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.
A Phase 3, Randomized, Placebo-controlled, Double-blind, Multicenter, Induction Study to Investigate the Efficacy and Safety of GED-0301 For the Treatment of Subjects With Active Crohn's Disease
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.
You CAN'T join if...
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.
University of California at San Franciscoaccepting new patients San Francisco, California, 94158, United States
High Desert Gastroenterology, Inc.accepting new patients Lancaster, California, 93534, United States
Ventura Clinical Trialsnot yet accepting patients Ventura, California, 93003, United States
Facey Medical Foundationaccepting new patients Mission Hills, California, 91345, United States
T. Joseph Raoof MD Incaccepting new patients Encino, California, 91436, United States
Cedars-Sinai Medical Centeraccepting new patients Los Angeles, California, 90048, United States
University of Southern California Medical Centernot yet accepting patients Los Angeles, California, 90032, United States
HCP Clinical Research LLCaccepting new patients Anaheim, California, 92801, United States
Valley View Internal Medicineaccepting new patients Garden Grove, California, 92843, United States