Back to resultsAlicaforsen (ISIS 2302) in Patients With Active Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Alicaforsen
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's
Eligibility Criteria
Inclusion Criteria Age >/= 12 years Weight >/= 36 kg CDAI score of 220 - 400 Documentation of Crohn's disease activity by endoscopy, biopsy or imaging in the last 2 years No TNF-α inhibitor treatment for three months prior to first study drug infusion Exclusion Criteria Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation Extensive external fistulization (> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C Malignancy within 3 years or poorly controlled medical illness Requires intravenous heparin therapy or with a history of a bleeding problem
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00048113
First Posted
October 24, 2002
Last Updated
December 1, 2022
Sponsor
Ionis Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00048113
Brief Title
Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease
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 Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 10, 2001 (Actual)
Primary Completion Date
April 27, 2002 (Actual)
Study Completion Date
April 27, 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ionis Pharmaceuticals, Inc.
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Alicaforsen
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Age >/= 12 years
Weight >/= 36 kg
CDAI score of 220 - 400
Documentation of Crohn's disease activity by endoscopy, biopsy or imaging in the last 2 years
No TNF-α inhibitor treatment for three months prior to first study drug infusion
Exclusion Criteria
Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation
Extensive external fistulization (> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy
Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C
Malignancy within 3 years or poorly controlled medical illness
Requires intravenous heparin therapy or with a history of a bleeding problem
Facility Information:
City
Little Rock
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Arkansas
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United States
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Orange
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San Diego
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Arvada
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Jacksonville
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Chicago
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Lexington
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Metairie
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Mexico
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Buffalo
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Rochester
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Greensboro
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Raleigh
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Cincinnati
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Cleveland
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Hamilton
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Milwaukee
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Edmonton
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Canada
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Vancouver
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British Columbia
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Canada
City
Quebec
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.centerwatch.com
Description
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Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease
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