Clinical trial NCT00072943: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Colitis
Intestinal Disease
Gastrointestinal Disease
Digestive System Disease
Keywords: Crohn's Disease
Colitis
Monoclonal antibody therapy
anti-interferon gamma
Lead sponsor: Facet Biotech
Sponsor class: INDUSTRY
First posted: 2003-11-17
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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