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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01266135
First received: December 17, 2010
Last updated: April 2, 2014
Last verified: April 2014

December 17, 2010
April 2, 2014
December 2010
April 2013   (final data collection date for primary outcome measure)
  • To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Change in forced vital capacity (FVC) at 52 weeks as compared to baseline [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Measure safety and tolerability as assessed by reported AEs and effects on routine laboratory evaluations.
To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01266135 on ClinicalTrials.gov Archive Site
  • To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Time to clinical worsening: [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Measure: Incidence of exacerbation of IPF during the study
  • Progression of fibrosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measure progression of fibrosis in the lungs as measured by Quantitative High Resolution Computerized Tomography (HRCT)
  • Pharmacokinetics of QAX576 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measure concentrations of QAX576 and its metabolites in blood throughout the study
  • To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
  • Drug: QAX576
    QAX576 10 mg/kg intravenous infusion
  • Drug: Placebo
    Placebo to QAX576 intravenous infusion
  • Experimental: Arm 1: QAX576 10 mg/kg
    Intervention: Drug: QAX576
  • Placebo Comparator: Arm 2: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT01266135
CQAX576A2203, 2010-020688-18
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP