Idiopathic Pulmonary Fibrosis
Conditions
Keywords
Interstitial Lung Disease, Usual Interstitial Pneumonia, Fibrosis,, Pulmonary Fibrosis,, Respiratory Disease,, Interstitial Lung Disease,, Biological Therapy,, Therapeutic Uses,
Brief summary
This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.
Interventions
DRUGQAX576
QAX576 10 mg/kg intravenous infusion
DRUGPlacebo
Placebo to QAX576 intravenous infusion
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Idiopathic Pulmonary Fibrosis (IPF), based on an appropriate clinical definition of IPF as detailed in the ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management Diagnosis must be confirmed by a diagnostic HRCT or surgical lung biopsy. * A 6-minute walk test (6MWT) distance ≥50 meters at Screening (use of supplemental oxygen allowed).
Exclusion criteria
* Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports tobacco use or has a urine cotinine levels in the range defined as 'smokers' per the local lab. * Lung residual volume \> 120% predicted at Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF | 1 year | — |
| Change in forced vital capacity (FVC) at 52 weeks as compared to baseline | 1 year | 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. |
| Safety and tolerability of QAX576. | 1 year | Measure safety and tolerability as assessed by reported AEs and effects on routine laboratory evaluations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exacerbation of IPF | 1 year | Measure: Incidence of exacerbation of IPF during the study |
| To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy | 1 year | — |
| Pharmacokinetics of QAX576 | 1 year | Measure concentrations of QAX576 and its metabolites in blood throughout the study |
| Progression of fibrosis | 1 year | Measure progression of fibrosis in the lungs as measured by Quantitative High Resolution Computerized Tomography (HRCT) |
| To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood | 1 year | — |
| Time to clinical worsening: | 1 year | 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 |
Countries
United Kingdom, United States
Outcome results
None listed