Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease
ISIS 2302-CS21, 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
1 other identifier
interventional
150
6 countries
15
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 29, 2002
CompletedFirst Posted
Study publicly available on registry
October 30, 2002
CompletedAugust 15, 2022
August 1, 2022
October 29, 2002
August 11, 2022
Conditions
Interventions
Eligibility Criteria
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 (15)
Unknown Facility
Kortrijk, Belgium
Unknown Facility
Roeselare, Belgium
Unknown Facility
Hradic Kralove 2, Czechia
Unknown Facility
Olomouc, Czechia
Unknown Facility
Prague, Czechia
Unknown Facility
Ústí nad Orlicí, Czechia
Unknown Facility
Minden, Germany
Unknown Facility
Münster, Germany
Unknown Facility
Torino, Italy
Unknown Facility
Krakow, Poland
Unknown Facility
Szczecin, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Wroclaw, Poland
Unknown Facility
Barcelona, Spain
Unknown Facility
Valencia, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 29, 2002
First Posted
October 30, 2002
Study Start
May 1, 2002
Last Updated
August 15, 2022
Record last verified: 2022-08