Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT01266135
Status:
TERMINATED
Last Update Posted:
2020-12-19
First Post:
2010-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D012120', 'term': 'Respiration Disorders'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'dispFirstSubmitDate': '2020-08-20', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2010-12-17', 'dispFirstSubmitQcDate': '2020-08-20', 'studyFirstSubmitQcDate': '2010-12-22', 'dispFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF', 'timeFrame': '1 year'}, {'measure': 'Change in forced vital capacity (FVC) at 52 weeks as compared to baseline', 'timeFrame': '1 year', '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.'}, {'measure': 'Safety and tolerability of QAX576.', 'timeFrame': '1 year', 'description': 'Measure safety and tolerability as assessed by reported AEs and effects on routine laboratory evaluations.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy', 'timeFrame': '1 year'}, {'measure': 'To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood', 'timeFrame': '1 year'}, {'measure': 'Time to clinical worsening:', 'timeFrame': '1 year', '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'}, {'measure': 'Exacerbation of IPF', 'timeFrame': '1 year', 'description': 'Measure: Incidence of exacerbation of IPF during the study'}, {'measure': 'Progression of fibrosis', 'timeFrame': '1 year', 'description': 'Measure progression of fibrosis in the lungs as measured by Quantitative High Resolution Computerized Tomography (HRCT)'}, {'measure': 'Pharmacokinetics of QAX576', 'timeFrame': '1 year', 'description': 'Measure concentrations of QAX576 and its metabolites in blood throughout the study'}]}, 'conditionsModule': {'keywords': ['Interstitial Lung Disease', 'Usual Interstitial Pneumonia', 'Fibrosis,', 'Pulmonary Fibrosis,', 'Respiratory Disease,', 'Interstitial Lung Disease,', 'Biological Therapy,', 'Therapeutic Uses,'], 'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=11844', 'label': 'Results for CQAX576A2203 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n* 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.\n* A 6-minute walk test (6MWT) distance ≥50 meters at Screening (use of supplemental oxygen allowed).\n\nExclusion criteria\n\n* 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.\n* Lung residual volume \\> 120% predicted at Screening."}, 'identificationModule': {'nctId': 'NCT01266135', 'briefTitle': 'Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CQAX576A2203'}, 'secondaryIdInfos': [{'id': '2010-020688-18'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: QAX576 10 mg/kg', 'interventionNames': ['Drug: QAX576']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2: Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'QAX576', 'type': 'DRUG', 'description': 'QAX576 10 mg/kg intravenous infusion', 'armGroupLabels': ['Arm 1: QAX576 10 mg/kg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to QAX576 intravenous infusion', 'armGroupLabels': ['Arm 2: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '15219', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'LE3 9QP', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'SW3 6PH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}