Last updated on March 2018

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

Brief description of study

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.

Clinical Study Identifier: NCT02596893

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Associate Director Clinical Trial Disclosure

Hospital Raja Perempuan Zainab II
Kota Bahru, Malaysia

Associate Director Clinical Trial Disclosure

Hospital Universiti Sains Malaysia
Kelantan, Malaysia