Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT04442269
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2020-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Investigating Treatment With Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED)
Sponsor:
Organization:
Raw JSON
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The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 19, 'seriousNumAtRisk': 27, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 29, 'seriousNumAtRisk': 35, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'COVID-19', 'stats': 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'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0558', 'groupId': 'OG000'}, {'value': '0.203', 'spread': '0.0482', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.201', 'ciLowerLimit': '0.0768', 'ciUpperLimit': '0.3256', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Week 24', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with available data for analysis in the statistical model'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of ABPA-related Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}], 'classes': [{'title': 'Adjusted Rate', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Negative Binomial Regression Model did not converge.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Negative Binomial Regression Model did not 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It is based on the treatment allocated as randomized'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Severe Respiratory Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}], 'classes': [{'title': 'Adjusted Rate', 'categories': [{'measurements': [{'value': '1.551', 'groupId': 'OG000'}, {'value': '0.695', 'groupId': 'OG001'}]}]}, {'title': 'Unadjusted Rate', 'categories': [{'measurements': [{'value': '0.943', 'groupId': 'OG000'}, {'value': '0.545', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Over the 24 to 52 Week Treatment Period', 'description': 'Defined as new onset of symptoms or clinical worsening of respiratory symptoms requiring systemic corticosteroid treatment for ≥3 consecutive days; for participants who are on maintenance systemic corticosteroids, at least double the dose of maintenance systemic corticosteroids for ≥3 consecutive days (with or without antibiotic therapy if indicated)\n\nAdjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years)', 'unitOfMeasure': 'Events per person year', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) includes all randomized participants. It is based on the treatment allocated as randomized'}, {'type': 'SECONDARY', 'title': 'Annualized Rate of Severe Respiratory Exacerbations Requiring Either Hospitalization or Observation for >24 Hours in an ED/Urgent Care Facility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}], 'classes': [{'title': 'Adjusted Rate', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Negative Binomial Regression Model did not converge.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Negative Binomial Regression Model did not converge.', 'groupId': 'OG001'}]}]}, {'title': 'Unadjusted Rate', 'categories': [{'measurements': [{'value': '0.041', 'groupId': 'OG000'}, {'value': '0.128', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Over the 24 to 52 Week Treatment Period', 'description': 'Annualized rate of severe respiratory exacerbations requiring either hospitalization or observation for \\>24 hours in an emergency department/urgent care facility (events per person-year)\n\nAdjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years)', 'unitOfMeasure': 'Events per person year', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) includes all randomized participants. It is based on the treatment allocated as randomized'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.10', 'spread': '1.102', 'groupId': 'OG000'}, {'value': '-1.24', 'spread': '1.081', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.878', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '1.208', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.87', 'spread': '1.233', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '1.359', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.84', 'spread': '1.183', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '1.241', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Over the 24 to 52 Week Treatment Period', 'description': 'ACQ is completed by patient to measure both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. The ACQ-5 score is the mean of the first 5 questions, between 0 (totally controlled) and 6 (severely uncontrolled). A higher score indicates lower asthma control. Participants with a score below 1.0 reflect adequately controlled asthma and participants with scores above 1.0 reflect inadequately controlled asthma. The optimal cut-point score of 1.50 should be used to be confident that a patient has inadequately controlled asthma.', 'unitOfMeasure': 'ACQ-5 Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest'}, {'type': 'SECONDARY', 'title': "Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.463', 'spread': '16.3993', 'groupId': 'OG000'}, {'value': '-17.956', 'spread': '14.6184', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.626', 'spread': '14.5412', 'groupId': 'OG000'}, {'value': '-23.079', 'spread': '15.9104', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.796', 'spread': '16.4257', 'groupId': 'OG000'}, {'value': '-20.178', 'spread': '15.5266', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.938', 'spread': '15.3127', 'groupId': 'OG000'}, {'value': '-25.309', 'spread': '20.1035', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Over the 24 to 52 Week Treatment Period', 'description': 'SGRQ will be completed by the patient to measure and quantify health status in adult participants with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL).', 'unitOfMeasure': 'SGRQ Total Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Reduction in the SGRQ Total Score of 4 Points or Greater From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '30.72', 'upperLimit': '69.28'}, {'value': '85.3', 'groupId': 'OG001', 'lowerLimit': '69.87', 'upperLimit': '93.55'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000', 'lowerLimit': '42.95', 'upperLimit': '80.27'}, {'value': '87.1', 'groupId': 'OG001', 'lowerLimit': '71.15', 'upperLimit': '94.87'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '36.55', 'upperLimit': '75.53'}, {'value': '86.2', 'groupId': 'OG001', 'lowerLimit': '69.44', 'upperLimit': '94.50'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000', 'lowerLimit': '46.01', 'upperLimit': '84.64'}, {'value': '89.3', 'groupId': 'OG001', 'lowerLimit': '72.80', 'upperLimit': '96.29'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 52 Weeks', 'description': 'SGRQ will be completed by the patient to measure and quantify health status in adult participants with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL).', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants must have both the baseline and at least one post-baseline measurement at the given post-baseline time point to be included in the calculation of the proportion at the given post-baseline time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total IgE in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.665', 'spread': '40.2236', 'groupId': 'OG000'}, {'value': '-47.245', 'spread': '19.4110', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.945', 'spread': '27.6767', 'groupId': 'OG000'}, {'value': '-57.752', 'spread': '18.0812', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.767', 'spread': '42.8914', 'groupId': 'OG000'}, {'value': '-62.175', 'spread': '17.0285', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Over the 24 to 52 Week Treatment Period', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in A Fumigatus-specific IgE in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.099', 'spread': '39.7612', 'groupId': 'OG000'}, {'value': '-39.859', 'spread': '25.3095', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.766', 'spread': '39.9041', 'groupId': 'OG000'}, {'value': '-45.654', 'spread': '26.7915', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.618', 'spread': '94.6306', 'groupId': 'OG000'}, {'value': '-49.126', 'spread': '30.6790', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Over the 24 to 52 Week Treatment Period', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.80', 'spread': '23.521', 'groupId': 'OG000'}, {'value': '-22.04', 'spread': '38.410', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.11', 'spread': '20.571', 'groupId': 'OG000'}, {'value': '-21.48', 'spread': '40.538', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.38', 'spread': '21.896', 'groupId': 'OG000'}, {'value': '-19.18', 'spread': '37.122', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.79', 'spread': '27.634', 'groupId': 'OG000'}, {'value': '-19.04', 'spread': '35.471', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Over the 24 to 52 Week Treatment Period', 'unitOfMeasure': 'ppb', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '44.069', 'groupId': 'OG000'}, {'value': '-29.91', 'spread': '32.527', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.80', 'spread': '44.053', 'groupId': 'OG000'}, {'value': '-24.56', 'spread': '43.975', 'groupId': 'OG001'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.43', 'spread': '54.887', 'groupId': 'OG000'}, {'value': '-19.83', 'spread': '48.308', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.55', 'spread': '56.506', 'groupId': 'OG000'}, {'value': '-20.35', 'spread': '48.100', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Over the 24 to 52 Week Treatment Period', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through the end of the 52 Week Treatment Period', 'unitOfMeasure': 'Participants with TEAEs', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set (SAF) includes all randomized participants who received any study drug; it is based on the treatment received'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Responses and Titer Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}], 'classes': [{'title': 'TE & TB Maximum Titer Category Low (<1,000)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'TE & TB Maximum Titer Category Moderate (1,000 to 10,000)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TE & TB Maximum Titer Category High (>10,000)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 64 Weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set (PKAS) includes all randomized participants who received any study drug and who had at least one non-missing drug concentration result following the first dose of study drug. The PKAS is based on the treatment received rather than as randomized.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Functional Dupilumab in Serum by Treatment Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.8', 'spread': '35.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.5', 'spread': '53.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.2', 'spread': '55.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '4.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 64 Weeks', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all randomized participants who received dupilumab and who had at least one non-missing dupilumab result following the first dose. The PKAS is based on the treatment received rather than as randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance'}, {'id': 'FG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Decision by the Investigator/Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Travel Limitations', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Matching dupilumab without active substance'}, {'id': 'BG001', 'title': 'Dupilumab 300 mg Q2W', 'description': 'Subcutaneous (SC) dose every two weeks (Q2W)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'spread': '14.38', 'groupId': 'BG000'}, {'value': '61.2', 'spread': '8.62', 'groupId': 'BG001'}, {'value': '59.4', 'spread': '11.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-24', 'size': 1041841, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-25T11:19', 'hasProtocol': True}, {'date': '2024-03-05', 'size': 802719, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-25T11:18', 'hasProtocol': False}]}}, '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': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2020-06-04', 'resultsFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2020-06-19', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-25', 'studyFirstPostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo', 'timeFrame': 'At Week 24'}], 'secondaryOutcomes': [{'measure': 'Annualized Rate of ABPA-related Exacerbations', 'timeFrame': 'Over the 24 to 52 Week Treatment Period', 'description': 'Defined as severe respiratory exacerbations that are associated with a doubling of serum total Immunoglobulin E (IgE) from the prior pre-exacerbation value.\n\nAdjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years)'}, {'measure': 'Annualized Rate of Severe Respiratory Exacerbations', 'timeFrame': 'Over the 24 to 52 Week Treatment Period', 'description': 'Defined as new onset of symptoms or clinical worsening of respiratory symptoms requiring systemic corticosteroid treatment for ≥3 consecutive days; for participants who are on maintenance systemic corticosteroids, at least double the dose of maintenance systemic corticosteroids for ≥3 consecutive days (with or without antibiotic therapy if indicated)\n\nAdjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years)'}, {'measure': 'Annualized Rate of Severe Respiratory Exacerbations Requiring Either Hospitalization or Observation for >24 Hours in an ED/Urgent Care Facility', 'timeFrame': 'Over the 24 to 52 Week Treatment Period', 'description': 'Annualized rate of severe respiratory exacerbations requiring either hospitalization or observation for \\>24 hours in an emergency department/urgent care facility (events per person-year)\n\nAdjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years)'}, {'measure': 'Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score', 'timeFrame': 'Over the 24 to 52 Week Treatment Period', 'description': 'ACQ is completed by patient to measure both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. The ACQ-5 score is the mean of the first 5 questions, between 0 (totally controlled) and 6 (severely uncontrolled). A higher score indicates lower asthma control. Participants with a score below 1.0 reflect adequately controlled asthma and participants with scores above 1.0 reflect inadequately controlled asthma. The optimal cut-point score of 1.50 should be used to be confident that a patient has inadequately controlled asthma.'}, {'measure': "Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score", 'timeFrame': 'Over the 24 to 52 Week Treatment Period', 'description': 'SGRQ will be completed by the patient to measure and quantify health status in adult participants with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL).'}, {'measure': 'Percentage of Participants Achieving a Reduction in the SGRQ Total Score of 4 Points or Greater From Baseline', 'timeFrame': 'Up to 52 Weeks', 'description': 'SGRQ will be completed by the patient to measure and quantify health status in adult participants with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL).'}, {'measure': 'Percent Change From Baseline in Total IgE in Serum', 'timeFrame': 'Over the 24 to 52 Week Treatment Period'}, {'measure': 'Percent Change From Baseline in A Fumigatus-specific IgE in Serum', 'timeFrame': 'Over the 24 to 52 Week Treatment Period'}, {'measure': 'Absolute Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)', 'timeFrame': 'Over the 24 to 52 Week Treatment Period'}, {'measure': 'Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)', 'timeFrame': 'Over the 24 to 52 Week Treatment Period'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Baseline', 'timeFrame': 'Through the end of the 52 Week Treatment Period'}, {'measure': 'Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Responses and Titer Over Time', 'timeFrame': 'Up to 64 Weeks'}, {'measure': 'Concentrations of Functional Dupilumab in Serum by Treatment Regimen', 'timeFrame': 'Up to 64 Weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Bronchopulmonary Aspergillosis']}, 'referencesModule': {'references': [{'pmid': '33027187', 'type': 'DERIVED', 'citation': 'Kao CC, Hanania NA, Parulekar AD. The impact of fungal allergic sensitization on asthma. Curr Opin Pulm Med. 2021 Jan;27(1):3-8. doi: 10.1097/MCP.0000000000000740.'}], 'seeAlsoLinks': [{'url': 'https://www.trialsummaries.com/', 'label': 'A Plain Language Summary is available on TrialSummaries.com'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the efficacy of dupilumab on lung function in participants with Allergic Bronchopulmonary Aspergillosis (ABPA).\n\nThe secondary objectives of the study are:\n\n* To evaluate the effects of dupilumab on exacerbations in participants with ABPA\n* To evaluate the effects of dupilumab on ABPA-related exacerbations\n* To evaluate the effects of dupilumab on hospitalization/emergency department (ED)/urgent care visits in participants with ABPA\n* To evaluate the effects of dupilumab on asthma control in participants with ABPA\n* To evaluate the effects of dupilumab on health-related quality of life (HRQoL) in participants with ABPA\n* To evaluate the effects of dupilumab on serum total immunoglobulin E (IgE) and Aspergillus-specific IgE concentrations\n* To evaluate the effects of dupilumab on Fractional exhaled Nitric Oxide (FeNO) levels\n* To evaluate safety and tolerability of dupilumab in participants with ABPA\n* To evaluate dupilumab concentrations in serum and the incidence of anti-dupilumab antibodies in participants with ABPA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Diagnosis of both ABPA and asthma\n* On a maintenance therapy for their asthma with controller medication which must include inhaled corticosteroids (ICS) and may include 1 or more additional controller medications including a long-acting beta agonist (LABA), leukotriene receptor antagonist (LTRA), and/or long-acting muscarinic receptor antagonist (LAMA), etc for at least 12 weeks, with a stable dose and regimen with no change in the dose or frequency of administration for at least 4 weeks prior to the screening visit and between the screening and baseline/randomization visits\n* For participants on OCS (oral corticosteroid): must be on a chronic stable dose (no change in the dose) of OCS of up to 10 mg/day (for participants taking daily corticosteroids) or up to 30 mg every alternate day (for participants taking alternate day corticosteroids) (prednisone/prednisolone or the equivalent) for at least 4 weeks prior to the screening visit and between the screening and the baseline/randomization visit\n* Must have experienced ≥1 severe respiratory exacerbation requiring treatment with systemic corticosteroids or hospitalization or treatment in ED/urgent care within 12 months prior to the screening visit or must be receiving chronic stable low-dose OCS per above criteria\n\nKey Exclusion Criteria:\n\n* Weight less than 30.0 kilograms\n* Current smoker or e-cigarette user, cessation of smoking or e-cigarette use within 6 months prior to randomization, or \\>=10 pack-years smoking history\n* Post-bronchodilator FEV1 \\<30% predicted normal at screening\n* Respiratory exacerbation requiring systemic corticosteroids within 4 weeks prior to screening and between screening and baseline visit (for patients on daily or alternate day OCS, exacerbation requiring at least double the maintenance dose of corticosteroids)\n* Upper or lower respiratory tract infection within the 4 weeks prior to screening (visit 1) or between the screening and randomization visits\n* Significant chronic pulmonary disease other than asthma complicated with ABPA (eg, physician-diagnosed bronchiectasis due to a condition other than ABPA; cystic fibrosis; sarcoidosis; interstitial lung disease not due to ABPA; chronic obstructive pulmonary disease \\[COPD\\] not due to ABPA; hypereosinophilic syndrome; etc), a diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts\n* Diagnosis or suspected diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) (also called Churg-Strauss Syndrome)\n\nNOTE: Other protocol defined inclusion / exclusion criteria applies.'}, 'identificationModule': {'nctId': 'NCT04442269', 'briefTitle': 'Investigating Treatment With Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis', 'orgStudyIdInfo': {'id': 'R668-ABPA-1923'}, 'secondaryIdInfos': [{'id': '2019-002619-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dupilumab', 'description': 'Loading subcutaneous (SC) dose on day 1, followed by SC dose, every two weeks (Q2W)', 'interventionNames': ['Drug: dupilumab']}, {'type': 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