Crohn Disease Clinical Trial
Official title:
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease
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.
n/a
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