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.

Condition	Treatment or Intervention	Phase
Crohn's Disease	Drug: Alicaforsen	Phase III

Further Study Details: 

Expected Total Enrollment:  150

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Arkansas
      Little Rock,  Arkansas,  United States
California
      San Diego,  California,  United States
      Orange,  California,  United States
Colorado
      Arvada,  Colorado,  United States
Florida
      Winter Park,  Florida,  United States
      Jacksonville,  Florida,  United States
Illinois
      Chicago,  Illinois,  United States
Kentucky
      Lexington,  Kentucky,  United States
      Louisville,  Kentucky,  United States
Louisiana
      Metairie,  Louisiana,  United States
Maryland
      Baltimore,  Maryland,  United States
      Chevy Chase,  Maryland,  United States
Michigan
      Detroit,  Michigan,  United States
Missouri
      Mexico,  Missouri,  United States
Nebraska
      Lincoln,  Nebraska,  United States
New York
      Buffalo,  New York,  United States
      Rochester,  New York,  United States
North Carolina
      Raleigh,  North Carolina,  United States
      Greensboro,  North Carolina,  United States
Ohio
      Hamilton,  Ohio,  United States
      Cleveland,  Ohio,  United States
      Cincinnati,  Ohio,  United States
Oklahoma
      Oklahoma City,  Oklahoma,  United States
Oregon
      Portland,  Oregon,  United States
Washington
      Tacoma,  Washington,  United States
Wisconsin
      Milwaukee,  Wisconsin,  United States
      Madison,  Wisconsin,  United States
Canada
      Quebec,  Canada
Canada, Alberta
      Edmonton,  Alberta,  Canada
Canada, British Columbia
      Vancouver,  British Columbia,  Canada

Study ID Numbers:  ISIS 2302-CS20
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  October 24, 2002
ClinicalTrials.gov Identifier:  NCT00048113
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08