Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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3 August 2020 |
Main ID: |
EUCTR2015-001925-18-GB |
Date of registration:
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18/11/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease
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Scientific title:
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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. - A randomized, double-blind, study to explore the efficacy and safety o |
Date of first enrolment:
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24/02/2016 |
Target sample size:
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1064 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001925-18 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: no Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Austria
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Belgium
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Bulgaria
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Canada
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Croatia
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Czech Republic
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Denmark
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Estonia
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Finland
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France
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Germany
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Greece
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Hungary
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Israel
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Italy
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Korea, Republic of
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Latvia
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Netherlands
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New Zealand
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Norway
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Poland
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Portugal
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Romania
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Russian Federation
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Serbia
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Slovakia
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South Africa
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Spain
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Sweden
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Switzerland
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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ClinicalTrialDisclosure
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Address:
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9225 Indian Creek Parkway, Suite 900
66210
Overland Park, Kansas
United States |
Telephone:
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+1 888 2601599 |
Email:
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ClinicalTrialDisclosure@celgene.com |
Affiliation:
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Celgene Corporation |
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Name:
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ClinicalTrialDisclosure
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Address:
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9225 Indian Creek Parkway, Suite 900
66210
Overland Park, Kansas
United States |
Telephone:
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+1 888 2601599 |
Email:
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ClinicalTrialDisclosure@celgene.com |
Affiliation:
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Celgene Corporation |
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Key inclusion & exclusion criteria
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Inclusion criteria: Diagnosis of CD with a duration of at least 3 months prior to the Screening Visit Presence of ileitis, ileocolitis or colitis, as determined by ileocolonoscopy at screening. Active disease, defined as a CDAI score = 220 and = 450 at screening Must have a 7-day average stool frequency = 3.5 or abdominal pain = 1.5 at screening. Must have a total SES-CD = 6 at screening, or the ileum segmental SESCD = 4 at screening Must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (ie, azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]); or biologics for the treatment of CD (ie, infliximab, adalimumab, certolizumab or vedolizumab) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1010 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria: Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease associated colitis Local manifestations of CD such as abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy Strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, colonic strictures that are not passable with an adult colonoscope, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded. Any intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit Prior treatment with mycophenolic acid, tacrolimus, sirolimus, cyclosporine, thalidomide or apheresis (eg, Adacolumn®) within 8 weeks prior to the Screening Visit Use of intravenous (IV) corticosteroids within 2 weeks prior to the Screening Visit Use of topical GI treatments such as 5-aminosalicylic acid (5-ASA) or corticosteroid enemas or suppositories within 2 weeks prior to the Screening Visit Use of bile acid sequestrants, (eg, cholestyramine) within 3 weeks prior to the Screening Visit Prior treatment with biologics for the treatment of CD (approved or investigational), other than infliximab, adalimumab, certolizumab or vedolizumab Prior treatment with more than 3 biologics for the treatment of CD (ie, infliximab, adalimumab, certolizumab or vedolizumab). Treatment with a biologic within 8 weeks prior to the Screening Visit, or 5 elimination half lives, whichever is longer.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Active Crohn's disease MedDRA version: 20.0
Level: LLT
Classification code 10021315
Term: Ileitis terminal
System Organ Class: 100000016693
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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Intervention(s)
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Product Name: Mongersen Product Code: GED-0301 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: mongersen CAS Number: 1443994-98-6 Current Sponsor code: GED-0301 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: To evaluate the efficacy of GED-0301 compared with placebo on clinical activity at 12 Weeks, in subjects with active Crohn’s disease (CD).
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Primary end point(s): Efficacy as clinical remision: the proportion of subjects achieving clinical remission defined as a (CDAI) score < 150 at Week 12
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Secondary Objective: To evaluate the efficacy of GED-0301 compared with placebo on endoscopic outcomes, as measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD) in subjects with active CD; To evaluate the long term efficacy of GED-0301 compared with placebo on clinical activity in subjects with active CD To evaluate the efficacy of GED-0301 compared with placebo on corticosteroid-free clinical remission in subjects with active CD; To evaluate the long-term efficacy of GED-0301 compared with placebo on clinical activity and endoscopic outcomes in subjects with active CD; To evaluate the safety and tolerability of GED-0301 in subjects with active CD.
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Timepoint(s) of evaluation of this end point: Week 12
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Secondary Outcome(s)
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Secondary end point(s): Proportion of subjects achieving: - clinical remission, defined as a CDAI score < 150, at Week 52. - endoscopic response-50 (ER-50), defined as a reduction of at least 50% in SES-CD compared with baseline, at Week 52. Proportion of subjects with clinical response: - defined as a decrease from baseline in CDAI = 100 points, at Week 12. - defined as a decrease from baseline in CDAI = 100 points, at Week 4. Proportion of subjects: - achieving clinical remission, defined as a CDAI score < 150, at Week 4. - who achieve corticosteroid-free clinical remission (CDAI <150) at Week 52 among subjects receiving oral corticosteroids for CD at baseline. - achieving sustained clinical remission, defined as a CDAI score < 150,at both Week 12 and Week 52. - with endoscopic response-25 (ER-25), defined as a reduction of at least 25% in the SES-CD compared with baseline, at Week 12. - endoscopic remission, defined as SES-CD = 2, at Week 52. Type, frequency, severity, seriousness, and relationship of AEs to IP. Number of subjects who discontinue investigational product (IP) due to any AE. Clinically significant changes in vital signs, ECG and/or laboratory findings.
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Timepoint(s) of evaluation of this end point: as given above
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Secondary ID(s)
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GED-0301-CD-002
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Source(s) of Monetary Support
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Celgene Corporation
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Ethics review
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Status: Approved
Approval date: 24/02/2016
Contact:
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