Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that was terminated before completion, run by Celgene. The registered enrollment target is 310 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02641392
The ClinicalTrials.gov registry entry for NCT02641392 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02641392 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.