A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02641392
• Date of registration: 23/12/2015
• Prospective Registration: Yes
• Primary sponsor: Celgene
• Public title: A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
• Scientific title: A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
• Date of first enrolment: July 25, 2016
• Target sample size: 310
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02641392
• 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, 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

Key inclusion & exclusion criteria

Inclusion Criteria for Adult Subjects:

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

- Male or female = 18 years of age.

- Subject must have participated in the GED-0301-CD-002 or GED 0301 CD 003 study.

- Subject must use protocol approved contraception.

Inclusion Criteria for Adolescent Subjects:

Adolescent subjects must satisfy the following criteria to be screened and enrolled in the
study

- Male or female 12 to 17 years of age.

- Subject must have participated in the GED 0301 CD 003 study.

- Subject is able to swallow the IP tablets.

- Subject must use protocol approved contraception.

Exclusion Criteria for Adult and Adolescent Subjects:

The presence of any of the following will exclude a subject from screening and enrollment:

- Subject had experienced a serious adverse event (SAE) related to the investigational
product while participating in the previous Phase 3 GED-0301 study.

- Subject has initiated biologic agents, such as TNF-a blockers or integrin antagonists.

- Subject is pregnant or breastfeeding.

- Subject has developed a known hypersensitivity to oligonucleotides, GED 0301 or any
ingredient in the investigational product.



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

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: GED-0301

Other: Placebo

Primary Outcome(s)

Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208 [Time Frame: From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose]

Secondary ID(s)

GED-0301-CD-004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02641392