Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-01 @ 11:41 PM
Study NCT ID:
NCT03827018
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2019-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
KPL-301 for Subjects With Giant Cell Arteritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013700', 'term': 'Giant Cell Arteritis'}], 'ancestors': [{'id': 'D020293', 'term': 'Vasculitis, Central Nervous System'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001167', 'term': 'Arteritis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C561644', 'term': 'mavrilimumab'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'studyinfo@kiniksa.com', 'phone': '1-781-431-9100', 'title': 'Clinical Operations Study Director', 'organization': 'Kiniksa Pharmaceuticals (UK), Ltd. c/o Kiniksa Pharmaceuticals Corp.'}, 'certainAgreement': {'otherDetails': 'Sponsor has the sole and exclusive right to publish information obtained from the trial. PI has no right to publish. PI may be invited to publish.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-Cause Mortality: From signing of informed consent (up to 6 weeks prior to Baseline) through Final Safety Follow-up / Week 38 Adverse Events: from first dose of study drug through Final Safety Follow-up / Week 38', 'eventGroups': [{'id': 'EG000', 'title': 'Mavrilimumab', 'description': 'Participants randomized to mavrilimumab receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 33, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants randomized to placebo receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 25, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Carbon monoxide diffusing capacity decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Hypertrophic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Flare by Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mavrilimumab', 'description': 'Participants randomized to mavrilimumab receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to placebo receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable per Kaplan-Meier method (insufficient number of subjects with events)', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '25.1', 'comment': 'Not estimable per Kaplan-Meier method (insufficient number of subjects with events)', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0263', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.92', 'pValueComment': 'Comparison of KPL-301 and placebo with respect to time to flare calculated by using a log-rank test stratified by randomization strata.', 'estimateComment': '95% confidence interval was calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 26', 'description': 'Time to flare by Week 26 was defined as time from randomization to the date of first flare occurring within the 26-week period, as assessed by independent adjudication. Kaplan-Meier method used to estimate the survival functions for each treatment arm.\n\nFlare/relapse was defined as a C-reactive protein (CRP) of 1 mg/dL or greater and/or erythrocyte sedimentation rate (ESR) of 30 mm/h or greater AND at least one of the following signs or symptoms attributed to GCA: Cranial symptoms (new-onset localized headache; scalp or temporal artery tenderness; ischemic-related vision loss; unexplained mouth or jaw pain upon mastication; transient ischemic attack or stroke related to GCA); Extracranial symptoms (claudication of the extremities; symptoms of polymyalgia rheumatica); New or worsening angiographic abnormalities detected via MRI, CT/CTA, or PET-CT of the aorta or other great vessels or via ultrasound of the temporal arteries.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (mITT) Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Sustained Remission Rate at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mavrilimumab', 'description': 'Participants randomized to mavrilimumab receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to placebo receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.2', 'groupId': 'OG000', 'lowerLimit': '67.9', 'upperLimit': '91.6'}, {'value': '49.9', 'groupId': 'OG001', 'lowerLimit': '29.6', 'upperLimit': '67.3'}]}]}], 'analyses': [{'pValue': '0.0038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.3', 'ciLowerLimit': '10.7', 'ciUpperLimit': '55.8', 'pValueComment': 'Two-sided p-value and 95% CI for the difference in sustained remission between two arms using normal approximation. Placebo arm is the reference.', 'groupDescription': 'Secondary endpoints were analyzed in hierarchical order.', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The sustained remission rate at Week 26 is defined as the percentage of participants with sustained remission, as assessed by independent adjudication, at Week 26, derived from the time to flare curve. Kaplan-Meier Survival Estimates with standard error and 95% CI for each arm. Participants who completed the treatment period without a flare by Week 26 were considered to have sustained remission.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Time to Elevated Erythrocyte Sedimentation Rate (ESR) by Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mavrilimumab', 'description': 'Participants randomized to mavrilimumab receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to placebo receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'comment': 'Not estimable per Kaplan-Meier method (insufficient number of subjects with events)', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': 'NA'}, {'value': '12.1', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '16.6'}]}]}], 'analyses': [{'pValue': '0.0277', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '0.27', 'ciUpperLimit': '0.95', 'pValueComment': 'Calculated by using a log-rank test stratified by randomization strata.', 'estimateComment': 'Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.', 'groupDescription': 'Secondary endpoints were analyzed in hierarchical order.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 26', 'description': 'Elevated ESR is defined as first occurrence of ESR value ≥ 30 mm/hr. Participants with elevated ESR within 3 days of first dose are excluded from the analysis. Kaplan-Meier method used to estimate the survival functions for each treatment arm.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period. Participants with elevated ESR within 3 days of first dose are excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Elevated C-Reactive Protein (CRP) by Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mavrilimumab', 'description': 'Participants randomized to mavrilimumab receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to placebo receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable per Kaplan-Meier method (insufficient number of subjects with events)', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': 'NA'}, {'value': '12.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '24.1'}]}]}], 'analyses': [{'pValue': '0.0378', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '0.19', 'ciUpperLimit': '0.98', 'pValueComment': 'Calculated by using a log-rank test stratified by randomization strata.', 'estimateComment': 'Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.', 'groupDescription': 'Secondary endpoints were analyzed in hierarchical order.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 26', 'description': 'Elevated CRP is defined as first occurrence of CRP value ≥ 1.0 mg/dL. Participants with elevated CRP within 3 days of first dose are excluded from the analysis. Kaplan-Meier method used to estimate the survival functions for each treatment arm.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period. Participants with elevated CRP within 3 days of first dose are excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Signs/Symptoms of Giant Cell Arteritis (GCA) or New or Worsening Vasculitis on Imaging by Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mavrilimumab', 'description': 'Participants randomized to mavrilimumab receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to placebo receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable per Kaplan-Meier method (insufficient number of subjects with events)', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '25.1', 'comment': 'Not estimable per Kaplan-Meier method (insufficient number of subjects with events)', 'groupId': 'OG001', 'lowerLimit': '15.1', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0651', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '0.22', 'ciUpperLimit': '1.06', 'pValueComment': 'Calculated by using a log-rank test stratified by randomization strata.', 'estimateComment': 'Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.', 'groupDescription': 'Secondary endpoints were analyzed in hierarchical order.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 26', 'description': 'Kaplan-Meier method used to estimate the survival functions for each treatment arm.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Cumulative Corticosteroid Dose at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mavrilimumab', 'description': 'Participants randomized to mavrilimumab receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to placebo receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '2074.15', 'spread': '708.433', 'groupId': 'OG000'}, {'value': '2402.98', 'spread': '1014.446', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0667', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) means difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-326.45', 'ciLowerLimit': '-675.99', 'ciUpperLimit': '23.09', 'pValueComment': 'Calculated using ANCOVA with treatment arm and randomization strata as discrete variables, and corticosteroid starting dose as a continuous variable.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistic'}], 'paramType': 'MEAN', 'timeFrame': 'Week 26', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal ESR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mavrilimumab', 'description': 'Participants randomized to mavrilimumab receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to placebo receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000', 'lowerLimit': '29.8', 'upperLimit': '61.3'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '32.7'}]}]}], 'analyses': [{'pValue': '0.0201', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.0', 'ciLowerLimit': '11.1', 'ciUpperLimit': '50.8', 'pValueComment': '95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistic'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'Participants were considered to have completed the corticosteroid taper if by week 26 receiving 1 mg/day for those who start with 60 mg/day, or 0 mg/day for those who start with doses \\< 60 mg/day. 95% CI calculated using Clopper-Pearson confidence intervals.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal CRP Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mavrilimumab', 'description': 'Participants randomized to mavrilimumab receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to placebo receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '39.5'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '32.7'}]}]}], 'analyses': [{'pValue': '0.5533', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.5', 'ciLowerLimit': '-8.7', 'ciUpperLimit': '27.8', 'pValueComment': '95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistic'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'Participants were considered to have completed the corticosteroid taper if by week 26 receiving 1 mg/day for those who start with 60 mg/day, or 0 mg/day for those who start with doses \\< 60 mg/day. 95% CI calculated using Clopper-Pearson confidence intervals.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Completed the 26-week Corticosteroid Taper and Who Had No Signs or Symptoms of GCA Nor New or Worsening Vasculitis by Imaging by Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mavrilimumab', 'description': 'Participants randomized to mavrilimumab receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to placebo receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '55.4', 'upperLimit': '84.3'}, {'value': '32.1', 'groupId': 'OG001', 'lowerLimit': '15.9', 'upperLimit': '52.4'}]}]}], 'analyses': [{'pValue': '0.0031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.3', 'ciLowerLimit': '17.2', 'ciUpperLimit': '61.3', 'pValueComment': '95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'Participants were considered to have completed the corticosteroid taper if by week 26 receiving 1 mg/day for those who start with 60 mg/day, or 0 mg/day for those who start with doses \\< 60 mg/day. 95% CI calculated using Clopper-Pearson confidence intervals.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Cumulative Corticosteroid Dose at the End of the Washout Safety Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mavrilimumab', 'description': 'Participants randomized to mavrilimumab receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to placebo receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '2464.93', 'spread': '1106.636', 'groupId': 'OG000'}, {'value': '2845.45', 'spread': '1320.115', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1629', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) means difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-380.82', 'ciLowerLimit': '-919.66', 'ciUpperLimit': '158.02', 'pValueComment': 'Calculated using ANCOVA with treatment arm and randomization strata as discrete variables, and corticosteroid starting dose as a continuous variable', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive statistics'}], 'paramType': 'MEAN', 'timeFrame': 'Final Safety Follow-up visit (Week 38)', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Analysis Set: all randomized participants who received at least 1 dose of mavrilimumab or placebo and had at least 1 assessment in the double-blind treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mavrilimumab', 'description': 'Participants randomized to mavrilimumab receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants randomized to placebo receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Completed Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'comment': 'Completed Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mavrilimumab', 'description': 'Participants randomized to mavrilimumab receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants randomized to placebo receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.7', 'spread': '6.98', 'groupId': 'BG000'}, {'value': '69.7', 'spread': '8.31', 'groupId': 'BG001'}, {'value': '69.7', 'spread': '7.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Other, Not Specified', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', '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': '41', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-30', 'size': 6555853, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-17T13:35', 'hasProtocol': True}, {'date': '2020-09-10', 'size': 3732128, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-02T11:26', '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', 'interventionModelDescription': 'Upon successful completion of the screening procedures, diagnosis criteria will be entered into an interactive web response system, and eligible subjects will be stratified for randomized study treatment into two cohorts according to whether subjects have new-onset or relapsing/refractory disease.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'dispFirstSubmitDate': '2021-08-02', 'completionDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2019-01-25', 'resultsFirstSubmitDate': '2023-08-02', 'studyFirstSubmitQcDate': '2019-01-31', 'dispFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-21', 'studyFirstPostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Flare by Week 26', 'timeFrame': 'Week 26', 'description': 'Time to flare by Week 26 was defined as time from randomization to the date of first flare occurring within the 26-week period, as assessed by independent adjudication. Kaplan-Meier method used to estimate the survival functions for each treatment arm.\n\nFlare/relapse was defined as a C-reactive protein (CRP) of 1 mg/dL or greater and/or erythrocyte sedimentation rate (ESR) of 30 mm/h or greater AND at least one of the following signs or symptoms attributed to GCA: Cranial symptoms (new-onset localized headache; scalp or temporal artery tenderness; ischemic-related vision loss; unexplained mouth or jaw pain upon mastication; transient ischemic attack or stroke related to GCA); Extracranial symptoms (claudication of the extremities; symptoms of polymyalgia rheumatica); New or worsening angiographic abnormalities detected via MRI, CT/CTA, or PET-CT of the aorta or other great vessels or via ultrasound of the temporal arteries.'}], 'secondaryOutcomes': [{'measure': 'Sustained Remission Rate at Week 26', 'timeFrame': 'Week 26', 'description': 'The sustained remission rate at Week 26 is defined as the percentage of participants with sustained remission, as assessed by independent adjudication, at Week 26, derived from the time to flare curve. Kaplan-Meier Survival Estimates with standard error and 95% CI for each arm. Participants who completed the treatment period without a flare by Week 26 were considered to have sustained remission.'}, {'measure': 'Time to Elevated Erythrocyte Sedimentation Rate (ESR) by Week 26', 'timeFrame': 'Week 26', 'description': 'Elevated ESR is defined as first occurrence of ESR value ≥ 30 mm/hr. Participants with elevated ESR within 3 days of first dose are excluded from the analysis. Kaplan-Meier method used to estimate the survival functions for each treatment arm.'}, {'measure': 'Time to Elevated C-Reactive Protein (CRP) by Week 26', 'timeFrame': 'Week 26', 'description': 'Elevated CRP is defined as first occurrence of CRP value ≥ 1.0 mg/dL. Participants with elevated CRP within 3 days of first dose are excluded from the analysis. Kaplan-Meier method used to estimate the survival functions for each treatment arm.'}, {'measure': 'Time to Signs/Symptoms of Giant Cell Arteritis (GCA) or New or Worsening Vasculitis on Imaging by Week 26', 'timeFrame': 'Week 26', 'description': 'Kaplan-Meier method used to estimate the survival functions for each treatment arm.'}, {'measure': 'Cumulative Corticosteroid Dose at Week 26', 'timeFrame': 'Week 26'}, {'measure': 'Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal ESR', 'timeFrame': 'Week 26', 'description': 'Participants were considered to have completed the corticosteroid taper if by week 26 receiving 1 mg/day for those who start with 60 mg/day, or 0 mg/day for those who start with doses \\< 60 mg/day. 95% CI calculated using Clopper-Pearson confidence intervals.'}, {'measure': 'Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal CRP Level', 'timeFrame': 'Week 26', 'description': 'Participants were considered to have completed the corticosteroid taper if by week 26 receiving 1 mg/day for those who start with 60 mg/day, or 0 mg/day for those who start with doses \\< 60 mg/day. 95% CI calculated using Clopper-Pearson confidence intervals.'}, {'measure': 'Percentage of Participants Who Completed the 26-week Corticosteroid Taper and Who Had No Signs or Symptoms of GCA Nor New or Worsening Vasculitis by Imaging by Week 26', 'timeFrame': 'Week 26', 'description': 'Participants were considered to have completed the corticosteroid taper if by week 26 receiving 1 mg/day for those who start with 60 mg/day, or 0 mg/day for those who start with doses \\< 60 mg/day. 95% CI calculated using Clopper-Pearson confidence intervals.'}, {'measure': 'Cumulative Corticosteroid Dose at the End of the Washout Safety Follow-up Period', 'timeFrame': 'Final Safety Follow-up visit (Week 38)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['GCA', 'temporal arteritis', "Horton's disease"], 'conditions': ['Giant Cell Arteritis']}, 'referencesModule': {'references': [{'pmid': '35264321', 'type': 'DERIVED', 'citation': 'Cid MC, Unizony SH, Blockmans D, Brouwer E, Dagna L, Dasgupta B, Hellmich B, Molloy E, Salvarani C, Trapnell BC, Warrington KJ, Wicks I, Samant M, Zhou T, Pupim L, Paolini JF; KPL-301-C001 Investigators. Efficacy and safety of mavrilimumab in giant cell arteritis: a phase 2, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022 May;81(5):653-661. doi: 10.1136/annrheumdis-2021-221865. Epub 2022 Mar 9.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the efficacy of mavrilimumab (KPL-301) versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant cell arteritis (GCA).', 'detailedDescription': 'This Phase 2 randomized, double-blind, placebo-controlled proof of concept study will evaluate the efficacy and safety of mavrilimumab co-administered with a 26-week corticosteroid taper in subjects with GCA. The study will consist of a screening period (up to 6 weeks), a 26-week double-blind placebo-controlled period during which subjects will receive blinded mavrilimumab or placebo co-administered with a 26-week corticosteroid taper, and a 12-week washout safety follow-up period during which subjects will discontinue and wash off blinded mavrilimumab or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Selected Inclusion Criteria:\n\n1. Subjects with new-onset or relapsing/refractory GCA.\n2. Westergren erythrocyte sedimentation rate \\> 30 mm/hour or c-reactive protein ≥ 1 mg/ dL.\n3. Remission of GCA at or before Day 0.\n4. Female subjects must be postmenopausal or permanently sterile following documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation or having a male partner with vasectomy as affirmed by the subject, or nonpregnant, nonlactating, and if sexually active having agreed to use a highly effective method of contraception.\n5. Male subjects must have documented vasectomy or if sexually active must agree to use a highly effective method of contraception with their partners of childbearing potential.\n\nSelected Exclusion Criteria:\n\n1. Transplanted organs (except corneal transplant performed more than 3 months prior to randomization).\n2. Concurrent enrollment in another interventional clinical study.\n3. Treatment with non-biologic investigational drug therapy within 4 weeks or 5 half-lives of the study agent, whichever was longer, prior to screening.\n4. Cell-depleting biological therapies within 12 months prior to Day 0, or noncell-depleting biological therapies within 8 weeks (or 5 half-lives, whichever is longer) prior to screening.\n5. Treatment with alkylating agents within 12 weeks prior to screening.\n6. Intramuscular, Intra-articular or IV corticosteroids within 4 weeks prior to screening.\n7. Receipt of live (attenuated) vaccine within the 4 weeks before Day 0.\n8. Treatment with hydroxychloroquine, cyclosporine A, azathioprine, cyclophosphamide, or mycophenolate mofetil (MMF) within 4 weeks of screening.\n9. Female subjects who are pregnant, intending to become pregnant, or are breastfeeding.\n10. Known history of allergy or reaction to any component of the mavrilimumab or placebo formulation or to any other biologic therapy or prednisone or any of its excipients.\n11. Positive (or 2 indeterminate) QuantiFERON test results.\n12. Clinically significant active infection or infection requiring hospitalization or IV antibiotics within 12 weeks before screening or opportunistic infection within 6 months before screening.\n13. Chronic active hepatitis B infection.\n14. Subjects at a high risk of infection, a history of an infected joint prosthesis still in situ, leg ulcers, indwelling urinary catheter, or persistent or recurrent chest infections.\n15. History of cancer within the last 10 years, except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured.\n16. Evidence of clinically-uncontrolled respiratory disease.\n17. History of chronic respiratory tract infections.'}, 'identificationModule': {'nctId': 'NCT03827018', 'briefTitle': 'KPL-301 for Subjects With Giant Cell Arteritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kiniksa Pharmaceuticals International, plc'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis', 'orgStudyIdInfo': {'id': 'KPL-301-C001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'mavrilimumab', 'description': 'Subjects randomized to mavrilimumab will receive 150 mg every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.', 'interventionNames': ['Combination Product: mavrilimumab', 'Drug: prednisone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Subjects randomized to placebo will receive placebo every other week by subcutaneous injection co-administered with a 26-week corticosteroid taper.', 'interventionNames': ['Combination Product: placebo', 'Drug: prednisone']}], 'interventions': [{'name': 'mavrilimumab', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['KPL-301'], 'description': '1 mL of 150 mg in a pre-filled syringe', 'armGroupLabels': ['mavrilimumab']}, {'name': 'placebo', 'type': 'COMBINATION_PRODUCT', 'description': '1 mL of placebo in a pre-filled syringe', 'armGroupLabels': ['placebo']}, {'name': 'prednisone', 'type': 'DRUG', 'description': 'Prednisone tablets for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone United States Pharmacopeia (USP)', 'armGroupLabels': ['mavrilimumab', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 1703', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 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