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 (Participant, 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:

Genetics Home Reference related topics: idiopathic pulmonary fibrosis

MedlinePlus related topics: Pulmonary Fibrosis

Genetic and Rare Diseases Information Center resources: Idiopathic Pulmonary Fibrosis

U.S. FDA Resources

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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 ]
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 Outcome 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


Enrollment:	40
Study Start Date:	December 2010
Study Completion Date:	April 2013
Primary Completion Date:	April 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


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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	Novartis Pharmaceuticals

More Information


Responsible Party:	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:	April 14, 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


Interstitial Lung Disease Usual Interstitial Pneumonia Fibrosis, Pulmonary Fibrosis,	Respiratory Disease, Interstitial Lung Disease, Biological Therapy, Therapeutic Uses,

Additional relevant MeSH terms:


Fibrosis Idiopathic Pulmonary Fibrosis Idiopathic Interstitial Pneumonias Pulmonary Fibrosis	Pathologic Processes Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 26, 2017