Overview

This trial is active, not recruiting.

Condition crohn's disease
Treatment alicaforsen
Phase phase 3
Sponsor Isis Pharmaceuticals
Start date May 2002
Trial size 150 participants
Trial identifier NCT00048295, ISIS 2302-CS21

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Masking double-blind
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 12 years old.

Inclusion Criteria 1. Age >/= 12 years 2. Weight >/= 36 kg 3. CDAI score of 220 – 400 4. Documentation of Crohn’s disease activity by endoscopy, biopsy or imaging in the last 2 years 5. No TNF-α inhibitor treatment for three months prior to first study drug infusion Exclusion Criteria 1. Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation 2. Extensive external fistulization (> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy 3. Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C 4. Malignancy within 3 years or poorly controlled medical illness 5. Requires intravenous heparin therapy or with a history of a bleeding problem

Additional Information

Official title ISIS 2302-CS21, 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
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Isis Pharmaceuticals.