Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease



Status:Terminated
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/2/2019
Start Date:December 8, 2015
End Date:January 5, 2018

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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

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.


Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

- Male or female ≥ 18 years

- Active Crohn's disease (CD) disease as determined by the Crohn's Disease Activity
Index (CDAI) score and the Simple Endoscopic Score for Crohn's Disease (SES-CD)

- Must meet a determined average minimum number of daily stools or rating of abdominal
pain over a 7 day period

- Subject must have failed or experienced intolerance to at least one of the following:
budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine,
6-mercaptopurine, or methotrexate); or biologics for the treatment of CD.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

- Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis,
microscopic colitis, radiation colitis or diverticular disease-associated colitis

- Local manifestations of Crohn's Disease (CD) such as symptomatic/severe strictures,
abscesses, short bowel syndrome; or other disease complications for which surgery
might be indicated or could confound the evaluation of efficacy

- Intestinal resection within 6 months or any intra-abdominal surgery within 3 months
prior to the Screening Visit

- Ileostomy or a colostomy

- Subject has a history of any clinically significant medical condition that, in the
investigator's opinion, would prevent the subject from participating in the study.
We found this trial at
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Chattanooga, Tennessee 37421
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Chapel Hill, North Carolina 27599
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1000 Blythe Blvd
Charlotte, North Carolina 28203
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
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7000 Fannin St
Houston, Texas 77030
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425 University Blvd.
Indianapolis, Indiana 46202
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
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701 Doctors Dr
Kinston, North Carolina 28504
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740 South Limestone Street
Lexington, Kentucky 40536
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
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Minneapolis, Minnesota 55455
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1211 Medical Center Dr
Nashville, Tennessee 37232
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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60 Crittenden Blvd # 70
Rochester, New York 14642
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201 Presidents Circle
Salt Lake City, Utah 84108
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1709 S Rock Rd
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Winter Park, Florida 32789
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Albuquerque, New Mexico 87109
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
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1120 15th Street
Augusta, Georgia 30912
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22 S Greene St
Baltimore, Maryland 21201
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733 North Broadway
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Caro, Michigan 48723
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Centerville, Ohio 45429
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Charlottesville, Virginia 22903
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303 E Chicago Ave
Chicago, Illinois 60611
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5841 S Maryland Ave
Chicago, Illinois 60637
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2049 E 100th St
Cleveland, Ohio 44106
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1 Medical Center Dr
Lebanon, New Hampshire 03756
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500 S Preston St
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600 Highland Ave
Madison, Wisconsin 53792
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
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259 1st St
Mineola, New York 11501
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New Haven, Connecticut 6520
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