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

• Status: Terminated
• Trial end date: 2018-01-04
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study.

The GED-0301-CD-003 trial was not initiated; see detailed description.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation

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-α 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.