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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by Isis Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00048295
First received: October 29, 2002
Last updated: June 23, 2005
Last verified: April 2004

October 29, 2002
June 23, 2005
May 2002
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Complete list of historical versions of study NCT00048295 on ClinicalTrials.gov Archive Site
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Alicaforsen (ISIS 2302) in Patients With Active Crohn’s Disease
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

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Crohn's Disease
Drug: Alicaforsen
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
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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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland,   Belgium,   Czech Republic,   Germany,   Italy,   Spain
 
NCT00048295
ISIS 2302-CS21
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Isis Pharmaceuticals
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Isis Pharmaceuticals
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP