Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Study Overview
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Brief Summary
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This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.

Official Title
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Randomized, Double-blind, Placebo-controlled, Multiple-dose, Exploratory Proof of Concept Study to Assess the Safety, Tolerability, Efficacy, Pharmacodynamic (PD) and Pharmacokinetics of QAX576 in Patients With Rapidly Progressive IPF

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: QAX576
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: QAX576 10 mg/kg<br> | Drug: QAX576<br>* QAX576 10 mg/kg intravenous infusion<br>|
| Placebo Comparator: Arm 2: Placebo<br> | Drug: Placebo<br>* Placebo to QAX576 intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biological Therapy,, Interstitial Lung Disease, Usual Interstitial Pneumonia, Fibrosis,, Pulmonary Fibrosis,, Respiratory Disease,, Interstitial Lung Disease,, Therapeutic Uses,