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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2013

Interventions

  • Drug: QAX576
    • QAX576 10 mg/kg intravenous infusion
  • Drug: Placebo
    • Placebo to QAX576 intravenous infusion

Arms, Groups and Cohorts

  • Experimental: Arm 1: QAX576 10 mg/kg
  • Placebo Comparator: Arm 2: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: 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.
    • Time Frame: 1 year
    • Measure safety and tolerability as assessed by reported AEs and effects on routine laboratory evaluations.

Secondary Measures

  • 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:
    • Time Frame: 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
  • Exacerbation of IPF
    • Time Frame: 1 year
    • Measure: Incidence of exacerbation of IPF during the study
  • Progression of fibrosis
    • Time Frame: 1 year
    • Measure progression of fibrosis in the lungs as measured by Quantitative High Resolution Computerized Tomography (HRCT)
  • Pharmacokinetics of QAX576
    • Time Frame: 1 year
    • Measure concentrations of QAX576 and its metabolites in blood throughout the study

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

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