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

Idiopathic Pulmonary Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01266135
• Other study ID #: CQAX576A2203
• Secondary ID: 2010-020688-18
• Status: Terminated
• Phase: Phase 2
• Start date: December 2010
• Est. completion date: April 2013

Study information

• Verified date: April 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Novartis Investigative Site	Cambridge
United Kingdom	Novartis Investigative Site	Leicester
United Kingdom	Novartis Investigative Site	London
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Durham	North Carolina
United States	Novartis Investigative Site	Gainesville	Florida
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	Orlando	Florida
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF		1 year
Primary	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
Primary	Safety and tolerability of QAX576.	Measure safety and tolerability as assessed by reported AEs and effects on routine laboratory evaluations.	1 year
Secondary	To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy		1 year
Secondary	To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood		1 year
Secondary	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
Secondary	Exacerbation of IPF	Measure: Incidence of exacerbation of IPF during the study	1 year
Secondary	Progression of fibrosis	Measure progression of fibrosis in the lungs as measured by Quantitative High Resolution Computerized Tomography (HRCT)	1 year
Secondary	Pharmacokinetics of QAX576	Measure concentrations of QAX576 and its metabolites in blood throughout the study	1 year

External Links

•   Results for CQAX576A2203 from the Novartis Clinical Trials website