SD, IL-13 Production Rate in IPF

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate how QAX576 affects levels of interleukin 13 (IL-13) in patients with idiopathic pulmonary fibrosis (IPF).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Men and women between the ages of 40 and 80 years with a confirmed diagnosis of idiopathic pulmonary fibrosis

• Both men and women must be on non-childbearing potential. Additional information regarding this requirement is available at screening.

• Capability to meet certain lung function tests at screening

• Non-smokers

• No participation in another clinical study within 4 weeks of study start.

Exclusion Criteria:

• Certain medical conditions may exclude candidates from participation.

• Blood loss or donation of 400 mL or more within 2 months of study start Significant illness (other than respiratory) within 2 weeks of study start

• Past medical personal or close family history of clinically significant ECG abnormalities

• Connective tissue disorders

• Active infection or history of systemic parasitic infection

• Known hypersensitivity to the drug.

• History of immunocompromise, including a positive HIV test result.

• History of drug or alcohol abuse within 12 months of study start

• Any condition that may compromise patient safety