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

Phase 2

Terminated

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: QAX576; Drug: Placebo

• Registration Number: NCT01266135
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-17
• Study First Submitted QC: 2010-12-22
• Study First Posted: 2010-12-24
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2015-04
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-28
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: QAX576 10 mg/kg	QAX576	-
Arm 2: Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in forced vital capacity (FVC) at 52 weeks as compared to baseline	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.
To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF	1 year
Safety and tolerability of QAX576.	1 year	Measure safety and tolerability as assessed by reported AEs and effects on routine laboratory evaluations.

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy	1 year
To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood	1 year
Pharmacokinetics of QAX576	1 year	Measure concentrations of QAX576 and its metabolites in blood throughout the study
Time to clinical worsening:	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	1 year	Measure: Incidence of exacerbation of IPF during the study
Progression of fibrosis	1 year	Measure progression of fibrosis in the lungs as measured by Quantitative High Resolution Computerized Tomography (HRCT)

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 London, United Kingdom