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

Belgium
      Roeselare,  Belgium
      Kortrijk,  Belgium
Czech Republic
      Usti nad Orlici,  Czech Republic
      Olomouc,  Czech Republic
      Praha,  Czech Republic
      Hradic Kralove 2,  Czech Republic
      Prague,  Czech Republic
Germany
      Minden,  Germany
      Munster,  Germany
Italy
      Torino,  Italy
Poland
      Krakow,  Poland
      Warszawa,  Poland
      Szczecin,  Poland
      Wroclaw,  Poland
Spain
      Valencia,  Spain
      Barcelona,  Spain

Study ID Numbers:  ISIS 2302-CS21
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  October 29, 2002
ClinicalTrials.gov Identifier:  NCT00048295
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08