Study terminated by Sponsor following a recommendation from external DMC based on lack of emerging benefit; there were no new emergent safety findings

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.

This is a long-term active treatment study in patients with Crohn's disease (CD). Subjects who met the early escape criteria in Study GED-0301-CD-002, or subjects who completed Study GED-0301-002 or GED-0301-003, may be eligible for this study. Primary objective is to assess long-term safety of GED 0301. Additional efficacy and patient reported outcomes will be explored.

There are 5 possible treatment groups for GED-0301-CD-002 Subjects (Groups 1-5). There are 3 possible treatment groups for GED-0301-CD-003 subjects (Groups 1-3). Treatment is assigned based on clinical improvement achieved or not achieved from the core GED-0301 study.

1. continuous GED-0301 160 mg once daily for 12 weeks, followed by alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;
2. alternating GED-0301 160 mg once daily for 4 weeks with placebo once daily for 4 weeks, through Week 208;
3. alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;
4. continuous GED-0301 40 mg once daily through Week 208;
5. alternating placebo once daily for 4 weeks, followed by GED-0301 40 mg once daily for 4 weeks, through Week 208.

The GED-0301-CD-003 trial was not initiated; the GED-0301 program was terminated; no safety findings were noted.

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.

.Results from a center cannot be submitted for publication before results of multicenter study are published unless it is > 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.