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NCT00072943 Clinical Trial

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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00072943
Other study ID # 707
Secondary ID
Status Completed
Phase Phase 2
First received November 12, 2003
Last updated March 9, 2012
Start date March 2002
Est. completion date April 2004

Study information
Verified date March 2012
Source Facet Biotech
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 175
Est. completion date April 2004
Est. primary completion date April 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility - 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• anti-Interferon-gamma monoclonal antibody

Locations
Country Name City State
Canada Queen Elizabeth II Health Science Center, McKenzie Building, Pathology Halifax, Nova Scotia
Canada London Health Science Center, University Campus London, Ontario
Canada Vancouver General Hospital, Dept. of Medicine Vancouver British Columbia
Canada Health Science Centre Winnipeg Manitoba
United States Advanced Clinical Research Institute Anaheim California
United States Atlanta Gastroenterology Associates Atlanta Georgia
United States Massachusetts General Hospital, Gastrointestinal Unit Boston Massachusetts
United States Carolina Digestion Health Associates Charlottesville North Carolina
United States University of Virginia Health System Charlottesville Virginia
United States Doctor's Office Chicago Illinois
United States Consultants for Clinical Research Cincinnati Ohio
United States The Cleveland Clinic Foundation Cleveland Ohio
United States Gainesville VA Medical Center Gainesville Florida
United States Houston Medical Research Associates Houston Texas
United States University of Kentucky Medical Center, Division of Digestive Disease & Nutrition Lexington Kentucky
United States Gastroenterology Specialities P.C. Lincoln Nebraska
United States Doctor's Office Orange California
United States University Pittsburgh Medical Center, Division of Gastroenterology, Hepatology and Nutrition, Inflammatory Bowel Disease Center Pittsburgh Pennsylvania
United States Waterside Clinical Research Services, Inc. West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Facet Biotech

Countries where clinical trial is conducted

United States,  Canada, 

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Completed NCT02265588 - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD). N/A
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