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

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

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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 |
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.

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
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 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
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 |
Interstitial Lung Disease Usual Interstitial Pneumonia Fibrosis, Pulmonary Fibrosis, |
Respiratory Disease, Interstitial Lung Disease, Biological Therapy, Therapeutic Uses, |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis |
Pathologic Processes Lung Diseases Respiratory Tract Diseases |