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

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ClinicalTrials.gov Identifier: NCT00048113
Recruitment Status : Completed
First Posted : October 25, 2002
Last Update Posted : October 17, 2007
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Alicaforsen Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048113


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Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00048113     History of Changes
Other Study ID Numbers: ISIS 2302-CS20
First Posted: October 25, 2002    Key Record Dates
Last Update Posted: October 17, 2007
Last Verified: October 2007

Keywords provided by Ionis Pharmaceuticals, Inc.:
Crohn's

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Alicaforsen
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs