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

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ClinicalTrials.gov Identifier: NCT01266135
Recruitment Status : Terminated
First Posted : December 24, 2010
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: QAX576 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : December 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF [ Time Frame: 1 year ]
  2. 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.

  3. 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 :
  1. To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy [ Time Frame: 1 year ]
  2. To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood [ Time Frame: 1 year ]
  3. 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

  4. Exacerbation of IPF [ Time Frame: 1 year ]
    Measure: Incidence of exacerbation of IPF during the study

  5. Progression of fibrosis [ Time Frame: 1 year ]
    Measure progression of fibrosis in the lungs as measured by Quantitative High Resolution Computerized Tomography (HRCT)

  6. Pharmacokinetics of QAX576 [ Time Frame: 1 year ]
    Measure concentrations of QAX576 and its metabolites in blood throughout the study


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266135


Locations
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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01266135    
Other Study ID Numbers: CQAX576A2203
2010-020688-18
First Posted: December 24, 2010    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: April 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:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases