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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Treatment: Drugs - GED-0301
Treatment: Drugs - Placebo

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


Treatment: Drugs: GED-0301


Treatment: Drugs: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Percentage of Participants Who Achieved a Clinical Remission at Week 12 - Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the affect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved Clinical Remission at Week 52 - Clinical remission is defined as a CDAI score < 150 and is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants With Endoscopic Response-50 Centrally Read at Week 52 - An endoscopic response-50 is defined as a reduction of at least 50% compared with baseline in simple endoscopic score for Crohn's Disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include:
Ulcers scored as:
0: no
aphthous (0.1-0.5 cm)
large (0.5-2 cm)
very large (>2 cm)
Surface involved disease 0: 0%
<50%
50-75%
>75%
Surface involved by ulcerations:
0: 0%
<10%
10-30%
>30% - Narrowings:
0: No
Single, can be passed
Multiple, can be passed
Cannot be passed Grand Total = SES-CD score
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
The Percentage of Participants Who Achieved a Clinical Response at Week 12 - A clinical response is defined as a CDAI score decrease from baseline = 100 points. The CDAI is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
The Percentage of Participants Who Achieved a Clinical Response at Week 4 - A clinical response is defined as a decrease from baseline in CDAI = 100 points. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.
Timepoint [4] 0 0
Week 4
Secondary outcome [5] 0 0
The Percentage of Participants Who Achieved a Clinical Remission at Week 4 - A clinical remission is a CDAI score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.
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 - The percentage of participants who were receiving oral corticosteroids for Crohn's disease, at baseline and achieved a clinical remission (CDAI score <150) at Week 52 without corticosteroids. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.
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 - For participants who achieved a sustained clinical remission at both week 12 and 52, the clinical remission is a CDAI score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.
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 - An endoscopic response-25 is defined as a reduction of at least 25% compared with baseline in simple endoscopic score for Crohn's disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include:
Ulcers scored as:
0: no
aphthous (0.1-0.5 cm)
large (0.5-2 cm)
very large (>2 cm)
Surface involved disease 0: 0%
<50%
50-75%
>75%
Surface involved by ulcerations:
0: 0%
<10%
10-30%
>30% - Narrowings:
0: No
Single, can be passed
Multiple, can be passed
Cannot be passed Grand Total = SES-CD score
Timepoint [8] 0 0
Week 0, Week 12
Secondary outcome [9] 0 0
Percentage of Participants With Endoscopic Remission Centrally Read at Week 52 - Endoscopic remission is defined as a simple endoscopic score for Crohn's disease (SES-CD) of =2 at the specified timeframe. The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include:
Ulcers scored as:
0: no
aphthous (0.1-0.5 cm)
large (0.5-2 cm)
very large (>2 cm)
Surface involved disease 0: 0%
<50%
50-75%
>75%
Surface involved by ulcerations:
0: 0%
<10%
10-30%
>30% - Narrowings:
0: No
Single, can be passed
Multiple, can be passed
Cannot be passed Grand Total = SES-CD score
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 - 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.
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 - A TEAE was defined as any AE occurring or worsening on or after the first dose 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 [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
Gender
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
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)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
Centre For Digestive Diseases - Five Dock
Recruitment hospital [5] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [10] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [11] 0 0
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
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
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2050 - Camperdown
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2139 - Concord
Recruitment postcode(s) [4] 0 0
2046 - Five Dock
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
5042 - Bedford Park
Recruitment postcode(s) [10] 0 0
3128 - Box Hill
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
6150 - Murdoch
Recruitment postcode(s) [13] 0 0
3350 - Ballarat
Recruitment postcode(s) [14] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [15] 0 0
3065 - Fitzroy
Recruitment postcode(s) [16] 0 0
3084 - Heidelberg
Recruitment postcode(s) [17] 0 0
4006 - Herston
Recruitment postcode(s) [18] 0 0
2751 - Kingswood, NSW
Recruitment outside Australia
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Heidelberg
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Jena
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Kiel
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Leipzig
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Lueneburg
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Magdeburg
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Mannheim
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Minden
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Muenchen
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Muenster
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München
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Ulm
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Alexandroupolis
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Athens
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of study is to test the effects of an experimental medication GED-0301
(mongersen) in patients who have active Crohn's disease. The study will test GED-0301
compared to placebo for 52 weeks. The study treatment is blinded which means that patients
and the study doctor will not know which treatment has been assigned. Patients in this study
will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids,
immunosupressants and antibiotics for the treatment of Crohn's disease.

After 12 weeks in the study until the end of the study, patients who do not have an
improvement in their Crohns disease symptoms will have the option to enter a long term active
treatment study. Participants who discontinued the study anytime or completed the study at
Week 52 were then observed for an additional 4 weeks.
Trial website
https://clinicaltrials.gov/show/NCT02596893
Trial related presentations / publications
Gold SL, Cohen-Mekelburg S, Schneider Y, Steinlauf A. Perianal Fistulas in Patients With Crohn's Disease, Part 2: Surgical, Endoscopic, and Future Therapies. Gastroenterol Hepatol (N Y). 2018 Sep;14(9):521-528.
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02596893