Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-05 @ 1:42 AM
Study NCT ID:
NCT03346434
Status:
COMPLETED
Last Update Posted:
2022-07-28
First Post:
2017-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643', 'title': 'Clinical Trials Administrator', 'organization': 'Regeneron Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': "The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From day of first treatment up to Week 28 (end of study)', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 45, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 29, 'seriousNumAtRisk': 83, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1; 23.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1; 23.1'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1; 23.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1 (Part A)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 46, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1; 23.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1; 23.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1 (Part B)'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1 (Part A)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1; 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1; 23.1'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1 (Part A)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1 (Part B)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1; 23.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1; 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1; 23.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1 (Part A)'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1 (Part A)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1 (Part A)'}], 'seriousEvents': [{'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1 (Part A)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1 (Part B)'}, {'term': 'Cellulitis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1 (Part B)'}, {'term': 'Dermatitis infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1 (Part B)'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1 (Part B)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1 (Part B)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part A: Maximum Observed Serum Concentration (Cmax) of Functional Dupilumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'spread': '7.44', 'groupId': 'OG000', 'lowerLimit': '7.44'}, {'value': '49.8', 'spread': '11.3', 'groupId': 'OG001', 'lowerLimit': '11.3'}, {'value': '20.1', 'spread': '6.81', 'groupId': 'OG002', 'lowerLimit': '6.81'}, {'value': '46.1', 'spread': '11.1', 'groupId': 'OG003', 'lowerLimit': '11.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-dose on Days 1, 3, 8, 18, and 29', 'description': 'Serum concentration of functional dupilumab was reported.', 'unitOfMeasure': 'Milligrams per Liter (mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set (PKAS) included all treated participants who received any study drug (safety analysis set) and who had at least 1 non-missing functional dupilumab measurement following the administration of the first dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Part A: Dose Normalized Maximum Observed Serum Concentration (Cmax/Dose) of Dupilumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.39', 'spread': '2.48', 'groupId': 'OG000', 'lowerLimit': '2.48'}, {'value': '8.30', 'spread': '1.89', 'groupId': 'OG001', 'lowerLimit': '1.89'}, {'value': '6.70', 'spread': '2.27', 'groupId': 'OG002', 'lowerLimit': '2.27'}, {'value': '7.68', 'spread': '1.86', 'groupId': 'OG003', 'lowerLimit': '1.86'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-dose on Days 1, 3, 8, 18, and 29', 'description': 'Dose normalized was calculated as Cmax obtained directly from the concentration versus time curve divided by dose. Cmax/dose was measured in Milligrams per Liter/Milligrams per Kilogram (\\[mg/L\\]/\\[mg/kg\\]).', 'unitOfMeasure': '[mg/L]/[mg/kg]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PKAS included all treated participants who received any study drug (safety analysis set) and who had at least 1 non-missing functional dupilumab measurement following the administration of the first dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Part A: Time to Reach the Maximum Serum Concentration (Tmax) of Dupilumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG001', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG003', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.97', 'spread': '1.87', 'groupId': 'OG000', 'lowerLimit': '1.87', 'upperLimit': '7.82'}, {'value': '1.95', 'spread': '1.75', 'groupId': 'OG001', 'lowerLimit': '1.75', 'upperLimit': '3.08'}, {'value': '2.10', 'spread': '1.80', 'groupId': 'OG002', 'lowerLimit': '1.80', 'upperLimit': '7.99'}, {'value': '1.92', 'spread': '1.72', 'groupId': 'OG003', 'lowerLimit': '1.72', 'upperLimit': '3.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose on Days 1, 3, 8, 18, and 29', 'description': 'Tmax was obtained directly from the concentration versus time curve.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PKAS included all treated participants who received any study drug (safety analysis set) and who had at least 1 non-missing functional dupilumab measurement following the administration of the first dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Part A: Last Quantifiable Serum Concentration (Clast) of Dupilumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.64', 'spread': '6.16', 'groupId': 'OG000', 'lowerLimit': '6.16'}, {'value': '6.14', 'spread': '4.69', 'groupId': 'OG001', 'lowerLimit': '4.69'}, {'value': '5.64', 'spread': '4.52', 'groupId': 'OG002', 'lowerLimit': '4.52'}, {'value': '15.1', 'spread': '9.48', 'groupId': 'OG003', 'lowerLimit': '9.48'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-dose on Days 1, 3, 8, 18, and 29', 'description': 'Clast is the last measurable serum concentration of dupilumab.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PKAS included all treated participants who received any study drug (safety analysis set) and who had at least 1 non-missing functional dupilumab measurement following the administration of the first dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Part A: Time of the Last Quantifiable Serum Concentration (Tlast) of Dupilumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.8', 'spread': '6.79', 'groupId': 'OG000', 'lowerLimit': '6.79', 'upperLimit': '28.0'}, {'value': '26.5', 'spread': '15.0', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '32.0'}, {'value': '8.56', 'spread': '6.88', 'groupId': 'OG002', 'lowerLimit': '6.88', 'upperLimit': '16.9'}, {'value': '16.0', 'spread': '6.95', 'groupId': 'OG003', 'lowerLimit': '6.95', 'upperLimit': '28.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose on Days 1, 3, 8, 18, and 29', 'description': 'Tlast was defined as the last time point with a measurable serum concentration of dupilumab.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PKAS included all treated participants who received any study drug (safety analysis set) and who had at least 1 non-missing functional dupilumab measurement following the administration of the first dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Part A: Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast) of Dupilumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}], 'classes': [{'categories': [{'measurements': [{'value': '198', 'spread': '125', 'groupId': 'OG000', 'lowerLimit': '125'}, {'value': '622', 'spread': '184', 'groupId': 'OG001', 'lowerLimit': '184'}, {'value': '123', 'spread': '86.0', 'groupId': 'OG002', 'lowerLimit': '86.0'}, {'value': '493', 'spread': '294', 'groupId': 'OG003', 'lowerLimit': '294'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-dose on Days 1, 3, 8, 18, and 29', 'description': 'AUClast was defined as area under the serum concentration time-curve from zero to the last measured concentration.', 'unitOfMeasure': 'Days*Milligrams per Liter (day*mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PKAS included all treated participants who received any study drug (safety analysis set) and who had at least 1 non-missing functional dupilumab measurement following the administration of the first dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Part A: Dose Normalized Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast/Dose) of Dupilumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.0', 'spread': '41.6', 'groupId': 'OG000', 'lowerLimit': '41.6'}, {'value': '104', 'spread': '30.6', 'groupId': 'OG001', 'lowerLimit': '30.6'}, {'value': '41.0', 'spread': '28.7', 'groupId': 'OG002', 'lowerLimit': '28.7'}, {'value': '82.1', 'spread': '48.9', 'groupId': 'OG003', 'lowerLimit': '48.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-dose on Days 1, 3, 8, 18, and 29', 'description': 'Dose normalized AUClast was calculated by AUClast/dose.', 'unitOfMeasure': '[day*mg/L]/[mg/kg]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PKAS included all treated participants who received any study drug (safety analysis set) and who had at least 1 non-missing functional dupilumab measurement following the administration of the first dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Part A: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 4', 'description': 'Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. Serious AE (SAE) was defined as any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE was defined as AE starting/worsening after first intake of study drug. TEAEs included participants with both SAEs and non-SAEs. Number of participants with TEAEs is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set (SAF) included all participants who received any study drug and were analyzed based on the actual treatment received.'}, {'type': 'PRIMARY', 'title': 'Part A: Number of Participants With TEAEs by Severity According to Qualitative Toxicity Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 4', 'description': 'Severity of TEAEs were graded using Qualitative Toxicity Scale, as follows: Mild: Participant is aware of the event or symptom, but the event or symptom is easily tolerated; Moderate: Participant experiences sufficient discomfort to interfere with or reduce his or her usual level of activity; Severe: Significant impairment of functioning: the participant is unable to carry out his or her usual activities. Number of participants with TEAEs by severity were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SAF included all participants who received any study drug and were analyzed based on the actual treatment received.'}, {'type': 'PRIMARY', 'title': "Part B: Percentage of Participants With Investigator's Global Assessment (IGA) Score 0 or 1 at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '-0.42', 'groupId': 'OG000', 'lowerLimit': '-0.42', 'upperLimit': '8.21'}, {'value': '27.7', 'spread': '18.45', 'groupId': 'OG001', 'lowerLimit': '18.45', 'upperLimit': '38.62'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.8', 'ciLowerLimit': '13.27', 'ciUpperLimit': '34.37', 'pValueComment': 'Threshold for significance at 0.05 level.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "The IGA is an assessment scale used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 to 4 where 0 = clear; 1=almost clear; 2=mild; 3=moderate; 4=severe. A negative change from baseline indicated improvement. Percentage of participants with IGA score of '0' or '1' is reported.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, adverse event (AE), lack of efficacy were imputed as non responder. Missing data due to any other reason including COVID-19 were imputed using multiple imputation (MI). Participants were considered as non-responders after initiation of rescue treatment.'}, {'type': 'PRIMARY', 'title': 'Part B: Percentage of Participants With Eczema Area and Severity Index (EASI) -75 (EASI-75) (≥75% Improvement From Baseline) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'spread': '3.65', 'groupId': 'OG000', 'lowerLimit': '3.65', 'upperLimit': '17.74'}, {'value': '53.0', 'spread': '41.74', 'groupId': 'OG001', 'lowerLimit': '41.74', 'upperLimit': '64.07'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.3', 'ciLowerLimit': '29.47', 'ciUpperLimit': '55.16', 'pValueComment': 'Threshold for significance at 0.05 level.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI score is 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 indicating the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline at Week 16.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, lack of efficacy were imputed as non responder. Missing data due to any other reason including COVID-19 were imputed using MI. Participants were considered as non-responders after initiation of rescue treatment.'}, {'type': 'SECONDARY', 'title': 'Part A: Number of Participants With Serious TEAEs and Severe TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}], 'classes': [{'title': 'Participants with serious TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Participants with severe TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 4', 'description': 'Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Severe TEAE: significant impairment of functioning the participant is unable to carry out his or her usual activities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SAF included all participants who received any study drug and was analyzed based on the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Part A: Percent Change From Baseline in EASI Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.6', 'spread': '47.37', 'groupId': 'OG000', 'lowerLimit': '47.37'}, {'value': '-48.7', 'spread': '28.89', 'groupId': 'OG001', 'lowerLimit': '28.89'}, {'value': '-22.4', 'spread': '42.52', 'groupId': 'OG002', 'lowerLimit': '42.52'}, {'value': '-43.2', 'spread': '35.55', 'groupId': 'OG003', 'lowerLimit': '35.55'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The EASI score is 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 indicated the worse severity of AD. A negative change from baseline indicated improvement.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The SAF included all participants who received any study drug and was analyzed based on the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Part A: Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.6', 'spread': '26.18', 'groupId': 'OG000', 'lowerLimit': '26.18'}, {'value': '-31.9', 'spread': '17.45', 'groupId': 'OG001', 'lowerLimit': '17.45'}, {'value': '-22.4', 'spread': '26.44', 'groupId': 'OG002', 'lowerLimit': '26.44'}, {'value': '-28.1', 'spread': '27.84', 'groupId': 'OG003', 'lowerLimit': '27.84'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The SCORAD is used to assess the extent and severity of AD. Extent and severity of eczema as well as subjective symptoms (insomnia, etc) were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease). A negative change from baseline indicated improvement.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF included all participants who received any study drug and was analyzed based on the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Part A: Percentage of Participants With IGA Score 0 or 1 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'spread': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '44.50'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '30.85'}, {'value': '10.0', 'spread': '0.25', 'groupId': 'OG002', 'lowerLimit': '0.25', 'upperLimit': '44.50'}, {'value': '10.0', 'spread': '0.25', 'groupId': 'OG003', 'lowerLimit': '0.25', 'upperLimit': '44.50'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': "The IGA is an assessment scale used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 to 4 where 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. Percentage of participants with IGA score of '0' or '1' were reported.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF included all participants who received any study drug and was analyzed based on the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Part A: Number of Participants With at Least One Positive Treatment-Emergent Anti-Drug Antibodies (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'OG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}], 'classes': [{'title': 'TB Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TE Response', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 57', 'description': 'Treatment boosted (TB) Response: Any post-dose positive result at least 9-fold over the baseline level when baseline is positive; Treatment emergent (TE) Response: Post-dose positive result when baseline results were negative.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ADA Analysis Set (AAS) included all treated participants who received any study drug and who had at least 1 non-missing ADA result following the first dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With at Least One Serious Adverse Event (SAE) Through Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through Week 16', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF included all randomized participants who received at least one dose of study drug and was analysed as treated.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With at Least One Skin Infection Treatment Emergent Adverse Event (TEAE) (Excluding Herpetic Infection) Through Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through Week 16', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF included all randomized participants who received at least one dose of study drug and was analysed as treated.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With at Least One Positive Treatment-Emergent ADA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 197', 'description': 'Treatment emergent (TE): Post-dose positive result when baseline results were negative.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'AAS included all participants who received any study drug and who had at least one non-missing ADA result after the first dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Part B: Percent Change From Baseline in EASI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.6', 'spread': '5.13', 'groupId': 'OG000', 'lowerLimit': '5.13'}, {'value': '-70.0', 'spread': '4.85', 'groupId': 'OG001', 'lowerLimit': '4.85'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.4', 'ciLowerLimit': '-62.38', 'ciUpperLimit': '-38.40', 'pValueComment': 'Threshold for significance at 0.05 level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 16', 'description': 'The EASI score is used to measure the severity and extent of AD and measures 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 indicating the worse severity of AD. A negative change from baseline indicated improvement.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomisation (as randomised). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline worst observation carried forward (WOCF). If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach.'}, {'type': 'SECONDARY', 'title': 'Part B: Percent Change From Baseline in Weekly Average of Daily Worst Scratch/Itch/Numerical Rating Scale (NRS) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'spread': '5.22', 'groupId': 'OG000', 'lowerLimit': '5.22'}, {'value': '-49.4', 'spread': '5.03', 'groupId': 'OG001', 'lowerLimit': '5.03'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.1', 'ciLowerLimit': '-59.47', 'ciUpperLimit': '-34.79', 'pValueComment': 'Threshold for significance at 0.05 level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 16', 'description': "Pruritus NRS is an assessment tool used to report intensity of participant's pruritus (itch), both average \\& maximum intensity, during 24-hr recall period. Participants were asked two questions: 1) For average itch intensity: how would you rate your itch overall (on average) during the previous 24 hrs; 2) For maximum itch intensity: How would you rate your itch at the worst moment during the previous 24 hrs? Both questions were rated on a scale: 0-10 with 0=no itch \\& 10=worst itch imaginable. A negative change from baseline indicated improvement.", 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach.'}, {'type': 'SECONDARY', 'title': 'Part B: Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Scratch/Itch/NRS ≥4 Points at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '2.25', 'groupId': 'OG000', 'lowerLimit': '2.25', 'upperLimit': '15.51'}, {'value': '48.1', 'spread': '37.05', 'groupId': 'OG001', 'lowerLimit': '37.05', 'upperLimit': '59.15'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.2', 'ciLowerLimit': '26.18', 'ciUpperLimit': '52.27', 'pValueComment': 'Threshold for significance at 0.05 level.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "Pruritus NRS is an assessment tool used to report intensity of subject's pruritus (itch), both average \\& maximum intensity, during 24-hr recall period. Subjects were asked two questions: 1) For average itch intensity: how would you rate your itch overall (on average) during the previous 24 hrs; \\& 2) For maximum itch intensity: How would you rate your itch at the worst moment during the previous 24 hrs? Both questions were rated on a scale: 0-10 with 0=no itch \\& 10=worst itch imaginable.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, lack of efficacy were imputed as non responder. Missing data due to any other reason including COVID-19 were imputed using MI. Participants were considered as non-responders after initiation of rescue treatment.'}, {'type': 'SECONDARY', 'title': 'Part B: Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Scratch/Itch/NRS ≥3 Points at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '2.59', 'groupId': 'OG000', 'lowerLimit': '2.59', 'upperLimit': '17.22'}, {'value': '53.3', 'spread': '42.29', 'groupId': 'OG001', 'lowerLimit': '42.29', 'upperLimit': '64.22'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.3', 'ciLowerLimit': '30.03', 'ciUpperLimit': '56.67', 'pValueComment': 'Threshold for significance at 0.05 level.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "Pruritus NRS is an assessment tool used to report intensity of participant's pruritus (itch), both average \\& maximum intensity, during 24-hr recall period. Participants were asked two questions: 1) For average itch intensity: how would you rate your itch overall (on average) during the previous 24 hrs; \\& 2) For maximum itch intensity: How would you rate your itch at the worst moment during the previous 24 hrs? Both questions were rated on a scale: 0-10 with 0=no itch \\& 10=worst itch imaginable.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, lack of efficacy were imputed as non responder. Missing data due to any other reason including COVID-19 were imputed using MI. Participants were considered as non-responders after initiation of rescue treatment.'}, {'type': 'SECONDARY', 'title': 'Part B: Percentage of Participants Who Achieved EASI-50 (≥50% Improvement From Baseline) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'spread': '11.09', 'groupId': 'OG000', 'lowerLimit': '11.09', 'upperLimit': '29.23'}, {'value': '68.7', 'spread': '57.56', 'groupId': 'OG001', 'lowerLimit': '57.56', 'upperLimit': '78.41'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '48.5', 'ciLowerLimit': '35.03', 'ciUpperLimit': '62.00', 'pValueComment': 'Threshold for significance at 0.05 level.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI score is 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 indicating the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline at Week 16.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, lack of efficacy were imputed as non responder. Missing data due to any other reason including COVID-19 were imputed using MI. Participants were considered as non-responders after initiation of rescue treatment.'}, {'type': 'SECONDARY', 'title': 'Part B: Percentage of Participants Who Achieved EASI-90 (≥90% Improvement From Baseline) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '-1.02', 'groupId': 'OG000', 'lowerLimit': '-1.02', 'upperLimit': '6.66'}, {'value': '25.3', 'spread': '16.39', 'groupId': 'OG001', 'lowerLimit': '16.39', 'upperLimit': '36.04'}]}]}], 'analyses': [{'pValue': '= 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.5', 'ciLowerLimit': '12.37', 'ciUpperLimit': '32.60', 'pValueComment': 'Threshold for significance at 0.05 level.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI score is 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 indicating the worse severity of AD. EASI-90 responders were the participant who achieved ≥90% overall improvement in EASI score from baseline at Week 16.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, lack of efficacy were imputed as non responder. Missing data due to any other reason including COVID-19 were imputed using MI. Participants were considered as non-responders after initiation of rescue treatment.'}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.74', 'spread': '2.926', 'groupId': 'OG000', 'lowerLimit': '2.926'}, {'value': '-35.00', 'spread': '2.815', 'groupId': 'OG001', 'lowerLimit': '2.815'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.27', 'ciLowerLimit': '-31.204', 'ciUpperLimit': '-17.329', 'pValueComment': 'Threshold for significance at 0.05 level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '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. A negative change from baseline indicated improvement.', 'unitOfMeasure': 'Percentage of Body Surface Area (BSA)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participant. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach.'}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.8', 'spread': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.92'}, {'value': '-12.9', 'spread': '0.89', 'groupId': 'OG001', 'lowerLimit': '0.89'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.1', 'ciLowerLimit': '-11.26', 'ciUpperLimit': '-6.89', 'pValueComment': 'Threshold for significance at 0.05 level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '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\\]). A negative change from baseline indicated improvement.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach.'}, {'type': 'SECONDARY', 'title': 'Part B: Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.2', 'spread': '3.54', 'groupId': 'OG000', 'lowerLimit': '3.54'}, {'value': '-54.7', 'spread': '3.39', 'groupId': 'OG001', 'lowerLimit': '3.39'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.4', 'ciLowerLimit': '-46.65', 'ciUpperLimit': '-30.21', 'pValueComment': 'Threshold for significance at 0.05 level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 16', 'description': 'The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis (AD). 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). A negative change from baseline indicated improvement.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participant. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach.'}, {'type': 'SECONDARY', 'title': "Part B: Change From Baseline in Participant's Sleep Quality NRS at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'spread': '0.256', 'groupId': 'OG000', 'lowerLimit': '0.256'}, {'value': '2.04', 'spread': '0.251', 'groupId': 'OG001', 'lowerLimit': '0.251'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.70', 'ciLowerLimit': '1.093', 'ciUpperLimit': '2.317', 'pValueComment': 'Threshold significance was at 0.05 level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 16', 'description': "A sleep diary is completed by the parent/caregiver, included 2 questions assessing the caregiver's sleep, and 6 questions assessing the child's sleep based on caregiver observation. Sleep diary items, either alone or in combination serve as subjective measures of sleep quality, difficulty falling asleep, nighttime awakenings, and sleep duration. Sleep quality is measured using an 11-point NRS (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep.", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach.'}, {'type': 'SECONDARY', 'title': "Part B: Change From Baseline in Participant's Skin Pain NRS at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.302', 'groupId': 'OG000', 'lowerLimit': '0.302'}, {'value': '-3.93', 'spread': '0.295', 'groupId': 'OG001', 'lowerLimit': '0.295'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.31', 'ciLowerLimit': '-4.029', 'ciUpperLimit': '-2.600', 'pValueComment': 'Threshold significance at 0.05 level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 16', 'description': 'Skin pain was assessed by the parent/caregiver and measured using a 11-point scale (0 to 10) in which 0 indicated no pain while 10 indicated worst pain possible. A negative change from baseline indicated improvement.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach.'}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Dermatitis Family Index (DFI) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.68', 'spread': '0.839', 'groupId': 'OG000', 'lowerLimit': '0.839'}, {'value': '-10.48', 'spread': '0.806', 'groupId': 'OG001', 'lowerLimit': '0.806'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.80', 'ciLowerLimit': '-9.789', 'ciUpperLimit': '-5.814', 'pValueComment': 'Threshold significance at 0.05 level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 16', 'description': "DFI is a 10-item questionnaire with items inquiring about housework, food preparation, sleep, family leisure activity, shopping, expenditure, tiredness, emotional distress, relationships, and impact of helping with treatment on the primary caregiver's life. DFI questions were scored on a four-point Likert scale ranging from 0 to 3, so that the total DFI score ranges from 0 to 30. Timeframe of reference was the past week. A higher DFI score indicated greater impairment in family Quality of life (QOL) as affected by atopic dermatitis. A negative change from baseline indicated improvement.", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach.'}, {'type': 'SECONDARY', 'title': "Part B: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.66', 'groupId': 'OG000', 'lowerLimit': '1.66'}, {'value': '-10.0', 'spread': '1.56', 'groupId': 'OG001', 'lowerLimit': '1.56'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.5', 'ciLowerLimit': '-10.29', 'ciUpperLimit': '-4.75', 'pValueComment': 'Threshold significance at 0.05 level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 16', 'description': 'CDLQI is a validated 10 question tool to measure impact of skin disease on QOL in children by assessing how much the skin problem has affected the subjects over past week. Nine questions were scored as follows: Very much = 3, Quite a lot = 2, Only a little = 1, Not at all or unanswered = 0. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question (max. = 30, min. = 0). Higher the score, the greater the impact on QOL. A negative change from baseline indicated improvement.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach.'}, {'type': 'SECONDARY', 'title': "Part B: Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.95', 'spread': '1.078', 'groupId': 'OG000', 'lowerLimit': '1.078'}, {'value': '-10.91', 'spread': '1.159', 'groupId': 'OG001', 'lowerLimit': '1.159'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.96', 'ciLowerLimit': '-11.711', 'ciUpperLimit': '-6.202', 'pValueComment': 'Threshold significance at 0.05 level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 16', 'description': "Infants' Dermatitis Quality of Life Index (IDQOL) is used to evaluate quality of life for subjects of age less than 4 years. IDQOL questionnaires were designed for infants (below the age of 4 years) with atopic dermatitis. The IDQOL was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. A negative change from baseline indicated improvement.", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Missing data due to withdrawn consent, AE, or lack of efficacy and data after rescue were imputed by post baseline WOCF. If there was no post baseline assessment, the baseline value was used. Missing values due to other reasons including COVID-19 were imputed by MI approach.'}, {'type': 'SECONDARY', 'title': 'Part B: Percentage of Topical Corticosteroid (TCS) Medication-free Days From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.9'}, {'value': '0.21', 'spread': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}], 'analyses': [{'pValue': '= 0.0015', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Threshold significance is at 0.05 level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Week 16', 'description': 'Percentage of TCS medication-free days was calculated as the number of days that a subject used neither TCS/TCI nor system rescue therapy divided by the study days.', 'unitOfMeasure': 'Percentage of Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).'}, {'type': 'SECONDARY', 'title': 'Part B: Mean Weekly Dose of Low Potency TCS in Grams From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '1.44', 'groupId': 'OG000', 'lowerLimit': '1.44'}, {'value': '10.5', 'spread': '1.39', 'groupId': 'OG001', 'lowerLimit': '1.39'}]}]}], 'analyses': [{'pValue': '= 0.0997', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-6.35', 'ciUpperLimit': '0.56', 'pValueComment': 'Threshold significance at 0.05 level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline up to Week 16', 'description': 'Mean weekly dose of TCS in grams/week for low potency TCS from baseline to Week 16 is reported.', 'unitOfMeasure': 'Grams per Week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).'}, {'type': 'SECONDARY', 'title': 'Part B: Mean Weekly Dose of TCS in Grams for Medium or High Potency TCS From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '1.70', 'groupId': 'OG000', 'lowerLimit': '1.70'}, {'value': '3.0', 'spread': '1.54', 'groupId': 'OG001', 'lowerLimit': '1.54'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline up to Week 16', 'description': 'Mean weekly dose of TCS in grams/week for medium or high potency TCS from baseline to Week 16 is reported.', 'unitOfMeasure': 'Grams per Week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).'}, {'type': 'SECONDARY', 'title': 'Part B: Mean Number of Caregiver Missed Work Days Through Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'OG001', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.05', 'spread': '8.975', 'groupId': 'OG000', 'lowerLimit': '8.975'}, {'value': '2.49', 'spread': '5.524', 'groupId': 'OG001', 'lowerLimit': '5.524'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Week 16', 'description': 'Mean of number of caregiver missed work days through Week 16 is reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'FG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'FG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'FG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'FG004', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'FG005', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '79'}, {'groupId': 'FG005', 'numSubjects': '83'}]}, {'type': 'Completed Part A', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Completed Part B (Week 16)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '76'}, {'groupId': 'FG005', 'numSubjects': '83'}]}, {'type': 'Completed Part B (Week 28)', 'comment': 'End of Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '78'}, {'groupId': 'FG005', 'numSubjects': '82'}]}], 'dropWithdraws': [{'type': 'Randomized in Error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Transitioned to OLE study at Week 16 (NCT02612454)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '75'}, {'groupId': 'FG005', 'numSubjects': '81'}]}]}], 'recruitmentDetails': 'This study was conducted in 2 parts: Part A and Part B; Participants who enrolled in Part A of study were not eligible to participate in Part B.', 'preAssignmentDetails': 'Participants in Part A enrolled in 2 sequential age cohorts: Cohort 1 (≥2 to \\<6 yrs) and Cohort 2 (≥6 months to \\<2 yrs). Each age cohort received dupilumab in 1 of 2 doses: 3 milligrams per kilogram (mg/kg) or 6 mg/kg. Participants in Part B were randomized to 1 of 2 treatment groups: placebo + topical corticosteroids (TCS) or dupilumab 200/300 mg every four weeks (Q4W) + TCS.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}, {'value': '83', 'groupId': 'BG005'}, {'value': '202', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg', 'description': 'Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'BG001', 'title': 'Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'BG002', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'BG003', 'title': 'Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg', 'description': 'Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety.'}, {'id': 'BG004', 'title': 'Part B: Placebo + TCS', 'description': 'Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \\[EOS\\] period).'}, {'id': 'BG005', 'title': 'Part B: Dupilumab 200 mg or 300 mg Q4W + TCS', 'description': 'Participants with baseline weight of ≥ 5 to \\< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \\< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period).'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '6 months - <2 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}]}]}, {'title': '≥2 years and <6 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}, {'value': '77', 'groupId': 'BG005'}, {'value': '171', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}, {'value': '73', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}, {'value': '129', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}, {'value': '72', 'groupId': 'BG005'}, {'value': '173', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Investigator Global Assessment (IGA)', 'classes': [{'categories': [{'title': 'IGA=3 (moderate)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '37', 'groupId': 'BG006'}]}, {'title': 'IGA=4 (severe)', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '63', 'groupId': 'BG005'}, {'value': '165', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The IGA is an assessment scale used in clinical studies to rate the severity of atopic dermatitis (AD) globally, based on a 5-point scale ranging from 0 to 4 where 0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-28', 'size': 1243611, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-14T15:41', 'hasProtocol': True}, {'date': '2021-05-07', 'size': 1087908, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-14T15:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Part A: Open Label;\n\nPart B: Masked, Randomized'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Part A: Single-ascending-dose cohorts staggered by age;\n\nPart B: Parallel Group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-27', 'studyFirstSubmitDate': '2017-02-06', 'resultsFirstSubmitDate': '2022-06-14', 'studyFirstSubmitQcDate': '2017-11-14', 'lastUpdatePostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-27', 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Maximum Observed Serum Concentration (Cmax) of Functional Dupilumab', 'timeFrame': 'Post-dose on Days 1, 3, 8, 18, and 29', 'description': 'Serum concentration of functional dupilumab was reported.'}, {'measure': 'Part A: Dose Normalized Maximum Observed Serum Concentration (Cmax/Dose) of Dupilumab', 'timeFrame': 'Post-dose on Days 1, 3, 8, 18, and 29', 'description': 'Dose normalized was calculated as Cmax obtained directly from the concentration versus time curve divided by dose. Cmax/dose was measured in Milligrams per Liter/Milligrams per Kilogram (\\[mg/L\\]/\\[mg/kg\\]).'}, {'measure': 'Part A: Time to Reach the Maximum Serum Concentration (Tmax) of Dupilumab', 'timeFrame': 'Post-dose on Days 1, 3, 8, 18, and 29', 'description': 'Tmax was obtained directly from the concentration versus time curve.'}, {'measure': 'Part A: Last Quantifiable Serum Concentration (Clast) of Dupilumab', 'timeFrame': 'Post-dose on Days 1, 3, 8, 18, and 29', 'description': 'Clast is the last measurable serum concentration of dupilumab.'}, {'measure': 'Part A: Time of the Last Quantifiable Serum Concentration (Tlast) of Dupilumab', 'timeFrame': 'Post-dose on Days 1, 3, 8, 18, and 29', 'description': 'Tlast was defined as the last time point with a measurable serum concentration of dupilumab.'}, {'measure': 'Part A: Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast) of Dupilumab', 'timeFrame': 'Post-dose on Days 1, 3, 8, 18, and 29', 'description': 'AUClast was defined as area under the serum concentration time-curve from zero to the last measured concentration.'}, {'measure': 'Part A: Dose Normalized Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast/Dose) of Dupilumab', 'timeFrame': 'Post-dose on Days 1, 3, 8, 18, and 29', 'description': 'Dose normalized AUClast was calculated by AUClast/dose.'}, {'measure': 'Part A: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)', 'timeFrame': 'Baseline up to Week 4', 'description': 'Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. Serious AE (SAE) was defined as any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE was defined as AE starting/worsening after first intake of study drug. TEAEs included participants with both SAEs and non-SAEs. Number of participants with TEAEs is reported.'}, {'measure': 'Part A: Number of Participants With TEAEs by Severity According to Qualitative Toxicity Scale', 'timeFrame': 'Baseline up to Week 4', 'description': 'Severity of TEAEs were graded using Qualitative Toxicity Scale, as follows: Mild: Participant is aware of the event or symptom, but the event or symptom is easily tolerated; Moderate: Participant experiences sufficient discomfort to interfere with or reduce his or her usual level of activity; Severe: Significant impairment of functioning: the participant is unable to carry out his or her usual activities. Number of participants with TEAEs by severity were reported.'}, {'measure': "Part B: Percentage of Participants With Investigator's Global Assessment (IGA) Score 0 or 1 at Week 16", 'timeFrame': 'Week 16', 'description': "The IGA is an assessment scale used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 to 4 where 0 = clear; 1=almost clear; 2=mild; 3=moderate; 4=severe. A negative change from baseline indicated improvement. Percentage of participants with IGA score of '0' or '1' is reported."}, {'measure': 'Part B: Percentage of Participants With Eczema Area and Severity Index (EASI) -75 (EASI-75) (≥75% Improvement From Baseline) at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score is 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 indicating the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline at Week 16.'}], 'secondaryOutcomes': [{'measure': 'Part A: Number of Participants With Serious TEAEs and Severe TEAEs', 'timeFrame': 'Baseline up to Week 4', 'description': 'Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Severe TEAE: significant impairment of functioning the participant is unable to carry out his or her usual activities.'}, {'measure': 'Part A: Percent Change From Baseline in EASI Score at Week 4', 'timeFrame': 'Week 4', 'description': 'The EASI score is 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 indicated the worse severity of AD. A negative change from baseline indicated improvement.'}, {'measure': 'Part A: Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 4', 'timeFrame': 'Week 4', 'description': 'The SCORAD is used to assess the extent and severity of AD. Extent and severity of eczema as well as subjective symptoms (insomnia, etc) were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease). A negative change from baseline indicated improvement.'}, {'measure': 'Part A: Percentage of Participants With IGA Score 0 or 1 at Week 4', 'timeFrame': 'Week 4', 'description': "The IGA is an assessment scale used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 to 4 where 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. Percentage of participants with IGA score of '0' or '1' were reported."}, {'measure': 'Part A: Number of Participants With at Least One Positive Treatment-Emergent Anti-Drug Antibodies (ADA)', 'timeFrame': 'Baseline up to Day 57', 'description': 'Treatment boosted (TB) Response: Any post-dose positive result at least 9-fold over the baseline level when baseline is positive; Treatment emergent (TE) Response: Post-dose positive result when baseline results were negative.'}, {'measure': 'Part B: Number of Participants With at Least One Serious Adverse Event (SAE) Through Week 16', 'timeFrame': 'Baseline through Week 16'}, {'measure': 'Part B: Number of Participants With at Least One Skin Infection Treatment Emergent Adverse Event (TEAE) (Excluding Herpetic Infection) Through Week 16', 'timeFrame': 'Baseline through Week 16'}, {'measure': 'Part B: Number of Participants With at Least One Positive Treatment-Emergent ADA', 'timeFrame': 'Baseline up to Day 197', 'description': 'Treatment emergent (TE): Post-dose positive result when baseline results were negative.'}, {'measure': 'Part B: Percent Change From Baseline in EASI Score at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score is used to measure the severity and extent of AD and measures 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 indicating the worse severity of AD. A negative change from baseline indicated improvement.'}, {'measure': 'Part B: Percent Change From Baseline in Weekly Average of Daily Worst Scratch/Itch/Numerical Rating Scale (NRS) at Week 16', 'timeFrame': 'Week 16', 'description': "Pruritus NRS is an assessment tool used to report intensity of participant's pruritus (itch), both average \\& maximum intensity, during 24-hr recall period. Participants were asked two questions: 1) For average itch intensity: how would you rate your itch overall (on average) during the previous 24 hrs; 2) For maximum itch intensity: How would you rate your itch at the worst moment during the previous 24 hrs? Both questions were rated on a scale: 0-10 with 0=no itch \\& 10=worst itch imaginable. A negative change from baseline indicated improvement."}, {'measure': 'Part B: Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Scratch/Itch/NRS ≥4 Points at Week 16', 'timeFrame': 'Week 16', 'description': "Pruritus NRS is an assessment tool used to report intensity of subject's pruritus (itch), both average \\& maximum intensity, during 24-hr recall period. Subjects were asked two questions: 1) For average itch intensity: how would you rate your itch overall (on average) during the previous 24 hrs; \\& 2) For maximum itch intensity: How would you rate your itch at the worst moment during the previous 24 hrs? Both questions were rated on a scale: 0-10 with 0=no itch \\& 10=worst itch imaginable."}, {'measure': 'Part B: Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Scratch/Itch/NRS ≥3 Points at Week 16', 'timeFrame': 'Week 16', 'description': "Pruritus NRS is an assessment tool used to report intensity of participant's pruritus (itch), both average \\& maximum intensity, during 24-hr recall period. Participants were asked two questions: 1) For average itch intensity: how would you rate your itch overall (on average) during the previous 24 hrs; \\& 2) For maximum itch intensity: How would you rate your itch at the worst moment during the previous 24 hrs? Both questions were rated on a scale: 0-10 with 0=no itch \\& 10=worst itch imaginable."}, {'measure': 'Part B: Percentage of Participants Who Achieved EASI-50 (≥50% Improvement From Baseline) at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score is 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 indicating the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline at Week 16.'}, {'measure': 'Part B: Percentage of Participants Who Achieved EASI-90 (≥90% Improvement From Baseline) at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI score is 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 indicating the worse severity of AD. EASI-90 responders were the participant who achieved ≥90% overall improvement in EASI score from baseline at Week 16.'}, {'measure': 'Part B: Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 16', 'timeFrame': '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. A negative change from baseline indicated improvement.'}, {'measure': 'Part B: Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16', 'timeFrame': '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\\]). A negative change from baseline indicated improvement.'}, {'measure': 'Part B: Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16', 'timeFrame': 'Week 16', 'description': 'The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis (AD). 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). A negative change from baseline indicated improvement.'}, {'measure': "Part B: Change From Baseline in Participant's Sleep Quality NRS at Week 16", 'timeFrame': 'Week 16', 'description': "A sleep diary is completed by the parent/caregiver, included 2 questions assessing the caregiver's sleep, and 6 questions assessing the child's sleep based on caregiver observation. Sleep diary items, either alone or in combination serve as subjective measures of sleep quality, difficulty falling asleep, nighttime awakenings, and sleep duration. Sleep quality is measured using an 11-point NRS (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep."}, {'measure': "Part B: Change From Baseline in Participant's Skin Pain NRS at Week 16", 'timeFrame': 'Week 16', 'description': 'Skin pain was assessed by the parent/caregiver and measured using a 11-point scale (0 to 10) in which 0 indicated no pain while 10 indicated worst pain possible. A negative change from baseline indicated improvement.'}, {'measure': 'Part B: Change From Baseline in Dermatitis Family Index (DFI) at Week 16', 'timeFrame': 'Week 16', 'description': "DFI is a 10-item questionnaire with items inquiring about housework, food preparation, sleep, family leisure activity, shopping, expenditure, tiredness, emotional distress, relationships, and impact of helping with treatment on the primary caregiver's life. DFI questions were scored on a four-point Likert scale ranging from 0 to 3, so that the total DFI score ranges from 0 to 30. Timeframe of reference was the past week. A higher DFI score indicated greater impairment in family Quality of life (QOL) as affected by atopic dermatitis. A negative change from baseline indicated improvement."}, {'measure': "Part B: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16", 'timeFrame': 'Week 16', 'description': 'CDLQI is a validated 10 question tool to measure impact of skin disease on QOL in children by assessing how much the skin problem has affected the subjects over past week. Nine questions were scored as follows: Very much = 3, Quite a lot = 2, Only a little = 1, Not at all or unanswered = 0. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question (max. = 30, min. = 0). Higher the score, the greater the impact on QOL. A negative change from baseline indicated improvement.'}, {'measure': "Part B: Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16", 'timeFrame': 'Week 16', 'description': "Infants' Dermatitis Quality of Life Index (IDQOL) is used to evaluate quality of life for subjects of age less than 4 years. IDQOL questionnaires were designed for infants (below the age of 4 years) with atopic dermatitis. The IDQOL was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. A negative change from baseline indicated improvement."}, {'measure': 'Part B: Percentage of Topical Corticosteroid (TCS) Medication-free Days From Baseline to Week 16', 'timeFrame': 'Baseline up to Week 16', 'description': 'Percentage of TCS medication-free days was calculated as the number of days that a subject used neither TCS/TCI nor system rescue therapy divided by the study days.'}, {'measure': 'Part B: Mean Weekly Dose of Low Potency TCS in Grams From Baseline to Week 16', 'timeFrame': 'Baseline up to Week 16', 'description': 'Mean weekly dose of TCS in grams/week for low potency TCS from baseline to Week 16 is reported.'}, {'measure': 'Part B: Mean Weekly Dose of TCS in Grams for Medium or High Potency TCS From Baseline to Week 16', 'timeFrame': 'Baseline up to Week 16', 'description': 'Mean weekly dose of TCS in grams/week for medium or high potency TCS from baseline to Week 16 is reported.'}, {'measure': 'Part B: Mean Number of Caregiver Missed Work Days Through Week 16', 'timeFrame': 'Baseline through Week 16', 'description': 'Mean of number of caregiver missed work days through Week 16 is reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eczema'], 'conditions': ['Dermatitis, Atopic']}, 'referencesModule': {'references': [{'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. The Safety Data of Dupilumab for the Treatment of Moderate-to-Severe Atopic Dermatitis in Infants, Children, Adolescents, and Adults. Am J Clin Dermatol. 2025 Nov;26(6):981-1002. doi: 10.1007/s40257-025-00952-w. Epub 2025 Sep 24.'}, {'pmid': '40338484', 'type': 'DERIVED', 'citation': 'Rossi AB, Mello AM, Zahn J. Dupilumab Efficacy in Children with Atopic Dermatitis with Different Phenotypes and Endotypes: A Case Series. Adv Ther. 2025 Jul;42(7):3186-3206. doi: 10.1007/s12325-025-03150-6. Epub 2025 May 8.'}, {'pmid': '39588375', 'type': 'DERIVED', 'citation': 'Kamal MA, Kosloski MP, Lai CH, Partridge MA, Rajadhyaksha M, Kanamaluru V, Bansal A, Shabbir A, Shumel B, Ardeleanu M, Richards SM, Yan H, Xu CR, Rodriguez-Marco A, Xiao J, Khokhar FA, Gherardi G, Babilonia E, Maloney J, Mortensen E, Akinlade B, Braunstein N, Stahl N, Torri A, Davis JD, DiCioccio AT. Immunogenicity of dupilumab in adult and pediatric patients with atopic dermatitis. Front Immunol. 2024 Nov 11;15:1466372. doi: 10.3389/fimmu.2024.1466372. eCollection 2024.'}, {'pmid': '39470878', 'type': 'DERIVED', 'citation': 'Boguniewicz M, Sher LD, Paller AS, Arkwright PD, Yoshihara S, Chen Z, Shah P, Marco AR. Dupilumab is Efficacious in Young Children with Atopic Dermatitis Regardless of Type 2 Comorbidities. Adv Ther. 2024 Dec;41(12):4601-4616. doi: 10.1007/s12325-024-02998-4. Epub 2024 Oct 29.'}, {'pmid': '38743155', 'type': 'DERIVED', 'citation': 'Paller AS, Siegfried EC, Simpson EL, Cork MJ, Sidbury R, Chen IH, Khokhar FA, Xiao J, Dubost-Brama A, Bansal A. Dupilumab Safety and Efficacy up to 1 Year in Children Aged 6 Months to 5 Years with Atopic Dermatitis: Results from a Phase 3 Open-Label Extension Study. Am J Clin Dermatol. 2024 Jul;25(4):655-668. doi: 10.1007/s40257-024-00859-y. Epub 2024 May 14.'}, {'pmid': '38267692', 'type': 'DERIVED', 'citation': 'Paller AS, Siegfried EC, Cork MJ, Arkwright PD, Eichenfield LF, Ramien M, Khokhar FA, Chen Z, Zhang A, Cyr SL. Infections in Children Aged 6 Months to 5 Years Treated with Dupilumab in a Placebo-Controlled Clinical Trial of Moderate-to-Severe Atopic Dermatitis. Paediatr Drugs. 2024 Mar;26(2):163-173. doi: 10.1007/s40272-023-00611-9. Epub 2024 Jan 24.'}, {'pmid': '38194047', 'type': 'DERIVED', 'citation': 'Paller AS, Pinter A, Wine Lee L, Aschoff R, Zdybski J, Schnopp C, Praestgaard A, Bansal A, Shumel B, Prescilla R, Bastian M. Efficacy and Safety of Dupilumab Treatment with Concomitant Topical Corticosteroids in Children Aged 6 Months to 5 Years with Severe Atopic Dermatitis. Adv Ther. 2024 Mar;41(3):1046-1061. doi: 10.1007/s12325-023-02753-1. Epub 2024 Jan 9.'}, {'pmid': '37480432', 'type': 'DERIVED', 'citation': 'Siegfried EC, Simpson EL, Cork MJ, Arkwright PD, Wine Lee L, Chen Z, Prescilla R, Bansal A, Levit NA, Rodriguez Marco A. Dupilumab Treatment Leads to Rapid and Consistent Improvement of Atopic Dermatitis in All Anatomical Regions in Patients Aged 6 Months to 5 Years. Dermatol Ther (Heidelb). 2023 Sep;13(9):1987-2000. doi: 10.1007/s13555-023-00960-w. Epub 2023 Jul 22.'}, {'pmid': '36800177', 'type': 'DERIVED', 'citation': 'Yang N, Ye Y, Shao J, Wu H, Xu Q, Zhu J, Liu J, Li Z. Efficacy of Dupilumab in Children 6 Months to 11 Years Old With Atopic Dermatitis: A Retrospective Real-World Study in China. Dermatitis. 2024 Jan-Feb;35(S1):S39-S46. doi: 10.1089/derm.2022.0069. Epub 2023 Feb 17.'}, {'pmid': '36529811', 'type': 'DERIVED', 'citation': 'Paller AS, Siegfried EC, Cork MJ, Wollenberg A, Arkwright PD, Gonzalez ME, Lockshin B, Chen Z, Bansal A, Levit NA, Prescilla R. Laboratory Safety from a Randomized 16-Week Phase III Study of Dupilumab in Children Aged 6 Months to 5 Years with Moderate-to-Severe Atopic Dermatitis. Paediatr Drugs. 2023 Jan;25(1):67-77. doi: 10.1007/s40272-022-00553-8. Epub 2022 Dec 19.'}, {'pmid': '36116481', 'type': 'DERIVED', 'citation': "Paller AS, Simpson EL, Siegfried EC, Cork MJ, Wollenberg A, Arkwright PD, Soong W, Gonzalez ME, Schneider LC, Sidbury R, Lockshin B, Meltzer S, Wang Z, Mannent LP, Amin N, Sun Y, Laws E, Akinlade B, Dillon M, Kosloski MP, Kamal MA, Dubost-Brama A, Patel N, Weinreich DM, Yancopoulos GD, O'Malley JT, Bansal A; participating investigators. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022 Sep 17;400(10356):908-919. doi: 10.1016/S0140-6736(22)01539-2."}]}, 'descriptionModule': {'briefSummary': 'This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety, pharmacokinetics (PK) and efficacy of dupilumab in participants 6 months to less than 6 years of age with moderate-to-severe atopic dermatitis (AD).', 'detailedDescription': '1. Part A (open-label, single-ascending-dose, sequential cohort phase 2 study):\n\n * Primary objective is to characterize the safety and PK of dupilumab administered as a single dose in pediatric participants, 6 months to less than 6 years of age, with severe AD.\n * Secondary objective is to evaluate the efficacy and immunogenicity of a single dose of dupilumab in participants 6 months to less than 6 years of age with severe AD.\n2. Part B (randomized, double-blind, parallel-group, placebo-controlled phase 3 study):\n\n * Primary objective is to demonstrate the efficacy of multiple doses of dupilumab over 16 weeks of treatment when administered concomitantly with topical corticosteroids (TCS) in pediatric participants, 6 months to less than 6 years of age, with moderate-to-severe AD.\n * Secondary objective is to assess the safety and immunogenicity of multiple doses of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in participants 6 months to less than 6 years of age with moderate-to-severe AD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria\n\n* Diagnosis of atopic dermatitis (AD) according to the American Academy of Dermatology consensus criteria at the screening visit\n* Participants with documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s)\n* IGA score at screening and baseline visits\n* part A: IGA = 4\n* part B: IGA ≥3\n* EASI score at screening and baseline visits\n* part A: EASI ≥21\n* part B: EASI ≥16\n* Body Surface Area (BSA) involvement at screening and baseline visits\n* part A: ≥15%\n* part B: ≥10%\n* At least 11 (of a total of 14\\*) applications of a topical emollient (moisturizer) during the 7 consecutive days immediately before the baseline visit (not including the day of randomization) (for part B of the study only)\n* Baseline worst scratch/itch score weekly average score for maximum scratch/itch intensity ≥4 (for part B of the study only)\n* At least 11 (of a total of 14) daily applications of low potency TCS during the 2-week TCS standardization period (beginning on day -14) leading up to the baseline visit (for part B of the study only).\n\nKey Exclusion Criteria\n\n* Prior treatment with dupilumab\n* History of important side effects of low potency topical corticosteroids (only applicable for part B of the study)\n* Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit\n* Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit\n* Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit.\n* Known or suspected immunodeficiency, known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit, established diagnosis of HBV infection or HBV seropositivity at screening, established diagnosis of HCV infection or HCV seropositivity at screening\n* History of malignancy at any time before the baseline visit\n* Diagnosed active endoparasitic infections or at high risk of these infections\n* Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study\n* Body weight \\<5 kg or ≥30 kg at baseline (only applicable part B of the study)\n\nNote: Other protocol defined Inclusion/ Exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT03346434', 'acronym': 'Liberty AD', 'briefTitle': 'Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Phase 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Dupilumab in Patients Aged ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'R668-AD-1539'}, 'secondaryIdInfos': [{'id': '2016-000955-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A (Open label Dupilumab): Age cohorts 1 & 2', 'description': 'Age cohort 1: ≥2 years old to \\<6 years old\n\nAge cohort 2: ≥6 months to \\<2 years old', 'interventionNames': ['Drug: Dupilumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part B (Double-blind): Dupilumab dose 1', 'description': 'The results of part A will be used to guide the selection of dose levels and dosing frequency for part B.', 'interventionNames': ['Drug: Dupilumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part B (Double-blind): Dupilumab dose 2', 'description': 'The results of part A will be used to guide the selection of dose levels and dosing frequency for part B.', 'interventionNames': ['Drug: Dupilumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part B (Double-Blind): Placebo', 'interventionNames': ['Drug: Matching placebo']}], 'interventions': [{'name': 'Dupilumab', 'type': 'DRUG', 'otherNames': ['DUPIXENT®', 'REGN668', 'SAR231893'], 'description': 'Solution for injection, subcutaneous (SC)', 'armGroupLabels': ['Part A (Open label Dupilumab): Age cohorts 1 & 2', 'Part B (Double-blind): Dupilumab dose 1', 'Part B (Double-blind): Dupilumab dose 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