Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-02-06 @ 3:41 AM
Study NCT ID:
NCT02277769
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2014-10-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@regeneron.com', 'title': 'Clinical Trial Management', 'organization': 'Regeneron Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': "Not less than 45 days prior to submission for publication or presentation, the Institution shall, or cause the Principal Investigator to, provide the Sponsor with a copy of the Manuscript. The Institution shall consider in good faith any comments from the Sponsor regarding the content, and shall delete Confidential Information upon written request of the Sponsor. At the Sponsor's request, the Institution shall delay publication for an additional 60 days to allow patent applications to be filed.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product.', 'description': "Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \\[Week 28\\]). Analysis was performed on safety population.", 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants exposed to Placebo (for Dupilumab) for 16 weeks (mean exposure of 14 weeks)', 'otherNumAtRisk': 234, 'deathsNumAtRisk': 234, 'otherNumAffected': 109, 'seriousNumAtRisk': 234, 'deathsNumAffected': 0, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Participants exposed to Dupilumab 300 mg alternating with placebo qw for 16 weeks (mean exposure of 15 weeks).', 'otherNumAtRisk': 236, 'deathsNumAtRisk': 236, 'otherNumAffected': 84, 'seriousNumAtRisk': 236, 'deathsNumAffected': 3, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Participants exposed to Dupilumab 300 mg qw for 16 weeks (mean exposure of 15 weeks).', 'otherNumAtRisk': 237, 'deathsNumAtRisk': 237, 'otherNumAffected': 90, 'seriousNumAtRisk': 237, 'deathsNumAffected': 1, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 58, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 84, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 20, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 29, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 50, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 136, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 39, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 49, 'numAffected': 39}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Angle closure glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Colonic pseudo-obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Endocarditis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Septic embolus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Tetany', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': "Hodgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Hypoxic-Ischaemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Schizophrenia, paranoid type', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}, {'term': 'Dermatitis exfoliative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'meddra (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Investigator\'s Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '239', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}, {'value': '36.1', 'groupId': 'OG001'}, {'value': '36.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.6', 'ciLowerLimit': '20.46', 'ciUpperLimit': '34.69', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.9', 'ciLowerLimit': '20.87', 'ciUpperLimit': '34.99', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '239', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000'}, {'value': '44.2', 'groupId': 'OG001'}, {'value': '48.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.3', 'ciLowerLimit': '24.75', 'ciUpperLimit': '39.94', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.3', 'ciLowerLimit': '28.69', 'ciUpperLimit': '43.81', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}, {'value': '36.0', 'groupId': 'OG001'}, {'value': '39.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.5', 'ciLowerLimit': '19.13', 'ciUpperLimit': '33.87', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.5', 'ciLowerLimit': '22.11', 'ciUpperLimit': '36.95', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': "Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement (Reduction ≥3 Points) in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}, {'value': '50.6', 'groupId': 'OG001'}, {'value': '49.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.8', 'ciLowerLimit': '30.03', 'ciUpperLimit': '45.60', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.3', 'ciLowerLimit': '28.56', 'ciUpperLimit': '44.06', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': "Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥3.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (NRS) Score to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.1', 'spread': '27.66', 'groupId': 'OG000'}, {'value': '-47.2', 'spread': '28.50', 'groupId': 'OG001'}, {'value': '-50.9', 'spread': '30.56', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.9', 'ciLowerLimit': '-36.04', 'ciUpperLimit': '-21.83', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.8', 'ciLowerLimit': '-40.20', 'ciUpperLimit': '-25.49', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': "Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]).", 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '22.7', 'groupId': 'OG001'}, {'value': '27.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.3', 'ciLowerLimit': '9.99', 'ciUpperLimit': '22.68', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.3', 'ciLowerLimit': '14.66', 'ciUpperLimit': '27.93', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 4', 'description': "Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}, {'value': '12.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.8', 'ciLowerLimit': '5.54', 'ciUpperLimit': '13.98', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.8', 'ciLowerLimit': '7.31', 'ciUpperLimit': '16.32', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 2', 'description': "Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.41', 'spread': '1.973', 'groupId': 'OG000'}, {'value': '-3.56', 'spread': '2.258', 'groupId': 'OG001'}, {'value': '-3.87', 'spread': '2.426', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.10', 'ciLowerLimit': '-2.605', 'ciUpperLimit': '-1.587', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.47', 'ciLowerLimit': '-2.982', 'ciUpperLimit': '-1.957', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': "Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.7', 'spread': '33.45', 'groupId': 'OG000'}, {'value': '-69.6', 'spread': '27.84', 'groupId': 'OG001'}, {'value': '-71.6', 'spread': '27.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.2', 'ciLowerLimit': '-43.46', 'ciUpperLimit': '-28.86', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.2', 'ciLowerLimit': '-45.55', 'ciUpperLimit': '-30.88', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '239', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000'}, {'value': '65.2', 'groupId': 'OG001'}, {'value': '61.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.2', 'ciLowerLimit': '35.12', 'ciUpperLimit': '51.29', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.1', 'ciLowerLimit': '30.92', 'ciUpperLimit': '47.19', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 16 were considered as non-responders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '239', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.8', 'ciLowerLimit': '16.09', 'ciUpperLimit': '29.59', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.3', 'ciLowerLimit': '16.63', 'ciUpperLimit': '30.05', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-90 scores at Week 16 were considered as non-responders.', 'unitOfMeasure': 'percentage of particpants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent Body Surface Area (BSA) to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.48', 'spread': '17.810', 'groupId': 'OG000'}, {'value': '-31.69', 'spread': '19.614', 'groupId': 'OG001'}, {'value': '-32.97', 'spread': '20.400', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.99', 'ciLowerLimit': '-22.062', 'ciUpperLimit': '-13.927', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.51', 'ciLowerLimit': '-23.491', 'ciUpperLimit': '-15.529', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck \\[9%\\], anterior trunk \\[18%\\], back \\[18%\\], upper limbs \\[18%\\], lower limbs \\[36%\\], and genitals \\[1%\\]). It was reported as a percentage of all major body sections combined.', 'unitOfMeasure': 'percentage of body surface area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.7', 'spread': '25.48', 'groupId': 'OG000'}, {'value': '-53.5', 'spread': '25.23', 'groupId': 'OG001'}, {'value': '-56.0', 'spread': '25.53', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-31.4', 'ciLowerLimit': '-37.36', 'ciUpperLimit': '-25.40', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33.8', 'ciLowerLimit': '-39.75', 'ciUpperLimit': '-27.80', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.0', 'spread': '5.75', 'groupId': 'OG000'}, {'value': '-9.7', 'spread': '6.20', 'groupId': 'OG001'}, {'value': '-10.3', 'spread': '6.75', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.7', 'ciLowerLimit': '-6.86', 'ciUpperLimit': '-4.47', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.9', 'ciLowerLimit': '-7.10', 'ciUpperLimit': '-4.72', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.8', 'spread': '6.07', 'groupId': 'OG000'}, {'value': '-10.7', 'spread': '6.89', 'groupId': 'OG001'}, {'value': '-11.7', 'spread': '7.13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.0', 'ciLowerLimit': '-8.36', 'ciUpperLimit': '-5.57', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.0', 'ciLowerLimit': '-9.36', 'ciUpperLimit': '-6.64', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life \\[QOL\\]).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '4.44', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '5.42', 'groupId': 'OG001'}, {'value': '-6.2', 'spread': '6.01', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-5.34', 'ciUpperLimit': '-3.09', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-6.04', 'ciUpperLimit': '-3.81', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.3', 'spread': '25.03', 'groupId': 'OG000'}, {'value': '-47.5', 'spread': '27.0', 'groupId': 'OG001'}, {'value': '-48.4', 'spread': '27.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.7', 'ciLowerLimit': '-33.73', 'ciUpperLimit': '-21.70', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.9', 'ciLowerLimit': '-35.03', 'ciUpperLimit': '-22.74', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Weekly Average of Peak Daily Pruritus NRS Score to Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.3', 'spread': '21.91', 'groupId': 'OG000'}, {'value': '-24.1', 'spread': '21.22', 'groupId': 'OG001'}, {'value': '-21.2', 'spread': '24.96', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.7', 'ciLowerLimit': '-21.96', 'ciUpperLimit': '-13.53', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg q2w vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.0', 'ciLowerLimit': '-19.16', 'ciUpperLimit': '-10.78', 'pValueComment': 'Threshold for significance at 0.025 level.', 'estimateComment': 'Dupilumab 300 mg qw vs Placebo', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 2', 'description': "Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]).", 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 16', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study \\[Week 28\\]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. Statistical significance in the hierarchical testing of secondary hypotheses was broken at this endpoint. Therefore, subsequent secondary efficacy endpoints were not tested for statistical significance.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 16', 'description': 'Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study \\[Week 28\\]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set which included all randomized participants who received any study drug, and was analyzed based on the treatment received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'OG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 16', 'description': 'Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study \\[Week 28\\]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'FG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'FG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '233'}, {'groupId': 'FG002', 'numSubjects': '239'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '233'}, {'groupId': 'FG002', 'numSubjects': '239'}]}, {'type': 'Safety Population', 'achievements': [{'comment': '1 participant received at least 1 injection of Dupilumab 300mg(analyzed in Dupilumab 300 mg q2w arm)', 'groupId': 'FG000', 'numSubjects': '234'}, {'comment': '3 participants (1 \\[placebo\\] + 2 \\[Dupilumab 300 mg qw arm\\]) analyzed in Dupilumab 300 mg q2w arm', 'groupId': 'FG001', 'numSubjects': '236'}, {'comment': '2 participants received fewer injections of Dupilumab 300 mg (analyzed in Dupilumab 300 mg q2w arm)', 'groupId': 'FG002', 'numSubjects': '237'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '190'}, {'groupId': 'FG001', 'numSubjects': '220'}, {'groupId': 'FG002', 'numSubjects': '221'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Other than specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'The study was conducted in 10 countries between 03 December 2014 and 21 January 2016. A total of 962 participants were screened in the study.', 'preAssignmentDetails': 'Out of 962 participants, 708 were randomized and 707 were treated in the study. Participants were randomized in 1:1:1 ratio to receive Dupilumab 300 mg once weekly (qw), Dupilumab 300 mg every 2 weeks (q2w) or Placebo qw.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}, {'value': '708', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.'}, {'id': 'BG001', 'title': 'Dupilumab 300 mg q2w', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'BG002', 'title': 'Dupilumab 300 mg qw', 'description': 'Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}, {'value': '708', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '37.4', 'spread': '14.09', 'groupId': 'BG000'}, {'value': '36.9', 'spread': '13.96', 'groupId': 'BG001'}, {'value': '37.1', 'spread': '14.51', 'groupId': 'BG002'}, {'value': '37.1', 'spread': '14.17', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}, {'value': '708', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '408', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}, {'value': '708', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '219', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}, {'value': '657', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}, {'value': '708', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}, {'value': '489', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}, {'value': '708', 'groupId': 'BG003'}]}], 'categories': [{'title': 'North and South America', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '346', 'groupId': 'BG003'}]}, {'title': 'Western Europe', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}, {'title': 'Eastern Europe', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}, {'title': 'Asia Pacific', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eczema Area and Severity Index (EASI) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}, {'value': '708', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '33.6', 'spread': '14.31', 'groupId': 'BG000'}, {'value': '31.8', 'spread': '13.08', 'groupId': 'BG001'}, {'value': '31.9', 'spread': '12.70', 'groupId': 'BG002'}, {'value': '32.4', 'spread': '13.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Investigator's Global Assessment (IGA) Score", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}, {'value': '708', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.50', 'groupId': 'BG000'}, {'value': '3.5', 'spread': '0.50', 'groupId': 'BG001'}, {'value': '3.5', 'spread': '0.50', 'groupId': 'BG002'}, {'value': '3.5', 'spread': '0.50', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}, {'value': '705', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '1.85', 'groupId': 'BG000'}, {'value': '7.6', 'spread': '1.60', 'groupId': 'BG001'}, {'value': '7.5', 'spread': '1.81', 'groupId': 'BG002'}, {'value': '7.5', 'spread': '1.76', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "Pruritus NRS scale is an assessment tool that is used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0= no itch; 10= worst itch imaginable\\]).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number of participants analyzed = participants with available data for the baseline parameter.'}, {'title': 'Body Surface Area (BSA) Involvement with AD', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}, {'value': '708', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '54.3', 'spread': '23.06', 'groupId': 'BG000'}, {'value': '52.7', 'spread': '21.23', 'groupId': 'BG001'}, {'value': '52.2', 'spread': '21.51', 'groupId': 'BG002'}, {'value': '53.1', 'spread': '21.94', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Body surface area affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck \\[9%\\], anterior trunk \\[18%\\], back \\[18%\\], upper limbs \\[18%\\], lower limbs \\[36%\\], and genitals \\[1%\\]). It was reported as a percentage of all major body sections combined.', 'unitOfMeasure': 'percentage of body surface area', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SCORing Atopic Dermatitis (SCORAD) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}, {'value': '699', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '69.2', 'spread': '14.91', 'groupId': 'BG000'}, {'value': '67.2', 'spread': '13.48', 'groupId': 'BG001'}, {'value': '67.5', 'spread': '13.10', 'groupId': 'BG002'}, {'value': '68.0', 'spread': '13.86', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number of participants analyzed = participants with available data for the baseline parameter.'}, {'title': 'Dermatology Life Quality Index (DLQI) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}, {'value': '708', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '15.4', 'spread': '7.69', 'groupId': 'BG000'}, {'value': '15.4', 'spread': '7.07', 'groupId': 'BG001'}, {'value': '16.0', 'spread': '7.33', 'groupId': 'BG002'}, {'value': '15.6', 'spread': '7.37', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score indicative of a poor QOL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Oriented Eczema Measure (POEM)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}, {'value': '708', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '21.0', 'spread': '5.94', 'groupId': 'BG000'}, {'value': '20.8', 'spread': '5.49', 'groupId': 'BG001'}, {'value': '20.9', 'spread': '5.59', 'groupId': 'BG002'}, {'value': '20.9', 'spread': '5.67', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life \\[QOL\\]).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Global Individual Signs Score (GISS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}, {'value': '708', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '1.78', 'groupId': 'BG000'}, {'value': '9.0', 'spread': '1.80', 'groupId': 'BG001'}, {'value': '9.0', 'spread': '1.75', 'groupId': 'BG002'}, {'value': '9.1', 'spread': '1.77', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Hospital Anxiety Depression Scale (HADS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}, {'value': '691', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13.7', 'spread': '8.32', 'groupId': 'BG000'}, {'value': '13.7', 'spread': '7.52', 'groupId': 'BG001'}, {'value': '14.6', 'spread': '8.24', 'groupId': 'BG002'}, {'value': '14.0', 'spread': '8.04', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number of participants analyzed = participants with available data for the baseline parameter.'}], 'populationDescription': 'Baseline population included all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 708}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'dispFirstSubmitDate': '2017-01-11', 'completionDateStruct': {'date': '2016-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-21', 'studyFirstSubmitDate': '2014-10-27', 'dispFirstSubmitQcDate': '2017-01-11', 'resultsFirstSubmitDate': '2017-08-16', 'studyFirstSubmitQcDate': '2014-10-28', 'dispFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-12', 'studyFirstPostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Investigator\'s Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16', 'timeFrame': 'Week 16', 'description': 'IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.'}, {'measure': 'Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': "Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders."}, {'measure': 'Percentage of Participants With Improvement (Reduction ≥3 Points) in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': "Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders."}, {'measure': 'Percent Change From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (NRS) Score to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': "Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\])."}, {'measure': 'Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4', 'timeFrame': 'Baseline to Week 4', 'description': "Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders."}, {'measure': 'Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2', 'timeFrame': 'Baseline to Week 2', 'description': "Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders."}, {'measure': 'Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': "Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\])."}, {'measure': 'Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.'}, {'measure': 'Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 16 were considered as non-responders.'}, {'measure': 'Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-90 scores at Week 16 were considered as non-responders.'}, {'measure': 'Change From Baseline in Percent Body Surface Area (BSA) to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck \\[9%\\], anterior trunk \\[18%\\], back \\[18%\\], upper limbs \\[18%\\], lower limbs \\[36%\\], and genitals \\[1%\\]). It was reported as a percentage of all major body sections combined.'}, {'measure': 'Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).'}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.'}, {'measure': 'Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'The POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life \\[QOL\\]).'}, {'measure': 'Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.'}, {'measure': 'Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).'}, {'measure': 'Percent Change From Baseline in Weekly Average of Peak Daily Pruritus NRS Score to Week 2', 'timeFrame': 'Baseline to Week 2', 'description': "Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \\[0 = no itch; 10 = worst itch imaginable\\])."}, {'measure': 'Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment', 'timeFrame': 'Baseline up to Week 16', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study \\[Week 28\\]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. Statistical significance in the hierarchical testing of secondary hypotheses was broken at this endpoint. Therefore, subsequent secondary efficacy endpoints were not tested for statistical significance.'}, {'measure': 'Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16', 'timeFrame': 'Baseline up to Week 16', 'description': 'Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study \\[Week 28\\]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.'}, {'measure': 'Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16', 'timeFrame': 'Baseline up to Week 16', 'description': 'Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study \\[Week 28\\]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dermatitis, Atopic']}, 'referencesModule': {'references': [{'pmid': '27690741', 'type': 'RESULT', 'citation': 'Simpson EL, Bieber T, Guttman-Yassky E, Beck LA, Blauvelt A, Cork MJ, Silverberg JI, Deleuran M, Kataoka Y, Lacour JP, Kingo K, Worm M, Poulin Y, Wollenberg A, Soo Y, Graham NM, Pirozzi G, Akinlade B, Staudinger H, Mastey V, Eckert L, Gadkari A, Stahl N, Yancopoulos GD, Ardeleanu M; SOLO 1 and SOLO 2 Investigators. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. N Engl J Med. 2016 Dec 15;375(24):2335-2348. doi: 10.1056/NEJMoa1610020. Epub 2016 Sep 30.'}, {'pmid': '40993471', 'type': 'DERIVED', 'citation': 'Langley RG, Gherardi G, Coleman A, Ardeleanu M, Rodriguez-Marco A, Levy S, Bansal A, Chen Z, Rossi AB, Shumel B, Khokhar FA. 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Epub 2021 Jun 18.'}, {'pmid': '34037993', 'type': 'DERIVED', 'citation': 'Hamilton JD, Harel S, Swanson BN, Brian W, Chen Z, Rice MS, Amin N, Ardeleanu M, Radin A, Shumel B, Ruddy M, Patel N, Pirozzi G, Mannent L, Graham NMH. Dupilumab suppresses type 2 inflammatory biomarkers across multiple atopic, allergic diseases. Clin Exp Allergy. 2021 Jul;51(7):915-931. doi: 10.1111/cea.13954. Epub 2021 Jun 26.'}, {'pmid': '33453450', 'type': 'DERIVED', 'citation': 'Boguniewicz M, Beck LA, Sher L, Guttman-Yassky E, Thaci D, Blauvelt A, Worm M, Corren J, Soong W, Lio P, Rossi AB, Lu Y, Chao J, Eckert L, Gadkari A, Hultsch T, Ruddy M, Mannent LP, Graham NMH, Pirozzi G, Chen Z, Ardeleanu M. Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1212-1223.e6. doi: 10.1016/j.jaip.2020.12.059. Epub 2021 Jan 13.'}, {'pmid': '33165005', 'type': 'DERIVED', 'citation': 'Silverberg JI, Simpson EL, Guttman-Yassky E, Cork MJ, de Bruin-Weller M, Yosipovitch G, Eckert L, Chen Z, Ardeleanu M, Shumel B, Hultsch T, Rossi AB, Hamilton JD, Orengo JM, Ruddy M, Graham NMH, Pirozzi G, Gadkari A. Dupilumab Significantly Modulates Pain and Discomfort in Patients With Atopic Dermatitis: A Post Hoc Analysis of 5 Randomized Clinical Trials. Dermatitis. 2021 Oct 1;32(1S):S81-S91. doi: 10.1097/DER.0000000000000698.'}, {'pmid': '31424712', 'type': 'DERIVED', 'citation': 'Alexis AF, Rendon M, Silverberg JI, Pariser DM, Lockshin B, Griffiths CE, Weisman J, Wollenberg A, Chen Z, Davis JD, Li M, Eckert L, Gadkari A, Shumel B, Rossi AB, Graham NM, Ardeleanu M. Efficacy of Dupilumab in Different Racial Subgroups of Adults With Moderate-to-Severe Atopic Dermatitis in Three Randomized, Placebo-Controlled Phase 3 Trials. J Drugs Dermatol. 2019 Aug 1;18(8):804-813.'}, {'pmid': '31407311', 'type': 'DERIVED', 'citation': 'Wollenberg A, Beck LA, Blauvelt A, Simpson EL, Chen Z, Chen Q, Shumel B, Khokhar FA, Hultsch T, Rizova E, Rossi AB, Graham NMH, Pirozzi G, Lu Y, Ardeleanu M. Laboratory safety of dupilumab in moderate-to-severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY AD CHRONOS). Br J Dermatol. 2020 May;182(5):1120-1135. doi: 10.1111/bjd.18434. Epub 2019 Dec 1.'}, {'pmid': '31066001', 'type': 'DERIVED', 'citation': 'Eichenfield LF, Bieber T, Beck LA, Simpson EL, Thaci D, de Bruin-Weller M, Deleuran M, Silverberg JI, Ferrandiz C, Folster-Holst R, Chen Z, Graham NMH, Pirozzi G, Akinlade B, Yancopoulos GD, Ardeleanu M. Infections in Dupilumab Clinical Trials in Atopic Dermatitis: A Comprehensive Pooled Analysis. Am J Clin Dermatol. 2019 Jun;20(3):443-456. doi: 10.1007/s40257-019-00445-7.'}, {'pmid': '30791102', 'type': 'DERIVED', 'citation': "Silverberg JI, Simpson EL, Ardeleanu M, Thaci D, Barbarot S, Bagel J, Chen Z, Eckert L, Chao J, Korotzer A, Rizova E, Rossi AB, Lu Y, Graham NMH, Hultsch T, Pirozzi G, Akinlade B. Dupilumab provides important clinical benefits to patients with atopic dermatitis who do not achieve clear or almost clear skin according to the Investigator's Global Assessment: a pooled analysis of data from two phase III trials. Br J Dermatol. 2019 Jul;181(1):80-87. doi: 10.1111/bjd.17791. Epub 2019 Apr 11."}, {'pmid': '28503712', 'type': 'DERIVED', 'citation': 'Simpson EL. Dupilumab Improves General Health-Related Quality-of-Life in Patients with Moderate-to-Severe Atopic Dermatitis: Pooled Results from Two Randomized, Controlled Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2017 Jun;7(2):243-248. doi: 10.1007/s13555-017-0181-6. Epub 2017 May 13.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Chronic AD that has been present for at least 3 years before the screening visit;\n2. ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits;\n3. Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).\n\nExclusion Criteria:\n\n1. Participation in a prior Dupilumab clinical study.\n2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit;\n3. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:\n\n * Immunosuppressive/ immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)\n * Phototherapy for AD\n4. Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit;\n5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;\n6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;\n7. Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit;\n8. Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit;\n9. Known or suspected history of immunosuppression;\n10. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study;\n11. Women unwilling to use adequate birth control, if of reproductive potential and sexually active.\n\nNote: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed."}, 'identificationModule': {'nctId': 'NCT02277769', 'acronym': 'SOLO 2', 'briefTitle': 'Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'R668-AD-1416'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Two subcutaneous injections of Placebo (for 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