Celgene GED-0301 Phase III for Subjects With Crohn's Disease

Condition


Study Name

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease (IRB no. 43510)


Phase

Phase III


Summary

The purpose of this study is to evaluate the effects of an investigational drug called GED-0301 and to determine whether it can improve the symptoms of Crohn’s disease. Researchers will examine two doses of GED-0301 compared to placebo (inactive substance) and will assess how well the drug is tolerated. Researchers will also administer biomarker tests. Biomarkers are substances naturally occurring in the body, such as proteins, that indicate how the study drug is working.


Eligibility

Key Inclusion Criteria

  • Diagnosis of Crohn’s disease with a duration of at least three months before screening
  • Presence of ileitis, ileocolitis or colitis, as determined by ileocolonoscopy
  • Active disease

Key Exclusion Criteria

  • Diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis
  • Local manifestations of Crohn’s disease such as abscesses and short bowel syndrome

Please see additional list of inclusion and exclusion criteria.


Principal Investigator

Gil Melmed, MD


Contact

Elizabeth Khanishian
Phone: 310-423-2041
Email: elizabeth.khanishian@cshs.org