Ignite Creation Date:
2025-12-24 @ 3:26 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT02641392
Status:
TERMINATED
Last Update Posted:
2019-01-29
First Post:
2015-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Sponsor:
Celgene
Organization:
Study Overview
Official Title:
A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Status:
TERMINATED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated by Sponsor following a recommendation from external DMC based on lack of emerging benefit; there were no new emergent safety findings
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
The GED-0301-CD-003 trial was not initiated; see detailed description.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: