Overview

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