicine
- The Vancouver Clinic
- Concord Repatriation General Hospital
- Centre For Digestive Diseases
- Liverpool Hospital
- Mater Adult Hospital
- Royal Adelaide Hospital
- Box Hill Hospital
- The Alfred Hospital
- Monash Medical Centre Clayton
- LKH Universitaetsklinikum Graz
- Medizinische Universitat Innsbruck
- KH der Barmherzigen Bruder Linz
- LKH - Universitätsklinikum der PMU Salzburg
- KH der Barmherzigen Brüder St.Veit an der Glan
- Krankenanstalt Rudolfstiftung Wien
- AKH Medizinische Universitat Wien
- Universitair Ziekenhuis Brussel
- UZ Leuven
- CHU Sart Tilman
- MHAT Kaspela EOOD
- MHAT Ruse AD
- Second MHAT Sofia AD
- City Clinic UMHAC EOOD
- UMHAT Sv Ivan Rilski EAD
- UMHAT Tsaritsa Yoanna - ISUL EAD
- MHAT Doverie AD
- University of Calgary
- University of Alberta
- South Edmonton Gastroenterology
- Vancouver General Hospital
- GI Research Institute
- PerCuro Clinical Research
- Brandon Medical Arts Clinic
- McMaster University Health Sciences Center
- London Health Science Center U. Hospital
- LHSC Victoria Hospital
- Montfort Hospital
- Mount Sinai Hospital
- Toronto Digestive Disease Associates Inc
- Medicine Professional Corporation
- Centre de sante et de services sociaux Champlain Charles Le Moyne
- McGill University Health Centre Glen Site Royal Victoria Hospital
- Clinical Hospital Centre Osijek
- Fakultni nemocnice u sv Anny v Brne
- Hepato-Gastroenterologie HK
- PreventaMed
- CCBR Prague CZ
- Aarhus Universitetshospital
- Alborg Universitets Hospital
- Nordsjaellands Hospital Frederikssund
- Herlev Hospital
- Koge Sygehus
- Regionshospitalet Silkeborg
- CHU Amiens Hopital Sud
- CHU Besancon Hopital Jean Minjoz
- CHU Tours Hopital Trousseau
- CHU Clermont Ferrand
- Hopital Beaujon
- CHU Nantes Hotel Dieu
- CHU Nice Hopital de lArchet 2
- Groupe Hospitalier Sud Hopital Haut Leveque USN
- Centre Hospitalier Lyon Sud
- CHU Reims Hopital Robert Debre
- CHU Rennes Hopital Pontchaillou
- CHU Saint Etienne Hopital Nord
- CHU Strasbourg Hopital Hautepierre
- CHU de Toulouse Hopital Rangueil
- Hopital de Brabois Adultes
- Charite Universitaetsmedizin Berlin Campus Benjamin Franklin
- DRK Kliniken Berlin Westend
- Krankenhaus Waldfriede e V
- Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
- Universitaetsklinikum Carl Gustav Carus TU Dresden
- Universitaetsklinikum Erlangen
- Kliniken Essen-Mitte
- Agaplesion Markus Krankenhaus
- Universitaetsklinikum Halle Saale
- Asklepios Klinik Hamburg
- Medizinische Hochschule Hannover
- Universitaetsklinikum Heidelberg
- Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter
- Universitaetsklinikum Jena
- Universitaetsklinikum Schleswig Holstein Campus Kiel
- University Leipzig
- EUGASTRO GmbH
- Medizinisches Zentrum Klinikum Lueneburg
- Klinikum Mannheim GmbH Universitaetsklinikum
- Gastro Campus Research
- Klinikum der Universitaet Muenchen
- Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer
- Universitaetsklinikum Regensburg
- Universitaetsklinikum Ulm
- University General Hospital of Alexandroupolis
- General Hospital of Athens Evangelismos
- Athens Medical Center
- University General Hospital of Patras
- DRC Gyogyszervizsgalo Kozpont Kft
- Magyar Honvedseg Egeszsegugyi Kozpont
- Semmelweis Egyetem AOK
- Endomedix Diagnosztikai Kozpont
- Debreceni Egyetem Klinikai Kozpont
- Szent Pantaleon Korhaz Rendelointezet Dunaujvaros
- Petz Aladar Megyei Oktato Korhaz
- Clinfan Szolgaltato Kft
- HaEmek Medical Center
- Soroka University Medical Center
- Rambam Health Care Campus
- Shaare Zedek Medical Center
- Hadassah University Hospital
- Rabin Medical Center
- Chaim Sheba Medical Center
- Kaplan Medical Center
- Tel Aviv Sourasky Medical Center Department of Hematology
- The Baruch Padeh MC, Poriya
- Assaf Harofeh Medical Center
- Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
- Azienda Ospedaliera Universitaria Policlinico G Martino
- Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
- Azienda Ospedaliera Vincenzo Cervello
- Fondazione IRCCS Policlinico San Matteo
- Universita Campus Bio Medico di Roma
- Policlinico Universitario Agostino Gemelli
- Azienda Ospedaliera San Camillo Forlanini
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata
- Istituto Clinico Humanitas
- IRCCS Policlinico San Donato
- IRCCS Ospedale Casa Sollievo della Sofferenza
- Dong-A University Hospital
- Pusan National University Hospital
- Yeungnam University Medical Center
- Hanyang University Guri Hospital
- CHA Bundang Medical Center CHA University
- Seoul National University Bundang Hospital
- Kyung Hee University Hospital
- Kangbuk Samsung Hospital
- Severance Hospital, Yonsei University Health System
- Samsung Medical Center
- Digestive Diseases Center Gastro
- Pauls Stradins Clinical University Hospital
- VU Medisch Centrum
- Academisch Medisch Centrum
- Amphia Ziekenhuis
- Radboudumc
- Zuyderland Medisch Centrum
- St. Elisabeth Ziekenhuis
- Akershus universitetssykehus HF
- Oslo Universitetssykehus Rikshospitalet
- Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA
- Indywidualna Praktyka Lekarska Maciej Zymla
- SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow
- Centrum Medyczne Medyk
- Endoskopia Sp. z o.o.
- Hospital de Braga
- Hospital da Senhora da Oliveira Guimaraes
- S.C MedLife S.A
- CMI Dr. Tirnaveanu Amelita
- Centrul de Gastroenterologie Dr. Goldis
- TSBIH Territorial Clinical Hospital
- SBHI of NN region RCH of NN n.a. N.A.Semashko
- SBEIHPE Novosibirsk State Medical University
- FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS
- Evromedservis
- SEIHPE Rostov State Medical University of MoH of RF
- SPb SBIH City Hospital # 26
- NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways
- Clinical Center Zvezdara
- Military Medical Academy
- Clinical Center Bezanijska Kosa
- Fakultna nemocnica s poliklinikou F. D. Roosevelta
- Alian s.r.o.
- Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.
- Fakultna nemocnica Nitra
- KM Management, spol. s r.o.
- GASTRO I., s.r.o.
- Hospital del Mar
- Hospital Clinic I Provincial de Barcelona
- Hospital Universitario Puerta de Hierro Majadahonda
- Corporacion Sanitaria Parc Tauli
- Hospital Universitario Miguel Servet
- Danderyds Sjukhus AB
- Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner
- Ankara University Medical Faculty
- Yeditepe University Medical School Hospital
- Istanbul University Cerrahpasa Medical Faculty Hospital
- 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
- Kocaeli Derince Training and Research Hospital
- RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU
- CI of PH Kharkiv CCH #2
- Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus
- Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC
- Kyiv City Clinical Hospital #1
- SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU
- CI Odesa Regional Clinical Hospital
- Ternopil City Communal Emergency Medical Care Hospital
- CI Zaporizhzhia Regional Clinical Hospital of ZRC
- Royal Devon and Exeter Hospital Wonford
- Glasgow Royal Infirmary
- Queen Elizabeth University Hospital
- Hull Royal Infirmary
- Royal London Hospital
- St Marys Hospital
- Manchester Royal Infirmary
- Nottingham University Hospitals Queens Medical Centre
- John Radcliffe Hospital
- Royal Shrewsbury Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
GED-0301 (160 mg) followed by Placebo intermittent 160 mg
Intermittent GED-0301 160 mg and placebo
Intermittent placebo and GED-0301 40 mg
Continuous GED-0301 40 mg
Intermittent placebo and GED-0301 160 mg
GED-0301 160 mg once daily (QD) for 12 weeks, followed by alternating Placebo (PBO) QD for 4 weeks with GED 0301 160 mg QD for 4 weeks, up to 208 weeks, if the subject previously received Placebo in the prior GED-0301 Study
Alternating GED-0301 160 mg once daily (QD) for 4 weeks with placebo (PBO) QD for 4 weeks, up to 208 weeks, depending on previous response in the prior GED-0301 study
Alternating PBO once daily (QD) for 4 weeks with GED-0301 40 mg QD for 4 weeks with, up to 208 weeks, depending on previous response in the prior GED-0301 study
GED-0301 40 mg once daily (QD) for up to 208 weeks
Alternating PBO QD for 4 weeks with GED-0301 160 mg QD for 4 weeks, through Week 208