Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072943
Status:
COMPLETED
Last Update Posted:
2012-03-13
First Post:
2003-11-12
Brief Title:
A Humanized Anti-Interferon-γ Monoclonal Antibody HuZAF for Moderate to Severe Crohns Disease
Sponsor:
Facet Biotech
Organization:
Facet Biotech
Study Overview
Official Title:
A Phase II Double-Blind Placebo-Controlled Study to Determine the Safety and Efficacy of a Humanized Anti-Interferon-γ Monoclonal Antibody HuZAF Administered to Patients With Moderate to Severe Crohns Disease
Status:
COMPLETED
Status Verified Date:
2012-03
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:
The purpose of the HARMONY study is to assess the safety and efficacy of an investigational drug called HuZAF in patients with moderate to severe Crohns disease CD HuZAF is a humanized anti-Interferon-gamma anti-IFN-γ monoclonal antibody which binds and blocks IFN-γ a protein in the immune system that is involved in inflammation Antibodies are proteins normally produced by our immune system to help fight off foreign substances Scientists have been able to make therapeutic humanized monoclonal antibodies similar to the antibodies in our bodies to target diseases
Detailed Description:
Participants will be randomized assigned by chance to one of five treatment groups consisting of four groups differing in the amount of study drug given and one placebo group The initial dose of study drug will be given intravenously injected into a vein in the arm Four weeks later three subsequent doses of study drug will be given subcutaneously through the skin every four weeks for three doses Patients will be followed for approximately six months after receiving their final dose
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