SD, IL-13 Production Rate in IPF

Completed · Phase 2

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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

Key facts

Study ID

NCT00532233

Run by

Novartis Pharmaceuticals

People needed

52

Starts

2007-09-01

Expected to finish

2009-06-01

Last updated by the study team

2020-12-19

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — New Orleans, Louisiana, United States
• Novartis Investigative Site — Rochester, Minnesota, United States
• Novartis Investigative Site — Durham, North Carolina, United States
• Novartis Investigative Site — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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