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

March 9, 2012 updated by: Facet Biotech

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

175

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Facet Biotech

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (ACTUAL)

April 1, 2004

Study Completion (ACTUAL)

April 1, 2004

Study Registration Dates

First Submitted

November 12, 2003

First Submitted That Met QC Criteria

November 14, 2003

First Posted (ESTIMATE)

November 17, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

March 13, 2012

Last Update Submitted That Met QC Criteria

March 9, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 707

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn's Disease

Clinical Trials on anti-Interferon-gamma monoclonal antibody

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe