An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis
Public ClinicalTrials.gov record NCT02601300. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Open-Label, Multicenter Study to Explore the Efficacy and Safety of MONGERSON (GED-0301) in Subjects With Active Ulcerative Colitis.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02601300
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 41 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 13, 2015
- Primary completion
- Sep 5, 2016
- Completion
- Aug 7, 2017
- Last update posted
- Oct 16, 2018
2015 – 2017
United States locations
- U.S. sites
- 20
- U.S. states
- 11
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Macks Research Group | Newport Beach | California | 92660 | — |
| Medical Associates Research Associates | San Diego | California | 92123 | — |
| Florida Research Network, LLC | Gainesville | Florida | 32605 | — |
| University of Miami School of Medicine | Miami | Florida | 33136 | — |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Concorde Medical Group | New York | New York | 10016 | — |
| Rochester General Hospital | Rochester | New York | 14621 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| Gastroenterology Center of The Midsouth PC | Germantown | Tennessee | 38138 | — |
| Nashville Gastrointestinal Specialists | Nashville | Tennessee | 37211 | — |
| Vanderbilt University | Nashville | Tennessee | 37212 | — |
| Texas Digestive Disease Consultants - Dallas | Dallas | Texas | 75231 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Texas Digestive Disease Consultants - Southlake | Southlake | Texas | 76092 | — |
| McGuire Veterans Affairs Medical Center | Richmond | Virginia | 23249 | — |
| Dean Medical Center | Madison | Wisconsin | 53715 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02601300, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2018 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02601300 live on ClinicalTrials.gov.