This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Novartis Investigative Site
Gainesville, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Boston, Massachusetts, United States
To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF
Time frame: 1 year
Change in forced vital capacity (FVC) at 52 weeks as compared to baseline
Measure: FVC was measured using a spirometer according to American Thoracic Society / European Respiratory Society guidelines at screening and week 52 of the treatment period.
Time frame: 1 year
Safety and tolerability of QAX576.
Measure safety and tolerability as assessed by reported AEs and effects on routine laboratory evaluations.
Time frame: 1 year
To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy
Time frame: 1 year
To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood
Time frame: 1 year
Time to clinical worsening:
Measure: Time to clinical worsening defined as fall in FVC or Diffusing Capacity of the lung for Carbon Monoxide (DLco), lung transplant or lung disease (IPF)-related death
Time frame: 1 year
Exacerbation of IPF
Measure: Incidence of exacerbation of IPF during the study
Time frame: 1 year
Progression of fibrosis
Measure progression of fibrosis in the lungs as measured by Quantitative High Resolution Computerized Tomography (HRCT)
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Novartis Investigative Site
Durham, North Carolina, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
San Antonio, Texas, United States
Novartis Investigative Site
Cambridge, United Kingdom
Novartis Investigative Site
Leicester, United Kingdom
Novartis Investigative Site
London, United Kingdom
Time frame: 1 year
Pharmacokinetics of QAX576
Measure concentrations of QAX576 and its metabolites in blood throughout the study
Time frame: 1 year