NCT00048113

Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease

ISIS 2302-CS20, Phase 3 Double-Masked, Placebo-Controlled Study of Alicaforsen (ISIS 2302), an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Active Crohn's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (planned)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Alicaforsen

Timeline

• Start date: 2001-01-10
• Primary completion: 2002-04-27
• Completion: 2002-04-27
• First posted: 2002-10-25
• Last updated: 2022-12-05

Locations

30 sites across 2 countries: United States, Canada