Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-06 @ 8:24 AM
Study NCT ID:
NCT02962960
Status:
COMPLETED
Last Update Posted:
2023-01-12
First Post:
2016-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582345', 'term': 'anifrolumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'phone': '301-398-5799', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca AB'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 weeks', 'description': 'An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during the clinical study (from and including the day of first dose of investigational product, up to, and including, the date of last dose of investigational product pluts 14 days). This change may or may not be caused by the treatment being studied.', 'eventGroups': [{'id': 'EG000', 'title': 'Anifrolumab - Lower Dose', 'description': '1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 12, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Anifrolumab - Higher Dose', 'description': '2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 11, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo Comparator', 'description': 'Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 7, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abscess Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Acute Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Conjunctivitis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Panic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Myopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 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'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Nasal Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Nasal Septum Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 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'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Food Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Mouth Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Paraesthesia Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Spinal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Renal Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Anembryonic Gestation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Endometrial Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Face Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Feeling Hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Mycobacterium Tuberculosis Complex Test Positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Foot Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Spinal Compression Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Subcutaneous Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}], 'seriousEvents': [{'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Otitis Media Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Mouth Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Systemic Lupus Erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Lupus Nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Concentration of Anifrolumab in Serum After First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anifrolumab - Lower Dose', 'description': '1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50'}, {'id': 'OG001', 'title': 'Anifrolumab - Higher Dose', 'description': '2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50'}], 'classes': [{'categories': [{'measurements': [{'value': '14.058', 'spread': '49.8151', 'groupId': 'OG000'}, {'value': '28.115', 'spread': '74.4916', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0', 'description': 'Maximum concentration (Cmax) of anifrolumab is based on sample collected 5 to 8 days after the first dose of strudy treatment.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received anifrolumab and who had at least one quantifiable serum PK observation post first dose.'}, {'type': 'PRIMARY', 'title': 'Steady-state Serum Trough (Predose) Concentration (Ctrough) of Anifrolumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anifrolumab - Lower Dose', 'description': '1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50'}, {'id': 'OG001', 'title': 'Anifrolumab - Higher Dose', 'description': '2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50'}], 'classes': [{'categories': [{'measurements': [{'value': '15.618', 'spread': '81.3595', 'groupId': 'OG000'}, {'value': '16.926', 'spread': '9205.6677', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 12', 'description': 'Steady-state serum through concentration (Ctrough) is based on sample collected at Week 12 prior to dosing of study treatment (predose).', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received anifrolumab and who had at least one quantifiable serum PK observation post first dose.'}, {'type': 'PRIMARY', 'title': '21-gene Type 1 IFN Signature Score (Fold-change)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Anifrolumab - Lower Dose', 'description': '1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50'}, {'id': 'OG001', 'title': 'Anifrolumab - Higher Dose', 'description': '2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50'}, {'id': 'OG002', 'title': 'Placebo Comparator', 'description': 'Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '3.69', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '5.73', 'groupId': 'OG001'}, {'value': '14.3', 'spread': '6.68', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': '21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. Levels of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control.', 'unitOfMeasure': 'fold change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who are 21-gene IFN test high at baseline.'}, {'type': 'PRIMARY', 'title': '21-gene Type 1 IFN Neutralization Ratio (Percent Suppression of Fold Change)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Anifrolumab - Lower Dose', 'description': '1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50'}, {'id': 'OG001', 'title': 'Anifrolumab - Higher Dose', 'description': '2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50'}, {'id': 'OG002', 'title': 'Placebo Comparator', 'description': 'Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50'}], 'classes': [{'categories': [{'measurements': [{'value': '77.5', 'spread': '24.16', 'groupId': 'OG000'}, {'value': '80.5', 'spread': '36.65', 'groupId': 'OG001'}, {'value': '15.1', 'spread': '49.63', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': '21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. For each individual participant and assessment, the level of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control, as the median of 100-(((baseline-Week 12)/baseline)\\*100) for the 21 genes. At a population level, the results are presented as mean the above.', 'unitOfMeasure': 'percentage neutralization', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who are 21-gene IFN test high at baseline.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Antidrug Antibody (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Anifrolumab - Lower Dose', 'description': '1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50'}, {'id': 'OG001', 'title': 'Anifrolumab - Higher Dose', 'description': '2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50'}, {'id': 'OG002', 'title': 'Placebo Comparator', 'description': 'Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 52', 'description': 'Post-baseline ADA incidence based on the number of participants with Antidrug antibody (ADA)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Neutralizing Antibodies (nAb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Anifrolumab - Lower Dose', 'description': '1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50'}, {'id': 'OG001', 'title': 'Anifrolumab - Higher Dose', 'description': '2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50'}, {'id': 'OG002', 'title': 'Placebo Comparator', 'description': 'Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 52', 'description': 'Incidence of detectable nAb in post-baseline ADA positive participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).'}, {'type': 'SECONDARY', 'title': 'Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Anifrolumab - Lower Dose', 'description': '1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50'}, {'id': 'OG001', 'title': 'Anifrolumab - Higher Dose', 'description': '2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50'}, {'id': 'OG002', 'title': 'Placebo Comparator', 'description': 'Pooled placebo comparator to both anifrolumab lower and higher doses, adminstered as either 1ml (1 injection) or 2x1ml (2 injections), once every second week, as added to standar of case, from week 0 to week 50'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Any serious adverse event', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any adverse event of special interest', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 52', 'description': 'Number of participants with any AEs (Adverse events), any SAEs (serious adverse events), and any adverse events of special interest (AESI) are summarized. More details are reported in the Adverse Events section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Anifrolumab - Lower Dose', 'description': '1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50'}, {'id': 'OG001', 'title': 'Anifrolumab - Higher Dose', 'description': '2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50'}, {'id': 'OG002', 'title': 'Placebo Comparator to Lower Dose', 'description': 'Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50'}, {'id': 'OG003', 'title': 'Placebo Comparator to Higher Dose', 'description': 'Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50'}], 'classes': [{'title': 'Systolic Blood Pressure (mmHg) - Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '12.08', 'groupId': 'OG000'}, {'value': '3', 'spread': '6.63', 'groupId': 'OG001'}, {'value': '-5.8', 'spread': '13.99', 'groupId': 'OG002'}, {'value': '7.3', 'spread': '8.96', 'groupId': 'OG003'}]}]}, {'title': 'Systolic Blood Pressure (mmHg) - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '10.96', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '12.96', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '8.53', 'groupId': 'OG002'}, {'value': '12.5', 'spread': '19.36', 'groupId': 'OG003'}]}]}, {'title': 'Systolic Blood Pressure (mmHg) - Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '19.70', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '14.91', 'groupId': 'OG001'}, {'value': '12.2', 'spread': '8.61', 'groupId': 'OG002'}, {'value': '4.5', 'spread': '7.14', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic Blood Pressure (mmHg) - Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '10.02', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '6.71', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '6.50', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '4.35', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic Blood Pressure (mmHg) - Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '6.87', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '7.54', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '7.13', 'groupId': 'OG002'}, {'value': '6.8', 'spread': '5.38', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic Blood Pressure (mmHg) - Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '12.23', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '6.86', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '8.22', 'groupId': 'OG002'}, {'value': '8.8', 'spread': '6.29', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 60', 'description': 'Change from baseline for vital signs.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Anifrolumab - 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Abnormal (NCS) Week 52', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Normal baseline - not done Week 52', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal (NCS) baseline - Normal Week 52', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal (NCS) baseline - Abnormal (NCS) Week 52', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal (NCS) baseline - not done Week 52', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Not done baseline - Normal Week 52', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Not done baseline - Abnormal (NCS) Week 52', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Not done baseline - Not done Week 52', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Normal baseline - Abnormal (CS) Week 52', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal (NCS) baseline - Abnormal (CS) Week 52', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Not done baseline - 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Lower Dose', 'description': '1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50'}, {'id': 'OG001', 'title': 'Anifrolumab - Higher Dose', 'description': '2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50'}, {'id': 'OG002', 'title': 'Placebo Comparator to Lower Dose', 'description': 'Placebo comparator to anifrolumab lower dose, adminstered as 1ml (1 injection), once every second week, as added to standard of case, from week 0 to week 50'}, {'id': 'OG003', 'title': 'Placebo Comparator to Higher Dose', 'description': 'Placebo comparator to anifrolumab higher dose, adminstered as 2ml (2 injections), once every second week, as added to standard of case, from week 0 to week 50'}], 'classes': [{'title': 'Protein/Creatinine - Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.37029', 'spread': '5.186672', 'groupId': 'OG000'}, {'value': '-0.13007', 'spread': '1.123807', 'groupId': 'OG001'}, {'value': '-0.03056', 'spread': '0.056701', 'groupId': 'OG002'}, {'value': '0.32764', 'spread': '0.337631', 'groupId': 'OG003'}]}]}, {'title': 'Protein/Creatinine - 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'1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-20', 'size': 5573044, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-19T09:53', 'hasProtocol': True}, {'date': '2018-02-27', 'size': 491006, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-07-11T07:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'dispFirstSubmitDate': '2018-09-04', 'completionDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-19', 'studyFirstSubmitDate': '2016-09-23', 'dispFirstSubmitQcDate': '2018-09-12', 'resultsFirstSubmitDate': '2019-07-11', 'studyFirstSubmitQcDate': '2016-11-09', 'dispFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-16', 'studyFirstPostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Concentration of Anifrolumab in Serum After First Dose', 'timeFrame': 'Week 0', 'description': 'Maximum concentration (Cmax) of anifrolumab is based on sample collected 5 to 8 days after the first dose of strudy treatment.'}, {'measure': 'Steady-state Serum Trough (Predose) Concentration (Ctrough) of Anifrolumab', 'timeFrame': 'Week 12', 'description': 'Steady-state serum through concentration (Ctrough) is based on sample collected at Week 12 prior to dosing of study treatment (predose).'}, {'measure': '21-gene Type 1 IFN Signature Score (Fold-change)', 'timeFrame': 'Week 12', 'description': '21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. Levels of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control.'}, {'measure': '21-gene Type 1 IFN Neutralization Ratio (Percent Suppression of Fold Change)', 'timeFrame': 'Week 12', 'description': '21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. For each individual participant and assessment, the level of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control, as the median of 100-(((baseline-Week 12)/baseline)\\*100) for the 21 genes. At a population level, the results are presented as mean the above.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Antidrug Antibody (ADA)', 'timeFrame': 'Baseline to Week 52', 'description': 'Post-baseline ADA incidence based on the number of participants with Antidrug antibody (ADA)'}, {'measure': 'Number of Participants With Neutralizing Antibodies (nAb)', 'timeFrame': 'Baseline to Week 52', 'description': 'Incidence of detectable nAb in post-baseline ADA positive participants.'}, {'measure': 'Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI)', 'timeFrame': 'Baseline to Week 52', 'description': 'Number of participants with any AEs (Adverse events), any SAEs (serious adverse events), and any adverse events of special interest (AESI) are summarized. More details are reported in the Adverse Events section.'}, {'measure': 'Change From Baseline for Vital Signs', 'timeFrame': 'Baseline to Week 60', 'description': 'Change from baseline for vital signs.'}, {'measure': 'Change From Baseline for Physical Examination', 'timeFrame': 'Baseline to Week 60', 'description': 'Physical examination is reported as change from baseline in body weight.'}, {'measure': 'Change From Baseline for 12-lead ECG', 'timeFrame': 'Baseline to Week 52', 'description': 'The 12-lead ECG measurements were assessed by the investigators, and reported as normal, abnormal (not clinically significant \\[NCS\\]), abnormal (clinically significant \\[CS\\]), or not done.'}, {'measure': 'Value of Haemoglobin Blood Test to Detect Change From Baseline', 'timeFrame': 'Baseline to Week 60', 'description': 'Change from baseline in haemoglobin blood tests are reported.'}, {'measure': 'Value of Haematology Blood Tests to Detect Change From Baseline', 'timeFrame': 'Baseline to Week 60', 'description': 'Change from baseline in haematology blood tests (leucocytes \\[particle concentration\\], platelets \\[particle concentration\\]) are reported.'}, {'measure': 'Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline', 'timeFrame': 'Baseline to Week 60', 'description': 'Change from baseline in protein-creatinine ratio urinalysis tests are reported.'}, {'measure': 'Value of Total Protein Urinalysis Test to Detect Change From Baseline', 'timeFrame': 'Baseline to Week 60', 'description': 'Change from baseline in total protein urinalysis tests are reported.'}, {'measure': 'Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum)', 'timeFrame': 'Baseline to Week 60', 'description': 'Change from baseline in clinical chemistry blood tests (Alanine Aminotransferase, Aspartate Aminotransferase) are reported.'}, {'measure': 'Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum)', 'timeFrame': 'Baseline to Week 60', 'description': 'Change from baseline in clinical creatinine chemistry blood tests (serum) are reported.'}, {'measure': 'Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline', 'timeFrame': 'Baseline to Week 60', 'description': 'Change from baseline in the Erythrocyte Sedimentation Rate (ESR) inflammatory marker is reported.'}, {'measure': 'Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline', 'timeFrame': 'Baseline to Week 60', 'description': 'Change from baseline in Anti-Double Stranded DNA IgG (anti-dsDNA) is reported.'}, {'measure': 'Number of Participants With Positive Hepatitis B Core Antibody Post-baseline.', 'timeFrame': 'Baseline to Week 60', 'description': 'Change from screening in Hepatitis B core antibody was monitored during the study for participants tested positive at screening.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '38279367', 'type': 'DERIVED', 'citation': 'Bruce IN, Nami A, Schwetje E, Pierson ME, Rouse T, Chia YL, Kuruvilla D, Abreu G, Tummala R, Lindholm C. Pharmacokinetics, pharmacodynamics, and safety of subcutaneous anifrolumab in patients with systemic lupus erythematosus, active skin disease, and high type I interferon gene signature: a multicentre, randomised, double-blind, placebo-controlled, phase 2 study. Lancet Rheumatol. 2021 Feb;3(2):e101-e110. doi: 10.1016/S2665-9913(20)30342-8. Epub 2020 Nov 20.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3461C00008&attachmentIdentifier=6978de0c-751d-42dc-991c-5a41f7df59f4&fileName=D3461c00008_sap_redacted.pdf&versionIdentifier=', 'label': 'SAP redacted'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and tolerability of anifrolumab given via the subcutaneous (SC) route of administration in adult Systemic Lupus Erythematosus (SLE) subjects with a type I Interferon (IFN) test high result and active skin manifestations while receiving Standard of Care (SOC) treatment. In addition, the efficacy of anifrolumab on SLE skin manifestations will be characterized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 through 70 years\n2. Diagnosis of paediatric or adult SLE for \\> 24 weeks and fulfilling ≥4 of the 11 American College of Rheumatology (ACR) classification criteria with at least one being:\n\n * Positive antinuclear antibody (ANA) or\n * Elevated anti-dsDNA antibodies or\n * anti-Smith (anti-Sm) antibodies\n3. Interferon high test result\n4. Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10\n5. Currently receiving at least 1 of the following for treatment of SLE:\n\n • Oral prednisone or equivalent of ≤40 mg/day for a minimum of 2 weeks prior to signing the Informed Consent Form (ICF) and with stable dose for at least 2 weeks prior to randomization\n\n • Any of the following medications for at least 12 weeks prior to signing the ICF, and at a stable doses for at least 8 weeks prior to randomization: (i) Azathioprine ≤200 mg/day (ii) Antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine) (iii) Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day (iv) Oral, subcutaneous (SC), or intramuscular methotrexate ≤25 mg/week (v) Mizoribine ≤150 mg/day\n6. Must not have signs of active or latent tuberculosis (TB).\n7. Must not be pregnant or breastfeeding.\n\nExclusion Criteria:\n\n1. Active severe or unstable neuropsychiatric SLE\n2. Active severe SLE-driven renal disease\n3. Any severe herpes infection at any time\n4. Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or HIV infection.\n5. Known history of a primary immunodeficiency (splenectomy, or any underlying condition predisposing for infection\n6. Receipt of any investigation product within 4 weeks or 5 half -lives prior to signing of the ICF\n7. History of cancer, apart from:\n\n * Squamous or basal cell carcinoma of the skin if successfully treated.\n * Cervical cancer in situ if successfully treated'}, 'identificationModule': {'nctId': 'NCT02962960', 'briefTitle': 'A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Following Subcutaneous Administration in Adult Systemic Lupus Erythematosus Subjects With Type I Interferon Test High Result and Active Skin Manifestations.', 'orgStudyIdInfo': {'id': 'D3461C00008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anifrolumab - Lower dose', 'description': '1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50', 'interventionNames': ['Drug: Anifrolumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo matching for lower dose of Anifrolumab', 'description': '1ml, once every second week, one subcutaneous injection added to stand of care, from week 0 to week 50', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Anifrolumab - Higher dose', 'description': '2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50', 'interventionNames': ['Drug: Anifrolumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo matching for higher dose of Anifrolumab', 'description': '2×1ml , once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Anifrolumab', 'type': 'DRUG', 'description': 'subcutaneous administration every 2 weeks from week 0 to week 50', 'armGroupLabels': ['Anifrolumab - Higher dose', 'Anifrolumab - Lower dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'subcutaneous administration every two weeks from week 0 to week 50', 'armGroupLabels': ['Placebo matching for higher dose of Anifrolumab', 'Placebo matching for lower dose of Anifrolumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91360', 'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '32810', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77034', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '8900', 'city': 'Zalaegerszeg', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.83695, 'lon': 16.84401}}, {'zip': '85-168', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '00-874', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '14068', 'city': 'Anyang-si', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}, {'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '41944', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '61469', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}