A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study.

The GED-0301-CD-003 trial was not initiated; see detailed description.

Study Overview

• Status: Terminated
• Conditions: Crohn's Disease
• Intervention / Treatment: Other: Placebo; Drug: GED-0301

Detailed Description

This is a long-term active treatment study in patients with Crohn's disease (CD). Subjects who met the early escape criteria in Study GED-0301-CD-002, or subjects who completed Study GED-0301-002 or GED-0301-003, may be eligible for this study. Primary objective is to assess long-term safety of GED 0301. Additional efficacy and patient reported outcomes will be explored.

There are 5 possible treatment groups for GED-0301-CD-002 Subjects (Groups 1-5). There are 3 possible treatment groups for GED-0301-CD-003 subjects (Groups 1-3). Treatment is assigned based on clinical improvement achieved or not achieved from the core GED-0301 study.

1. continuous GED-0301 160 mg once daily for 12 weeks, followed by alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;
2. alternating GED-0301 160 mg once daily for 4 weeks with placebo once daily for 4 weeks, through Week 208;
3. alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;
4. continuous GED-0301 40 mg once daily through Week 208;
5. alternating placebo once daily for 4 weeks, followed by GED-0301 40 mg once daily for 4 weeks, through Week 208.

The GED-0301-CD-003 trial was not initiated; the GED-0301 program was terminated; no safety findings were noted.

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Bentleigh East, Australia, 3165
    • Monash Medical Centre Clayton
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Five Dock, New South Wales, Australia, 2046
      • Centre For Digestive Diseases
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Adult Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
• Austria
  • Graz, Austria, 8036
    • LKH Universitaetsklinikum Graz
  • Innsbruck, Austria, 6020
    • Medizinische Universität Innsbruck
  • Linz, Austria, 4021
    • KH der Barmherzigen Brüder Linz
  • Salzburg, Austria, 5020
    • LKH - Universitätsklinikum der PMU Salzburg
  • St Veit An Der Glan, Austria, 9300
    • KH der Barmherzigen Brüder St.Veit an der Glan
  • Wein, Austria, 1030
    • Krankenanstalt Rudolfstiftung Wien
  • Wein, Austria, 1090
    • AKH Medizinische Universitat Wien
• Belgium
  • Brussels, Belgium, 1090
    • Universitair Ziekenhuis Brussel
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liege, Belgium, 4000
    • CHU Sart Tilman
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • MHAT Kaspela EOOD
  • Ruse, Bulgaria, 7002
    • MHAT Ruse AD
  • Sofia, Bulgaria, 1202
    • Second MHAT Sofia AD
  • Sofia, Bulgaria, 1407
    • City Clinic UMHAC EOOD
  • Sofia, Bulgaria, 1431
    • UMHAT Sv Ivan Rilski EAD
  • Sofia, Bulgaria, 1527
    • UMHAT Tsaritsa Yoanna - ISUL EAD
  • Sofia, Bulgaria, 1632
    • MHAT Doverie AD
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary
    • Edmonton, Alberta, Canada, T6G 2X8
      • University of Alberta
    • Edmonton, Alberta, Canada, T6L 6K3
      • South Edmonton Gastroenterology
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • GI Research Institute
    • Victoria, British Columbia, Canada, V8V 3P9
      • PerCuro Clinical Research
  • Manitoba
    • Brandon, Manitoba, Canada, R7A 0N7
      • Brandon Medical Arts Clinic
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University Health Sciences Center
    • London, Ontario, Canada, N6A 5A5
      • London Health Science Center U. Hospital
    • London, Ontario, Canada, N6A 5W9
      • LHSC Victoria Hospital
    • Ottawa, Ontario, Canada, K1K 0T2
      • Montfort Hospital
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Toronto Digestive Disease Associates Inc
    • Waterloo, Ontario, Canada, N2J 1C4
      • Medicine Professional Corporation
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Centre de sante et de services sociaux Champlain Charles Le Moyne
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre Glen Site Royal Victoria Hospital
• Croatia
  • Osijek, Croatia, 31000
    • Clinical Hospital Centre Osijek
• Czechia
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv Anny v Brne
  • Hradec Kralove, Czechia, 50012
    • Hepato-Gastroenterologie HK
  • Olomouc, Czechia, 77900
    • PreventaMed
  • Praha 3, Czechia, 13000
    • CCBR Prague CZ
• Denmark
  • Aahus C, Denmark, 8000
    • Aarhus Universitetshospital
  • Alborg, Denmark, 9000
    • Ålborg Universitets Hospital
  • Frederikssund, Denmark, 3600
    • Nordsjaellands Hospital Frederikssund
  • Herlev, Denmark, 2730
    • Herlev Hospital
  • Koge, Denmark, 4600
    • Koge Sygehus
  • Silkeborg, Denmark, 8600
    • Regionshospitalet Silkeborg
• France
  • Amiens Cedex, France, 80054
    • CHU Amiens Hôpital sud
  • Besancon Cedex, France, 25030
    • CHU Besancon Hopital Jean Minjoz
  • Chambray les Tours, France, 37170
    • CHU Tours Hôpital Trousseau
  • Clermont-Ferrand, France, 63000
    • CHU Clermont Ferrand
  • Clichy cedex, France, 92110
    • Hopital Beaujon
  • Nantes Cedex 1, France, 44093
    • CHU Nantes Hôtel Dieu
  • Nice Cedex 3, France, 06200
    • CHU Nice Hopital de lArchet 2
  • Pessac, France, 33604
    • Groupe Hospitalier Sud Hopital Haut Leveque USN
  • Pierre Benite cedex, France, 69495
    • Centre Hospitalier Lyon Sud
  • Reims, France, 51092
    • CHU Reims Hopital Robert Debré
  • Rennes cedex 09, France, 35033
    • Chu Rennes Hopital Pontchaillou
  • Saint Etienne, France, 42055
    • CHU Saint Etienne Hopital Nord
  • Strasbourg Cedex, France, 67098
    • CHU Strasbourg Hôpital Hautepierre
  • Toulouse Cedex 09, France, 31059
    • CHU de Toulouse Hôpital Rangueil
  • Vandoeuvre les Nancy, France, 54511
    • Hôpital de Brabois Adultes
• Germany
  • Berlin, Germany, 14050
    • DRK Kliniken Berlin Westend
  • Berlin, Germany, 12200
    • Charite Universitaetsmedizin Berlin Campus Benjamin Franklin
  • Berlin, Germany, 14163
    • Krankenhaus Waldfriede e V
  • Bochum, Germany, 44789
    • Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Erlangen, Germany, 91054
    • Universitaetsklinikum Erlangen
  • Essen, Germany, 45136
    • Kliniken Essen-Mitte
  • Frankfurt, Germany, 60431
    • Agaplesion Markus Krankenhaus
  • Halle, Germany, 06120
    • Universitaetsklinikum Halle Saale
  • Hamburg, Germany, 22559
    • Asklepios Klinik Hamburg
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg
  • Heidelberg, Germany, 69121
    • Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter
  • Jena, Germany, 07740
    • Universitaetsklinikum Jena
  • Kiel, Germany, 24105
    • Universitaetsklinikum Schleswig Holstein Campus Kiel
  • Leipzig, Germany, 4103
    • Eugastro GmbH
  • Leipzig, Germany, 04103
    • University Leipzig
  • Lueneburg, Germany, 21339
    • Medizinisches Zentrum Klinikum Lueneburg
  • Mannheim, Germany, 68167
    • Klinikum Mannheim GmbH Universitaetsklinikum
  • Muenster, Germany, 48159
    • Gastro Campus Research
  • München, Germany, 81377
    • Klinikum der Universitaet Muenchen
  • Niedersachsen, Germany, 38126
    • Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer
  • Regensburg, Germany, 93053
    • Universitaetsklinikum Regensburg
  • Ulm, Germany, 89081
    • Universitaetsklinikum Ulm
• Greece
  • Alexandroupolis, Greece, 68100
    • University General Hospital of Alexandroupolis
  • Athens, Greece, 10676
    • General Hospital of Athens Evangelismos
  • Athens, Greece, 15125
    • Athens Medical Center
  • Rio Patras, Greece, 26500
    • University General Hospital of Patras
• Hungary
  • Balatonfured, Hungary, 8230
    • DRC Gyogyszervizsgalo Kozpont Kft
  • Budapest, Hungary, 1062
    • Magyar Honvedseg Egeszsegugyi Kozpont
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem AOK
  • Budapest, Hungary, 1139
    • Endomedix Diagnosztikai Kozpont
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Dunaujvaros, Hungary, 2400
    • Szent Pantaleon Kórház Rendelőintézet Dunaújváros
  • Gyor, Hungary, 9024
    • Petz Aladár Megyei Oktató Kórház
  • Szekszard, Hungary, 7100
    • CLINFAN Szolgáltató Kft
• Israel
  • Afula, Israel, 18341
    • HaEmek Medical Center
  • Beer Sheva, Israel, 84101
    • Soroka University Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah University Hospital
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center
  • Ramat Gan, Israel, 52621
    • Chaim Sheba Medical Center
  • Rechovot, Israel, 76100
    • Kaplan Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center Department of Hematology
  • Tiberias, Israel, 1520800
    • The Baruch Padeh MC, Poriya
  • Zerifin, Israel, 70300
    • Assaf Harofeh Medical Center
• Italy
  • Bologna, Italy, 40138
    • Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
  • Messina, Italy, 98125
    • Azienda Ospedaliera Universitaria Policlinico G Martino
  • Milano, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  • Palermo, Italy, 90146
    • Azienda Ospedaliera Vincenzo Cervello
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo
  • Roma, Italy, 00168
    • Policlinico Universitario Agostino Gemelli
  • Roma, Italy, 00128
    • Universita Campus Bio Medico di Roma
  • Rome, Italy, 00152
    • Azienda Ospedaliera San Camillo Forlanini
  • Rome, Italy, 133
    • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Rozzano (MI), Italy, 20089
    • Istituto Clinico Humanitas
  • San Donato Milanese, Italy, 20097
    • IRCCS Policlinico San Donato
  • San Giovanni Rotondo FG, Italy, 71013
    • IRCCS Ospedale Casa Sollievo della Sofferenza
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Daegu, Korea, Republic of, 42415
    • Yeungnam University Medical Center
  • Guri-si, Korea, Republic of, 11923
    • Hanyang University Guri Hospital
  • Seongnam-si, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seongnam-si,, Korea, Republic of, 13496
    • Cha Bundang Medical Center Cha University
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 02447
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital, Yonsei University Health System
• Latvia
  • Riga, Latvia, LV1002
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, LV-1006
    • Digestive Diseases Center GASTRO
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU Medisch Centrum
  • Amsterdam, Netherlands, 1105
    • Academisch Medisch Centrum
  • Breda, Netherlands, 4819 EV
    • Amphia Ziekenhuis
  • Nijmegen, Netherlands, 6525 GA
    • Radboudumc
  • Sittard-Geleen, Netherlands, 6162 BG
    • Zuyderland Medisch Centrum
  • Tilburg, Netherlands, 5022 GC
    • St. Elisabeth Ziekenhuis
• Norway
  • Lørenskog, Norway, 1478
    • Akershus universitetssykehus HF
  • Oslo, Norway, N-0027
    • Oslo Universitetssykehus Rikshospitalet
• Poland
  • Kielce, Poland, 25-364
    • Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA
  • Knurow, Poland, 44-190
    • Indywidualna Praktyka Lekarska Maciej Zymla
  • Lodz, Poland, 90-647
    • SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow
  • Rzeszow, Poland, 35-055
    • Centrum Medyczne Medyk
  • Sopot, Poland, 81-756
    • ENDOSKOPIA Sp. z o.o.
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Guimaraes, Portugal, 4835-044
    • Hospital da Senhora da Oliveira Guimarães
• Romania
  • Bucuresti, Romania, 010719
    • S.C MedLife S.A
  • Oradea, Romania, 410066
    • CMI Dr. Tirnaveanu Amelita
  • Timisoara, Romania, 300002
    • Centrul de Gastroenterologie Dr. Goldis
• Russian Federation
  • Krasnoyarsk, Russian Federation, 660022
    • TSBIH Territorial Clinical Hospital
  • Nizhny Novgorod, Russian Federation, 603126
    • SBHI of NN region RCH of NN n.a. N.A.Semashko
  • Novosibirsk, Russian Federation, 630054
    • SBEIHPE Novosibirsk State Medical University
  • Novosibirsk, Russian Federation, 630117
    • FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS
  • Pushkin, Russian Federation, 196603
    • Evromedservis
  • Rostov-on-Don, Russian Federation, 344022
    • SEIHPE Rostov State Medical University of MoH of RF
  • Saint-Petersburg, Russian Federation, 196247
    • SPb SBIH City Hospital # 26
  • Samara, Russian Federation, 443041
    • NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11080
    • Clinical Center Bezanijska Kosa
  • Belgrade, Serbia, 11000
    • Clinical Center Zvezdara
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
    • Fakultna nemocnica s poliklinikou F. D. Roosevelta
  • Bardejov, Slovakia, 08501
    • ALIAN s.r.o.
  • Malacky, Slovakia, 90122
    • Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.
  • Nitra, Slovakia, 949 01
    • Fakultna nemocnica Nitra
  • Nitra, Slovakia, 94901
    • KM Management, spol. s r.o.
  • Presov, Slovakia, 080 01
    • Gastro I., s.r.o.
• Spain
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona
  • Majadahonda, Spain, 28222
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Sabadell, Spain, 08208
    • Corporacion Sanitaria Parc Tauli
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
• Sweden
  • Stockholm, Sweden, 18288
    • Danderyds sjukhus AB
• Switzerland
  • Bern, Switzerland, 3012
    • Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner
• Turkey
  • Ankara, Turkey, 06100
    • Ankara University Medical Faculty
  • Istanbul, Turkey, 34349
    • Acibadem Fulya Hospital
  • Istanbul, Turkey, 34668
    • Haydarpasa Numune Training and Research Hospital
  • Istanbul, Turkey, 34854
    • Istanbul Medeniyet Uni Goztepe Training&Res Hosp
  • Istanbul, Turkey, 34098
    • Istanbul University Cerrahpasa Medical Faculty Hospital
  • Istanbul, Turkey, 31755
    • Yeditepe University Medical School Hospital
  • Istanbul, Turkey, 34899
    • Marmara University Pendik Training and Research Hospital
  • Izmir, Turkey, 35100
    • Ege University Medical Faculty
  • Kocaeli, Turkey, 41380
    • Kocaeli Derince Training and Research Hospital
• Ukraine
  • Chernivtsi, Ukraine, 58001
    • RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU
  • Kharkiv, Ukraine, 61037
    • CI of PH Kharkiv CCH #2
  • Kirovohrad, Ukraine, 25006
    • Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus
  • Kyiv, Ukraine, 04053
    • SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU
  • Kyiv, Ukraine, 02091
    • Kyiv City Clinical Hospital #1
  • Kyiv, Ukraine, 01030
    • Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC
  • Odessa, Ukraine, 65025
    • CI Odesa Regional Clinical Hospital
  • Ternopil, Ukraine, 46000
    • Ternopil City Communal Emergency Medical Care Hospital
  • Zaporozhje, Ukraine, 69600
    • CI Zaporizhzhia Regional Clinical Hospital of ZRC
• United Kingdom
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon and Exeter Hospital Wonford
  • Glasgow, United Kingdom, G51 4TF
    • Queen Elizabeth University Hospital
  • Glasgow, Scotland, United Kingdom, G4 OSF UK
    • Glasgow Royal Infirmary
  • Hull, United Kingdom, HU3 2JZ
    • Hull Royal Infirmary
  • London, United Kingdom, E1 1BB
    • Royal London Hospital
  • London, United Kingdom, W2 1NY
    • St Marys Hospital
  • Manchester, United Kingdom, M13 9WL
    • Manchester Royal Infirmary
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospitals Queens Medical Centre
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital
  • Shrewsbury, United Kingdom, SY38XQ
    • Royal Shrewsbury Hospital
• United States
  • California
    • San Diego, California, United States, 902123
      • Medical Associates Research Group Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates, Llc
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Kansas
    • Pratt, Kansas, United States, 67124
      • Health Science Research Center, LLC
    • Wichita, Kansas, United States, 67208
      • Via Christi Research a division of Via Christi Hospitals Wichita Inc
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Gastroenterology Associates LLC
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Metropolitan Gastroenterology
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
    • Wyoming, Michigan, United States, 49519
      • Gastroenterology Associates of Western Michigan PLC
  • Missouri
    • Belton, Missouri, United States, 64012
      • Ehrhardt Clinical Research LLC
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Trial Management Associates LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch LLC
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Clinical Research Institute LLC
    • Dallas, Texas, United States, 75231
      • Texas Digestive Disease Consultants - Dallas
    • Flower Mound, Texas, United States, 75028
      • Texas Digestive Disease Consultants - Southlake
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston
    • San Antonio, Texas, United States, 78229
      • Sagact Pllc
    • San Antonio, Texas, United States, 78229
      • San Antonio Military Medical Center
    • Tyler, Texas, United States, 75701
      • Digestive Health Specialists of Tyler
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98104
      • University of Washington School of Medicine
    • Vancouver, Washington, United States, 98664-4896
      • The Vancouver Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GED-0301 (160 mg) followed by Placebo intermittent 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	Drug: GED-0301; Mongersen; Other Names: Mongersen
Experimental: Intermittent GED-0301 160 mg and placebo; 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	Other: Placebo; Placebo; Drug: GED-0301; Mongersen; Other Names: Mongersen
Experimental: Intermittent placebo and GED-0301 40 mg; 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	Other: Placebo; Placebo; Drug: GED-0301; Mongersen; Other Names: Mongersen
Experimental: Continuous GED-0301 40 mg; GED-0301 40 mg once daily (QD) for up to 208 weeks	Drug: GED-0301; Mongersen; Other Names: Mongersen
Experimental: Intermittent placebo and GED-0301 160 mg; Alternating PBO QD for 4 weeks with GED-0301 160 mg QD for 4 weeks, through Week 208	Other: Placebo; Placebo; Drug: GED-0301; Mongersen; Other Names: Mongersen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208	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. 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.	From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Guillermo Rossiter, MD, Celgene

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2016
• Primary Completion (Actual): January 4, 2018
• Study Completion (Actual): January 4, 2018

Study Registration Dates

• First Submitted: December 23, 2015
• First Submitted That Met QC Criteria: December 23, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Crohn's Disease; Mongersen; Irritable Bowel Disease; GED 0301
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: GED-0301-CD-004