Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease
Public ClinicalTrials.gov record NCT00048113. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00048113
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 9, 2001
- Primary completion
- Apr 26, 2002
- Completion
- Apr 26, 2002
- Last update posted
- Dec 4, 2022
2001 – 2002
United States locations
- U.S. sites
- 27
- U.S. states
- 18
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | Orange | California | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | Arvada | Colorado | — | — |
| Not listed | Jacksonville | Florida | — | — |
| Not listed | Winter Park | Florida | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Lexington | Kentucky | — | — |
| Not listed | Louisville | Kentucky | — | — |
| Not listed | Metairie | Louisiana | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Chevy Chase | Maryland | — | — |
| Not listed | Detroit | Michigan | — | — |
| Not listed | Mexico | Missouri | — | — |
| Not listed | Lincoln | Nebraska | — | — |
| Not listed | Buffalo | New York | — | — |
| Not listed | Rochester | New York | — | — |
| Not listed | Greensboro | North Carolina | — | — |
| Not listed | Raleigh | North Carolina | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Cleveland | Ohio | — | — |
| Not listed | Hamilton | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Portland | Oregon | — | — |
| Not listed | Tacoma | Washington | — | — |
| Not listed | Madison | Wisconsin | — | — |
| Not listed | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00048113, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 4, 2022 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00048113 live on ClinicalTrials.gov.