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NCT02601300 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT02601300 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 41 participants.
The verdict
NCT02601300, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
This is a phase 2, open-label, multicenter study to explore the efficacy and safety of oral GED- 0301 in subjects with active UC, defined as a modified Mayo score (MMS) ≥ 4 and ≤ 9 and a Mayo endoscopic subscore≥ 2. Approximately 40 subjects will be enrolled using an Interactive Voice Response System (IVRS) or an Interactive Web Response System (IWRS) to receive open-label, oral GED-0301 160 mg for duration of 52 week treatment. Enrollment of subjects with previous exposure to TNF-α blockers will be limited to approximately 15 subjects. The number of subjects with extensive colitis is targeted to comprise approximately 50% of the entire study population.
Interventions
- DRUG GED-0301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2015-12-14 |
| Est. Completion | 2017-08-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02601300
The ClinicalTrials.gov registry entry for NCT02601300 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 41 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 1 intervention - of which GED-0301 is the first listed.
NCT02601300 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02601300 about?
NCT02601300 is a clinical study titled "An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis". This is a phase 2, open-label, multicenter study to explore the efficacy and safety of oral GED- 0301 in subjects with active UC, defined as a modified Mayo score (MMS) ≥ 4 and ≤ 9 and a Mayo endoscopic subscore≥ 2. Approximately 40 subjects will be enrolled using an Interactive Voice Response Syst...
What is the current status of trial NCT02601300?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2015-12-14. Estimated completion is 2017-08-08.
What interventions are being tested in trial NCT02601300?
The interventions under investigation include: GED-0301 (DRUG).
Who is sponsoring clinical trial NCT02601300?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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