Back to resultsA Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease
Primary Purpose
Crohn's Disease, Colitis, Intestinal Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
anti-Interferon-gamma monoclonal antibody
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, Colitis, Monoclonal antibody therapy, anti-interferon gamma
Eligibility Criteria
Patients 18-70 years old Patients with moderate to severe Crohn's disease Patients who have had Crohn's disease for at least 6 months Patients who have previously been treated for Crohn's disease
Sites / Locations
- Advanced Clinical Research Institute
- Doctor's Office
- Gainesville VA Medical Center
- Waterside Clinical Research Services, Inc.
- Atlanta Gastroenterology Associates
- Doctor's Office
- University of Kentucky Medical Center, Division of Digestive Disease & Nutrition
- Massachusetts General Hospital, Gastrointestinal Unit
- Gastroenterology Specialities P.C.
- Carolina Digestion Health Associates
- Consultants for Clinical Research
- The Cleveland Clinic Foundation
- University Pittsburgh Medical Center, Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center
- Houston Medical Research Associates
- University of Virginia Health System
- Vancouver General Hospital, Dept. of Medicine
- Health Science Centre
- Queen Elizabeth II Health Science Center, McKenzie Building, Pathology
- London Health Science Center, University Campus
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00072943
Brief Title
A Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease
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 Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Facet Biotech
4. Oversight
5. Study Description
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 Crohn's 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Colitis, Intestinal Disease, Gastrointestinal Disease, Digestive System Disease
Keywords
Crohn's Disease, Colitis, Monoclonal antibody therapy, anti-interferon gamma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
175 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
anti-Interferon-gamma monoclonal antibody
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients 18-70 years old
Patients with moderate to severe Crohn's disease
Patients who have had Crohn's disease for at least 6 months
Patients who have previously been treated for Crohn's disease
Facility Information:
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Doctor's Office
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Gainesville VA Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Waterside Clinical Research Services, Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Doctor's Office
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1426
Country
United States
Facility Name
University of Kentucky Medical Center, Division of Digestive Disease & Nutrition
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Massachusetts General Hospital, Gastrointestinal Unit
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Gastroenterology Specialities P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68503
Country
United States
Facility Name
Carolina Digestion Health Associates
City
Charlottesville
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University Pittsburgh Medical Center, Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Houston Medical Research Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Vancouver General Hospital, Dept. of Medicine
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Health Science Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Queen Elizabeth II Health Science Center, McKenzie Building, Pathology
City
Halifax,
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V8
Country
Canada
Facility Name
London Health Science Center, University Campus
City
London,
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.ccfa.org
Description
Crohn's and Colitis Foundation of America
URL
http://www.harmonystudy.com
Description
Harmony Study
Learn more about this trial
A Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease
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