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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: Clinical Trial Phase 3 study, sponsored by Celgene.
NCT02596893 is a Phase 3 study that was terminated before completion, run by Celgene. The registered enrollment target is 701 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score \< 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the affect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.
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 |
Why NCT02596893 stopped before completion
NCT02596893 is an interventional study that assigns participants to a tested intervention. The registered 701 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02596893 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02596893's enrollment target sits among peer trials
701 506th of 2000 higher than 1,495 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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