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NCT02367183 · ClinicalTrials.gov registry record · Phase 1
A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease
A Phase 1 study of Crohn Disease, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 20
- Study locations
NCT02367183: Completed Phase 1 study of Crohn Disease, sponsored by Celgene.
NCT02367183 is a Phase 1 study of Crohn Disease that has completed, run by Celgene. The registered enrollment target is 64 participants, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02367183, a Phase 1 study of Crohn Disease, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is design to explore the effect of GED-0301 on clinical and endoscopic outcome and to evaluate its safety in subjects with active Crohn's disease.
Primary Outcome
The change from baseline in the Simplified Endoscopic Activity Score for Crohn's disease (SES-CD) score at Induction Week 12.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG GED-0301
Study Locations (20)
Florida
- Florida Research Network, LLC - Gainesville
- University of Florida Shands Endoscopy Center University of Florida at Gainesville - Gainesville
- Borland - Groover Clinic - Jacksonville
- University of Miami - Miami
- Gastroenterology Group of Naples - Naples
- Advanced Medical Research Center - Port Orange
- Shafran Gastroenterology Center - Winter Park
California
- Cedars Sinai Medical Center - Los Angeles
- Macks Research Group - Newport Beach
- Medical Associates Research Group - San Diego
- University of California, San Francisco Medical Center - San Francisco
New York
- NYU Langone Long Island Clinical Research Associates - Great Neck
- Concorde Medical Group - New York
- Cornell University - New York
Georgia
- Atlanta Gastroenterology Associates, LLC - Atlanta
- Gastroenterology Specialists - Suwanee
Michigan
- University of Michigan - Ann Arbor
- Clinical Research Institute of Michigan, LLC - Chesterfield
Kentucky
- University of Louisville - Louisville
Maryland
- Metropolitan Gastroenterology - Chevy Chase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2015-04-08 |
| Est. Completion | 2017-12-14 |
| Phase | Phase 1 |
What the finished NCT02367183 record still lists
NCT02367183 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 205-participant average among 71 other Crohn Disease trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02367183 names 20 study sites across 7 states, led by Florida, California, New York.
Frequently Asked Questions
What is clinical trial NCT02367183 about?
NCT02367183 is a clinical study titled "A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease". This study is design to explore the effect of GED-0301 on clinical and endoscopic outcome and to evaluate its safety in subjects with active Crohn's disease.
What is the current status of trial NCT02367183?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2015-04-08. Estimated completion is 2017-12-14.
What conditions does trial NCT02367183 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT02367183?
The interventions under investigation include: Placebo (DRUG), GED-0301 (DRUG).
Who is sponsoring clinical trial NCT02367183?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02367183 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02367183's enrollment target sits among peer trials
64 42nd of 71 higher than 30 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease 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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