A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02974322
• Date of registration: 23/11/2016
• Prospective Registration: Yes
• Primary sponsor: Celgene
• Public title: A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease
• Scientific title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease
• Date of first enrolment: December 1, 2017
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02974322
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, Croatia, Czech Republic, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Latvia, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Denesh Chitkara, MD
• Affiliation: Celgene Corporation

Key inclusion & exclusion criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

- Male or female = 12 years

- Subject is able to swallow the IP tablets

- 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 7day 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 (ie,
infliximab, adalimumab, certolizumab, or vedolizumab).

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, or colitis due to
immunodeficiency

- Local manifestations of Crohn's Disease (CD) such as abscesses, short bowel syndrome;
or other disease complications for which surgery might be indicated or could confound
the evaluation of efficacy

- Subject has strictures with prestenotic dilatation, requiring procedural intervention,
or with obstructive symptoms. In addition, subjects with colonic strictures that are
not passable with an age-appropriate colonoscope, or strictures in the ileum or
ileocecal valve that are fibrotic in nature, will be excluded

- 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

- Adolescents with delayed growth or pubertal development who are on corticosteroids at
baseline and who should not continue treatment with the same dose of corticosteroids
until the Week 12 visit.



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: GED-0301

Drug: Placebo

Primary Outcome(s)

Clinical remission defined by an average daily liquid or soft stool frequency and abdominal pain score (US) and Crohn's Disease Activity Index (CDAI) (Rest of World) [Time Frame: week 12]

Secondary Outcome(s)

Endoscopic improvement by the Simple Endoscopic Score for Crohn's Disease (SES-CD) [Time Frame: Week 12]

Clinical response defined by CDAI [Time Frame: Week 4, week 12]

Clinical remission defined by PCDAI [Time Frame: Week 12]

Adverse Events (AEs) [Time Frame: Up to 20 weeks]

Pharmacokinetics (PK)- plasma concentration of GED-0301 [Time Frame: Week 4, week 8]

Clinical remission defined by an average daily liquid or soft stool frequency and abdominal pain score (US) and CDAI [Time Frame: Week 4, week 12]

Secondary ID(s)

GED-0301-CD-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors