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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - 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.
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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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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
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Wein
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Shrewsbury

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

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02641392
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02641392