NCT00048113

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2001

Shorter than P25 for phase_3

Geographic Reach
2 countries

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2001

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2002

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2002

Completed
Last Updated

December 5, 2022

Status Verified

October 1, 2007

Enrollment Period

1.3 years

First QC Date

October 24, 2002

Last Update Submit

December 1, 2022

Conditions

Crohn's Disease

Keywords

Crohn's

Interventions

AlicaforsenDRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Unknown Facility

Little Rock, Arkansas, United States

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Orange, California, United States

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San Diego, California, United States

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Arvada, Colorado, United States

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Jacksonville, Florida, United States

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Winter Park, Florida, United States

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Chicago, Illinois, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Metairie, Louisiana, United States

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Baltimore, Maryland, United States

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Chevy Chase, Maryland, United States

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Detroit, Michigan, United States

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Mexico, Missouri, United States

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Lincoln, Nebraska, United States

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Buffalo, New York, United States

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Rochester, New York, United States

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Greensboro, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Hamilton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Tacoma, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Québec, Canada

Location

Related Links

MeSH Terms

Conditions

Crohn Disease

Interventions

alicaforsen

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 24, 2002

First Posted

October 25, 2002

Study Start

January 10, 2001

Primary Completion

April 27, 2002

Study Completion

April 27, 2002

Last Updated

December 5, 2022

Record last verified: 2007-10

Locations

US(27)CA(3)