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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020688-18 |
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This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: QAX576 10 mg/kg | Experimental |
| |
| Arm 2: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QAX576 | Drug | QAX576 10 mg/kg intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 1 year |
| Safety and tolerability of QAX576. | Measure safety and tolerability as assessed by reported AEs and effects on routine laboratory evaluations. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy | 1 year | |
| To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood | 1 year |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Gainesville | Florida | 32611 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CQAX576A2203 from the Novartis Clinical Trials website | View source |
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| Placebo |
| Drug |
Placebo to QAX576 intravenous infusion |
|
| 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 | 1 year |
| Exacerbation of IPF | Measure: Incidence of exacerbation of IPF during the study | 1 year |
| Progression of fibrosis | Measure progression of fibrosis in the lungs as measured by Quantitative High Resolution Computerized Tomography (HRCT) | 1 year |
| Pharmacokinetics of QAX576 | Measure concentrations of QAX576 and its metabolites in blood throughout the study | 1 year |
| Orlando |
| Florida |
| 32803 |
| United States |
| Novartis Investigative Site | Boston | Massachusetts | 02115 | United States |
| Novartis Investigative Site | Durham | North Carolina | 27710 | United States |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15219 | United States |
| Novartis Investigative Site | Nashville | Tennessee | 37203 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78229 | United States |
| Novartis Investigative Site | Cambridge | CB2 2QQ | United Kingdom |
| Novartis Investigative Site | Leicester | LE3 9QP | United Kingdom |
| Novartis Investigative Site | London | SW3 6PH | United Kingdom |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D005355 | Fibrosis |
| D011658 | Pulmonary Fibrosis |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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