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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: Completed Phase 2 study, sponsored by Celgene.
NCT02601300 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Clinical remission was defined as a modified Mayo score of ≤ 2, with no individual subscore \> 1, at Week 8. The MMS was based on a modification of the total Mayo score (TMS) which included the stool frequency, rectal bleeding, and endoscopic subscores of the TMS and excluded the Physician's Global Assessment (PGA) subscore, since this was a global measure that is subjective in nature. The MMS ranges from 0 to 9 points with higher scores indicating greater disease severity. The endoscopy subscor
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 |
What the finished NCT02601300 record still lists
NCT02601300 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 1 intervention - of which GED-0301 is the first listed.
NCT02601300 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02601300's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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