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

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ClinicalTrials.gov 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.

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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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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 ClinicalTrials.gov identifier (NCT number): NCT00072943

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Sponsors and Collaborators
Facet Biotech
Additional Information:
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Responsible Party: Facet Biotech
ClinicalTrials.gov Identifier: NCT00072943    
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:
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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