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Completed

NCT Number: NCT00072943

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

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.

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Key information

Conditions

Crohn's Disease Colitis Colonic Diseases Crohn Disease Digestive System Disease Digestive System Diseases Gastroenteritis Gastrointestinal Disease Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Disease Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vancouver General Hospital, Dept. of Medicine, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

anti-Interferon-gamma monoclonal antibody

Drug

Sponsors and collaborators

Lead sponsor

Facet Biotech

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Nov 17, 2003
Registry last updated
Mar 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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