ClinicalTrials.gov record
A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease
ClinicalTrials.gov ID: NCT02974322
Public ClinicalTrials.gov record NCT02974322. 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 Study of the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent 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 effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The study will test GED-0301 compare to placebo for 12 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. Adolescent patients will also be allowed treatment with stable doses of exclusive enteral nutrition and growth hormone. All patients who complete the study will have the option to enter a long term active treatment study.
Study identification
- NCT ID
- NCT02974322
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 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 1, 2017 (Estimated)
- Primary completion
- Nov 17, 2018 (Estimated)
- Completion
- Dec 24, 2018 (Estimated)
- Last update posted
- Nov 14, 2017
2017 – 2018
United States locations
- U.S. sites
- 136
- U.S. states
- 34
- U.S. cities
- 110
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dcr-Pi Pc | Litchfield Park | Arizona | 85340 | — |
| Arizona Digestive Health | Mesa | Arizona | 85024 | — |
| Arizona Digestive Health | Phoenix | Arizona | 85006 | — |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | — |
| Arizona Digestive Health | Sun City | Arizona | 85351 | — |
| Gastroenterology Associates PA | Little Rock | Arkansas | 72205 | — |
| Valley View Internal Medicine | Garden Grove | California | 92843 | — |
| High Desert Gastroenterology, Inc. | 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 | — |
| University of California at San Francisco (PARENT) | San Francisco | California | 94115 | — |
| HCP Clinical Research LLC | Torrance | California | 90502 | — |
| 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 | — |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | — |
| Florida Center for Gastroenterology | Largo | Florida | 33777 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Advance Medical Research Center | Miami | Florida | 33155 | — |
| Cordova Research Institute | 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 | — |
| Advanced Medical Research Center | Port Orange | Florida | 32127 | — |
| East Coast Institute for Research LLC | Saint Augustine | Florida | 32086 | — |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33603 | — |
| Cleveland Clinic Florida Weston | Weston | Florida | 33331 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| Georgia Regents University | Augusta | Georgia | 30912 | — |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | — |
| Atlanta Gastroenterology Specialists PC | Suwanee | Georgia | 30024 | — |
| Northwestern University-Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Northshore University Healthsystem Research Institute | Evanston | Illinois | 60201 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202-5121 | — |
| 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 | 40536 | — |
| 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 Group | Baltimore | Maryland | 21201 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21218 | — |
| Charm City Research Group | Towson | Maryland | 21204 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Lahey Clinic Inc. - PARENT ACCOUNT | Burlington | Massachusetts | 01805 | — |
| UMass Medical Center | Worcester | Massachusetts | 01655 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48105 | — |
| Medex Research Institute | Caro | Michigan | 48723 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Henry Ford Health System | Novi | Michigan | 48377 | — |
| Gastroenterology Associates of Western Michigan PLC | Wyoming | Michigan | 49519 | — |
| 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 Research | Washington | Missouri | 63090 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| AGA Clinical Research Associates LLC | Egg Harbor | New Jersey | 08234 | — |
| North Shore-LIJ Health System-Division of Rheumatology | Great Neck | New York | 11021 | — |
| NYU Langone Long Island Clinical Research 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 | — |
| New York University School of Medicine | New York | New York | 10016 | — |
| Mount Sinai School of Medicine | 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, P.A. | 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 | — |
| 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 | Winston-Salem | North Carolina | 27103 | — |
| Ohio Clinical Research Partners LLC | Akron | Ohio | 44333 | — |
| Clinical Inquest Center Ltd | Beavercreek | Ohio | 45431 | — |
| Dr. Deepak Sarwal, MD | Centerville | Ohio | 45429 | — |
| UC Health Clinical Trials Office | Cincinnati | Ohio | 45206 | — |
| Consultants for Clinical Research Inc. | Cincinnati | Ohio | 45219 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Springfield Health Care Center | Springfield | Ohio | 45504 | — |
| Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | 73104 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health & Science University | Portland | Oregon | 97229 | — |
| Main Line Gastroenterology | Havertown | Pennsylvania | 19083-2742 | — |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | — |
| Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| University of Pennsylvania School of Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Penn State University Milton S Hershey Medical Center | State College | Pennsylvania | 16803 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Carolinas Healthcare System | Charleston | South Carolina | 28203 | — |
| 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 | — |
| Gulf Coast Research Group LLC | Houston | Texas | 77004 | — |
| Methodist Hospital | Houston | Texas | 77030 | — |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| Houston Endoscopy and Research Center | Houston | Texas | 77079 | — |
| Digestive Health Center | Pasadena | Texas | 77505 | — |
| Texas Digestive Disease Consultants - Southlake | Southlake | Texas | 76092 | — |
| Digestive Health Specialists of Tyler | Tyler | Texas | 75701 | — |
| University of Utah Division of Gastroenterology | Salt Lake City | Utah | 84132 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Charlottesville Medical Research Center | Charlottesville | Virginia | 22911 | — |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | — |
| 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 Cancer Institute Research | Seattle | Washington | 98104 | — |
| University of Washington School of Medicine | Seattle | Washington | 98104 | — |
| The Vancouver Clinic | Vancouver | Washington | 98664-4896 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53705 | — |
| Dean Clinic Oregon | Madison | Wisconsin | 53716 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 175 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02974322, 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 Nov 14, 2017 · Synced Oct 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02974322 live on ClinicalTrials.gov.