SD, IL-13 Production Rate in IPF
- Registration Number
- NCT00532233
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 QAX576 QAX576
- Primary Outcome Measures
Name Time Method -To investigate the possibility that some IPF patients experience increased IL-13 production. Blood samples to be collected pre-dose and weekly after dosing. -To investigate the hypothesis that QAX576 will neutralize IL-13 in patients with IPF Week 1,2,3 and 4
- Secondary Outcome Measures
Name Time Method -To evaluate the changes in biomarkers in blood over time in patients with IPF. Serum samples will be obtained at pre-dose and 2 weeks post-dose. Week 3
Trial Locations
- Locations (1)
Novartis Investigative Site
🇺🇸Pittsburgh, Pennsylvania, United States