Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF) - Full Text View

Purpose

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

Condition	Intervention	Phase
Idiopathic Pulmonary Fibrosis	Drug: QAX576 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Interstitial Lung Diseases Pneumonia Pulmonary Fibrosis

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome 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 ] [ 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.

Secondary Outcome Measures:

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

Enrollment:	60
Study Start Date:	December 2010
Study Completion Date:	March 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1: QAX576 10 mg/kg	Drug: QAX576 QAX576 10 mg/kg intravenous infusion
Placebo Comparator: Arm 2: Placebo	Drug: Placebo Placebo to QAX576 intravenous infusion

Eligibility

Criteria

Inclusion Criteria:

Diagnosis of Idiopathic Pulmonary Fibrosis.
A 6-minute walk test (6MWT) distance ≥50 meters at Screening (use of supplemental oxygen allowed)

Exclusion Criteria:

Smokers
Forced Expiratory Volume in One Second/Forced Vital Capacity ratio < 0.6 at screening (pre or post-bronchodilator)
Lung residual volume > 120% predicted at Screening
High-Resolution Computed Tomography (HRCT) showing only ground glass infiltrates without other typical features of pulmonary fibrosis

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266135

Locations

United States, Florida
Novartis Investigative Site
Gainesville, Florida, United States, 32611
Novartis Investigative Site
Orlando, Florida, United States, 32803
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02115
United States, North Carolina
Novartis Investigative Site
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15219
United States, Tennessee
Novartis Investigative Site
Nashville, Tennessee, United States, 37203
United States, Texas
Novartis Investigative Site
San Antonio, Texas, United States, 78229
United Kingdom
Novartis Investigative Site
Cambridge, United Kingdom, CB2 2QQ
Novartis Investigative Site
Leicester, United Kingdom, LE3 9QP
Novartis Investigative Site
London, United Kingdom, SW3 6PH

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01266135 History of Changes
Other Study ID Numbers:	CQAX576A2203, 2010-020688-18
Study First Received:	December 17, 2010
Last Updated:	March 29, 2013
Health Authority:	United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

Interstitial Lung Disease
Usual Interstitial Pneumonia
Fibrosis,
Pulmonary Fibrosis,

Respiratory Disease,
Interstitial Lung Disease,
Biological Therapy,
Therapeutic Uses,

Additional relevant MeSH terms:

Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes

Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on May 23, 2013