Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02641392




Registration number
NCT02641392
Ethics application status
Date submitted
23/12/2015
Date registered
29/12/2015
Date last updated
29/01/2019

Titles & IDs
Public title
A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Scientific title
A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Secondary ID [1] 0 0
GED-0301-CD-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GED-0301
Other interventions - Placebo

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

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

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

Experimental: Continuous GED-0301 40 mg - GED-0301 40 mg once daily (QD) for up to 208 weeks

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


Treatment: Drugs: GED-0301
Mongersen

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208
Timepoint [1] 0 0
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

Eligibility
Key inclusion 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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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-a 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/01/2018
Sample size
Target
Accrual to date
Final
310
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Centre For Digestive Diseases - Five Dock
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Monash Medical Centre Clayton - Bentleigh East
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2046 - Five Dock
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3165 - Bentleigh East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Austria
State/province [14] 0 0
Graz
Country [15] 0 0
Austria
State/province [15] 0 0
Innsbruck
Country [16] 0 0
Austria
State/province [16] 0 0
Linz
Country [17] 0 0
Austria
State/province [17] 0 0
Salzburg
Country [18] 0 0
Austria
State/province [18] 0 0
St Veit An Der Glan
Country [19] 0 0
Austria
State/province [19] 0 0
Wein
Country [20] 0 0
Belgium
State/province [20] 0 0
Brussels
Country [21] 0 0
Belgium
State/province [21] 0 0
Leuven
Country [22] 0 0
Belgium
State/province [22] 0 0
Liege
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Plovdiv
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Ruse
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Sofia
Country [26] 0 0
Canada
State/province [26] 0 0
Alberta
Country [27] 0 0
Canada
State/province [27] 0 0
British Columbia
Country [28] 0 0
Canada
State/province [28] 0 0
Manitoba
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Croatia
State/province [31] 0 0
Osijek
Country [32] 0 0
Czechia
State/province [32] 0 0
Brno
Country [33] 0 0
Czechia
State/province [33] 0 0
Hradec Kralove
Country [34] 0 0
Czechia
State/province [34] 0 0
Olomouc
Country [35] 0 0
Czechia
State/province [35] 0 0
Praha 3
Country [36] 0 0
Denmark
State/province [36] 0 0
Aahus C
Country [37] 0 0
Denmark
State/province [37] 0 0
Alborg
Country [38] 0 0
Denmark
State/province [38] 0 0
Frederikssund
Country [39] 0 0
Denmark
State/province [39] 0 0
Herlev
Country [40] 0 0
Denmark
State/province [40] 0 0
Koge
Country [41] 0 0
Denmark
State/province [41] 0 0
Silkeborg
Country [42] 0 0
France
State/province [42] 0 0
Amiens Cedex
Country [43] 0 0
France
State/province [43] 0 0
Besancon Cedex
Country [44] 0 0
France
State/province [44] 0 0
Chambray les Tours
Country [45] 0 0
France
State/province [45] 0 0
Clermont-Ferrand
Country [46] 0 0
France
State/province [46] 0 0
Clichy cedex
Country [47] 0 0
France
State/province [47] 0 0
Nantes Cedex 1
Country [48] 0 0
France
State/province [48] 0 0
Nice Cedex 3
Country [49] 0 0
France
State/province [49] 0 0
Pessac
Country [50] 0 0
France
State/province [50] 0 0
Pierre Benite cedex
Country [51] 0 0
France
State/province [51] 0 0
Reims
Country [52] 0 0
France
State/province [52] 0 0
Rennes cedex 09
Country [53] 0 0
France
State/province [53] 0 0
Saint Etienne
Country [54] 0 0
France
State/province [54] 0 0
Strasbourg Cedex
Country [55] 0 0
France
State/province [55] 0 0
Toulouse Cedex 09
Country [56] 0 0
France
State/province [56] 0 0
Vandoeuvre les Nancy
Country [57] 0 0
Germany
State/province [57] 0 0
Berlin
Country [58] 0 0
Germany
State/province [58] 0 0
Bochum
Country [59] 0 0
Germany
State/province [59] 0 0
Dresden
Country [60] 0 0
Germany
State/province [60] 0 0
Erlangen
Country [61] 0 0
Germany
State/province [61] 0 0
Essen
Country [62] 0 0
Germany
State/province [62] 0 0
Frankfurt
Country [63] 0 0
Germany
State/province [63] 0 0
Halle
Country [64] 0 0
Germany
State/province [64] 0 0
Hamburg
Country [65] 0 0
Germany
State/province [65] 0 0
Hannover
Country [66] 0 0
Germany
State/province [66] 0 0
Heidelberg
Country [67] 0 0
Germany
State/province [67] 0 0
Jena
Country [68] 0 0
Germany
State/province [68] 0 0
Kiel
Country [69] 0 0
Germany
State/province [69] 0 0
Leipzig
Country [70] 0 0
Germany
State/province [70] 0 0
Lueneburg
Country [71] 0 0
Germany
State/province [71] 0 0
Mannheim
Country [72] 0 0
Germany
State/province [72] 0 0
Muenster
Country [73] 0 0
Germany
State/province [73] 0 0
München
Country [74] 0 0
Germany
State/province [74] 0 0
Niedersachsen
Country [75] 0 0
Germany
State/province [75] 0 0
Regensburg
Country [76] 0 0
Germany
State/province [76] 0 0
Ulm
Country [77] 0 0
Greece
State/province [77] 0 0
Alexandroupolis
Country [78] 0 0
Greece
State/province [78] 0 0
Athens
Country [79] 0 0
Greece
State/province [79] 0 0
Rio Patras
Country [80] 0 0
Hungary
State/province [80] 0 0
Balatonfured
Country [81] 0 0
Hungary
State/province [81] 0 0
Budapest
Country [82] 0 0
Hungary
State/province [82] 0 0
Debrecen
Country [83] 0 0
Hungary
State/province [83] 0 0
Dunaujvaros
Country [84] 0 0
Hungary
State/province [84] 0 0
Gyor
Country [85] 0 0
Hungary
State/province [85] 0 0
Szekszard
Country [86] 0 0
Israel
State/province [86] 0 0
Afula
Country [87] 0 0
Israel
State/province [87] 0 0
Beer Sheva
Country [88] 0 0
Israel
State/province [88] 0 0
Haifa
Country [89] 0 0
Israel
State/province [89] 0 0
Jerusalem
Country [90] 0 0
Israel
State/province [90] 0 0
Petah Tikva
Country [91] 0 0
Israel
State/province [91] 0 0
Ramat Gan
Country [92] 0 0
Israel
State/province [92] 0 0
Rechovot
Country [93] 0 0
Israel
State/province [93] 0 0
Tel Aviv
Country [94] 0 0
Israel
State/province [94] 0 0
Tiberias
Country [95] 0 0
Israel
State/province [95] 0 0
Zerifin
Country [96] 0 0
Italy
State/province [96] 0 0
Bologna
Country [97] 0 0
Italy
State/province [97] 0 0
Messina
Country [98] 0 0
Italy
State/province [98] 0 0
Milano
Country [99] 0 0
Italy
State/province [99] 0 0
Palermo
Country [100] 0 0
Italy
State/province [100] 0 0
Pavia
Country [101] 0 0
Italy
State/province [101] 0 0
Roma
Country [102] 0 0
Italy
State/province [102] 0 0
Rome
Country [103] 0 0
Italy
State/province [103] 0 0
Rozzano (MI)
Country [104] 0 0
Italy
State/province [104] 0 0
San Donato Milanese
Country [105] 0 0
Italy
State/province [105] 0 0
San Giovanni Rotondo FG
Country [106] 0 0
Korea, Republic of
State/province [106] 0 0
Busan
Country [107] 0 0
Korea, Republic of
State/province [107] 0 0
Daegu
Country [108] 0 0
Korea, Republic of
State/province [108] 0 0
Guri-si
Country [109] 0 0
Korea, Republic of
State/province [109] 0 0
Seongnam-si,
Country [110] 0 0
Korea, Republic of
State/province [110] 0 0
Seongnam-si
Country [111] 0 0
Korea, Republic of
State/province [111] 0 0
Seoul
Country [112] 0 0
Latvia
State/province [112] 0 0
Riga
Country [113] 0 0
Netherlands
State/province [113] 0 0
Amsterdam
Country [114] 0 0
Netherlands
State/province [114] 0 0
Breda
Country [115] 0 0
Netherlands
State/province [115] 0 0
Nijmegen
Country [116] 0 0
Netherlands
State/province [116] 0 0
Sittard-Geleen
Country [117] 0 0
Netherlands
State/province [117] 0 0
Tilburg
Country [118] 0 0
Norway
State/province [118] 0 0
Lørenskog
Country [119] 0 0
Norway
State/province [119] 0 0
Oslo
Country [120] 0 0
Poland
State/province [120] 0 0
Kielce
Country [121] 0 0
Poland
State/province [121] 0 0
Knurow
Country [122] 0 0
Poland
State/province [122] 0 0
Lodz
Country [123] 0 0
Poland
State/province [123] 0 0
Rzeszow
Country [124] 0 0
Poland
State/province [124] 0 0
Sopot
Country [125] 0 0
Portugal
State/province [125] 0 0
Braga
Country [126] 0 0
Portugal
State/province [126] 0 0
Guimaraes
Country [127] 0 0
Romania
State/province [127] 0 0
Bucuresti
Country [128] 0 0
Romania
State/province [128] 0 0
Oradea
Country [129] 0 0
Romania
State/province [129] 0 0
Timisoara
Country [130] 0 0
Russian Federation
State/province [130] 0 0
Krasnoyarsk
Country [131] 0 0
Russian Federation
State/province [131] 0 0
Nizhny Novgorod
Country [132] 0 0
Russian Federation
State/province [132] 0 0
Novosibirsk
Country [133] 0 0
Russian Federation
State/province [133] 0 0
Pushkin
Country [134] 0 0
Russian Federation
State/province [134] 0 0
Rostov-on-Don
Country [135] 0 0
Russian Federation
State/province [135] 0 0
Saint-Petersburg
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Samara
Country [137] 0 0
Serbia
State/province [137] 0 0
Belgrade
Country [138] 0 0
Slovakia
State/province [138] 0 0
Banska Bystrica
Country [139] 0 0
Slovakia
State/province [139] 0 0
Bardejov
Country [140] 0 0
Slovakia
State/province [140] 0 0
Malacky
Country [141] 0 0
Slovakia
State/province [141] 0 0
Nitra
Country [142] 0 0
Slovakia
State/province [142] 0 0
Presov
Country [143] 0 0
Spain
State/province [143] 0 0
Barcelona
Country [144] 0 0
Spain
State/province [144] 0 0
Majadahonda
Country [145] 0 0
Spain
State/province [145] 0 0
Sabadell
Country [146] 0 0
Spain
State/province [146] 0 0
Zaragoza
Country [147] 0 0
Sweden
State/province [147] 0 0
Stockholm
Country [148] 0 0
Switzerland
State/province [148] 0 0
Bern
Country [149] 0 0
Turkey
State/province [149] 0 0
Ankara
Country [150] 0 0
Turkey
State/province [150] 0 0
Istanbul
Country [151] 0 0
Turkey
State/province [151] 0 0
Izmir
Country [152] 0 0
Turkey
State/province [152] 0 0
Kocaeli
Country [153] 0 0
Ukraine
State/province [153] 0 0
Chernivtsi
Country [154] 0 0
Ukraine
State/province [154] 0 0
Kharkiv
Country [155] 0 0
Ukraine
State/province [155] 0 0
Kirovohrad
Country [156] 0 0
Ukraine
State/province [156] 0 0
Kyiv
Country [157] 0 0
Ukraine
State/province [157] 0 0
Odessa
Country [158] 0 0
Ukraine
State/province [158] 0 0
Ternopil
Country [159] 0 0
Ukraine
State/province [159] 0 0
Zaporozhje
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Exeter
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Glasgow, Scotland
Country [162] 0 0
United Kingdom
State/province [162] 0 0
Glasgow
Country [163] 0 0
United Kingdom
State/province [163] 0 0
Hull
Country [164] 0 0
United Kingdom
State/province [164] 0 0
London
Country [165] 0 0
United Kingdom
State/province [165] 0 0
Manchester
Country [166] 0 0
United Kingdom
State/province [166] 0 0
Nottingham
Country [167] 0 0
United Kingdom
State/province [167] 0 0
Oxford
Country [168] 0 0
United Kingdom
State/province [168] 0 0
Shrewsbury

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Guillermo Rossiter, MD
Address 0 0
Celgene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02641392