Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048113
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2002-10-24
Brief Title:
Alicaforsen ISIS 2302 in Patients With Active Crohns Disease
Sponsor:
Ionis Pharmaceuticals Inc
Organization:
Ionis Pharmaceuticals Inc
Study Overview
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 Crohns Disease
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Crohns 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None