A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn?s disease

• Register: EUCTR
• Last refreshed on: 26 February 2018
• Main ID: EUCTR2015-001925-18-ES
• Date of registration: 04/01/2016
• Prospective Registration: Yes
• Primary sponsor: Celgene Corporation
• Public title: A study to evaluate the drug Mongersen (GED-0301) for the treatment of 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. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease
• Date of first enrolment: 07/03/2016
• Target sample size: 1064
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001925-18
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Latvia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: ClinicalTrialDisclosure
• Affiliation: Celgene Corporation

• Name: ClinicalTrialDisclosure
• Affiliation: Celgene Corporation

Key inclusion & exclusion criteria

Inclusion criteria:
Diagnosis of CD with a duration of at least 3 months prior to the Screening Visit
Diagnosis of ileitis, ileocolitis or colitis, as determined by endoscopic, radiographic or any other imaging modality (eg, magnetic resonance imaging [MRI], computed tomography [CT] scan)
Active disease, defined as a CDAI score ? 220 and ? 450 at screening
Subject must have a 7-day average stool frequency ? 3.5 or abdominal pain ? 1.5 at screening
Subject must have a total SES-CD ? 6 at screening, or the ileum segmental SES-CD ? 4 at screening
Must have failed or experienced intolerance to at least one of the following: aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (ie, azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]); or biologics for the treatment of CD
Are the trial subjects under 18? no
Number of subjects for this age range:
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
Subject has local manifestations of CD such as strictures, abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
Subject had any intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit
Subject had 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 treatment such as 5-aminosalicylic acid (5-ASA) or corticosteroid enemas or suppositories within 2 weeks prior to the Screening Visit
Use of cholestyramine within 3 weeks prior to the Screening Visit
Prior treatment with more than 3 biologics for the treatment of CD
Treatment with a biologic within 8 weeks prior to the Screening Visit
Prior treatment with natalizumab


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Active Crohn's disease
MedDRA version: 18.1 Level: LLT Classification code 10021315 Term: Ileitis terminal System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

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

Primary Outcome(s)

Main Objective: To evaluate the efficacy of GED-0301 compared with placebo on clinical activity, as measured by the Crohn?s Disease Activity Index (CDAI) in subjects with active Crohn?s disease (CD).

Primary end point(s): Efficacy as clinical remision: the proportion of subjects achieving clinical remission defined as a Crohn?s Disease Activity Index (CDAI) score < 150 at Week 4

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 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.

Timepoint(s) of evaluation of this end point: Week 4

Secondary Outcome(s)

Secondary end point(s): The proportion of subjects with mucosal healing defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) ? 2 at Week 12, Week 52
The proportion of subjects with a reduction of at least 50% from baseline in SES-CD at Week 12, Week 52
The proportion of subjects achieving clinical remission defined as a CDAI score < 150 at Week 12, Week 52
The proportion of subjects who achieve corticosteroid-free clinical remission at Week 52 among subjects receiving oral corticosteroids at baseline
The proportion of subjects with an average daily liquid or soft stool frequency ? 3 and abdominal pain score ? 1 at Week 4, Week 12, Week 52
The proportion of subjects with an average daily liquid or soft stool frequency ? 1.5 and abdominal pain score ? 1 at Week 4, Week 12, Week 52
Type, frequency, severity, seriousness, and relationship of AEs to IP (Investigational Product) through Week 52
Number of subjects who discontinue IP due to any AE (Adverse Event) through Week 52
Clinically significant changes in vital signs and/or laboratory findings through Week 52

Timepoint(s) of evaluation of this end point: as given above

Secondary ID(s)

2015-001925-18-GB

GED-0301-CD-002

Source(s) of Monetary Support

Celgene Corporation