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.

Study Overview

• Status: Terminated
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: QAX576; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 2: Placebo	Drug: Placebo; Placebo to QAX576 intravenous infusion
Experimental: Arm 1: QAX576 10 mg/kg	Drug: QAX576; QAX576 10 mg/kg intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF		1 year
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
Safety and tolerability of QAX576.	Measure safety and tolerability as assessed by reported AEs and effects on routine laboratory evaluations.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Exacerbation of IPF	Measure: Incidence of exacerbation of IPF during the study	1 year
Progression of fibrosis	Measure progression of fibrosis in the lungs as measured by Quantitative High Resolution Computerized Tomography (HRCT)	1 year
Pharmacokinetics of QAX576	Measure concentrations of QAX576 and its metabolites in blood throughout the study	1 year

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CQAX576A2203 from the Novartis Clinical Trials website

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: December 17, 2010
• First Submitted That Met QC Criteria: December 22, 2010
• First Posted (Estimate): December 24, 2010

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Interstitial Lung Disease; Fibrosis,; Usual Interstitial Pneumonia; Therapeutic Uses,; Pulmonary Fibrosis,; Respiratory Disease,; Interstitial Lung Disease,; Biological Therapy,
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: CQAX576A2203; 2010-020688-18