Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
QAX576
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Interstitial Lung Disease, Usual Interstitial Pneumonia, Fibrosis,, Pulmonary Fibrosis,, Respiratory Disease,, Interstitial Lung Disease,, Biological Therapy,, Therapeutic Uses,
Eligibility 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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1: QAX576 10 mg/kg
Arm 2: Placebo
Arm Description
Outcomes
Primary Outcome Measures
To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF
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.
Safety and tolerability of QAX576.
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
To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood
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
Exacerbation of IPF
Measure: Incidence of exacerbation of IPF during the study
Progression of fibrosis
Measure progression of fibrosis in the lungs as measured by Quantitative High Resolution Computerized Tomography (HRCT)
Pharmacokinetics of QAX576
Measure concentrations of QAX576 and its metabolites in blood throughout the study
Full Information
NCT ID
NCT01266135
First Posted
December 17, 2010
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01266135
Brief Title
Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Interstitial Lung Disease, Usual Interstitial Pneumonia, Fibrosis,, Pulmonary Fibrosis,, Respiratory Disease,, Interstitial Lung Disease,, Biological Therapy,, Therapeutic Uses,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: QAX576 10 mg/kg
Arm Type
Experimental
Arm Title
Arm 2: Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
QAX576
Intervention Description
QAX576 10 mg/kg intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to QAX576 intravenous infusion
Primary Outcome Measure Information:
Title
To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF
Time Frame
1 year
Title
Change in forced vital capacity (FVC) at 52 weeks as compared to baseline
Description
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.
Time Frame
1 year
Title
Safety and tolerability of QAX576.
Description
Measure safety and tolerability as assessed by reported AEs and effects on routine laboratory evaluations.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy
Time Frame
1 year
Title
To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood
Time Frame
1 year
Title
Time to clinical worsening:
Description
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
Time Frame
1 year
Title
Exacerbation of IPF
Description
Measure: Incidence of exacerbation of IPF during the study
Time Frame
1 year
Title
Progression of fibrosis
Description
Measure progression of fibrosis in the lungs as measured by Quantitative High Resolution Computerized Tomography (HRCT)
Time Frame
1 year
Title
Pharmacokinetics of QAX576
Description
Measure concentrations of QAX576 and its metabolites in blood throughout the study
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Novartis Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Novartis Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Novartis Investigative Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Novartis Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Novartis Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Novartis Investigative Site
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SW3 6PH
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=11844
Description
Results for CQAX576A2203 from the Novartis Clinical Trials website
Learn more about this trial
Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
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