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NCT02641392 · ClinicalTrials.gov registry record · Phase 3
A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
A Phase 3 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 3
- Development phase
- 310
- Enrollment target
NCT02641392: Clinical Trial Phase 3 study, sponsored by Celgene.
NCT02641392 is a Phase 3 study that was terminated before completion, run by Celgene. The registered enrollment target is 310 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02641392, a Phase 3 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 310 participants
- Enrollment target
Study 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.
Primary Outcome
A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED- 0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.
Interventions
- OTHER Placebo
- DRUG GED-0301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2016-07-25 |
| Est. Completion | 2018-01-04 |
| Phase | Phase 3 |
Why NCT02641392 stopped before completion
NCT02641392 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02641392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02641392 about?
NCT02641392 is a clinical study titled "A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease". 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...
What is the current status of trial NCT02641392?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 310 participants. The study started on 2016-07-25. Estimated completion is 2018-01-04.
What interventions are being tested in trial NCT02641392?
The interventions under investigation include: Placebo (OTHER), GED-0301 (DRUG).
Who is sponsoring clinical trial NCT02641392?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02641392's enrollment target sits among peer trials
310 1107th of 2000 higher than 892 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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