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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00072943
First Posted: November 17, 2003
Last Update Posted: March 13, 2012
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.
Information provided by (Responsible Party):
Facet Biotech
  Purpose
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 Intervention Phase
Crohn's Disease Colitis Intestinal Disease Gastrointestinal Disease Digestive System Disease Drug: anti-Interferon-gamma monoclonal antibody Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Facet Biotech:

Estimated Enrollment: 175
Study Start Date: March 2002
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00072943


  Show 19 Study Locations
Sponsors and Collaborators
Facet Biotech
  More Information

Additional Information:
Responsible Party: Facet Biotech
ClinicalTrials.gov Identifier: NCT00072943     History of Changes
Other Study ID Numbers: 707
First Submitted: November 12, 2003
First Posted: November 17, 2003
Last Update Posted: March 13, 2012
Last Verified: March 2012

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

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