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

Sponsor:	PDL BioPharma, Inc.
Information provided by:	Facet Biotech
ClinicalTrials.gov Identifier:	NCT00072943

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Digestive Diseases

Drug Information available for: Interferon gamma-1b Immunoglobulins Globulin, Immune Interferons

U.S. FDA Resources

Further study details as provided by Facet Biotech:

Estimated Enrollment:	175
Study Start Date:	March 2002

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

PDL BioPharma, Inc.

More Information

Additional Information:

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

Harmony Study This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	707
Study First Received:	November 12, 2003
Last Updated:	August 2, 2008
ClinicalTrials.gov Identifier:	NCT00072943 History of Changes
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:

Anti-Infective Agents
Immunologic Factors
Interferon Type II
Antineoplastic Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Interferons
Colonic Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Antiviral Agents

Pharmacologic Actions
Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Therapeutic Uses
Crohn Disease
Gastroenteritis
Colitis
Immunoglobulins
Interferon-gamma, Recombinant

ClinicalTrials.gov processed this record on February 04, 2010