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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02596893




Registration number
NCT02596893
Ethics application status
Date submitted
3/11/2015
Date registered
4/11/2015
Date last updated
28/08/2019

Titles & IDs
Public title
Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease
Scientific 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
Secondary ID [1] 0 0
GED-0301-CD-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn 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
Experimental: GED0301 160mg x 12 weeks followed by periodic 160 mg GED0301 - GED-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

Experimental: GED0301 160mg x 12 weeks followed by periodic GED0301 40mg - GED-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

Experimental: GED0301 160mg x 12 weeks followed by continuous GED0301 40mg - GED-0301 160 mg once daily (QD) for 12 weeks; followed by continuous GED-0301 40 mg QD, until the Week 52 Visit

Placebo comparator: Placebo - Placebo once daily (QD) until the Week 52 Visit
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Percentage of Participants Who Achieved a Clinical Remission at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved Clinical Remission at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants With Endoscopic Response-50 Centrally Read at Week 52
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
The Percentage of Participants Who Achieved a Clinical Response at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
The Percentage of Participants Who Achieved a Clinical Response at Week 4
Timepoint [4] 0 0
Week 4
Secondary outcome [5] 0 0
The Percentage of Participants Who Achieved a Clinical Remission at Week 4
Timepoint [5] 0 0
Week 4
Secondary outcome [6] 0 0
The Percentage of Participants Who Achieved a Corticosteroid-Free Clinical Remission at Week 52
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Percentage of Participants Who Achieved a Sustained Clinical Remission at Both Week 12 and 52
Timepoint [7] 0 0
Weeks 12 and 52
Secondary outcome [8] 0 0
Percentage of Participants With Endoscopic Response-25 Centrally Read at Week 12
Timepoint [8] 0 0
Week 0, Week 12
Secondary outcome [9] 0 0
Percentage of Participants With Endoscopic Remission Centrally Read at Week 52
Timepoint [9] 0 0
Week 52
Secondary outcome [10] 0 0
The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE) From Week 0 to Week 52
Timepoint [10] 0 0
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
Secondary outcome [11] 0 0
The Number of Participants Who Discontinued IP Due to an Treatment Emergent Adverse Events
Timepoint [11] 0 0
From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 52.6 weeks

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
* 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.

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
8/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/01/2018
Sample size
Target
Accrual to date
Final
701
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Bankstown-Lidcombe Hospital - Bankstown
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Royal Prince Alfred Hospital - Camperdown
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Concord Repatriation General Hospital - Concord
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Centre For Digestive Diseases - Five Dock
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Liverpool Hospital - Liverpool
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Mater Adult Hospital - South Brisbane
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Princess Alexandra Hospital - Woolloongabba
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Royal Adelaide Hospital - Adelaide
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Flinders Medical Centre - Bedford Park
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Box Hill Hospital - Box Hill
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The Alfred Hospital - Melbourne
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Fiona Stanley Hospital - Murdoch
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Ballarat Base Hospital - Ballarat
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Monash Medical Centre Clayton - Bentleigh East
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St Vincents Hospital Melbourne - Fitzroy
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Austin Hospital - Heidelberg
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Royal Brisbane and Women's Hospital - Herston
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Nepean Hospital - Kingswood, NSW
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2200 - Bankstown
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2050 - Camperdown
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2139 - Concord
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2046 - Five Dock
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2170 - Liverpool
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4101 - South Brisbane
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4102 - Woolloongabba
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5000 - Adelaide
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5042 - Bedford Park
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3128 - Box Hill
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3165 - Bentleigh East
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3065 - Fitzroy
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3084 - Heidelberg
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4006 - Herston
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2751 - Kingswood, NSW
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Netherlands
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Netherlands
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Utrecht
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Hamilton
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Fredrikstad
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Norway
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Lørenskog
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Norway
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Oslo
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Norway
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Stavanger
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Poland
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Bydgoszcz
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Poland
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Romania
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Spain
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Spain
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Southhampton

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 Corporation
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 are available at https://clinicaltrials.gov/study/NCT02596893