A Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease
Information source: PDL BioPharma, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crohn's Disease; Colitis; Intestinal Disease; Gastrointestinal Disease; Digestive System Disease
Intervention: anti-Interferon-gamma monoclonal antibody (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: PDL BioPharma, Inc.
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Vancouver General Hospital, Dept. of Medicine, Vancouver, British Columbia V5Z 1M9, Canada
Advanced Clinical Research Institute, Anaheim, California 92801, United States
Doctor's Office, Orange, California 92868, United States
Waterside Clinical Research Services, Inc., West Palm Beach, Florida 33407, United States
Gainesville VA Medical Center, Gainesville, Florida 32608, United States
Atlanta Gastroenterology Associates, Atlanta, Georgia 30342, United States
Doctor's Office, Chicago, Illinois 60637-1426, United States
University of Kentucky Medical Center, Division of Digestive Disease & Nutrition, Lexington, Kentucky 40536, United States
Health Science Centre, Winnipeg, Manitoba R3A 1R9, Canada
Massachusetts General Hospital, Gastrointestinal Unit, Boston, Massachusetts 02114, United States
Gastroenterology Specialities P.C., Lincoln, Nebraska 68503, United States
Carolina Digestion Health Associates, Charlottesville, North Carolina 28211, United States
Queen Elizabeth II Health Science Center, McKenzie Building, Pathology, Halifax,, Nova Scotia B3H 1V8, Canada
The Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States
Consultants for Clinical Research, Cincinnati, Ohio 45219, United States
London Health Science Center, University Campus, London,, Ontario N6A 5A5, Canada
University Pittsburgh Medical Center, Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center, Pittsburgh, Pennsylvania 15261, United States
Houston Medical Research Associates, Houston, Texas 77090, United States
University of Virginia Health System, Charlottesville, Virginia 22908, United States
Additional Information
Crohn's and Colitis Foundation of America Harmony Study
Starting date: March 2002
Last updated: December 18, 2007
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