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NCT02596893 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease
A Phase 3 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 3
- Development phase
- 701
- Enrollment target
NCT02596893 is a Phase 3 study that was terminated before completion, run by Celgene. The registered enrollment target is 701 participants.
The verdict
NCT02596893, a Phase 3 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 701 participants
- Enrollment target
Study Summary
The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study. Participants who discontinued the study anytime or completed the study at Week 52 were then observed for an additional 4 weeks.
Interventions
- DRUG Placebo
- DRUG GED-0301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 701 participants |
| Start Date | 2015-12-08 |
| Est. Completion | 2018-01-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02596893
The ClinicalTrials.gov registry entry for NCT02596893 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 701 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.
NCT02596893 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02596893 about?
NCT02596893 is a clinical study titled "Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease". The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which...
What is the current status of trial NCT02596893?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 701 participants. The study started on 2015-12-08. Estimated completion is 2018-01-05.
What interventions are being tested in trial NCT02596893?
The interventions under investigation include: Placebo (DRUG), GED-0301 (DRUG).
Who is sponsoring clinical trial NCT02596893?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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