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| 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: | 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 |
| Estimated Enrollment: | 175 |
| Study Start Date: | March 2002 |
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 |
Contacts and Locations
Show 19 Study Locations More Information
| ClinicalTrials.gov Identifier: | NCT00072943 History of Changes |
| Other Study ID Numbers: | 707 |
| Study First Received: | November 12, 2003 |
| Last Updated: | August 2, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Crohn's Disease Colitis Monoclonal antibody therapy anti-interferon gamma |
|
Colitis Crohn Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Gastroenteritis Colonic Diseases Inflammatory Bowel Diseases Antibodies Immunoglobulins Antibodies, Monoclonal |
Interferon-gamma Interferon-gamma, Recombinant Interferons Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses Antineoplastic Agents |
