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.
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 ≥ 12 years
Subject is able to swallow the IP tablets
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 7day 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 (ie,infliximab, adalimumab, certolizumab, or vedolizumab).
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, or colitis due to immunodeficiency
Local manifestations of Crohn's Disease (CD) such as abscesses, short bowel syndrome;or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
Subject has strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, subjects with colonic strictures that are not passable with an age-appropriate colonoscope, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded
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
Adolescents with delayed growth or pubertal development who are on corticosteroids at baseline and who should not continue treatment with the same dose of corticosteroids until the Week 12 visit.
University of California at San Francisco (PARENT)not yet accepting patients San Francisco, California, 94115, United States
High Desert Gastroenterology, Inc.not yet accepting patients Lancaster, California, 93534, United States
Ventura Clinical Trialsnot yet accepting patients Ventura, California, 93003, United States
Facey Medical Foundationnot yet accepting patients Mission Hills, California, 91345, United States
Childrens Hospital Los Angeles RHUnot yet accepting patients Los Angeles, California, 90027-6062, United States
Cedars Sinai Medical Centernot yet accepting 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 LLCnot yet accepting patients Torrance, California, 90502, United States
Valley View Internal Medicinenot yet accepting patients Garden Grove, California, 92843, United States