ClinicalTrials.gov record
Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease
ClinicalTrials.gov ID: NCT02596893
Public ClinicalTrials.gov record NCT02596893. 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 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02596893
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 701 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 7, 2015
- Primary completion
- Jan 4, 2018
- Completion
- Jan 4, 2018
- Last update posted
- Aug 27, 2019
2015 – 2018
United States locations
- U.S. sites
- 150
- U.S. states
- 36
- U.S. cities
- 120
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ADDC Research LLC | Huntsville | Alabama | 35802 | — |
| Arizona Digestive Health | Mesa | Arizona | 85024 | — |
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| Colon & Digestive Health Specialists | Scottsdale | Arizona | 85260-1315 | — |
| Arizona Digestive Health | Sun City | Arizona | 85351 | — |
| Gastroenterology Associates PA | Little Rock | Arkansas | 72205 | — |
| HCP Clinical Research LLC | Anaheim | California | 92801 | — |
| T. Joseph Raoof MD Inc | Encino | California | 91436 | — |
| Valley View Internal Medicine | Garden Grove | California | 92843 | — |
| OM Research | Lancaster | California | 93534 | — |
| University of Southern California Medical Center | Los Angeles | California | 90032 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Facey Medical Foundation | Mission Hills | California | 91345 | — |
| Medical Associates Research Group Inc. | San Diego | California | 902123 | — |
| Clinical Applications Laboratories Inc | San Diego | California | 92103 | — |
| University of California at San Francisco | San Francisco | California | 94158 | — |
| Ventura Clinical Trials | Ventura | California | 93003 | — |
| University Of Colorado | Aurora | Colorado | 80045 | — |
| Innovative Clinical Research | Lafayette | Colorado | 80026 | — |
| Connecticut Gastroenterology Institute | Bristol | Connecticut | 06010 | — |
| Medical Research Center of Connecticut LLC | Hamden | Connecticut | 06518 | — |
| Connecticut GI PC Research Division | Hartford | Connecticut | 06106 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Florida Medical Research - Southeastern Integrated Medical | Gainesville | Florida | 32607 | — |
| Sarkis Clinical Trials - Parent | Gainesville | Florida | 32607 | — |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | — |
| Florida Center for Gastroenterology | Largo | Florida | 33777 | — |
| Advance Medical Research Center | Miami | Florida | 33155 | — |
| Cordova Research Institute | Miami | Florida | 33155 | — |
| My Community Research Center inc | Miami | Florida | 33155 | — |
| Sanitas Research | Miami | Florida | 33155 | — |
| Galiz Research LLC | Miami Springs | Florida | 33166 | — |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | — |
| GCRM | Orlando | Florida | 32801 | — |
| Center For Digestive Health | Orlando | Florida | 32803 | — |
| BRCR Medical Center Inc. | Plantation | Florida | 33322 | — |
| Advanced Medical Research Center | Port Orange | Florida | 32127 | — |
| East Coast Institute for Research LLC | Saint Augustine | Florida | 32086 | — |
| Cleveland Clinic Florida Weston | Weston | Florida | 33331 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| Atlanta Gastroenterology Associates, LLC | Atlanta | Georgia | 30342 | — |
| Georgia Regents University | Augusta | Georgia | 30912 | — |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | — |
| Atlanta Gastroenterology Specialists PC | Suwanee | Georgia | 30024 | — |
| Grand Teton Research Group PLLC | Idaho Falls | Idaho | 83404 | — |
| Northwestern University-Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| NorthShore University HealthSystem | Highland Park | Illinois | 60035 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Iowa Digestive Disease Center | Clive | Iowa | 50325 | — |
| Health Science Research Center, LLC | Pratt | Kansas | 67124 | — |
| Heartland Research Associates LLC | Wichita | Kansas | 67207 | — |
| Via Christi Research a division of Via Christi Hospitals Wichita Inc | Wichita | Kansas | 67208 | — |
| Graves Gilbert Clinic | Bowling Green | Kentucky | 42101 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40504 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Gastroenterology Associates LLC | Baton Rouge | Louisiana | 70809 | — |
| Clinical Trials of SW Louisiana LLC | Lake Charles | Louisiana | 70601 | — |
| Louisiana Research Center LLC | Shreveport | Louisiana | 71103 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21218 | — |
| Metropolitan Gastroenterology | Chevy Chase | Maryland | 20815 | — |
| Gastro Center of Maryland | Columbia | Maryland | 21045 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Commonwealth Clinical Studies PLLC | Brockton | Massachusetts | 02302 | — |
| UMass Medical Center | Worcester | Massachusetts | 01655 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Medex Research Institute | Caro | Michigan | 48723 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Henry Ford Medical Center - New Center One | Novi | Michigan | 48377 | — |
| Gastroenterology Associates of Western Michigan PLC | Wyoming | Michigan | 49519 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Ehrhardt Clinical Research LLC | Belton | Missouri | 64012 | — |
| Jefferson City Medical Group | Jefferson City | Missouri | 65203 | — |
| Mercy Research | Springfield | Missouri | 65806 | — |
| Saint Louis University | St Louis | Missouri | 63110 - 0250 | — |
| Mercy Clinic East Communities d/b/a Mercy Health Research | Washington | Missouri | 63090 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| AGA Clinical Research Associates LLC | Egg Harbor | New Jersey | 08234 | — |
| Southwest Gastroenterology Associates PC | Albuquerque | New Mexico | 87109 | — |
| Sing Chan Private Practice | Flushing | New York | 11355 | — |
| NYU Langone Nassau Gastroenterology Associates | Great Neck | New York | 11021 | — |
| Montefiore Medical Center PRIME | Lake Success | New York | 11041 | — |
| The Feinstein Institute for Medical Research PRIME | Manhasset | New York | 11030 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| North Shore Long Island Jewish Health System | New Hyde Park | New York | 11040 | — |
| Concord Medical Group PRIME | New York | New York | 10016 | — |
| New York University School of Medicine | New York | New York | 10016 | — |
| New York - Presbyterian/Weill Cornell Medical Center | New York | New York | 10021 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Premier Medical Group of the Hudson Valley PC | Poughkeepsie | New York | 12601 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Asheville Gastroenterology Associates, PA | Asheville | North Carolina | 28801 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Carolina Center for Liver Disease | Charlotte | North Carolina | 28203 | — |
| Gaffney Health Services | Charlotte | North Carolina | 28205 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28207 | — |
| PhysiqueMed Clinical Trials | Greensboro | North Carolina | 27455 | — |
| Kinston Medical Specialists PA | Kinston | North Carolina | 28501 | — |
| Clinical Trials of America, LLC | Mount Airy | North Carolina | 27030 | — |
| Trial Management Associates LLC | Wilmington | North Carolina | 28401 | — |
| PMG Research of Winston-Salem LLC | Winston-Salem | North Carolina | 27103-3914 | — |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| Ohio Clinical Research Partners LLC | Akron | Ohio | 44333 | — |
| Dr. Deepak Sarwal, MD | Centerville | Ohio | 45429 | — |
| UC Health Clinical Trials Office | Cincinnati | Ohio | 45206 | — |
| Consultants for Clinical Research Inc. | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44106 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Clinical Inquest Center Ltd | Huber Heights | Ohio | 45424-3239 | — |
| Springfield Health Care Center | Springfield | Ohio | 45504 | — |
| Oklahoma University Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Main Line Gastroenterology | Havertown | Pennsylvania | 19083-2742 | — |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | — |
| University of Pennsylvania School of Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Penn State University Milton S Hershey Medical Center | State College | Pennsylvania | 16803 | — |
| ClinSearch LLC | Chattanooga | Tennessee | 37421 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| Texas Clinical Research Institute LLC | Arlington | Texas | 76012 | — |
| Texas Digestive Disease Consultants - Dallas | Arlington | Texas | 76012 | — |
| Texas Digestive Disease Consultants Dallas | Dallas | Texas | 75231 | — |
| Texas Digestive Disease Consultants - Southlake | Flower Mound | Texas | 75028 | — |
| Gulf Coast Research Group LLC | Houston | Texas | 77004 | — |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | — |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| Houston Endoscopy and Research Center | Houston | Texas | 77079 | — |
| Sagact Pllc | San Antonio | Texas | 78229 | — |
| San Antonio Military Medical Center | San Antonio | Texas | 78229 | — |
| Scott & White Medical Center | Temple | Texas | 76508 | — |
| Digestive Health Specialist of Tyler | Tyler | Texas | 75701 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| University of Vermont | Colchester | Vermont | 05446 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Charlottesville Medical Research Center | Charlottesville | Virginia | 22911 | — |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | — |
| Emeritas Research Group | Leesburg | Virginia | 20176 | — |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| Hunter Holmes Mcguire Ctr | Richmond | Virginia | 23249 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| Harborview Medical Center | Seattle | Washington | 98104 | — |
| Swedish Medical Center | Seattle | Washington | 98104 | — |
| University of Washington School of Medicine | Seattle | Washington | 98104 | — |
| The Vancouver Clinic | Vancouver | Washington | 98664-4896 | — |
| Dean Clinic Oregon | Madison | Wisconsin | 53716 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226-3596 | — |
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 388 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02596893, 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 Aug 27, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02596893 live on ClinicalTrials.gov.