A Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00072943
Recruitment Status : Completed
First Posted : November 17, 2003
Last Update Posted : March 13, 2012
Information provided by (Responsible Party):
Facet Biotech

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Colitis Intestinal Disease Gastrointestinal Disease Digestive System Disease Drug: anti-Interferon-gamma monoclonal antibody Phase 2

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 Type : Interventional  (Clinical Trial)
Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : March 2002
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00072943

  Hide Study Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Doctor's Office
Orange, California, United States, 92868
United States, Florida
Gainesville VA Medical Center
Gainesville, Florida, United States, 32608
Waterside Clinical Research Services, Inc.
West Palm Beach, Florida, United States, 33407
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
United States, Illinois
Doctor's Office
Chicago, Illinois, United States, 60637-1426
United States, Kentucky
University of Kentucky Medical Center, Division of Digestive Disease & Nutrition
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Massachusetts General Hospital, Gastrointestinal Unit
Boston, Massachusetts, United States, 02114
United States, Nebraska
Gastroenterology Specialities P.C.
Lincoln, Nebraska, United States, 68503
United States, North Carolina
Carolina Digestion Health Associates
Charlottesville, North Carolina, United States, 28211
United States, Ohio
Consultants for Clinical Research
Cincinnati, Ohio, United States, 45219
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University Pittsburgh Medical Center, Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center
Pittsburgh, Pennsylvania, United States, 15261
United States, Texas
Houston Medical Research Associates
Houston, Texas, United States, 77090
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Canada, British Columbia
Vancouver General Hospital, Dept. of Medicine
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Health Science Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Queen Elizabeth II Health Science Center, McKenzie Building, Pathology
Halifax,, Nova Scotia, Canada, B3H 1V8
Canada, Ontario
London Health Science Center, University Campus
London,, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Facet Biotech

Additional Information:
Responsible Party: Facet Biotech Identifier: NCT00072943     History of Changes
Other Study ID Numbers: 707
First Posted: November 17, 2003    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: March 2012

Keywords provided by Facet Biotech:
Crohn's Disease
Monoclonal antibody therapy
anti-interferon gamma

Additional relevant MeSH terms:
Crohn Disease
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Colonic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents