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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02596893
• Date of registration: 03/11/2015
• Prospective Registration: Yes
• Primary sponsor: Celgene
• 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
• Date of first enrolment: December 8, 2015
• Target sample size: 701
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02596893
• 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, Bulgaria, Canada, Croatia, Czech Republic, Czechia, Denmark, Estonia, Finland, Former Serbia and Montenegro, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Latvia, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Guillermo Rossiter, 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 = 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.

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.



Age minimum: 18 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)

The Percentage of Participants Who Achieved a Clinical Remission at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Percentage of Participants Who Achieved a Sustained Clinical Remission at Both Week 12 and 52 [Time Frame: Weeks 12 and 52]

Percentage of Participants With Endoscopic Remission Centrally Read at Week 52 [Time Frame: Week 52]

The Number of Participants Who Discontinued IP Due to an Treatment Emergent Adverse Events [Time Frame: From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 52.6 weeks]

The Percentage of Participants Who Achieved a Clinical Remission at Week 4 [Time Frame: Week 4]

The Percentage of Participants Who Achieved a Corticosteroid-Free Clinical Remission at Week 52 [Time Frame: Week 52]

Percentage of Participants Who Achieved Clinical Remission at Week 52 [Time Frame: Week 52]

Percentage of Participants With Endoscopic Response-50 Centrally Read at Week 52 [Time Frame: Week 52]

The Percentage of Participants Who Achieved a Clinical Response at Week 12 [Time Frame: Week 12]

The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE) From Week 0 to Week 52 [Time Frame: 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]

The Percentage of Participants Who Achieved a Clinical Response at Week 4 [Time Frame: Week 4]

Percentage of Participants With Endoscopic Response-25 Centrally Read at Week 12 [Time Frame: Week 0, Week 12]

Secondary ID(s)

GED-0301-CD-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02596893