Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-01 @ 1:35 PM
Study NCT ID:
NCT01479595
Status:
COMPLETED
Last Update Posted:
2016-08-01
First Post:
2011-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'QBX258', 'description': 'Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.', 'otherNumAtRisk': 44, 'otherNumAffected': 13, 'seriousNumAtRisk': 44, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.', 'otherNumAtRisk': 21, 'otherNumAffected': 7, 'seriousNumAtRisk': 21, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'ABORTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'LARYNGEAL OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Asthma Control Questionnaire (ACQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBX258', 'description': 'Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.513', 'spread': '0.0970', 'groupId': 'OG000'}, {'value': '0.001', 'spread': '0.1487', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.514', 'ciLowerLimit': '-0.811', 'ciUpperLimit': '-0.217', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The ACQ consists of 7 questions assessing symptoms, rescue medication use and lung function. Except for lung function (FEV1), each question was scored on a 7-point scale where 0 = no impairment and 6 = maximum impairment. Scores ranged between 0 totally controlled to 6 (severely uncontrolled). Participants with a score below 1.0 are considered to have adequately controlled asthma. Participants with a score above 1.0 were considered not to be well controlled. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBX258', 'description': 'Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.076', 'spread': '0.0528', 'groupId': 'OG000'}, {'value': '0.050', 'spread': '0.0770', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'FEV1 was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Asthma Quality of Life Questionnaire (AQLQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBX258', 'description': 'Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.580', 'spread': '0.1294', 'groupId': 'OG000'}, {'value': '0.468', 'spread': '0.1878', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains: symptoms, emotions., exposure to environmental stimuli and activity limitation.\n\nPatients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The scale ranges from 1 to 7. The overall AQLQ score was the mean response to all 32 questions. Higher scores represent better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Morning and Evening Peak Expiratory Flow (PEF) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBX258', 'description': 'Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.'}], 'timeFrame': 'Baseline and 12 weeks', 'description': 'Morning and evening PEFs were recorded on an electronic diary (e-diary). PEF was assessed twice daily approximately 12 hours apart and the measurements were recorded in the e-diary.', 'reportingStatus': 'POSTED', 'populationDescription': 'No analysis was performed on the collected data with the eDiary device due to overall poor data quality (values were obtained that were not physiologically possible) and high variability. Therefore, there is no data to present for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Maximum Expiratory Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBX258', 'description': 'Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.099', 'spread': '0.4270', 'groupId': 'OG000'}, {'value': '0.025', 'spread': '0.3000', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Maximum expiratory flow was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.', 'unitOfMeasure': 'L/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBX258', 'description': 'Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Anti-QAX576 and anti-VAK694 antibodies in serum were analyzed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the QAX576 Analyte', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QBX258', 'description': 'Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.'}], 'classes': [{'title': 'Q576R SNP stratum: QQ (n=21)', 'categories': [{'measurements': [{'value': '169000', 'spread': '47000', 'groupId': 'OG000'}]}]}, {'title': 'Q576R SNP stratum: RR/QR (n=19)', 'categories': [{'measurements': [{'value': '184000', 'spread': '85000', 'groupId': 'OG000'}]}]}, {'title': 'QBX258 (n=40)', 'categories': [{'measurements': [{'value': '176000', 'spread': '67300', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183', 'description': 'Blood samples were obtained to measure Cmax,ss.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the VAK694 Analyte', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QBX258', 'description': 'Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.'}], 'classes': [{'title': 'Q576R SNP stratum: QQ (n=21)', 'categories': [{'measurements': [{'value': '56.7', 'spread': '8.90', 'groupId': 'OG000'}]}]}, {'title': 'Q576R SNP stratum: RR/QR (n=19)', 'categories': [{'measurements': [{'value': '58.6', 'spread': '14.9', 'groupId': 'OG000'}]}]}, {'title': 'QBX258 (n=40)', 'categories': [{'measurements': [{'value': '57.6', 'spread': '12.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183', 'description': 'Blood samples were obtained to measure Cmax,ss.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the QAX576 Analyte', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QBX258', 'description': 'Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.'}], 'classes': [{'title': 'Q576R SNP stratum: QQ (n=21)', 'categories': [{'measurements': [{'value': '37500', 'spread': '11900', 'groupId': 'OG000'}]}]}, {'title': 'Q576R SNP stratum: RR/QR (n=19)', 'categories': [{'measurements': [{'value': '32200', 'spread': '9930', 'groupId': 'OG000'}]}]}, {'title': 'QBX258 (n=40)', 'categories': [{'measurements': [{'value': '35000', 'spread': '11200', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183', 'description': 'Blood samples were obtained to measure Cmin,ss.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the VAK694 Analyte', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QBX258', 'description': 'Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.'}], 'classes': [{'title': 'Q576R SNP stratum: QQ (n=21)', 'categories': [{'measurements': [{'value': '10.7', 'spread': '2.69', 'groupId': 'OG000'}]}]}, {'title': 'Q576R SNP stratum: RR/QR (n=19)', 'categories': [{'measurements': [{'value': '9.83', 'spread': '2.94', 'groupId': 'OG000'}]}]}, {'title': 'QBX258 (n=40)', 'categories': [{'measurements': [{'value': '10.3', 'spread': '2.81', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183', 'description': 'Blood samples were obtained to measure Cmin,ss.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QBX258', 'description': 'Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.67', 'spread': '3.580', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '5.393', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 12 weeks', 'description': 'FeNO was assessed as a measure of airway inflammation. An FeNO machine was used to obtain the FeNO measurements. FeNO measurements were obtained prior to the spirometry assessments.', 'unitOfMeasure': 'parts per billion (ppb)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'QBX258', 'description': 'Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'PK Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Per Protocol Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were assigned to either QBX258 or placebo in a 2:1 ratio. Randomization was done by stratification of Q576R.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'QBX258', 'description': 'Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'spread': '11.71', 'groupId': 'BG000'}, {'value': '42.8', 'spread': '13.54', 'groupId': 'BG001'}, {'value': '42.6', 'spread': '12.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-20', 'studyFirstSubmitDate': '2011-11-22', 'resultsFirstSubmitDate': '2016-02-23', 'studyFirstSubmitQcDate': '2011-11-23', 'lastUpdatePostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-20', 'studyFirstPostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Asthma Control Questionnaire (ACQ) Score', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The ACQ consists of 7 questions assessing symptoms, rescue medication use and lung function. Except for lung function (FEV1), each question was scored on a 7-point scale where 0 = no impairment and 6 = maximum impairment. Scores ranged between 0 totally controlled to 6 (severely uncontrolled). Participants with a score below 1.0 are considered to have adequately controlled asthma. Participants with a score above 1.0 were considered not to be well controlled. A negative change from baseline indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Change in Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'FEV1 was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.'}, {'measure': 'Change in Asthma Quality of Life Questionnaire (AQLQ) Score', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains: symptoms, emotions., exposure to environmental stimuli and activity limitation.\n\nPatients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The scale ranges from 1 to 7. The overall AQLQ score was the mean response to all 32 questions. Higher scores represent better outcomes.'}, {'measure': 'Morning and Evening Peak Expiratory Flow (PEF) Rate', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Morning and evening PEFs were recorded on an electronic diary (e-diary). PEF was assessed twice daily approximately 12 hours apart and the measurements were recorded in the e-diary.'}, {'measure': 'Change From Baseline in Maximum Expiratory Flow', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Maximum expiratory flow was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.'}, {'measure': 'Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies', 'timeFrame': '12 weeks', 'description': 'Anti-QAX576 and anti-VAK694 antibodies in serum were analyzed.'}, {'measure': 'Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the QAX576 Analyte', 'timeFrame': 'days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183', 'description': 'Blood samples were obtained to measure Cmax,ss.'}, {'measure': 'Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the VAK694 Analyte', 'timeFrame': 'days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183', 'description': 'Blood samples were obtained to measure Cmax,ss.'}, {'measure': 'Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the QAX576 Analyte', 'timeFrame': 'days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183', 'description': 'Blood samples were obtained to measure Cmin,ss.'}, {'measure': 'Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the VAK694 Analyte', 'timeFrame': 'days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183', 'description': 'Blood samples were obtained to measure Cmin,ss.'}, {'measure': 'Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)', 'timeFrame': 'baseline, 12 weeks', 'description': 'FeNO was assessed as a measure of airway inflammation. An FeNO machine was used to obtain the FeNO measurements. FeNO measurements were obtained prior to the spirometry assessments.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Interleukin', 'QBX258', 'QAX576', 'VAK694'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with atopic asthma \\>1 year duration diagnosed according to the GINA guidelines.\n* Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 39 kg/m2.\n* Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of \\> 1.5.\n* FEV1 40 to 90% of predicted.\n\nExclusion Criteria:\n\n* Diagnosed with COPD as defined by the GOLD guidelines\n* Subjects who have had a respiratory tract infection within 4 weeks prior to screening.\n* Women of child-bearing potential must use highly effective methods of contraception during dosing and for at least 18 weeks after last study drug administration'}, 'identificationModule': {'nctId': 'NCT01479595', 'briefTitle': 'A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized Double-blind Multiple-dose Placebo-controlled Trial to Establish the Efficacy of QBX258 (Combination of VAK694 and QAX576) in Asthma That is Inadequately Controlled With Inhaled Corticosteroids and Long Acting Beta Agonists', 'orgStudyIdInfo': {'id': 'CQBX258X2201'}, 'secondaryIdInfos': [{'id': '2011-003066-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QBX258', 'description': 'Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.', 'interventionNames': ['Drug: QBX258']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'QBX258', 'type': 'DRUG', 'description': 'QBX258 infusion, a combination of VAK694 and QAX576, was supplied to the Investigator as open label bulk medication. The planned dose of VAK694 (lyophilisate in vial, 150 mg/vial), was 3 mg/kg. The planned dose of QAX576 (lyophilisate in vial, 150 mg/vial), was 6 mg/kg.', 'armGroupLabels': ['QBX258']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The placebo infusion was an equal volume of 5% dextrose for infusion and was provided by the clinical site.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '90274', 'city': 'Rolling Hills Estates', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.78779, 'lon': -118.35813}}, {'zip': '91108', 'city': 'San Marino', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.1214, 'lon': -118.10646}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55402', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97504-8741', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '65187', 'city': 'Wiesbaden', 'state': 'Germany', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '60596', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': 'SE11YR', 'city': 'London', 'state': 'United Kingdom', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M23 9QZ', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}, {'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}