ISIS 2302 is an antisense oligonucleotide drug that reduces the production of a specific protein called intercellular adhesion molecule (ICAM-1), a substance that plays a significant role in the increase of inflammation. People with Crohn's disease have been shown to over-produce ICAM-1 in their gut tissues. Alicaforsen works by blocking ICAM-1 messenger RNA, the "instruction" molecule that is required for the production of ICAM-1 protein. This trial will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week period, compared to a placebo. Patients may remain on stable background 5-ASA, antibiotic, or immunosuppressive drugs, and prednisone (or equivalent) at \</= 30 mg per day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
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Little Rock, Arkansas, United States
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Orange, California, United States
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San Diego, California, United States
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Arvada, Colorado, United States
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Jacksonville, Florida, United States
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Winter Park, Florida, United States
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Chicago, Illinois, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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