Clinical trial NCT00048113: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2002-10-25
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


Eligibility 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

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