Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04212169
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2019-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Pooled Placebo', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 29, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 11, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 14, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 25, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 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'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dermatitis infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Eczema infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urine analysis abnormal', 'stats': [{'groupId': 'EG000', 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'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dermatitis exfoliative generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Medical device removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline to Week 16 in EASI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'title': 'Percent change from baseline to Week 16 in EASI score analysed using MCP-mod dose response model', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No dose response model selected from the MCP-mod analysis because the dose response was absent', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No dose response model selected from the MCP-mod analysis because the dose response was absent', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No dose response model selected from the MCP-mod analysis because the dose response was absent', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No dose response model selected from the MCP-mod analysis because the dose response was absent', 'groupId': 'OG003'}]}]}, {'title': 'Percent change from baseline to Week 16 in EASI score analysed using a repeated measures mixed model', 'categories': [{'measurements': [{'value': '-51.31', 'spread': '5.214', 'groupId': 'OG000'}, {'value': '-50.03', 'spread': '7.419', 'groupId': 'OG001'}, {'value': '-45.43', 'spread': '8.402', 'groupId': 'OG002'}, {'value': '-53.02', 'spread': '4.858', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.888', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.27', 'ciLowerLimit': '-13.67', 'ciUpperLimit': '16.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.981', 'estimateComment': 'Differences less than 0 favours MEDI3506', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.549', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.87', 'ciLowerLimit': '-10.36', 'ciUpperLimit': '22.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.756', 'estimateComment': 'Differences less than 0 favours MEDI3506', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.807', 'groupIds': ['OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.72', 'ciLowerLimit': '-13.38', 'ciUpperLimit': '9.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.014', 'estimateComment': 'Differences less than 0 favours MEDI3506', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 16', 'description': 'The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model.', 'unitOfMeasure': 'Percentage of change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Data after study withdrawal or use of rescue therapy was excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 90% reduction from baseline in EASI score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Subjects who discontinued IP, withdrew from study or used rescue medication were considered as non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.6396', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.53', 'ciLowerLimit': '0.19', 'ciUpperLimit': '9.94', 'estimateComment': 'Odds ratio greater than 1 favours MEDI3506', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9999', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.76', 'ciLowerLimit': '0.03', 'ciUpperLimit': '6.38', 'estimateComment': 'Odds ratio greater than 1 favours MEDI3506', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0935', 'groupIds': ['OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.89', 'ciLowerLimit': '0.91', 'ciUpperLimit': '10.49', 'estimateComment': 'Odds ratio greater than 1 favours MEDI3506', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 75% reduction from baseline in EASI score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Subjects who discontinued IP, withdrew from study or used rescue medication were considered as non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 50% reduction from baseline in EASI score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Subjects who discontinued IP, withdrew from study or used rescue medication were considered as non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'title': 'IGA response rate at Week 16', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'IGA response rate at Week 16 using MCP-Mod dose-response analysis', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No dose response model was selected from MCP-mod analysis due to logistic regression not converging', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No dose response model was selected from MCP-mod analysis due to logistic regression not converging', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'No dose response model was selected from MCP-mod analysis due to logistic regression not converging', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No dose response model was selected from MCP-mod analysis due to logistic regression not converging', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.4450', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.06', 'ciLowerLimit': '0.08', 'ciUpperLimit': '119.65', 'estimateComment': 'Odds ratio greater than one favour MEDI3506', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9999', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '28.0', 'estimateComment': 'Odds ratio greater than 1 favours MEDI3506', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1132', 'groupIds': ['OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.50', 'ciLowerLimit': '0.75', 'ciUpperLimit': '130.35', 'estimateComment': 'Odds ratio greater than 1 favours MEDI3506', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'The IGA allows investigators to assess overall AD disease severity at 1 given time point and consists of a 5-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Subjects who discontinued IP, withdrew from the study, or required rescue therapy were considered as non responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Subjects who withdrew from the study or required rescue therapy considered as non-responders.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.41', 'spread': '0.356', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '0.519', 'groupId': 'OG001'}, {'value': '-2.01', 'spread': '0.595', 'groupId': 'OG002'}, {'value': '-2.24', 'spread': '0.348', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, excluding missing data at baseline or week 16.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.44', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '-1.66', 'spread': '2.62', 'groupId': 'OG001'}, {'value': '-1.52', 'spread': '1.61', 'groupId': 'OG002'}, {'value': '-1.63', 'spread': '2.30', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Skin pain (ie, worst skin pain experienced in the previous 24 hours) assessed using an NRS (0 to 10) with 0 = no pain and 10 = worst imaginable pain. The daily assessments were summarised as a weekly mean.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, excluding missing data at baseline or week 16.'}, {'type': 'SECONDARY', 'title': 'SCORAD: Percent Change From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.79', 'spread': '25.09', 'groupId': 'OG000'}, {'value': '-29.88', 'spread': '23.14', 'groupId': 'OG001'}, {'value': '-36.22', 'spread': '25.34', 'groupId': 'OG002'}, {'value': '-39.42', 'spread': '25.44', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'SCORAD is a clinical tool for assessing the severity of AD that evaluates the extent and intensity of AD lesions, in addition to subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.', 'unitOfMeasure': 'Percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, excluding missing data at baseline or week 16.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.81', 'spread': '17.09', 'groupId': 'OG000'}, {'value': '-11.07', 'spread': '10.92', 'groupId': 'OG001'}, {'value': '-9.46', 'spread': '13.23', 'groupId': 'OG002'}, {'value': '-23.13', 'spread': '19.35', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Change in percentage of body surface area (BSA) affected by AD from baseline at week 16.', 'unitOfMeasure': 'Percentage of body surface area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, excluding missing data at baseline or week 16.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in DLQI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.9', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '6.5', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '4.9', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '4.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': "The Dermatology Life Quality Index (DLQI) is a 10-item, patient- completed, health-related quality of life assessment of dermatology conditions with a recall period of 1 week. Each item is scored on a 4-point Likert scale with 0 = not at all ⁄not relevant, 1 = a little, 2 = a lot, and 3 = very much. The score from each item is summed, and the maximum total score is 30 while the minimum score is 0. Higher score means highest (adverse) effect on participant's life.", 'unitOfMeasure': 'Scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, excluding missing data at baseline or week 16.'}, {'type': 'SECONDARY', 'title': 'Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'title': 'No symptoms', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Very mild', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Very severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'The Patient Global Impression of Severity (PGI-S) is a tool that allows patients to rate the severity of a condition over the past 7 days with response options of "No symptoms", "Very mild", "Mild", "Moderate", "Severe" and "Very severe".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in POEM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.4', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '-3.7', 'spread': '8.7', 'groupId': 'OG002'}, {'value': '-6.3', 'spread': '6.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'The Patient-Oriented Eczema Measure (POEM) is a 7-item questionnaire for assessing disease symptoms including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping occurring in the past week. Each item is scored on a 5-point scale with 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = every day. The total POEM score is calculated by summing the score of each item resulting in a maximum of 28 and a minimum of 0, with higher values indicating severe disease', 'unitOfMeasure': 'Scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, excluding missing data at baseline or week 16.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in 5-D Itch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '3.4', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': '5.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'The 5-D Itch Scale is a questionnaire consisting of 5 items used specifically to measure the course of itch by asking for the degree, duration, disability and distribution of the pruritus within the last 2 weeks. The scores from each item are summed, with maximum score of 25 and minimum score of 5. Higher score represent worse outcome', 'unitOfMeasure': 'Scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, excluding missing data at baseline or week 16.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'title': 'At least one adverse event', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}, {'title': 'At least one investigational product related event', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'At least one event of ≥ grade 3 severity', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'At least one serious event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'At least one investigational product related serious event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 24 weeks', 'description': 'To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Oral or Tympanic Temperature Taken During Vital Signs Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '36.46', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '36.43', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '36.41', 'spread': '0.43', 'groupId': 'OG002'}, {'value': '36.52', 'spread': '0.39', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '36.49', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '36.71', 'spread': '0.41', 'groupId': 'OG001'}, {'value': '36.50', 'spread': '0.32', 'groupId': 'OG002'}, {'value': '36.47', 'spread': '0.39', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '36.44', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '36.63', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '36.55', 'spread': '0.42', 'groupId': 'OG002'}, {'value': '36.51', 'spread': '0.37', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 16 and week 24', 'description': 'Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.', 'unitOfMeasure': 'degrees C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure Taken During Vital Signs Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '117.7', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '119.3', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '123.8', 'spread': '9.9', 'groupId': 'OG002'}, {'value': '121.5', 'spread': '12.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '117.8', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '117.3', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '120.7', 'spread': '13.6', 'groupId': 'OG002'}, {'value': '119.8', 'spread': '10.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '118.9', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '117.6', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '120.1', 'spread': '15.1', 'groupId': 'OG002'}, {'value': '120.6', 'spread': '12.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 16 and week 24', 'description': 'Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Heart Rate Taken During Vital Signs Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '68.1', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '66.6', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '71.3', 'spread': '9.3', 'groupId': 'OG002'}, {'value': '68.2', 'spread': '11.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '69.4', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '66.9', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '65.9', 'spread': '8.6', 'groupId': 'OG002'}, {'value': '66.4', 'spread': '11.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '72.0', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '67.0', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '74.1', 'spread': '8.7', 'groupId': 'OG002'}, {'value': '67.6', 'spread': '10.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 16 and week 24', 'description': 'Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.', 'unitOfMeasure': 'Pulse Rate (beats/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Respiratory Rate Collected During Vital Signs Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.4', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '16.2', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '15.5', 'spread': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': 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'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'At Least One Post-Baseline Value Above ULN', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}, {'title': 'Values within normal range', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'Hematocrit', 'categories': [{'title': 'At Least One Post-Baseline Value Below LLN', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': 'At Least One Post-Baseline Value Above ULN', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, 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'categories': [{'title': 'At Least One Post-Baseline Value Below LLN', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}, {'title': 'At Least One Post-Baseline Value Above ULN', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Values within normal range', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}]}, {'title': 'Monocytes', 'categories': [{'title': 'At Least One Post-Baseline Value Below LLN', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'At Least One Post-Baseline Value Above ULN', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Values within normal range', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}, {'title': 'Platelet count', 'categories': [{'title': 'At Least One Post-Baseline Value Below LLN', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'At Least One Post-Baseline Value Above ULN', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Values within normal range', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 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{'title': 'At Least One Post-Baseline Value Above ULN', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Values within normal range', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin', 'categories': [{'title': 'At Least One Post-Baseline Value Below LLN', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'At Least One Post-Baseline Value Above ULN', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Values within normal range', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}]}, {'title': 'Urea Nitrogen', 'categories': [{'title': 'At Least One Post-Baseline Value Below LLN', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'At Least One Post-Baseline Value Above ULN', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': 'Values within normal range', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine', 'categories': [{'title': 'At Least One Post-Baseline Value Below LLN', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': 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'groupId': 'OG003'}]}, {'title': 'At Least One Post-Baseline Value Above ULN', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Values within normal range', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}]}, {'title': 'Erythrocytes', 'categories': [{'title': 'At Least One Post-Baseline Value Below LLN', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'At Least One Post-Baseline Value Above ULN', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Values within normal range', 'measurements': [{'value': 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'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'At Least One Post-Baseline Value Above ULN', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Values within normal range', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 24 weeks', 'description': 'To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Heart Rate (Beats/Min) Recorded on ECGs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.59', 'spread': '9.82', 'groupId': 'OG000'}, {'value': '65.61', 'spread': '6.87', 'groupId': 'OG001'}, {'value': '72.63', 'spread': '9.82', 'groupId': 'OG002'}, {'value': '65.18', 'spread': '9.43', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '66.02', 'spread': '9.97', 'groupId': 'OG000'}, {'value': '63.80', 'spread': '8.56', 'groupId': 'OG001'}, {'value': '65.42', 'spread': '9.08', 'groupId': 'OG002'}, {'value': '63.05', 'spread': '10.61', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '68.17', 'spread': '13.94', 'groupId': 'OG000'}, {'value': '63.88', 'spread': '10.41', 'groupId': 'OG001'}, {'value': '72.46', 'spread': '9.12', 'groupId': 'OG002'}, {'value': '64.58', 'spread': '9.43', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 16 and week 24', 'description': 'Collectively with other ECG parameters are used t assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'QT (Miliseconds) Recorded on ECGs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '385.43', 'spread': '27.75', 'groupId': 'OG000'}, {'value': '390.67', 'spread': '20.57', 'groupId': 'OG001'}, {'value': '380.04', 'spread': '26.38', 'groupId': 'OG002'}, {'value': '390.27', 'spread': '22.69', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '387.05', 'spread': '26.14', 'groupId': 'OG000'}, {'value': '390.40', 'spread': '24.24', 'groupId': 'OG001'}, {'value': '395.75', 'spread': '20.36', 'groupId': 'OG002'}, {'value': '391.95', 'spread': '29.22', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '385.88', 'spread': '34.31', 'groupId': 'OG000'}, {'value': '398.69', 'spread': '28.52', 'groupId': 'OG001'}, {'value': '383.15', 'spread': '19.05', 'groupId': 'OG002'}, {'value': '393.40', 'spread': '26.54', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 16 and week 24', 'description': 'Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': "Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance", 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'title': 'Week 16', 'categories': [{'title': 'Abnormal ECG: Clinically significant', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal ECG: Not Clinically significant', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}, {'title': 'Normal ECG', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}, {'title': 'Missing', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'categories': [{'title': 'Abnormal ECG: Clinically significant', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal ECG: Not Clinically significant', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}, {'title': 'Normal ECG', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}, {'title': 'Missing', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16 and week 24', 'description': 'Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Ejection Fraction Measured by Echocardiogram', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64.3', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '64.7', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '62.8', 'spread': '5.2', 'groupId': 'OG002'}, {'value': '63.6', 'spread': '4.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64.3', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '63.0', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '61.0', 'spread': '3.6', 'groupId': 'OG002'}, {'value': '65.2', 'spread': '5.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 16', 'description': 'To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.', 'unitOfMeasure': '% LVEF', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}, {'type': 'SECONDARY', 'title': 'Serum MEDI3506 Concentration Profiles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.377', 'spread': '242', 'groupId': 'OG000'}, {'value': '2.158', 'spread': '193', 'groupId': 'OG001'}, {'value': '5.979', 'spread': '118', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.018', 'spread': '184', 'groupId': 'OG000'}, {'value': '0.118', 'spread': '298', 'groupId': 'OG001'}, {'value': '0.188', 'spread': '234', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 16 and week 24', 'description': 'To evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'OG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'OG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'classes': [{'title': 'Baseline ADA result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Post-baseline ADA result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 24 weeks', 'description': 'To evaluate the immunogenicity of MEDI3506 in adult subjects with moderate-to-severe AD.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As-treated population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'FG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'FG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'FG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Other reason, unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '148', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Pooled Placebo'}, {'id': 'BG001', 'title': 'MEDI3506 Dose 1', 'description': 'MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'BG002', 'title': 'MEDI3506 Dose 2', 'description': 'MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'BG003', 'title': 'MEDI3506 Dose 3', 'description': 'MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.3', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '28.7', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '37.9', 'spread': '14.3', 'groupId': 'BG002'}, {'value': '34.6', 'spread': '11.8', 'groupId': 'BG003'}, {'value': '33.4', 'spread': '11.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'AMERICAN INDIAN OR ALASKA NATIVE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'ASIAN', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}, {'title': 'BLACK OR AFRICAN AMERICAN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'MULTIPLE CATEGORIES CHECKED', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'OTHER', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'WHITE', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '115', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'USA', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Eczema Area and Severity Index (EASI) score', 'classes': [{'categories': [{'measurements': [{'value': '28.81', 'spread': '8.90', 'groupId': 'BG000'}, {'value': '28.94', 'spread': '11.66', 'groupId': 'BG001'}, {'value': '28.36', 'spread': '11.87', 'groupId': 'BG002'}, {'value': '32.30', 'spread': '10.86', 'groupId': 'BG003'}, {'value': '30.07', 'spread': '10.43', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Eczema Area and Severity Index (EASI) score is a composite score of area of involvement and severity score of 4 different body areas. The severity score is based on erythema, oedema/papulation, excoriation and lichenification of 4 body areas which are head, trunk, upper limbs and lower limbs. The score ranges between 0 to 72 points. Higher EASI score indicates more severe disease.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-15', 'size': 7738119, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-19T05:22', 'hasProtocol': True}, {'date': '2022-06-08', 'size': 4394815, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-19T05:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigation product only will be prepared and administered by unmasked personnel. All subjects will receive the same number of injections at each dose.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomised to receive MEDI3506 dose 1, MEDI3506 Dose 2 or MEDI3506 dose 3 or placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-31', 'studyFirstSubmitDate': '2019-11-04', 'resultsFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2019-12-24', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-31', 'studyFirstPostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 16 in EASI Score', 'timeFrame': 'Week 16', 'description': 'The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16', 'timeFrame': 'Week 16', 'description': 'To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 90% reduction from baseline in EASI score.'}, {'measure': 'Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16', 'timeFrame': 'Week 16', 'description': 'To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 75% reduction from baseline in EASI score.'}, {'measure': 'Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16', 'timeFrame': 'Week 16', 'description': 'To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 50% reduction from baseline in EASI score.'}, {'measure': 'Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16', 'timeFrame': 'Week 16', 'description': 'The IGA allows investigators to assess overall AD disease severity at 1 given time point and consists of a 5-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease).'}, {'measure': 'Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS', 'timeFrame': 'Week 16', 'description': 'Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.'}, {'measure': 'Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS', 'timeFrame': 'Week 16', 'description': 'Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.'}, {'measure': 'Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS', 'timeFrame': 'Week 16', 'description': 'Skin pain (ie, worst skin pain experienced in the previous 24 hours) assessed using an NRS (0 to 10) with 0 = no pain and 10 = worst imaginable pain. The daily assessments were summarised as a weekly mean.'}, {'measure': 'SCORAD: Percent Change From Baseline to Week 16', 'timeFrame': 'Week 16', 'description': 'SCORAD is a clinical tool for assessing the severity of AD that evaluates the extent and intensity of AD lesions, in addition to subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.'}, {'measure': 'Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD', 'timeFrame': 'Week 16', 'description': 'Change in percentage of body surface area (BSA) affected by AD from baseline at week 16.'}, {'measure': 'Change From Baseline to Week 16 in DLQI', 'timeFrame': 'Week 16', 'description': "The Dermatology Life Quality Index (DLQI) is a 10-item, patient- completed, health-related quality of life assessment of dermatology conditions with a recall period of 1 week. Each item is scored on a 4-point Likert scale with 0 = not at all ⁄not relevant, 1 = a little, 2 = a lot, and 3 = very much. The score from each item is summed, and the maximum total score is 30 while the minimum score is 0. Higher score means highest (adverse) effect on participant's life."}, {'measure': 'Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16', 'timeFrame': 'Week 16', 'description': 'The Patient Global Impression of Severity (PGI-S) is a tool that allows patients to rate the severity of a condition over the past 7 days with response options of "No symptoms", "Very mild", "Mild", "Moderate", "Severe" and "Very severe".'}, {'measure': 'Change From Baseline to Week 16 in POEM', 'timeFrame': 'Week 16', 'description': 'The Patient-Oriented Eczema Measure (POEM) is a 7-item questionnaire for assessing disease symptoms including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping occurring in the past week. Each item is scored on a 5-point scale with 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = every day. The total POEM score is calculated by summing the score of each item resulting in a maximum of 28 and a minimum of 0, with higher values indicating severe disease'}, {'measure': 'Change From Baseline to Week 16 in 5-D Itch', 'timeFrame': 'Week 16', 'description': 'The 5-D Itch Scale is a questionnaire consisting of 5 items used specifically to measure the course of itch by asking for the degree, duration, disability and distribution of the pruritus within the last 2 weeks. The scores from each item are summed, with maximum score of 25 and minimum score of 5. Higher score represent worse outcome'}, {'measure': 'Occurrence of Adverse Events', 'timeFrame': 'up to 24 weeks', 'description': 'To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.'}, {'measure': 'Oral or Tympanic Temperature Taken During Vital Signs Assessment', 'timeFrame': 'Baseline, week 16 and week 24', 'description': 'Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.'}, {'measure': 'Systolic Blood Pressure Taken During Vital Signs Assessment', 'timeFrame': 'Baseline, week 16 and week 24', 'description': 'Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.'}, {'measure': 'Heart Rate Taken During Vital Signs Assessment', 'timeFrame': 'Baseline, week 16 and week 24', 'description': 'Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.'}, {'measure': 'Respiratory Rate Collected During Vital Signs Assessment', 'timeFrame': 'Baseline, week 16 and week 24', 'description': 'Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.'}, {'measure': 'Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology', 'timeFrame': 'up to 24 weeks', 'description': 'To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.'}, {'measure': 'Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry', 'timeFrame': 'up to 24 weeks', 'description': 'To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.'}, {'measure': 'Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis', 'timeFrame': 'up to 24 weeks', 'description': 'To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.'}, {'measure': 'Heart Rate (Beats/Min) Recorded on ECGs', 'timeFrame': 'Baseline, week 16 and week 24', 'description': 'Collectively with other ECG parameters are used t assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.'}, {'measure': 'QT (Miliseconds) Recorded on ECGs', 'timeFrame': 'Baseline, week 16 and week 24', 'description': 'Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.'}, {'measure': "Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance", 'timeFrame': 'Week 16 and week 24', 'description': 'Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.'}, {'measure': 'Left Ventricular Ejection Fraction Measured by Echocardiogram', 'timeFrame': 'Baseline and week 16', 'description': 'To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.'}, {'measure': 'Serum MEDI3506 Concentration Profiles', 'timeFrame': 'Week 16 and week 24', 'description': 'To evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.'}, {'measure': 'Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods', 'timeFrame': 'up to 24 weeks', 'description': 'To evaluate the immunogenicity of MEDI3506 in adult subjects with moderate-to-severe AD.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MEDI3506', 'Safety', 'Efficacy', 'Atopic Dermatitis', 'Eczema'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9182C00001&attachmentIdentifier=48b9bbe6-f0ed-437d-a775-dbb096d8d00a&fileName=d9182c00001-csp-amendment-9_Redacted_For_posting_Final.pdf&versionIdentifier=', 'label': 'Redacted CSP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9182C00001&attachmentIdentifier=8505791d-2be3-4bba-9073-9f92e0b31305&fileName=d9182c00001-sap-v3_Redacted_For_posting.pdf&versionIdentifier=', 'label': 'Redacted SAP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9182C00001&attachmentIdentifier=d9a38987-1db3-4e15-a11c-7f4b627341b5&fileName=d9182c00001-study-synopsis_Redacted_For_posting.pdf&versionIdentifier=', 'label': 'Redacted CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.', 'detailedDescription': 'This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.\n\nEach participant will be assigned randomly to a treatment arm, which could be different strengths of the active treatment or a placebo which does not contain active treatment. Both Participants and investigators will be masked to the treatment assignment.\n\nApproximately 152 participants will take part in this study. There is a 4 weeks screening period to determine eligibility. After eligibility is confirmed, participants will receive investigational drug or placebo during the 16 weeks treatment period. This is then followed by an 8-week follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 65 years inclusive at the time of consent.\n* Body mass index between 19.0 and 40.0 kg/m2 inclusive.\n* Documented history of chronic AD, for at least 1 year prior to screening Visit 1.\n* Meets at minimum 1 of the criteria, as follows:\n\n * History of inadequate response to topical medications for AD\n * Subject intolerance to treatment with topical medications for AD, or\n * Topical medications are otherwise medically inadvisable\n* AD that affects ≥ 10% of the body surface area (BSA).\n* An EASI score of ≥ 12 at Visit 1 and ≥ 16 at Visit 3 (Day 1).\n* An IGA score of ≥ 3.\n\nExclusion Criteria:\n\n* Any active medical or psychiatric condition, or other reason, that would interfere with evaluation of the investigational product or interpretation of subject safety or study results.\n* Any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram \\[ECG\\]) or from safety laboratory analysis.\n* Active dermatologic conditions that might confound the diagnosis of AD or would interfere with the assessment of the skin.\n* Known active allergic or irritant contact dermatitis.'}, 'identificationModule': {'nctId': 'NCT04212169', 'briefTitle': 'Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects With Moderate-to-severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'D9182C00001'}, 'secondaryIdInfos': [{'id': '2019-003304-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEDI3506 at dose level 1', 'description': 'Participant will receive multiple doses of MEDI3506 at dose level 1.', 'interventionNames': ['Drug: MEDI3506']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI3506 at dose level 2', 'description': 'Participant will receive multiple doses of MEDI3506 at dose level 2.', 'interventionNames': ['Drug: MEDI3506']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI3506 at dose level 3', 'description': 'Participant will receive multiple doses of MEDI3506 at dose level 3.', 'interventionNames': ['Drug: MEDI3506']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participant will receive multiple doses of Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MEDI3506', 'type': 'DRUG', 'description': 'multiple doses', 'armGroupLabels': ['MEDI3506 at dose level 1', 'MEDI3506 at dose level 2', 'MEDI3506 at dose level 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'multiple doses', 'armGroupLabels': 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For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.\n\nYes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. 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