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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:
Information provided by (Responsible Party):
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00072943
First received: November 12, 2003
Last updated: March 9, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00072943

  Show 19 Study Locations
Sponsors and Collaborators
Facet Biotech
  More Information

Additional Information:
Crohn's and Colitis Foundation of America  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Facet Biotech
ClinicalTrials.gov Identifier: NCT00072943     History of Changes
Other Study ID Numbers: 707
Study First Received: November 12, 2003
Last Updated: March 9, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on June 13, 2013