Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-29 @ 11:03 AM
Study NCT ID:
NCT04925934
Status:
COMPLETED
Last Update Posted:
2024-07-23
First Post:
2021-05-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of VIB7734 for the Treatment of Moderate to Severely Active SLE
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', 'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 56 weeks', 'description': 'SAS: included all participants who received any dose of IP. Participants were analyzed according to the treatment that they received. All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 17, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Daxdilimab 200mg Q4W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 30, 'seriousNumAtRisk': 72, 'deathsNumAffected': 1, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Daxdilimab 200mg Q12W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 29, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': "Huntington's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abortion induced incomplete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hydrosalpinx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Achieving a BILAG-2004 Index-based Combined Lupus Assessment (BICLA) Response and an OGC Dose ≤ 7.5 mg/Day and ≤ Baseline Dose of Prednisone or Equivalent at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.'}, {'id': 'OG001', 'title': 'Daxdilimab 200 mg Q4W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.'}, {'id': 'OG002', 'title': 'Daxdilimab 200 mg Q12W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.7474', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.8', 'ciLowerLimit': '-11.4', 'ciUpperLimit': '17.0', 'groupDescription': 'Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.9942', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.1', 'ciLowerLimit': '-14.2', 'ciUpperLimit': '14.1', 'groupDescription': 'Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 48', 'description': 'A BICLA response required improvement in all domains affected at baseline, assessed by the BILAG 2004, no worsening of other BILAG 2004 domains, no worsening of SLEDAI-2K or PGA scores compared with baseline, no use of restricted medications beyond the protocol-allowed threshold, and no discontinuation of IP.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: included all randomized participants who received any dose of IP. Participants were analyzed according to the treatment randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) Score ≥ 10 at Baseline Achieving ≥ 50% Reduction From Baseline in CLASI-A Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.'}, {'id': 'OG001', 'title': 'Daxdilimab 200 mg Q4W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.'}, {'id': 'OG002', 'title': 'Daxdilimab 200 mg Q12W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.1626', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '37.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '74.7', 'groupDescription': 'Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, randomization stratification factors and Baseline CLASI-A score in the model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.2873', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '24.1', 'ciLowerLimit': '-7.5', 'ciUpperLimit': '55.8', 'groupDescription': 'Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, randomization stratification factors and Baseline CLASI-A score in the model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The CLASI-A evaluates erythema (0-3 \\[higher scores indicate more severe redness\\]), scale/hypertrophy (0-2 \\[higher scores indicate more extensive scaling/thickening\\]), mucous membrane lesions (0 \\[absent\\] or 1 \\[present\\]), recent hair loss (0 \\[absent\\] or 1 \\[present\\]), and non-scarring alopecia (0-3 \\[(higher scores indicate more extensive hair loss without scarring\\]) at 13 anatomical sites on the skin. Total score is calculated by summing scores across all anatomical locations for each parameter. Higher total scores indicate greater disease activity and severity in SLE. Reduction of 50% in CLASI-A score was defined by meeting all the following conditions:\n\n1. A ≥ 50% reduction of CLASI-A score at Week 12 as compared to baseline.\n2. No use of restricted medications beyond the protocol-allowed threshold before assessment.\n3. No discontinuation of IP.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: included all randomized participants who received any dose of IP. Participants were analyzed according to the treatment randomized. Only participants with a CLASI-A score ≥ 10 at baseline were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving an SLE Responder Index (SRI)-4 Response and an OGC Dose ≤ 7.5 mg/Day and ≤ Baseline Dose of Prednisone or Equivalent at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.'}, {'id': 'OG001', 'title': 'Daxdilimab 200 mg Q4W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.'}, {'id': 'OG002', 'title': 'Daxdilimab 200 mg Q12W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.3220', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '8.6', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '22.7', 'groupDescription': 'Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.7364', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.9', 'ciLowerLimit': '-11.2', 'ciUpperLimit': '17.0', 'groupDescription': 'Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 48', 'description': 'The SRI-4 measures reduction in SLE disease activity and it is a composite measure that includes the SLEDAI-2K, BILAG-2004, and PGA. SRI responder was defined by meeting all of the following criteria: 1) Reduction of ≥4 points from baseline in SLEDAI-2K score; 2) no new BILAG A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \\[0-3 scale\\] from baseline) in the PGA.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: included all randomized participants who received any dose of IP. Participants were analyzed according to the treatment randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an OGC Dose ≥ 10 mg/Day of Prednisone or Equivalent at Baseline Who Maintained an OGC Dose ≤ 7.5 mg/Day From Week 36 Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.'}, {'id': 'OG001', 'title': 'Daxdilimab 200 mg Q4W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.'}, {'id': 'OG002', 'title': 'Daxdilimab 200 mg Q12W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.2805', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '11.7', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '29.4', 'groupDescription': 'Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, stratification factors (SLEDAI-2K only) and Baseline OGC dose included in the model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.3926', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '9.4', 'ciLowerLimit': '-8.6', 'ciUpperLimit': '27.3', 'groupDescription': 'Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, stratification factors (SLEDAI-2K only) and Baseline OGC dose included in the model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 36 up to Week 48', 'description': 'Maintenance of OGC reduction from Week 36 to Week 48 was defined by meeting all the following criteria:\n\n1. Achieved an OGC dose of ≤ 7.5 mg/day prednisone or equivalent at Week 36\n2. Maintained an OGC dose of ≤ 7.5 mg/day from Week 36 through Week 48\n3. No use of restricted medications beyond the protocol-allowed threshold before assessment\n4. No discontinuation of IP before assessment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: included all randomized participants who received any dose of IP. Participants were analyzed according to the treatment randomized. Data excludes participants from Russia and Ukraine sites. Only participants with an OGC dose ≥ 10 mg/day of prednisone or equivalent at baseline were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.'}, {'id': 'OG001', 'title': 'Daxdilimab 200 mg Q4W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.'}, {'id': 'OG002', 'title': 'Daxdilimab 200 mg Q12W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.0370', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '16.5', 'ciLowerLimit': '4.0', 'ciUpperLimit': '29.0', 'groupDescription': 'Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.4939', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.9', 'ciLowerLimit': '-6.7', 'ciUpperLimit': '16.4', 'groupDescription': 'Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 48', 'description': "LLDAS was defined by meeting all of the following criteria:\n\n1. SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG Gastrointestinal Body System\n2. No new lupus disease activity compared with the previous\n3. Physician's Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity\n4. A current prednisolone (or equivalent) dose ≤ 7.5 mg daily\n5. Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: included all randomized participants who received any dose of IP. Participants were analyzed according to the treatment randomized.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of Daxdilimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.'}, {'id': 'OG001', 'title': 'Daxdilimab 200 mg Q4W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.'}, {'id': 'OG002', 'title': 'Daxdilimab 200 mg Q12W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.011', 'spread': '0.026', 'groupId': 'OG001'}, {'value': '0.008', 'spread': '0.004', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.319', 'spread': '1.972', 'groupId': 'OG001'}, {'value': '3.301', 'spread': '1.718', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.714', 'spread': '3.079', 'groupId': 'OG001'}, {'value': '4.643', 'spread': '2.708', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.344', 'spread': '3.624', 'groupId': 'OG001'}, {'value': '1.372', 'spread': '1.189', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.035', 'spread': '3.377', 'groupId': 'OG001'}, {'value': '4.268', 'spread': '2.720', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.884', 'spread': '4.451', 'groupId': 'OG001'}, {'value': '1.239', 'spread': '1.097', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.539', 'spread': '4.224', 'groupId': 'OG001'}, {'value': '0.530', 'spread': '0.922', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.855', 'spread': '3.743', 'groupId': 'OG001'}, {'value': '3.590', 'spread': '2.522', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.951', 'spread': '4.047', 'groupId': 'OG001'}, {'value': '1.096', 'spread': '1.151', 'groupId': 'OG002'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.321', 'spread': '4.309', 'groupId': 'OG001'}, {'value': '0.366', 'spread': '0.471', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.652', 'spread': '3.426', 'groupId': 'OG001'}, {'value': '3.439', 'spread': '2.534', 'groupId': 'OG002'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.908', 'spread': '3.780', 'groupId': 'OG001'}, {'value': '1.115', 'spread': '1.378', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.543', 'spread': '4.637', 'groupId': 'OG001'}, {'value': '0.406', 'spread': '0.585', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set: included all participants who received any dose of daxdilimab in the study and had at least 1 quantifiable serum PK observation post-first dose. Participants were analyzed according to the treatment that they received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.'}, {'id': 'OG001', 'title': 'Daxdilimab 200 mg Q4W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.'}, {'id': 'OG002', 'title': 'Daxdilimab 200 mg Q12W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.'}], 'classes': [{'title': 'ADA not detected (negative) on trial', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}, {'title': 'ADA incidence', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Boosted ADA (≥ 4 × Baseline level)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'ADA detected (positive) on trial: ADA prevalence', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Only Baseline positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Only post-Baseline positive', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Both Baseline and post-Baseline positive', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Persistent positive', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Transient positive', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 56', 'description': 'A baseline ADA-positive participant was defined as a participant who had an ADA positive sample at baseline. ADA incidence is the number of the participants ADA positive post-Baseline only or who boosted their preexisting ADA (≥ 4 × Baseline level) during the trial. Persistent positive was defined as ADA positive at ≥ 2 post-Baseline assessments (with ≥ 16 weeks between first and last positive) or positive at last post-Baseline assessment. Transient positive was defined as ADA post-Baseline positive but did not fulfill the criteria of persistent positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS): included all participants who received any dose of IP. Participants were analyzed according to the treatment that they received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.'}, {'id': 'OG001', 'title': 'Daxdilimab 200 mg Q4W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.'}, {'id': 'OG002', 'title': 'Daxdilimab 200 mg Q12W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.5068', 'spread': '1.8486', 'groupId': 'OG000'}, {'value': '2.2960', 'spread': '1.7457', 'groupId': 'OG001'}, {'value': '1.9195', 'spread': '1.1990', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2324', 'spread': '1.8194', 'groupId': 'OG000'}, {'value': '-1.4240', 'spread': '1.9493', 'groupId': 'OG001'}, {'value': '-1.2903', 'spread': '1.2201', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4608', 'spread': '1.4125', 'groupId': 'OG000'}, {'value': '-1.5194', 'spread': '1.7555', 'groupId': 'OG001'}, {'value': '-1.1486', 'spread': '1.2090', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0275', 'spread': '1.7580', 'groupId': 'OG000'}, {'value': '-1.5164', 'spread': '1.8180', 'groupId': 'OG001'}, {'value': '-1.1134', 'spread': '1.5290', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '285.1519', 'spread': '1613.566', 'groupId': 'OG000'}, {'value': '-1.5131', 'spread': '1.6837', 'groupId': 'OG001'}, {'value': '-1.0320', 'spread': '1.1063', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3911', 'spread': '1.7344', 'groupId': 'OG000'}, {'value': '-1.5974', 'spread': '1.7705', 'groupId': 'OG001'}, {'value': '-0.5507', 'spread': '1.3090', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3513', 'spread': '1.7855', 'groupId': 'OG000'}, {'value': '-1.3367', 'spread': '1.5678', 'groupId': 'OG001'}, {'value': '-0.8496', 'spread': '1.2403', 'groupId': 'OG002'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1274', 'spread': '1.6962', 'groupId': 'OG000'}, {'value': '-1.4614', 'spread': '1.7634', 'groupId': 'OG001'}, {'value': '-0.9131', 'spread': '0.9845', 'groupId': 'OG002'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3194', 'spread': '1.6347', 'groupId': 'OG000'}, {'value': '-1.6540', 'spread': '1.6184', 'groupId': 'OG001'}, {'value': '-1.1322', 'spread': '1.3782', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1973', 'spread': '2.4112', 'groupId': 'OG000'}, {'value': '-1.4608', 'spread': '1.5647', 'groupId': 'OG001'}, {'value': '-0.7964', 'spread': '1.0055', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1483', 'spread': '3.7955', 'groupId': 'OG000'}, {'value': '-0.4353', 'spread': '0.5127', 'groupId': 'OG001'}, {'value': '0.0149', 'spread': '0.7999', 'groupId': 'OG002'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.0823', 'spread': '3.9807', 'groupId': 'OG000'}, {'value': '-2.3137', 'spread': '3.2514', 'groupId': 'OG001'}, {'value': '-0.7056', 'spread': '0.6729', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 32, Week 36, Week 44, Week 48, Week 52, Week 56', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS: included all participants who received any dose of IP. Participants were analyzed according to the treatment that they received. Only participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.'}, {'id': 'OG001', 'title': 'Daxdilimab 200 mg Q4W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.'}, {'id': 'OG002', 'title': 'Daxdilimab 200 mg Q12W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'AEs Grade 3 or higher', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AEs Resulting in Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 56', 'description': 'An adverse event (AE) is any untoward medical occurrence associated with the use of an intervention in humans whether or not it is considered intervention-related. TEAEs are AEs that started on or after the first dose of IP. An AE was considered serious (SAE) if it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolonged existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital abnormality/birth defect, or an important medical event. AE severity was rated according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS: included all participants who received any dose of IP. Participants were analyzed according to the treatment that they received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced AEs of Special Interest (AESI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.'}, {'id': 'OG001', 'title': 'Daxdilimab 200 mg Q4W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.'}, {'id': 'OG002', 'title': 'Daxdilimab 200 mg Q12W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.'}], 'classes': [{'title': 'Hypersensitivity Reaction Including Anaphylaxis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Opportunistic infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Viral infection/Reactivation', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 56', 'description': 'An AESI is an AE of scientific and medical interest specific to understanding of the IP and may require close monitoring and collection of additional information by the Investigator. AESIs for this study included:\n\n1. Hypersensitivity reaction, including anaphylaxis.\n2. Severe (Grade 3 or higher) viral infections/reactivations.\n3. Opportunistic infection.\n4. Malignancy (except non-melanoma skin cancer).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS: included all participants who received any dose of IP. Participants were analyzed according to the treatment that they received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.'}, {'id': 'FG001', 'title': 'Daxdilimab 200 mg Q4W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.'}, {'id': 'FG002', 'title': 'Daxdilimab 200 mg Q12W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Eastern European Conflict', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants with systemic lupus erythematosus (SLE) were enrolled at 68 sites in the United States, Argentina, Greece, India, Mexico, Poland, Serbia, Spain, Taiwan, Ukraine and Russia between May 2021 and June 2023.', 'preAssignmentDetails': 'Participants were randomized in a 1:1:1 ratio to take daxdilimab 200 mg every 4 weeks (Q4W) subcutaneously (SC), daxdilimab 200 mg every 12 weeks (Q12W) SC (with an additional 200 mg SC dose at Week 4) or matching placebo Q4W SC. Duration of treatment was up to 48 weeks. Randomization was stratified by SLE Disease Activity Index 2000 (SLEDAI-2K) total score at screening (≥ 10 or \\< 10) and prednisone or equivalent oral glucocorticoid (OGC) dose at baseline (≥ 10 mg/day or \\< 10 mg/day).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '214', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.'}, {'id': 'BG001', 'title': 'Daxdilimab 200 mg Q4W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.'}, {'id': 'BG002', 'title': 'Daxdilimab 200 mg Q12W', 'description': 'Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.0', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '44.5', 'spread': '13.1', 'groupId': 'BG001'}, {'value': '45.3', 'spread': '11.6', 'groupId': 'BG002'}, {'value': '43.6', 'spread': '12.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '200', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Multiple categories checked', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Participants Within Each OGC Stratification Dose Level', 'classes': [{'title': '< 10 mg/day', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}]}, {'title': '≥ 10 mg/day', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'OGC dose represents the baseline dose of prednisone or any equivalent corticosteroids.', 'unitOfMeasure': 'number of participants'}, {'title': 'SLEDAI-2K Score', 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '10.6', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '10.1', 'spread': '2.9', 'groupId': 'BG002'}, {'value': '10.2', 'spread': '3.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The SLEDAI-2K assessment consists of 24 lupus-related items. It is a weighted instrument, in which descriptors are multiplied by an organ\'s "weight". For example, renal descriptors are multiplied by 4 and CNS descriptors by 8; these weighted organ manifestations are totalled into the final score. The scores range from 0 to 105, with higher scores indicating more severe disease activity.', 'unitOfMeasure': 'Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'British Isles Lupus Assessment Group (BILAG)-2004 Score', 'classes': [{'categories': [{'measurements': [{'value': '19.2', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '19.5', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '19.8', 'spread': '5.5', 'groupId': 'BG002'}, {'value': '19.5', 'spread': '4.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The BILAG-2004 Index assesses lupus disease activity across 9 organ systems. Each organ system is graded from A (severe disease activity requiring urgent treatment; score of 12) to E (system never involved; score of 0). The organ system scores are summed to give an overall score ranging from 0 to 108 where higher scores indicate greater disease activity and severity.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Physician Global Assessment (PGA) Score', 'classes': [{'categories': [{'measurements': [{'value': '1.89', 'spread': '0.37', 'groupId': 'BG000'}, {'value': '1.96', 'spread': '0.32', 'groupId': 'BG001'}, {'value': '1.90', 'spread': '0.41', 'groupId': 'BG002'}, {'value': '1.91', 'spread': '0.37', 'groupId': 'BG003'}]}]}], 'paramType': 'MEDIAN', 'description': "The PGA takes into account various clinical factors, including the participant's symptoms, physical examination findings, laboratory results, and the physician's judgment. The PGA is scored with a range 0 to 3 where higher scores indicate greater disease activity and severity.", 'unitOfMeasure': 'Score', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full analysis set (FAS): included all randomized participants who received any dose of investigational product (IP). Participants were analyzed according to the treatment randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-10', 'size': 1422989, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-07T18:10', 'hasProtocol': True}, {'date': '2022-02-10', 'size': 965811, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-07T18:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blind, placebo-controlled, parallel-arm study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'dispFirstSubmitDate': '2024-02-26', 'completionDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-21', 'studyFirstSubmitDate': '2021-05-04', 'resultsFirstSubmitDate': '2024-06-07', 'studyFirstSubmitQcDate': '2021-06-08', 'dispFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-21', 'studyFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Achieving a BILAG-2004 Index-based Combined Lupus Assessment (BICLA) Response and an OGC Dose ≤ 7.5 mg/Day and ≤ Baseline Dose of Prednisone or Equivalent at Week 48', 'timeFrame': 'Week 48', 'description': 'A BICLA response required improvement in all domains affected at baseline, assessed by the BILAG 2004, no worsening of other BILAG 2004 domains, no worsening of SLEDAI-2K or PGA scores compared with baseline, no use of restricted medications beyond the protocol-allowed threshold, and no discontinuation of IP.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) Score ≥ 10 at Baseline Achieving ≥ 50% Reduction From Baseline in CLASI-A Score at Week 12', 'timeFrame': 'Week 12', 'description': 'The CLASI-A evaluates erythema (0-3 \\[higher scores indicate more severe redness\\]), scale/hypertrophy (0-2 \\[higher scores indicate more extensive scaling/thickening\\]), mucous membrane lesions (0 \\[absent\\] or 1 \\[present\\]), recent hair loss (0 \\[absent\\] or 1 \\[present\\]), and non-scarring alopecia (0-3 \\[(higher scores indicate more extensive hair loss without scarring\\]) at 13 anatomical sites on the skin. Total score is calculated by summing scores across all anatomical locations for each parameter. Higher total scores indicate greater disease activity and severity in SLE. Reduction of 50% in CLASI-A score was defined by meeting all the following conditions:\n\n1. A ≥ 50% reduction of CLASI-A score at Week 12 as compared to baseline.\n2. No use of restricted medications beyond the protocol-allowed threshold before assessment.\n3. No discontinuation of IP.'}, {'measure': 'Number of Participants Achieving an SLE Responder Index (SRI)-4 Response and an OGC Dose ≤ 7.5 mg/Day and ≤ Baseline Dose of Prednisone or Equivalent at Week 48', 'timeFrame': 'Week 48', 'description': 'The SRI-4 measures reduction in SLE disease activity and it is a composite measure that includes the SLEDAI-2K, BILAG-2004, and PGA. SRI responder was defined by meeting all of the following criteria: 1) Reduction of ≥4 points from baseline in SLEDAI-2K score; 2) no new BILAG A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \\[0-3 scale\\] from baseline) in the PGA.'}, {'measure': 'Number of Participants With an OGC Dose ≥ 10 mg/Day of Prednisone or Equivalent at Baseline Who Maintained an OGC Dose ≤ 7.5 mg/Day From Week 36 Through Week 48', 'timeFrame': 'Week 36 up to Week 48', 'description': 'Maintenance of OGC reduction from Week 36 to Week 48 was defined by meeting all the following criteria:\n\n1. Achieved an OGC dose of ≤ 7.5 mg/day prednisone or equivalent at Week 36\n2. Maintained an OGC dose of ≤ 7.5 mg/day from Week 36 through Week 48\n3. No use of restricted medications beyond the protocol-allowed threshold before assessment\n4. No discontinuation of IP before assessment'}, {'measure': 'Number of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 48', 'timeFrame': 'Week 48', 'description': "LLDAS was defined by meeting all of the following criteria:\n\n1. SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG Gastrointestinal Body System\n2. No new lupus disease activity compared with the previous\n3. Physician's Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity\n4. A current prednisolone (or equivalent) dose ≤ 7.5 mg daily\n5. Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents"}, {'measure': 'Serum Concentration of Daxdilimab', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48'}, {'measure': 'Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab', 'timeFrame': 'Baseline to Week 56', 'description': 'A baseline ADA-positive participant was defined as a participant who had an ADA positive sample at baseline. ADA incidence is the number of the participants ADA positive post-Baseline only or who boosted their preexisting ADA (≥ 4 × Baseline level) during the trial. Persistent positive was defined as ADA positive at ≥ 2 post-Baseline assessments (with ≥ 16 weeks between first and last positive) or positive at last post-Baseline assessment. Transient positive was defined as ADA post-Baseline positive but did not fulfill the criteria of persistent positive.'}, {'measure': 'Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 32, Week 36, Week 44, Week 48, Week 52, Week 56'}, {'measure': 'Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Week 56', 'description': 'An adverse event (AE) is any untoward medical occurrence associated with the use of an intervention in humans whether or not it is considered intervention-related. TEAEs are AEs that started on or after the first dose of IP. An AE was considered serious (SAE) if it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolonged existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital abnormality/birth defect, or an important medical event. AE severity was rated according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death).'}, {'measure': 'Number of Participants Who Experienced AEs of Special Interest (AESI)', 'timeFrame': 'Up to Week 56', 'description': 'An AESI is an AE of scientific and medical interest specific to understanding of the IP and may require close monitoring and collection of additional information by the Investigator. AESIs for this study included:\n\n1. Hypersensitivity reaction, including anaphylaxis.\n2. Severe (Grade 3 or higher) viral infections/reactivations.\n3. Opportunistic infection.\n4. Malignancy (except non-melanoma skin cancer).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lupus Erythematosus, Systemic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus in approximately 195 participants. The study duration will be 48 weeks, with a safety follow-up through week 56.There will be 3 parallel arms - 2 active treatment and 1 placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years to ≤ 70 years\n* Willing and able to understand and provide written informed consent.\n* Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE\n* Disease duration of at least 6 months\n* Active SLE as indicated by presence of all the following:\n\n 1. SLEDAI-2K total score ≥ 6 at Screening, excluding fever, SLE headache, or organic brain syndrome.\n 2. SLEDAI-2K total score ≥ 4, excluding points attributable to any urine or laboratory results, immunologic measures, fever, SLE headache, or organic brain syndrome at Screening and Baseline (Day 1).\n 3. At least one of the following BILAG 2004 Index levels of disease at Screening:\n* BILAG A disease in ≥ 1 organ system\n* BILAG B disease in ≥ 2 organ systems d. PGA score ≥ 1 on a 0 to 3 visual analog scale (VAS) at Screening\n\nHave at least one of the following at Screening per central lab:\n\n* ANA ≥ 1:80\n* Anti-dsDNA antibodies elevated to above normal range as established by the central laboratory (ie, positive results)\n* Anti-Smith antibodies elevated to above normal (ie, positive results) Ongoing treatment for SLE\n\n 1. Treatment with one or more disease-modifying anti-rheumatic drug (DMARD) or immunosuppressive medication: Any of the following medications each administered at conventional anti-rheumatic doses for treatment of SLE for at least 12 weeks before Screening (unless discontinued or dose adjusted for documented drug-related toxicity or size/weight), and at a stable dose (including route of administration) for a minimum of 8 weeks prior to Screening and maintained through Baseline (Day 1):\n 2. Treatment with OGC monotherapy (without the concomitant use of DMARDs or immunosuppressants):\n\n * Average daily dose of PO prednisone ≥ 10 mg but ≤ 40 mg (or prednisone equivalent) for a minimum of 4 weeks prior to Screening and a stable dose for minimum of 2 weeks prior to Screening. The dose of OGC must be kept for a minimum of 2 weeks prior to Randomization. Daily dosing or alternate day dosing of PO prednisone or equivalent is allowed.\n* Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Randomization.\n* Non-sterilized male participants who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Randomization and until 3 months (approximately 5 half-lives) after receipt of the last dose.\n\nExclusion Criteria:\n\n* Any condition that, in the opinion of the Investigator, or the Sponsor/Central Review Committee, would interfere with the evaluation of the IP or interpretation of participant safety or study results (including borderline disease activity)\n* History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or a previous mAb or human Ig therapy\n* Active LN or active severe or unstable neuropsychiatric SLE\n* Current diagnosis of non-SLE vasculitis syndrome, mixed connective tissue disease, or rheumatic (overlap) syndrome\n* Participation in another clinical study with an investigational drug within 4 weeks before Day 1\n* Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP\n* Major surgery within 8 weeks prior to Screening or elective surgery planned from Screening through Day 393.\n* Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks before Screening\n* Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection\n* Hepatitis B, Hepatitis C, active TB, any severe herpes infection, clinically active infection, or opportunistic infection\n* History of clinically significant cardiac disease including unstable angina; and/or myocardial infarction and/or congestive heart failure within 6 months prior to Randomization.\n* History of cancer within the past 5 years except, in situ carcinoma of the cervix, cutaneous basal cell or squamous cell carcinoma with curative therapy.\n* Receipt of a live-attenuated vaccine within 4 weeks before Day 1 Administration of inactivated (killed) vaccines is acceptable\n* The use of immunosuppressants, biologics and DMARDS within the protocol defined washout periods'}, 'identificationModule': {'nctId': 'NCT04925934', 'acronym': 'RECAST SLE', 'briefTitle': 'Study of VIB7734 for the Treatment of Moderate to Severely Active SLE', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'VIB7734.P2.S1'}, 'secondaryIdInfos': [{'id': '2020-005528-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VIB7734 SC (dosing interval 1)', 'interventionNames': ['Drug: VIB7734']}, {'type': 'EXPERIMENTAL', 'label': 'VIB7734 SC (dosing interval 2)', 'interventionNames': ['Drug: VIB7734']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo SC (dosing interval 3)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'VIB7734', 'type': 'DRUG', 'otherNames': ['Daxdilimab', 'HZN-7734'], 'description': 'VIB7734', 'armGroupLabels': ['VIB7734 SC (dosing interval 1)', 'VIB7734 SC (dosing interval 2)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo SC (dosing interval 3)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Inland Rheumatology Clinical Trials Incorporated', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '33765-2616', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida Inc - Clearwater', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Millennium Research', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'IRIS Research and Development LLC', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '33606-1246', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida Inc - Tampa', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '40504-2931', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Bluegrass Community Research Inc', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '11201', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Ambulatory Care Brooklyn Heights', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11030-3816', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Feinstein Institute For Medical Research', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical Center', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '28210-8509', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'DJL Clinical Research', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44130-3483', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Paramount Medical Research and Consulting LLC', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '78745-1485', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Tekton Research Inc', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '76034-5913', 'city': 'Colleyville', 'state': 'Texas', 'country': 'United States', 'facility': 'Precision Comprehensive Clinical Research Solutions', 'geoPoint': {'lat': 32.88096, 'lon': -97.15501}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Metroplex Clinical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75150', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwest Rheumatology Research, LLC', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '24541-1222', 'city': 'Danville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Spectrum Medical, Inc', 'geoPoint': {'lat': 36.58597, 'lon': -79.39502}}, {'zip': 'C1426ABP', 'city': 'Ciudad Autónoma de Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Consultorios Médicos Dr. Doreski'}, {'zip': 'C1430EGF', 'city': 'Estomba', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Clínica Adventista Belgrano', 'geoPoint': {'lat': -38.34888, 'lon': -61.80345}}, {'zip': 'B1902COS', 'city': 'La Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Framingham Centro Médico', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': 'B1878DVB', 'city': 'Quilmes', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto CER S.A', 'geoPoint': {'lat': -34.72065, 'lon': -58.25454}}, {'zip': 'B1878GEG', 'city': 'Quilmes', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto de Investigaciones Clinicas Quilmes SRL', 'geoPoint': {'lat': -34.72065, 'lon': -58.25454}}, {'zip': 'T4000AXL', 'city': 'San Miguel de Tucumán', 'state': 'Tucumán Province', 'country': 'Argentina', 'facility': 'Centro Medico Privado de Reumatologia', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': 'T4000AXL', 'city': 'San Miguel de Tucumán', 'state': 'Tucumán Province', 'country': 'Argentina', 'facility': 'Consultorio de Investigaciones Reumatologicas', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': '115 27', 'city': 'Athens', 'country': 'Greece', 'facility': "Athens General Hospital 'G Gennimatas", 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '115 27', 'city': 'Athens', 'country': 'Greece', 'facility': 'Laiko General Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '411 10', 'city': 'Larissa', 'country': 'Greece', 'facility': 'University General Hospital of Larissa', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '546 36', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Kianous Stavros', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '500003', 'city': 'Secunderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Krishna Institute of Medical Sciences'}, {'zip': '380005', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'AES - AS - Panchshil Hospital - Ahmedabad', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '395010', 'city': 'Surat', 'state': 'Gujarat', 'country': 'India', 'facility': 'AES - AS - Unity Trauma Center and ICU - Unity Hospital - Surat', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '580021', 'city': 'Hubli', 'state': 'Karnataka', 'country': 'India', 'facility': 'AES - AS - Sushruta Multispeciality Hospital & Research Center Pvt Ltd - Hubli', 'geoPoint': {'lat': 17.58662, 'lon': 76.51148}}, {'zip': '440012', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Jasleen Hospital', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '21200', 'city': 'Mexicali', 'state': 'Estado de Baja California', 'country': 'Mexico', 'facility': 'Centro de Investigación en Artritis y Osteoporosis', 'geoPoint': {'lat': 32.62781, 'lon': -115.45446}}, {'zip': '37000', 'city': 'León', 'state': 'Guanajuato', 'country': 'Mexico', 'facility': 'Morales Vargas Centro de Investigacion SC', 'geoPoint': {'lat': 21.12908, 'lon': -101.67374}}, {'zip': '44160', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '45030', 'city': 'Zapopan', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.', 'geoPoint': {'lat': 20.72111, 'lon': -103.38742}}, {'zip': '11850', 'city': 'San Miguel', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Centro de Investigación y Tratamiento Reumatológico S.C', 'geoPoint': {'lat': 19.39182, 'lon': -99.11795}}, {'zip': '97000', 'city': 'Mérida', 'state': 'Yucatán', 'country': 'Mexico', 'facility': 'Centro Peninsular de Investigacion S.C.P', 'geoPoint': {'lat': 20.967, 'lon': -89.62318}}, {'zip': '06760', 'city': 'Distrito Federal', 'country': 'Mexico', 'facility': 'AMAF Clinical Research,S.C.', 'geoPoint': {'lat': 16.59, 'lon': -93.02694}}, {'zip': '44600', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Clinica de Investigacion en Reumatologia y Obesidad', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44690', 'city': 'Jalisco', 'country': 'Mexico', 'facility': 'Centro de Estudios de Investigacion Basica Y Clinica SC', 'geoPoint': {'lat': 16.43033, 'lon': -91.97499}}, {'zip': '07760', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Consultorio de Reumatologia', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '61-545', 'city': 'Poznan', 'state': 'Greater Poland Voivodeship', 'country': 'Poland', 'facility': 'Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '30-363', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'Centrum Medyczne Plejady', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '30-510', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'Pratia MCM', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '67-100', 'city': 'Nowa Sól', 'state': 'Lubusz Voivodeship', 'country': 'Poland', 'facility': 'Twoja Przychodnia - Centrum Medyczne Nowa Sol', 'geoPoint': {'lat': 51.80333, 'lon': 15.71702}}, {'zip': '05-830', 'city': 'Nadarzyn', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'NZOZ Lecznica MAK-MED', 'geoPoint': {'lat': 52.09438, 'lon': 20.80776}}, {'zip': '00-874', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Medycyna Kliniczna Marzena Waszczak-Jeka', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '03-291', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Centrum Medyczne AMED', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '42-200', 'city': 'Częstochowa', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Centrum Medyczne Czestochowa - PRATIA', 'geoPoint': {'lat': 50.79646, 'lon': 19.12409}}, {'zip': '85-065', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Nasz Lekarz Osrodek Badan Klinicznych', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '91-365', 'city': 'Lodz', 'state': 'Łódź Voivodeship', 'country': 'Poland', 'facility': 'Centrym Medyczne AMED oddzial w Lodzi', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '650066', 'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Belyayev Clinical Hospital of the Kuzbass', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '111539', 'city': 'Moscow', 'country': 'Russia', 'facility': 'O.M. Filatov City Clinical Hospital #15', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '214025', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'Departmental Hospital at Smolensk Station "rzhd" JSC', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Institute of Rheumatology Belgrade', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Military Medical Academy', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '34000', 'city': 'Kragujevac', 'country': 'Serbia', 'facility': 'University Clinical Center Kragujevac', 'geoPoint': {'lat': 44.01667, 'lon': 20.91667}}, {'zip': '15006', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital Universitario A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '41010', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Quironsalud Infanta Luisa', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '81362', 'city': 'Kaohsiung City', 'state': 'Province of China', 'country': 'Taiwan', 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '100', 'city': 'Taipei', 'state': 'Province of China', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'state': 'Province of China', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital, Linkou', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'zip': '69005', 'city': 'Zaporizhzhia', 'state': 'Zaporizhzhia Oblast', 'country': 'Ukraine', 'facility': 'Medical Center of LLC Modern Clinic', 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}, {'zip': '04050', 'city': 'Kiyiv', 'country': 'Ukraine', 'facility': 'Limited Liability Company Medical Center Consilium', 'geoPoint': {'lat': 47.86401, 'lon': 31.02245}}, {'zip': '36024', 'city': 'Poltava', 'country': 'Ukraine', 'facility': 'ME Poltava Reg.Clin.Hospital n.a.M.V.Skliphosovskyi of Poltava Reg.Council', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}, {'name': 'Nisha Jain, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Horizon Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}