SHS_211083 SCHD CCLG 15282

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

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.

Inclusion Criteria:

•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: aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of CD

Exclusion Criteria:

•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 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
Phase III
All Other
Drew Schembre, M.D.
Celgene Corporation
Julie Wallick
  • Swedish Medical Center