Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT04656418
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2020-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054179', 'term': 'Angioedemas, Hereditary'}], 'ancestors': [{'id': 'D000799', 'term': 'Angioedema'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000081208', 'term': 'Hereditary Complement Deficiency Diseases'}, {'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@cslbehring.com', 'phone': '610-878-4000', 'title': 'Study Director', 'organization': 'CSL Behring'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to 3 months after the last injection (approximately 8 months)', 'description': 'Safety analysis set included all the randomized participants who provided written informed consent, underwent study screening procedures and received at least 1 dose of the investigational product.', 'eventGroups': [{'id': 'EG000', 'title': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 17, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 12, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Hereditary angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time-Normalized Number of Hereditary Angioedema (HAE) Attacks Per Month During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'spread': '0.683', 'groupId': 'OG000'}, {'value': '2.01', 'spread': '1.341', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test (Hierarchical Testing H01) at alpha = 5%.', 'statisticalMethod': 'Two-sided Wilcoxon test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for differences'}], 'paramType': 'MEAN', 'timeFrame': 'First injection up to 6 months', 'description': 'Time-normalized number of HAE attacks per month during treatment was calculated per participant as: \\[number of HAE attacks / length of participant treatment in days\\] \\* 30.4375.', 'unitOfMeasure': 'number of HAE attacks per month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis."}, {'type': 'SECONDARY', 'title': 'Percentage Change in the Time-normalized Number of HAE Attacks Per Month During the Treatment Period Compared to the Run-in Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.'}], 'classes': [{'title': '6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.67', 'spread': '22.433', 'groupId': 'OG000'}, {'value': '20.21', 'spread': '42.661', 'groupId': 'OG001'}]}]}, {'title': 'First 3-months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.10', 'spread': '21.255', 'groupId': 'OG000'}, {'value': '18.89', 'spread': '53.837', 'groupId': 'OG001'}]}]}, {'title': 'Second 3-months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.12', 'spread': '25.624', 'groupId': 'OG000'}, {'value': '29.87', 'spread': '55.529', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test.', 'groupDescription': '6 Months of treatment', 'statisticalMethod': 'Two-sided Wilcoxon test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for differences'}], 'paramType': 'MEAN', 'timeFrame': '6 months, first 3-months and second 3-months of treatment period', 'description': 'Percentage change in the time-normalized number of HAE attacks was calculated within a participant as:\n\n100 \\* \\[1 - (time-normalized number of HAE attacks per month during treatment period / time-normalized number of HAE attacks per month during run-in period)\\]. Time-normalized number of HAE attacks per month during treatment period was calculated per participant as: \\[number of HAE attacks / length of participant treatment in days\\] \\* 30.4375.', 'unitOfMeasure': 'percentage change in HAE attacks/month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at the specified time point."}, {'type': 'SECONDARY', 'title': 'Time-Normalized Number of HAE Attacks Per Month Requiring On-Demand Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'Total number of HAE attacks', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.'}], 'classes': [{'title': '6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'Total number of HAE attacks', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.663', 'groupId': 'OG000'}, {'value': '1.86', 'spread': '1.412', 'groupId': 'OG001'}]}]}, {'title': 'First 3-months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'Total number of HAE attacks', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.748', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '1.378', 'groupId': 'OG001'}]}]}, {'title': 'Second 3-months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'units': 'Total number of HAE attacks', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.610', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '1.626', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.', 'groupDescription': '6 Months of treatment', 'statisticalMethod': 'Two-sided Wilcoxon test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for differences'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.', 'groupDescription': 'First 3-months of treatment', 'statisticalMethod': 'Two-sided Wilcoxon test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for differences'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.', 'groupDescription': 'Second 3-months of treatment', 'statisticalMethod': 'Two-sided Wilcoxon test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for differences'}], 'paramType': 'MEAN', 'timeFrame': '6 months, first 3-months and second 3-months of treatment period', 'description': 'Time-normalized number of HAE attacks per month requiring on-demand treatment was calculated per participant as: \\[number of HAE attacks requiring on-demand treatment / length of participant in days\\] \\* 30.4375.', 'unitOfMeasure': 'number of HAE attacks per month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Total number of HAE attacks', 'denomUnitsSelected': 'Total number of HAE attacks', 'populationDescription': "ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at the specified time point."}, {'type': 'SECONDARY', 'title': 'Time-Normalized Number of Moderate or Severe HAE Attacks Per Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'Total number of HAE attacks', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.'}], 'classes': [{'title': '6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'Total number of HAE attacks', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.296', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '1.166', 'groupId': 'OG001'}]}]}, {'title': 'First 3-months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'Total number of HAE attacks', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.305', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '1.091', 'groupId': 'OG001'}]}]}, {'title': 'Second 3-months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'units': 'Total number of HAE attacks', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.320', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '1.296', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.', 'groupDescription': '6 Months of treatment', 'statisticalMethod': 'Two-sided Wilcoxon test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for differences'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.', 'groupDescription': 'First 3-months of treatment', 'statisticalMethod': 'Two-sided Wilcoxon test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for differences'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.', 'groupDescription': 'Second 3-months of treatment', 'statisticalMethod': 'Two-sided Wilcoxon test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for differences'}], 'paramType': 'MEAN', 'timeFrame': '6 months, first 3-months and second 3-months of treatment period', 'description': 'Time-normalized number of moderate or severe HAE attacks per month during treatment period was calculated per participant as: \\[number of moderate or severe HAE attacks / length of participant treatment in days\\] \\* 30.4375.', 'unitOfMeasure': 'number of HAE attacks per month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Total number of HAE attacks', 'denomUnitsSelected': 'Total number of HAE attacks', 'populationDescription': "ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at the specified time point."}, {'type': 'SECONDARY', 'title': 'Time-normalized Number of HAE Attacks Per Month in the First 3-months and Second 3-months of Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.'}], 'classes': [{'title': 'First 3-months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.749', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '1.287', 'groupId': 'OG001'}]}]}, {'title': 'Second 3-months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.652', 'groupId': 'OG000'}, {'value': '1.86', 'spread': '1.603', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.', 'groupDescription': 'First 3-months of treatment', 'statisticalMethod': 'Two-sided Wilcoxon test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for differences'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.', 'groupDescription': 'Second 3-months of treatment', 'statisticalMethod': 'Two-sided Wilcoxon test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for differences'}], 'paramType': 'MEAN', 'timeFrame': 'First 3-months and second 3-months of treatment period', 'description': 'Time-normalized number of HAE attacks per month during treatment was calculated per participant as: \\[number of HAE attacks / length of participant treatment in days\\] \\* 30.4375.', 'unitOfMeasure': 'number of HAE attacks per month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at the specified time point."}, {'type': 'SECONDARY', 'title': 'Relative Difference in Means in the Time-Normalized Number of HAE Attacks Per Month Between CSL312 to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL312 and Placebo Comparison Group', 'description': 'CSL312: Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.\n\nPlacebo: Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.'}], 'classes': [{'title': '6 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-86.51', 'groupId': 'OG000', 'lowerLimit': '-95.68', 'upperLimit': '-57.84'}]}]}, {'title': 'First 3-months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-86.64', 'groupId': 'OG000', 'lowerLimit': '-95.87', 'upperLimit': '-56.76'}]}]}, {'title': 'Second 3-months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-85.01', 'groupId': 'OG000', 'lowerLimit': '-95.62', 'upperLimit': '-48.74'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test (Hierarchical testing H02) at alpha = 5%.', 'statisticalMethod': 'Two-sided Wilcoxon test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for differences'}], 'paramType': 'MEAN', 'timeFrame': '6 months, first 3-months and second 3-months of treatment period', 'description': 'Relative difference in means in the time-normalized number of HAE attacks per month CSL312 to Placebo was calculated as: 100 \\* \\[(mean time-normalized number of HAE attacks for CSL312 - mean time-normalized number of HAE attacks for placebo) / mean time-normalized number of HAE attacks for placebo\\]. Time-normalized number of HAE attacks per month during treatment was calculated per participant as: \\[number of HAE attacks / length of participant treatment in days\\] \\* 30.4375.', 'unitOfMeasure': 'number of HAE attacks per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who provided written informed consent and underwent study screening procedures. 'Overall number of participants analyzed' indicates number of participants with data available for outcome measure (OM) analysis. 'Number analyzed' indicates number of participants with data available for analysis at specified time point. As pre-specified in protocol and SAP, data for this OM was reported for participants of CSL312 and Placebo Comparison group."}, {'type': 'SECONDARY', 'title': "Percentage of Participants With a Response to Subject's Global Assessment of Response to Therapy (SGART)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '41.7', 'groupId': 'OG001'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}, {'value': '20.8', 'groupId': 'OG001'}]}]}, {'title': 'Excellent', 'categories': [{'measurements': [{'value': '65.8', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': "SGART is a self-assessment by the participant and measures the subject's overall treatment response to the investigational product using the following ratings: 0 (none: worse or no response at all, not acceptable), 1 (poor: very little response, not acceptable), 2 (fair: some response, acceptable but could be better), 3 (good: good response, acceptable), and 4 (excellent: excellent response, as good as can be imagined).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis."}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE), and AEs of Special Interest (AESI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AESI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 3 months after the last injection (approximately 8 months)', 'description': "AE is any untoward medical occurrence in a participant administered with an investigational product which does not necessarily have a causal relationship with treatment, can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product, whether or not considered related to product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. An AESI is an AE of scientific and medical concern specific to sponsor's product or program, for which ongoing monitoring and rapid communication by investigator to sponsor is appropriate.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all the randomized participants who provided written informed consent, underwent study screening procedures and received at least 1 dose of the investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CSL312-induced Anti-CSL312 Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all the randomized participants who provided written informed consent, underwent study screening procedures and received at least 1 dose of the investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments Reported as Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 3 months after the last injection (approximately 8 months)', 'description': 'Laboratory assessments included: Hematology, biochemistry, urinalysis, and coagulation parameters.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all the randomized participants who provided written informed consent, underwent study screening procedures and received at least 1 dose of the investigational product.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least One AE, SAE, and AESI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AESI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug up to 3 months after the last injection (approximately 8 months)', 'description': "AE is any untoward medical occurrence in a participant administered with an investigational product which does not necessarily have a causal relationship with treatment, can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product, whether or not considered related to product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. An AESI is an AE of scientific and medical concern specific to sponsor's product or program, for which ongoing monitoring and rapid communication by investigator to sponsor is appropriate.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all the randomized participants who provided written informed consent, underwent study screening procedures and received at least 1 dose of the investigational product. The percentage of participants are rounded off to the single decimal point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CSL312-induced Anti-CSL312 Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all the randomized participants who provided written informed consent, underwent study screening procedures and received at least 1 dose of the investigational product. The percentage of participants are rounded off to the single decimal point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinically Significant Abnormalities in Laboratory Assessments Reported as TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug up to 3 months after the last injection (approximately 8 months)', 'description': 'Laboratory assessments included: Hematology, biochemistry, urinalysis, and coagulation parameters.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all the randomized participants who provided written informed consent, underwent study screening procedures and received at least 1 dose of the investigational product. The percentage of participants are rounded off to the single decimal point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg subcutaneous (SC) injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Intention-to-treat (ITT) Analysis Set', 'comment': 'ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Safety Analysis Set', 'comment': 'Safety analysis set included all the randomized participants who provided written informed consent, underwent study screening procedures and received at least 1 dose of the investigational product.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study centers in Canada, Germany, Hungary, Israel, Japan, Netherlands, and the United States from 27 January 2021 to 07 June 2022.', 'preAssignmentDetails': 'A total of 80 participants were screened, of which 64 participants were randomized and received the loading dose in the treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg SC injections, once monthly from Months 2 to 6.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'spread': '17.45', 'groupId': 'BG000'}, {'value': '37.8', 'spread': '12.80', 'groupId': 'BG001'}, {'value': '41.2', 'spread': '15.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-08', 'size': 12680637, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-06T20:02', 'hasProtocol': True}, {'date': '2021-04-21', 'size': 7662141, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-06T20:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2020-12-01', 'resultsFirstSubmitDate': '2023-06-07', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-07', 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-Normalized Number of Hereditary Angioedema (HAE) Attacks Per Month During Treatment Period', 'timeFrame': 'First injection up to 6 months', 'description': 'Time-normalized number of HAE attacks per month during treatment was calculated per participant as: \\[number of HAE attacks / length of participant treatment in days\\] \\* 30.4375.'}], 'secondaryOutcomes': [{'measure': 'Percentage Change in the Time-normalized Number of HAE Attacks Per Month During the Treatment Period Compared to the Run-in Period', 'timeFrame': '6 months, first 3-months and second 3-months of treatment period', 'description': 'Percentage change in the time-normalized number of HAE attacks was calculated within a participant as:\n\n100 \\* \\[1 - (time-normalized number of HAE attacks per month during treatment period / time-normalized number of HAE attacks per month during run-in period)\\]. Time-normalized number of HAE attacks per month during treatment period was calculated per participant as: \\[number of HAE attacks / length of participant treatment in days\\] \\* 30.4375.'}, {'measure': 'Time-Normalized Number of HAE Attacks Per Month Requiring On-Demand Treatment', 'timeFrame': '6 months, first 3-months and second 3-months of treatment period', 'description': 'Time-normalized number of HAE attacks per month requiring on-demand treatment was calculated per participant as: \\[number of HAE attacks requiring on-demand treatment / length of participant in days\\] \\* 30.4375.'}, {'measure': 'Time-Normalized Number of Moderate or Severe HAE Attacks Per Month', 'timeFrame': '6 months, first 3-months and second 3-months of treatment period', 'description': 'Time-normalized number of moderate or severe HAE attacks per month during treatment period was calculated per participant as: \\[number of moderate or severe HAE attacks / length of participant treatment in days\\] \\* 30.4375.'}, {'measure': 'Time-normalized Number of HAE Attacks Per Month in the First 3-months and Second 3-months of Treatment Period', 'timeFrame': 'First 3-months and second 3-months of treatment period', 'description': 'Time-normalized number of HAE attacks per month during treatment was calculated per participant as: \\[number of HAE attacks / length of participant treatment in days\\] \\* 30.4375.'}, {'measure': 'Relative Difference in Means in the Time-Normalized Number of HAE Attacks Per Month Between CSL312 to Placebo', 'timeFrame': '6 months, first 3-months and second 3-months of treatment period', 'description': 'Relative difference in means in the time-normalized number of HAE attacks per month CSL312 to Placebo was calculated as: 100 \\* \\[(mean time-normalized number of HAE attacks for CSL312 - mean time-normalized number of HAE attacks for placebo) / mean time-normalized number of HAE attacks for placebo\\]. Time-normalized number of HAE attacks per month during treatment was calculated per participant as: \\[number of HAE attacks / length of participant treatment in days\\] \\* 30.4375.'}, {'measure': "Percentage of Participants With a Response to Subject's Global Assessment of Response to Therapy (SGART)", 'timeFrame': 'Up to 6 months', 'description': "SGART is a self-assessment by the participant and measures the subject's overall treatment response to the investigational product using the following ratings: 0 (none: worse or no response at all, not acceptable), 1 (poor: very little response, not acceptable), 2 (fair: some response, acceptable but could be better), 3 (good: good response, acceptable), and 4 (excellent: excellent response, as good as can be imagined)."}, {'measure': 'Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE), and AEs of Special Interest (AESI)', 'timeFrame': 'From first dose of study drug up to 3 months after the last injection (approximately 8 months)', 'description': "AE is any untoward medical occurrence in a participant administered with an investigational product which does not necessarily have a causal relationship with treatment, can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product, whether or not considered related to product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. An AESI is an AE of scientific and medical concern specific to sponsor's product or program, for which ongoing monitoring and rapid communication by investigator to sponsor is appropriate."}, {'measure': 'Number of Participants With CSL312-induced Anti-CSL312 Antibodies', 'timeFrame': 'Up to 8 months'}, {'measure': 'Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments Reported as Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose of study drug up to 3 months after the last injection (approximately 8 months)', 'description': 'Laboratory assessments included: Hematology, biochemistry, urinalysis, and coagulation parameters.'}, {'measure': 'Percentage of Participants With at Least One AE, SAE, and AESI', 'timeFrame': 'From first dose of study drug up to 3 months after the last injection (approximately 8 months)', 'description': "AE is any untoward medical occurrence in a participant administered with an investigational product which does not necessarily have a causal relationship with treatment, can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product, whether or not considered related to product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. An AESI is an AE of scientific and medical concern specific to sponsor's product or program, for which ongoing monitoring and rapid communication by investigator to sponsor is appropriate."}, {'measure': 'Percentage of Participants With CSL312-induced Anti-CSL312 Antibodies', 'timeFrame': 'Up to 6 months'}, {'measure': 'Percentage of Participants With Clinically Significant Abnormalities in Laboratory Assessments Reported as TEAEs', 'timeFrame': 'From first dose of study drug up to 3 months after the last injection (approximately 8 months)', 'description': 'Laboratory assessments included: Hematology, biochemistry, urinalysis, and coagulation parameters.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hereditary Angioedema']}, 'referencesModule': {'references': [{'pmid': '36868261', 'type': 'DERIVED', 'citation': 'Craig TJ, Reshef A, Li HH, Jacobs JS, Bernstein JA, Farkas H, Yang WH, Stroes ESG, Ohsawa I, Tachdjian R, Manning ME, Lumry WR, Saguer IM, Aygoren-Pursun E, Ritchie B, Sussman GL, Anderson J, Kawahata K, Suzuki Y, Staubach P, Treudler R, Feuersenger H, Glassman F, Jacobs I, Magerl M. Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Apr 1;401(10382):1079-1090. doi: 10.1016/S0140-6736(23)00350-1. Epub 2023 Feb 28.'}, {'pmid': '36326435', 'type': 'DERIVED', 'citation': 'Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥ 12 years of age; diagnosed with clinically confirmed C1-INH hereditary angioedema; experience ≥ 3 attacks during the 3 months before screening.\n\nNote: For subjects taking any prophylactic HAE therapy during the 3 months before Screening, ≥ 3 HAE attacks may be documented over 3 consecutive months before commencing the prophylactic therapy.\n\nExclusion Criteria:\n\n* Concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticarial or hereditary angioedema type 3'}, 'identificationModule': {'nctId': 'NCT04656418', 'briefTitle': 'CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': 'A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema', 'orgStudyIdInfo': {'id': 'CSL312_3001'}, 'secondaryIdInfos': [{'id': '2020-000570-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CSL312', 'description': 'Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg subcutaneous (SC) injections, once monthly from Months 2 to 6.', 'interventionNames': ['Biological: CSL312']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CSL312', 'type': 'BIOLOGICAL', 'otherNames': ['Factor XIIa inhibitor monoclonal antibody', 'garadacimab'], 'description': 'Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody', 'armGroupLabels': ['CSL312']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Buffer without active ingredient', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Center of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Medical Research of Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Raffi Tachdjian MD, Inc.', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Allergy and Asthma Clinical Research', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Institute of Asthma and Allergy', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '45231', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bernstein Clinical Research Center LLC', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania State University', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'AARA Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta - Research Transition Facility', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'K1H 1E4', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Allergy Research Corp', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M3B 3S6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Gordon Sussman Clinical Research Inc.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G1V 4W2', 'city': 'Québec', 'country': 'Canada', 'facility': 'Clinique specialisee en allergie de la Capitale', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt Goethe-Universität', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'CRC Clinical Research / Hautklinik und Poliklinik der Universitätsklinik Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '64546', 'city': 'Mörfelden-Walldorf', 'country': 'Germany', 'facility': 'HZRM Hämophilie Zentrum Rhein Main GmbH', 'geoPoint': {'lat': 49.99472, 'lon': 8.58361}}, {'zip': '1088', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '7830604', 'city': 'Ashkelon', 'country': 'Israel', 'facility': 'Barzilai University Medical Center', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}, {'zip': '734-8551', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima University Hospital', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': "'650-0017", 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kobe University Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '216-8511', 'city': 'Kawasaki-shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'St.Marianna University School of Medicine Hospital'}, {'zip': '350-8550', 'city': 'Saitama', 'state': 'Kawagoe-shi', 'country': 'Japan', 'facility': 'Saitama Medical Center', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': "'849-8501", 'city': 'Saga', 'state': 'Saga-shi', 'country': 'Japan', 'facility': 'Saga University Hospital', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'zip': '425-0088', 'city': 'Yaizu-shi', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Koga Community Hospital'}, {'zip': '113-8431', 'city': 'Bunkyo', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Juntendo University Hospital'}, {'zip': '340-0041', 'city': 'Saitama', 'country': 'Japan', 'facility': 'Saiyu Soka Hospital', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam UMC, Location AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CSL Behring LLC'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.', 'ipdSharing': 'YES', 'description': 'CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.\n\nApplicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.\n\nIf the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.', 'accessCriteria': "Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.\n\nAn IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.\n\nThe requesting party must execute an appropriate data sharing agreement before IPD will be made available."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Behring', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}